Sterile Potassium Chloride Concentrate 15% (hameln)

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. In this leaflet: 1. What your medicine is and what it is used for 2. Before you receive it 3. How it is administered 4. Possible side effects 5. Storing your injection 6. Use by date Sterile Potassium Chloride Concentrate 15%

Each ml contains 0.15 g potassium chloride in a sterile solution for injection. The other ingredients are hydrochloric acid and water for injections.

Holder of the Marketing Authorisation: hameln pharmaceuticals ltd Gloucester United Kingdom Manufacturer: hameln Pharmaceuticals gmbh Langes Feld 13 31789 Hameln Germany What potassium chloride is and what it is used for

Potassium chloride occurs naturally in your body.

It is used to replace the loss of potassium from your body, if this cannot be achieved when given by mouth or in the diet.

The injection is supplied in clear glass ampoules containing 10 ml.

10 ampoules are supplied in each carton.

Before the injection is given to you

Please tell your doctor, nurse or pharmacist before being given the injection if you:

suffer from impaired kidney function suffer from Addison's disease (a disease characterised by a reduced secretion of hormones from a gland situated near the kidneys) are very dehydrated suffer from heat cramps suffer from disturbances in the salt content of your blood are pregnant or breast-feeding

Please inform your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed, especially diuretics (water tablets) as these may interfere with this injection.

How the injection is given to you

Your doctor, nurse or pharmacist will give you the injection.

Sterile Potassium Chloride Concentrate 15% may be given by an intravenous injection (into a vein).

In emergencies, it may be necessary to give the injection without your knowledge.

Your doctor will decide on the correct dosage for you and when or how the injection will be given.

The injection must be diluted at least 50 times before it is given to you.

Possible side effects

Like all medicines, potassium chloride can have side effects.

Potassium chloride may cause the following side effects:

pain at the site of injection inflammation of the vein into which the solution is being injected raised blood levels of potassium

If you experience these or any other side effects not mentioned in this leaflet, please inform your doctor, nurse or pharmacist

Storing your injection

Your injection will be stored under 25°C, protected from light and out of the reach and sight of children.

Use by date

The doctor, nurse or pharmacist will check that the injection is not past its expiry date before giving you the injection.

This leaflet was last updated on March 25th 2004.

PL01502/0007R

43856/19/04

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Dobutamine Concentrate 250 mg / 20 ml.

Dobutamine Concentrate

Important information about your medicine Your doctor or nurse will give you the injection If this injection causes you any problems talk to your doctor, nurse or pharmacist Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to any of the ingredients of this medicine Please tell your doctor or pharmacist, if you are taking any other medicines Read all of this leaflet carefully before you start using this medicine. In some circumstances this may not be possible and this leaflet will be kept in a safe place should you wish to read it. Keep this leaflet. You may need to read it again If you have any further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. Where to find information in this leaflet 1. What Dobutamine Concentrate is and what it is used for 2. Before you are given Dobutamine Concentrate 3. How to use Dobutamine Concentrate 4. Possible side effects 5. Storing Dobutamine Concentrate 6. Further information What Dobutamine Concentrate is and what it is used for

Dobutamine Concentrate belongs to a group of medicines known as inotropes, which make your heart beat more strongly. It is used:

in open heart surgery to treat heart disease to treat heart failure in shock as an alternative to exercise for stress testing the heart. Before you are given Dobutamine Concentrate You should NOT be given Dobutamine Concentrate if you: Are sensitive or allergic to Dobutamine Concentrate, sodium metabisulphite or any of the other ingredients in this injection. suffer from high blood pressure due to a tumour near the kidney (Phaeocromocytoma). Please tell your doctor or nurse before being given the injection if you: have recently had a heart attack are asthmatic have unstable angina have heart disease have high blood pressure have any condition that would make exercise dangerous for you. Using other medicines:

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Dobutamine Concentrate:

beta blockers (medicines used to relieve certain heart conditions, anxiety and migraine). anaesthetics. entacapone (a medicine to treat Parkinson’s Disease). Pregnancy or breast feeding:

Please tell your doctor or nurse before being given this injection if you are pregnant or breast feeding. The doctor will then decide if the injection is suitable for you.

Driving and using machines:

You should not drive or use machinery if you are affected by the administration of Dobutamine Concentrate.

How to use Dobutamine Concentrate

Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given. Dobutamine Concentrate is not normally given to children.

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, feel sick, are sick, feel anxious, feel palpitations, have a headache, feel short of breath or have chest pain you must tell the person giving you the injection.

Possible side effects

Like all medicines, Dobutamine Concentrate can cause side effects, although not everybody gets them.

Intravenous infusions may cause inflammation of the vein and damage to the skin at the injection site. The surrounding skin may feel warm and tender and redness may be present.

Death due to rupture of the heart muscle has occurred very rarely after giving dobutamine to assess the response of the heart to stress in patients with a recent heart attack. Your doctor will examine your heart before giving you Dobutamine Concentrate to decide if you are suitable to receive the drug.

The following side-effects have been reported: Hypersensitivity reactions involving rash and difficulty breathing including life threatening asthmatic episodes Changes in the levels of certain chemicals in the blood. Increased heart rate, palpitations, chest pain and changes to the rhythm of your heart. Changes to your blood pressure including both an increase and a decrease. difficulty in breathing (your breathing may stop) asthma headache nausea (feeling sick) Sudden, involuntary twitching of a muscle or group of muscles.

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.

Storing Dobutamine Concentrate

Your injection will be stored at less than 21°C and protected from light. The nurse or doctor will check that the injection is not past its expiry date before giving you the injection.

Further information What Dobutamine Concentrate contains:

This injection contains the active ingredient dobutamine hydrochloride. Each 1 ml contains dobutamine hydrochloride equivalent to 12.5 mg dobutamine in a sterile solution for injection.

This injection contains the following inactive ingredients: sodium metabisulphite, sodium hydroxide, hydrochloric acid, sterile water for injections and carbon dioxide.

What Dobutamine Concentrate looks like and contents of the pack:

Dobutamine Concentrate is supplied in 20 ml clear glass ampoules, in cartons containing one, five or ten ampoules. Not all sizes may be marketed.

The marketing authorisation number of this medicine is: PL 01502/0054

Marketing Authorisation Holder: hameln pharmaceuticals ltd Gloucester United Kingdom Manufacturer: hameln pharmaceuticals gmbh Langes Feld 13 31789 Hameln Germany

For any information about this medicine, please contact the Marketing Authorisation Holder

This leaflet was last approved 12.08.2008

43821/20/09

Read More:

Asthma, acute Medications

Drugs associated with Asthma, acute

The following drugs and medications are in some way related to, or used in the treatment of Asthma, acute. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Asthma, acute

Medical Encyclopedia:

Asthma Asthma - children Asthma and allergy - resources Occupational asthma
Drug List: A-Hydrocort A-Methapred-Solution Accuneb-Solution Adrenaclick-Auto-Injector Adrenalin Adrenalin-Chloride Airet-Solution Alupent Asthmahaler-Aerosol Baycadron Brethaire Brethine Bricanyl Bubbli-Pred Cortef De-Sone-La-Injection Decadron Depo-Medrol-Suspension Dexacen-4-Injection Dexacort-Phosphate-In-Turbinaire Dexamethasone-Intensol Dexasone-Injection Dexasone-La-Injection Dexpak-Tablets-Dose-Pack Elixophyllin-Elixir Epipen-Auto-Injector Epipen-2-Pak Epipen-Auto-Injector Epipen-Jr-Auto-Injector Epipen-Jr-2-Pak Epipen-Jr-Auto-Injector Flo-Pred Hydeltrasol Hydrocortone Isuprel Isuprel-Mistometer Key-Pred-Sp Maxair Maxair-Autohaler Medihaler-Epi Medihaler-Iso Medrol Medrol-Dosepak Metaprel Methylprednisolone-Dose-Pack Millipred Millipred-Dp Orapred Orapred-Odt Pediapred-Liquid Phyllocontin Pred-Ject-50 Predacort-50 Predalone-50 Predate-50 Prelone-Syrup Primatene-Mist-Aerosol Proair-Hfa-Aerosol Proventil Proventil-Hfa-Aerosol Quibron-T Quibron-T-Sr Solu-Cortef-Solution Solu-Medrol-Solution Solurex-Injection Solurex-La-Injection Theo-24-Sustained-Release-Capsules Theo-Dur Theo-Time Theocap-Sustained-Release-Capsules Theochron-Sustained-Release-Tablets Theolair-Tablets Tornalate Truphylline Truxophyllin Twinject-Auto-Injector Twinject-Auto-Injector Twinject-Auto-Injector-Two-Pack Uniphyl-Sustained-Release-Tablets Ventolin Ventolin-Hfa-Aerosol Veripred-20-Solution Volmax Vospire-Er-Extended-Release-Tablets Xopenex Xopenex-Concentrate Xopenex-Hfa-Aerosol Zema-Pak-10-Day

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Sterile Potassium Chloride Concentrate 20% (hameln)

1. Name Of The Medicinal Product

Sterile Potassium Chloride Concentrate 20%.

2. Qualitative And Quantitative Composition

20% of Potassium Chloride in 5ml.

3. Pharmaceutical Form

Sterile Injection.

4. Clinical Particulars 4.1 Therapeutic Indications

Sterile Potassium Chloride Concentrate 20% is used as a source of the potassium cation for the treatment or prevention of potassium depletion in patients for whom dietary measures or oral medication are inadequate. Potassium salts may also be used cautiously in those taking digoxin where potassium depletion may cause arrhythmias. Sterile Potassium Chloride Concentrate 20% must be administered by slow I.V, as a dilute solution.

4.2 Posology And Method Of Administration

Adults (including elderly) and Children:

Sterile Potassium Chloride Concentrate 20% must be diluted by adding to a large volume of intravenous fluid before use. For example, 10mls diluted with not less than 700mls 0.9% Sodium Chloride Intravenous Infusion BP, or other suitable diluent, and mixed well.

Dosage depends on the serum ionogram value and the acid-base state. A potassium deficiency is calculated according to the formula:

MMOL Potassium = KG BW x 0.2 x 2 x (4.5 – actual serum potassium (MMOL)).

(The extracellular volume is calculated from the body weight in kg x 0.2).

The maximum dosage is 20 MMOL potassium per hour.

It is recommended not to exceed 2-3 MMOL potassium per kg body weight in 24 hours.

4.3 Contraindications

Hyperkalaemia, hyperchloraemia, impaired renal function with oliguria, anuria or azotaemia, Addison's disease, acute dehydration and heat cramps.

4.4 Special Warnings And Precautions For Use

Sterile Potassium Chloride Concentrate 20% must not be injected undiluted.

Plasma potassium concentration must be measured at regular intervals to avoid the development of hyperkalaemia, especially in patients with renal impairment.

ECG monitoring facilities should be available.

Initial potassium replacement therapy should not involve glucose infusions, because glucose may cause a further decrease in the plasma potassium concentration.

Potassium supplements should be administered with caution in patients with cardiac disease and in patients who are receiving potassium sparing diuretics or other medications which may increase plasma potassium levels.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Potassium sparing diuretics:

Potassium supplements should not be administered with potassium- sparing diuretics (such as amiloride, spironolactone and triamterene), particularly in patients with impaired renal function. Any patients on this combination require close monitoring in order to diagnose a potential hyperkalaemic condition as soon as possible.

Angiotensin-converting enzyme inhibitors and angiotensin II receptor antagonists:

Patients taking ACE-inhibitors or angiotensin II receptor antagonists, especially those with impaired renal function, should be closely monitored, as the potassium sparing effect in combination with potassium infusion may result in hyperkalaemia.

Ciclosporin:

Concurrent use of ciclosporin may increase the risk of hyperkalaemia.

Glucose Infusion:

Concomitant use of glucose infusions in hypokalaemic patients may cause a further decrease in plasma potassium concentrations.

4.6 Pregnancy And Lactation

Sterile Potassium Chloride Concentrate 20%, may be used during pregnancy and lactation under the supervision of the prescribing physician.

4.7 Effects On Ability To Drive And Use Machines

Not known.

4.8 Undesirable Effects

Pain at the injection site and phlebitis may occur during IV administration of solutions containing 30 MMOL potassium or more per litre.

Hyperkalaemia is the most common and serious hazard of potassium therapy.

4.9 Overdose

Clinical signs and symptoms of potassium overdosage include: Paraesthesia of the extremities, listlessness, mental confusion, weakness or heaviness of the legs, flaccid paralysis, cold skin, grey pallor, peripheral vascular collapse, fall in blood pressure, cardiac arrhythmias and heart block. Extremely high plasma potassium concentrations (8-11 MMOL/litre) may cause death from cardiac depression, arrhythmias or arrest.

Cardiac arrhythmias or a serum concentration above 6.5 MMOL/litre, require immediate attention and may be treated by intravenous injection over 1-5 minutes of 10 – 20 ml of 10% Calcium Gluconate Injection B.P. with E.C.G. monitoring. Serum concentrations may be reduced by infusion of 300 – 500 mls per hour of 10%-25% glucose solutions containing up to 10 units of insulin for each 20 g of glucose, or by the infusion of sodium bicarbonate solution.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Potassium is the major cation of intracellular fluid and is essential for maintenance of acid-base balance, isotonicity and the electrodynamic characteristics of the cell. Potassium chloride is used as a source of the potassium cation for treatment or prevention of potassium depletion in patients in whom dietary measures are inadequate. Potassium chloride may also be used cautiously to abolish arrhythmias or cardiac glycoside toxicity precipitated by a loss of potassium.

5.2 Pharmacokinetic Properties

Potassium chloride is generally readily absorbed from the gastro-intestinal tract. Potassium is excreted mainly by the kidneys; it is secreted in the distal tubules which are also the site of sodium-potassium exchange. The capacity of the kidneys to conserve potassium is poor and urinary excretion of potassium continues even when there is severe depletion. Tubular secretion of potassium is influenced by several factors, including chloride ion concentration, hydrogen ion exchange, acid-base equilibrium and adrenal hormones. Some potassium is excreted in the faeces and small amounts may also be excreted in saliva, sweat, bile and pancreatic juice.

5.3 Preclinical Safety Data

No further information other than that which is included in the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Water for Injections Ph. Eur.

6.2 Incompatibilities

The compatibility of the large volume IV fluid intended for dilution should be checked before use.

6.3 Shelf Life

36 Months.

6.4 Special Precautions For Storage

Protect from light and store at less than 25°C.

6.5 Nature And Contents Of Container

5 and 10ml clear glass ampoules, hermetically sealed under flame at the gauging point. The ampoules are packed in cartons to contain 10 ampoules.

6.6 Special Precautions For Disposal And Other Handling

Use as directed by a physician.

ADMINISTRATIVE DATA 7. Marketing Authorisation Holder

hameln pharmaceuticals ltd

Gloucester

UK

8. Marketing Authorisation Number(S)

PL 01502/0015R

9. Date Of First Authorisation/Renewal Of The Authorisation

30th August 2001

10. Date Of Revision Of The Text

30/12/2008

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Cerezyme 200 U Powder for concentrate for solution for infusion

Cerezyme 200 U powder for concentrate for solution for infusion

Imiglucerase

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Cerezyme is and what it is used for. 2. Before you use Cerezyme. 3. How to use Cerezyme. 4. Possible side effects. 5. How to store Cerezyme. 6. Further Information What Cerezyme Is And What It Is Used For

Cerezyme is used to treat patients who have a confirmed diagnosis of Type I or Type 3 Gaucher disease, who show signs of the disease such as: anaemia (low number of red blood cells), a tendency to bleed easily (due to low numbers of platelets - a type of blood cell), spleen or liver enlargement or bone disease.

People with Gaucher disease have low levels of an enzyme called acid ?-glucosidase. This enzyme helps the body control levels of glucosylceramide. Glucosylceramide is a natural substance in the body, made of sugar and fat. In Gaucher disease glucosylceramide levels can get too high.

Cerezyme is an artificial enzyme called imiglucerase - this can replace the natural enzyme acid ?- glucosidase which is lacking or not active enough in patients with Gaucher disease.

The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly.

Before You Use Cerezyme Do not use Cerezyme If you are allergic (hypersensitive) to imiglucerase, or if you are allergic to any of the other ingredients of Cerezyme. Take special care with Cerezyme If you are treated with Cerezyme, you may experience an allergic reaction while you are being given the medicine or shortly after. If you experience a reaction like this, you should tell your doctor immediately. Your doctor may test if you have an allergic reaction to imiglucerase. Some patients with Gaucher disease have high blood pressure in the lungs (pulmonary hypertension). The cause can be unknown, or it can be due to heart, lung or liver problems. It can occur whether the patient is treated with Cerezyme or not. But, if you suffer with any shortness of breath you should tell your doctor. Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Cerezyme should not be given as a mixture with other medicinal products in the same infusion (drip).

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before using this medicine if you are pregnant or think you may be pregnant. Cautious use of Cerezyme during pregnancy and breastfeeding is recommended.

How To Use Cerezyme

Instructions for proper use

Cerezyme is given through a drip into a vein (by intravenous infusion).

It is supplied as a powder which will be mixed with sterile water before it is given.

Cerezyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Gaucher disease.

Your dose will be specific to you. Your doctor will work out your dose based on how severe your symptoms are, and other factors. The recommended dose of Cerezyme is 60 units/kg body weight given once every 2 weeks.

Your doctor will keep a close check on your response to your treatment, and may change your dose (up or down) until he/she finds the best dose to control your symptoms.

Once this dose is found your doctor will still keep a check on your responses to make sure you are using the right dose. This might be every 6 to 12 months.

There is no information on the effect of Cerezyme on brain-based symptoms of patients with chronic neuronopathic Gaucher disease. Therefore no special dosage regimen can be recommended.

The ICGG Gaucher Registry

You can ask your doctor to register your patient information into the “ICGG Gaucher Registry”.

The aims of this Registry are to increase the understanding of Gaucher disease and to check how well enzyme replacement therapy, like Cerezyme, works. This should lead to an improvement in the safe and effective use of Cerezyme. Your patient data will be registered anonymously–nobody will know it is information about you.

If you use more Cerezyme than you should

There are no cases of overdose of Cerezyme reported.

If you forget to use Cerezyme

If you have missed an infusion, please contact your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Cerezyme can cause side effects, although not everybody gets them.

If you experience any serious side effects or side effects not listed below, please tell your doctor immediately.

Common side effects (occurring in more than 1 in 100 patients) are:

breathlessness hives/ localised swelling of the skin or lining of the mouth or throat itching rash

Uncommon side effects (occurring in more than 1 in 1000 patients) are:

dizziness headache a sensation of tingling, pricking, burning or numbness of the skin increased heart rate bluish skin flushing fall in blood pressure vomiting nausea abdominal cramping diarrhoea pain in the joints infusion site discomfort infusion site burning infusion site swelling injection site sterile abcess chest discomfort fever rigors fatigue backache

Some side effects were seen primarily while patients were being given the medicine or shortly after. These have included itching, flushing, hives/localised swelling of the skin or lining of the mouth or throat, chest discomfort, increased heart rate, bluish skin, breathlessness, a sensation of tingling, pricking, burning or numbness of the skin, fall in blood pressure and backache. If you experience any of these symptoms, please tell your doctor immediately. You may need to be given additional medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids).

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Cerezyme

Keep out of the reach and sight of children.

Unopened vials:

Store in a refrigerator (2°C – 8°C)

Do not use Cerezyme after the expiry date printed on the labelling after the letters “EXP”. The expiry date refers to the last date of that month.

Diluted solution:

It is recommended that Cerezyme is used immediately after it has been mixed with sterile water.

The mixed solution in the vial cannot be stored and should be promptly diluted in an infusion bag; only the diluted solution can be held for up to 24 hours if it is kept cool (2°C – 8°C) and in the dark.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Cerezyme contains The active substance is imiglucerase. Imiglucerase is a modified form of the human enzyme acid ?-glucosidase produced by recombinant DNA technology. One vial contains 200 units of imiglucerase. After reconstitution, the solution contains 40 units of imiglucerase per ml. Other ingredients are: Mannitol Sodium citrate Citric acid monohydrate Polysorbate 80 Important information about some of the ingredients of Cerezyme

This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution. To be taken into consideration by patients on a controlled sodium diet.

What Cerezyme looks like and contents of the pack

Cerezyme, 200 U, is presented as a powder for concentrate for solution for infusion (in a vial-pack size of 1 or 25). Not all pack sizes may be marketed.

Cerezyme is supplied as a white to off-white powder. After reconstitution it is a clear, colourless liquid, free from foreign matter. The reconstituted solution must be further diluted.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden The Netherlands

Manufacturer

Genzyme Ltd. 37 Hollands Road Haverhill Suffolk CB9 8PU United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom/Ireland Genzyme Therapeutics Ltd. United Kingdom Tel:+44 1865 405200

This leaflet was last approved in: 06/2009

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/. There are also links to other websites about rare diseases and treatments.

Read More:

Myozyme 50 mg powder for concentrate for solution for infusion

Myozyme 50 mg powder for concentrate for solution for infusion

Alglucosidase alfa

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Myozyme is and what it is used for 2. Before you use Myozyme 3. How to use Myozyme 4. Possible side effects 5. How to store Myozyme 6. Further information What Myozyme Is And What It Is Used For

Myozyme is used to treat patients who have a confirmed diagnosis of Pompe disease.

People with Pompe disease have low levels of an enzyme called ?-glucosidase. This enzyme helps the body control levels of glycogen (a type of carbohydrate). Glycogen provides the body with energy, but in Pompe disease the levels can get too high.

Myozyme is an artificial enzyme called alglucosidase alfa – this can replace the natural enzyme which is lacking in Pompe disease.

In patients with late-onset Pompe disease a positive effect was observed over an 18 month period on lung function and walking ability. The evidence on the effect of Myozyme in severely affected patients with late onset Pompe disease is limited.

Before You Use Myozyme Do not use Myozyme

If you are allergic (hypersensitive) to alglucosidase alfa or any of the other ingredients of Myozyme.

Take special care with Myozyme

If you are treated with Myozyme, you may experience a reaction while you are being given the medicine or during the next 2 hours. This is known as an infusion-associated reaction and can sometimes be very severe. If you experience a reaction like this, you should tell your doctor immediately. You may need to be given additional medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids) or antipyretics.

Different groups of patients using Myozyme

The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly.

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

There is no experience of the use of Myozyme in pregnant women. Myozyme should not be used during pregnancy unless clearly necessary. It is recommended to stop breast-feeding when Myozyme is used. Ask your doctor or pharmacist for advice before taking any medicine.

How To Use Myozyme Instructions for proper use

Myozyme is given through a drip into a vein (by intravenous infusion). It is supplied as a powder which will be mixed with sterile water before it is given.

Myozyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Pompe disease.

The recommended dosage of Myozyme is 20 mg/kg body weight given once every 2 weeks.

If you use more Myozyme than you should

There are no cases of overdose reported.

If you forget to use Myozyme

If you have missed an infusion, please contact your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Myozyme can cause side effects, although not everybody gets them.

Side effects were mainly seen while patients were being given the medicine or shortly after (“infusion related effects”). Some of these infusion related side effects became serious. Should you experience any reaction like this, please tell your doctor immediately. You may need to be given additional medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids) or antipyretics.

Hives Rash Paleness Redness of the skin (Facial) flushing Increased or high blood pressure Bluish discolouration of the skin Fever or increased body temperature Chills Cough Increased breathing rate Increased or decreased heart rate Vomiting Agitation Tremor Swelling around the eyes Abnormal breathing sounds Difficulty in breathing (including shortness of breath) Headache Cold extremities (e.g. hands, feet) Tingling Pain or local reaction at the site of the drip Dizziness Irritability Itchy skin Retching Low blood pressure Bronchospasm Low level of oxygen in the blood Swelling of the face, swelling of the throat or severe combined swelling of the face, throat and tongue due to a severe allergic reaction Swelling of the arms and legs Feeling hot Increased sweating Eyes tearing Mottled skin Nausea Restlessness Wheezing Heart stopping Chest discomfort Chest pain (not in the heart) Throat tightness Diarrhoea Fatigue Muscle pain Muscle spasms

Life threatening reactions, including very severe generalised allergic reactions and anaphylactic shock, have been reported in some patients.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Myozyme

Keep out of the reach and sight of children

Store in a refrigerator (2°C – 8°C).

Do not use after the expiry date stated on the labelling after the letters ‘EXP’.

It is recommended that Myozyme is used immediately after it has been mixed with sterile water. However it can be kept for up to 24 hours if it is kept cool (2°C – 8°C) and in the dark.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Myozyme contains The active substance is alglucosidase alfa 50 mg. One vial contains 50 mg of alglucosidase alfa. After reconstitution, the solution contains 5 mg of alglucosidase alfa/ml and after dilution, the concentration varies from 0.5 mg to 4 mg/ml. The other ingredients are mannitol, sodium phosphate monobasic monohydrate sodium phosphate dibasic heptahydrate polysorbate 80 What Myozyme looks like and contents of the pack

Myozyme, 50 mg, is presented as a powder for concentrate for solution for infusion (in a vial- pack: sizes of 1, 10 or 25). Not all pack sizes may be marketed.

Myozyme is supplied as a white to off-white powder. After reconstitution it is a clear, colourless to pale yellow solution, which may contain particles. The reconstituted solution must be further diluted.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden The Netherlands

Manufacturer

Genzyme Ltd. 37 Hollands Road Haverhill Suffolk CB9 8PU United Kingdom Genzyme Ireland Ltd. IDA Industrial Park Old Kilmeaden Road Waterford Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom/Ireland Genzyme Therapeutics Ltd United Kingdom Tel:+44 1865 405200

This leaflet was last approved in 10/2009

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site :http://www.emea.europa.eu/. There are also links to other websites about rare diseases and treatments.

Read More:

Asthma, Maintenance Medications

Drugs associated with Asthma, Maintenance

The following drugs and medications are in some way related to, or used in the treatment of Asthma, Maintenance. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Asthma, Maintenance

Medical Encyclopedia:

Asthma Asthma - children Asthma and allergy - resources Occupational asthma
Drug List: A-Methapred-Solution Accolate Accuneb-Solution Advair Advair-Hfa-Inhaler Airet-Solution Alupent Alvesco Asmanex Brethaire Brethine Bricanyl Choledyl Choledyl-Sa Depo-Medrol-Suspension Dulera Elixophyllin-Elixir Flovent Flovent-Diskus-Powder Flovent-Hfa-Aerosol-Inhaler Flovent-Rotadisk-Powder Foradil Intal-Aerosol-Solution Intal-Inhaler-Inhalation Maxair Maxair-Autohaler Medrol Medrol-Dosepak Metaprel Methylprednisolone-Dose-Pack Perforomist Proair-Hfa-Aerosol Proventil Proventil-Hfa-Aerosol Pulmicort-Flexhaler-Powder Pulmicort-Nebuamp Pulmicort-Respules-Suspension Pulmicort Quibron-T Quibron-T-Sr Qvar-Aerosol-Solution Serevent Singulair Solu-Medrol-Solution Symbicort Theo-24-Sustained-Release-Capsules Theo-Dur Theo-Time Theocap-Sustained-Release-Capsules Theochron-Sustained-Release-Tablets Theolair-Tablets Tilade-Aerosol Tornalate Truxophyllin Uniphyl-Sustained-Release-Tablets Ventolin Ventolin-Hfa-Aerosol Volmax Vospire-Er-Extended-Release-Tablets Xolair Xopenex Xopenex-Concentrate Xopenex-Hfa-Aerosol Zyflo Zyflo-Cr-Extended-Release-Tablets

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Taxotere 20 mg

Taxotere 20 mg concentrate and solvent for solution for infusion

docetaxel

TAXOTERE 20 mg concentrate and solvent for solution for infusion

docetaxel

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your hospital pharmacist. If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or hospital pharmacist. In this leaflet: 1. What Taxotere is and what it is used for 2. Before you use Taxotere 3. How to use Taxotere 4. Possible side-effects 5. How to store Taxotere 6. Further information What Taxotere Is And What It Is Used For

The name of this medicine is TAXOTERE. Its common name is docetaxel. Docetaxel is a substance derived from the needles of yew trees.

Docetaxel belongs to the group of anti-cancer medicines called taxoids.

TAXOTERE has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer:

For the treatment of advanced breast cancer, TAXOTERE could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine. For the treatment of early breast cancer with lymph node involvement, TAXOTERE could be administered in combination with doxorubicin and cyclophosphamide. For the treatment of lung cancer, TAXOTERE could be administered either alone or in combination with cisplatin. For the treatment of prostate cancer, TAXOTERE is administered in combination with prednisone or prednisolone. For the treatment of metastatic gastric cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil. For the treatment of head and neck cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil. Before You Use Taxotere

You should not be given TAXOTERE if:

you experienced in the past a severe allergic reaction to it or to polysorbate 80 which is contained in the product. the number of white blood cells is too low. you have a severe liver disease. you are pregnant or breast feeding. Take special care with TAXOTERE:

Before each treatment with TAXOTERE, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive TAXOTERE. In case of white blood cell disturbances, you may experience associated fever or infections.

You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to TAXOTERE administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of TAXOTERE in particular allergic reactions and fluid retention (swelling of the hands,feet, legs or weight gain).

During treatment, you may be given medication to maintain the number of your blood cells.

Taking/using other medicines:

Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription. This is because TAXOTERE or the other medicine may not work as well as expected and you may be more likely to get a side effect.

Pregnancy and breast-feeding:

TAXOTERE must NOT be administered if you are pregnant or if you are planning to become pregnant. You must take adequate contraceptive precautions during therapy and for at least three months after TAXOTERE is no longer administered to you. If pregnancy occurs during your treatment, you must immediately inform your doctor.

You must NOT breast-feed while you are treated with TAXOTERE.

If you are thinking of becoming pregnant or breastfeeding discuss it with your doctor first.

Driving and using machines:

There is no reason why you cannot drive between courses of TAXOTERE except if you feel dizzy or are unsure of yourself.

How To Use Taxotere

TAXOTERE will be administered to you by a healthcare professional.

Usual dosage

The dose will depend on your weight and your general condition. Your doctor will calculate your body surface area in square meters (m2) and will determine the dose you should receive.

Method and route of administration

TAXOTERE will be given by infusion into one of your veins. The infusion will last approximately one hour during which you will be in the hospital.

Frequency of administration

You should usually receive your infusion once every 3 weeks.

Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to TAXOTERE. In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give him/her results of your blood tests. Such information will allow him/her to decide whether a dose reduction is needed. If you have any further questions on the use of this product, ask your doctor or hospital pharmacist.

Possible Side Effects

Like all other anticancer medicines, TAXOTERE can cause side effects, although not everybody gets them.

Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.

The most commonly reported adverse reactions of TAXOTERE alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.

The severity of adverse events of TAXOTERE may be increased when TAXOTERE is given in combination with other chemotherapeutic agents.

During the infusion at the hospital the following allergic reactions (experienced in more than 1 person in 10) may occur:

flushing, skin reactions, itching chest tightness; difficulty in breathing fever or chills back pain low blood pressure

More severe reactions may occur.

The hospital staff will monitor your condition closely during treatment. Tell them immediately if you notice any of these effects.

Between infusions of TAXOTERE the following may occur, and the frequency may vary with the combinations of drugs that are received:

Very Common: (experienced in more than 1 in 10 patients)

infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets, fever: if this happens you must tell your doctor immediately allergic reactions as described above loss of appetite (anorexia) insomnia feeling of numbness or pins and needles or pain in the joints of muscles headache alteration in sense of taste inflammation of the eye or increased tearing of the eyes swelling caused by faulty lymphatic drainage shortness of breath nasal drainage; inflammation of the throat and nose; cough bleeding from the nose sores in the mouth stomach upsets including nausea, vomiting and diarrhea, constipation abdominal pain indigestion short term hair loss (in most cases normal hair growth should return) redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body) change in the color of your nails, which may detach muscle aches and pains; back pain or bone pain change or absence of menstrual period swelling of the hands, feet, legs tiredness; or flu-like symptoms weight gain or loss

Common (experienced in less than 1 in 10 but more than 1 in 100 patients)

oral candidiasis dehydration dizziness hearing impaired decrease in blood pressure; irregular or rapid heart beat heart failure oesophagitis dry mouth difficulty or painful swallowing haemorrhage raised liver enzymes (hence the need for regular blood tests)

Uncommon: (experienced in more than 1 in 1,000 but less than 1 in 100)

fainting at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling inflammation of the colon, small intestine; intestinal perforation

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or hospital pharmacist.

How To Store Taxotere

Keep out of the reach and sight of children.

TAXOTERE should not be used after the expiry date shown on the pack.

Do not store above 25°C or below 2°C.

Store in the original package in order to protect from light.

The premix solution should be used immediately after preparation. However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature.

The infusion solution should be used within 4 hours at room temperature.

Further Information What TAXOTERE contains: The active substance is docetaxel. Each ml of docetaxel solution contains 40 mg of docetaxel anhydrous. One vial contains 20 mg docetaxel. The other ingredient is polysorbate 80. What TAXOTERE looks like and contents of the pack:

TAXOTERE 20 mg concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution containing 40 mg/ml docetaxel (anhydrous) in polysorbate 80.

Each blister carton of TAXOTERE 20 mg concentrate and solvent for solution for infusion contains:

one single-dose TAXOTERE vial and, one single-dose solvent for TAXOTERE vial Marketing Authorisation Holder: Aventis Pharma S.A. 20 avenue Raymond Aron 92165 Antony Cedex France Manufacturer: Aventis Pharma Dagenham Rainham Road South Dagenham Essex RM10 7XS United Kingdom

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom sanofi-aventis Tel:+44 (0) 1483 505 515

This leaflet was last updated in January 2007

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Adrenergic bronchodilators

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Adrenergic bronchodilators (specifically beta2-adrenoreceptor agonists) dilate the bronchi by a direct action on the beta2-adrenoreceptors on the bronchial smooth muscle and relax the muscle.

There are two categories of beta2-adrenoreceptor agonists used in asthma. The short acting adrenergic bronchodilators are used on an as needed basis to control symptoms of asthma. The longer acting bronchodilators are used regularly, twice daily, as adjunct therapy in patients whose asthma is poorly controlled by inhaled corticosteroids.

See also

Medical conditions associated with adrenergic bronchodilators:

Adams-Stokes SyndromeAllergic ReactionsAsthmaAsthma, acuteAsthma, MaintenanceAsystoleAV Heart BlockBronchitisBronchospasm During AnesthesiaBronchospasm ProphylaxisCardiac ArrhythmiaCOPDCOPD, AcuteCOPD, MaintenanceElectromechanical DissociationPremature LaborShock Drug List:Epipen-Auto-InjectorIsuprelIsuprel-MistometerForadilSereventXopenex-Hfa-AerosolXopenexBrovanaPrimatene-Mist-AerosolAlupentBricanylMaxairVolmaxXopenex-ConcentrateProventil-Hfa-AerosolBrethineProventilVentolin-Hfa-AerosolMaxair-AutohalerProair-Hfa-AerosolPerforomistVentolinVospire-Er-Extended-Release-TabletsAccuneb-SolutionAdrenaclick-Auto-InjectorAdrenalinAdrenalin-ChlorideAiret-SolutionArcaptaAsthmahaler-AerosolBrethaireBronkometerBronkosolEpipen-2-PakEpipen-Auto-InjectorEpipen-Jr-Auto-InjectorEpipen-Jr-2-PakEpipen-Jr-Auto-InjectorMedihaler-EpiMedihaler-IsoMetaprelTornalateTwinject-Auto-InjectorTwinject-Auto-InjectorTwinject-Auto-Injector-Two-Pack

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Venofer IV Iron Sucrose

Vifor (International) Inc.

VENOFER 20 mg/ml injection

[Iron sucrose (iron (III) hydroxide sucrose complex)]

Please read this leaflet carefully. It contains a summary of the information available on Venofer 20 mg/ml injection which is part of your hospital treatment. If after reading this you have any questions ask the doctor or nurse.

In this leaflet 1. What Venofer is and what it is used for. 2. Before you receive Venofer. 3. How Venofer is administered. 4. Possible side effects of Venofer. 5. Storing Venofer. What Venofer is and what it is used for

Venofer is a sterile, dark brown, non transparent, aqueous solution of iron intended to be used only for intravenous injection or as a concentrate for solution for infusion which contains the active ingredient iron as a solution of iron sucrose (iron(III)-hydroxide sucrose complex). The solution also contains sodium hydroxide and water for injection.

Venofer is supplied in glass ampoules which contain 5ml of solution which is equivalent to 100mg of iron. The product is supplied in cardboard boxes each containing 5 ampoules.

Marketing authorisation holder: Vifor France SA 123, rue Jules Guesde 92300 Levallois-Perret France Manufacturer: ALTANA Pharma AG Byk-Gulden-Str. 2 D-78467 Konstanz Germany

Venofer provides a source of iron that can help to replenish a shortage of iron in patients with iron deficiency.

The product is intended for use only in the following circumstances:

in a patient known to be intolerant to iron preparations taken by mouth, in a patient where there is a specific clinical need to deliver iron rapidly to the iron stores, in a patient with active inflammatory bowel disease where iron preparations taken by mouth are ineffective or not tolerated. Before you receive Venofer You should be aware that: a blood test should have been carried out to ensure treatment with this medicine is appropriate, the product should not be given at the same time as other iron preparations taken by mouth, Venofer should not be administered during the first three months of pregnancy and it should be administered with caution during the fourth to ninth month. intramuscular or intravenous iron preparations can cause severe allergic or anaphylactoid reactions which may be potentially fatal. Therefore the medicine should only be given if there are appropriate medical facilities immediately available, allergic reactions, sometimes involving joint pain, have been more commonly observed when the recommended dose is exceeded. the product is not approved for use in children. You should not receive Venofer if: you are known to be sensitive (allergic) to any iron preparations intended for intramuscular or intravenous administration, you have a history of asthma, eczema or other atopic allergies because then you are more susceptible to experience allergic reactions, your anaemia is not due to a shortage of iron, you have a history of cirrhosis or hepatitis or have increased liver enzymes, you have any acute or chronic infections because these may be worsened by giving intramuscular or intravenous iron. How Venofer is administered

Venofer should only be administered by the intravenous route by slow intravenous injection or by intravenous drip infusion which is the preferred route. The product must not be administered by intramuscular or subcutaneous injection. For intravenous infusion the 5ml ampoule (100mg iron) should be diluted in 0.9% saline. No other intravenous dilution solutions or therapeutic agents should be used.

Before receiving your first dose, you should receive a small "test dose" which may help reduce the chance of a serious reaction occurring.

The total dose of Venofer you require is given in single doses of one ampoule not more than three times per week. This may be increased to two ampoules not more than three times per week depending on the severity of your iron deficiency. Your doctor will take responsibility for calculating the appropriate dose and frequency of injections.

Possible side effects of Venofer

The most commonly reported side effects of Venofer are temporary changes in taste, low blood pressure, fever, shivering, injection site reactions and nausea. Non-serious allergic reactions occurred rarely. In general, allergic reactions are potentially the most serious side effects. In these reactions, very rarely symptoms of low blood pressure, facial swelling and difficulty in breathing can be involved. See ‘Before you receive Venofer’ section 2.

The following possible side effects have been reported following the administration of Venofer:

Nervous system disorders

Common (greater than or equal to 1% and less than 10%): temporary changes in taste (in particular metallic taste).

Uncommon (greater than or equal to 0.1% and less than 1%) : headache; dizziness.

Rare (greater than or equal to 0.01% and less than 0.1%): tingling, “pins and needles”

Isolated cases: decreased alertness, light-headed feeling, confusion.

Heart and blood vessel disorders

Uncommon: low blood pressure and collapse; rapid heart beat, palpitations.

Lungs and airways disorders

Uncommon: wheezing, difficulty in breathing.

Stomach and intestine disorders

Uncommon: nausea; vomiting; abdominal (e.g. stomach) pain; diarrhoea.

Skin disorders

Uncommon: itching; hives; rash, redness.

Muscle, bone and joint disorders

Uncommon: muscle cramps, muscle pain.

Isolated cases: swelling of joints.

General disorders and administration site disorders

Uncommon: fever, shivering, flushing; chest pain and chest tightness. Burning, swelling and similar reactions (sometimes involving veins) around the site of injection.

Rare: allergic reactions (rarely involving joint pain); swelling of hands and feet; tiredness, weakness; general feeling of illness.

Isolated cases: face and tongue swelling.

Storing Venofer

Venofer is to be kept out of the reach and sight of children.

The product should not be used after the expiry date printed on the label. The ampoules should be stored below 25°C in the original cartons. The product should not be frozen. Once the ampoules have been opened they should be used immediately. After dilution with 0.9% saline the solution should be used immediately or within 3 hours if stored at room temperature.

Further information

This leaflet does not tell you everything about Venofer. If you have any questions or are not sure about receiving treatment with this medicine, then ask your doctor. Please keep this leaflet until your course of treatment with Venofer has been completed.

This Leaflet was approved:

United Kingdom: December 2003

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ADHD (Attention Deficit Hyperactivity Disorder) Medications

Definition of ADHD: An inability to control behaviour due to difficulty in processing neural stimuli. More...

Drugs associated with ADHD

The following drugs and medications are in some way related to, or used in the treatment of ADHD. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under ADHD Oppositional Defiant Disorder (1 drug) Learn more about ADHD (Attention Deficit Hyperactivity Disorder)

Medical Encyclopedia:

Attention deficit hyperactivity disorder (ADHD)

Drugs.com Health Center:

Mental Health Disorders
Drug List: 5-Htp Adderall Adderall-Xr-Extended-Release-Capsules Aminomine Animi-3 Animi-3-With-Vitamin-D Concerta Cylert Daytrana Desoxyn Desoxyn-Gradumet Dexedrine Dextrostat Divista Eldepryl Epa-Fish-Oil Fish_Oil Fish-Oil-Ultra Focalin Focalin-Xr-Extended-Release-Capsules Icar-Prenatal-Essential-Omega-3 Intuniv Kapvay Liquadd-Solution Lovaza Marine-Lipid-Concentrate Maxepa Maxitears-Dry-Eye-Formula Maxivision-Omega-3-Formula Metadate-Cd-Controlled-Release-Capsules Metadate-Er Methylin Methylin-Er-Controlled-Release-Tablets Mi-Omega Mi-Omega-Nf Norpramin Omacor Omega-500 Pristiq Procentra-Solution Proepa Ritalin Ritalin-La-Extended-Release-Capsules Ritalin-Sr-Controlled-Release-Tablets Sea-Omega Sea-Omega-30 Sea-Omega-70 Strattera Theratears-Nutrition Theromega Tofranil Tofranil-Pm Vyvanse Zelapar

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Chirocaine 5mg / ml solution for injection / concentrate for solution for infusion

1. Name Of The Medicinal Product

Chirocaine 5 mg/ml solution for injection/concentrate for solution for infusion

2. Qualitative And Quantitative Composition

One ml contains 5 mg levobupivacaine as levobupivacaine hydrochloride.

Each ampoule contains 50 mg in 10 ml.

Excipients: 3.6mg/ml of sodium per ampoule.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection/concentrate for solution for infusion.

Clear colourless solution.

4. Clinical Particulars 4.1 Therapeutic Indications

Adults

Surgical anaesthesia

- Major, e.g. epidural (including for caesarean section), intrathecal, peripheral nerve block.

- Minor, e.g. local infiltration, peribulbar block in ophthalmic surgery.

Pain management

- Continuous epidural infusion, single or multiple bolus epidural administration for the management of pain especially post - operative pain or labour analgesia.

Children

Analgesia (ilioinguinal/iliohypogastric blocks).

4.2 Posology And Method Of Administration

Levobupivacaine should be administered only by, or under the supervision of, a clinician having the necessary training and experience.

The table below is a guide to dosage for the more commonly used blocks. For analgesia (e.g. epidural administration for pain management), the lower concentrations and doses are recommended. Where profound or prolonged anaesthesia is required with dense motor block (e.g. epidural or peribulbar block), the higher concentrations may be used. Careful aspiration before and during injection is recommended to prevent intravascular injection.

Aspiration should be repeated before and during administration of a bolus dose, which should be injected slowly and in incremental doses, at a rate of 7.5–30 mg/min, while closely observing the patient's vital functions and maintaining verbal contact.

If toxic symptoms occur, the injection should be stopped immediately.

Maximum dose

The maximum dosage must be determined by evaluating the size and physical status of the patient, together with the concentration of the agent and the area and route of administration. Individual variation in onset and duration of block does occur. Experience from clinical studies shows onset of sensory block adequate for surgery in 10-15 minutes following epidural administration, with a time to regression in the range of 6-9 hours.

The recommended maximum single dose is 150 mg.Where sustained motor and sensory block are required for a prolonged procedure, additional doses may be required. The maximum recommended dose during a 24 hour period is 400 mg. For post-operative pain management, the dose should not exceed 18.75 mg/hour.

Obstetrics

For caesarean section, higher concentrations than the 5.0 mg/ml solution should not be used (See 4.3). The maximum recommended dose is 150 mg.

For labour analgesia by epidural infusion, the dose should not exceed 12.5 mg/hour.

Children

In children, the maximum recommended dose for analgesia (ilioinguinal/iliohypogastric blocks) is 1.25 mg/kg/side.

The safety and efficacy of levobupivacaine in children for other indications have not been established.

Special populations

Debilitated, elderly or acutely ill patients should be given reduced doses of levobupivacaine commensurate with their physical status.

In the management of post-operative pain, the dose given during surgery must be taken into account.

There are no relevant data in patients with hepatic impairment (see sections 4.4 and 5.2).

Table of Doses

 

Concentration (mg/ml)1

Dose

Motor Block

Surgical Anaesthesia

     

Epidural (slow) bolus2 for surgery

- Adults

 

5.0-7.5

 

10-20 ml (50-150 mg)

 

Moderate to complete

Epidural slow injection3 for Caesarean Section

5.0

15-30 ml (75-150 mg)

Moderate to complete

Intrathecal

5.0

3 ml (15 mg)

Moderate to complete

Peripheral Nerve

 

Ilioinguinal/ Iliohypogastric blocks in children <12 years

2.5-5.0

 

2.5-5.0

1-40 ml (2.5-150 mg max

 

0.25-0.5 ml/kg (0.625-2.5 mg/kg)

Moderate to complete

 

Not applicable

Ophthalmic (peribulbar block)

7.5

5–15 ml (37.5-112.5 mg)

Moderate to complete

Local Infiltration

- Adults

 

2.5

 

1-60 ml (2.5-150 mg max )

 

Not applicable

Pain Management4

Labour Analgesia (epidural bolus5)

 

2.5

 

6-10 ml (15-25 mg)

 

Minimal to moderate

Labour Analgesia (epidural infusion)

1.256

4-10 ml/h (5-12.5 mg/h)

Minimal to moderate

Post-operative pain

1.256

2.5

10-15ml/h (12.5-18.75mg/h)

5-7.5ml/h (12.5–18.75mg/h)

Minimal to moderate

1 Levobupivacaine solution for injection/concentration for solution for infusion is available in 2.5, 5.0 and 7.5 mg/ml solutions.

2 Spread over 5 minutes (see also text).

3 Given over 15-20 minutes.

4 In cases where levobupivacaine is combined with other agents e.g. opioids in pain management, the levobupivacaine dose should be reduced and use of a lower concentration (e.g. 1.25 mg/ml) is preferable.

5 The minimum recommended interval between intermittent injections is 15 minutes.

6 For information on dilution, see section 6.6.

4.3 Contraindications

General contra-indications related to regional anaesthesia, regardless of the local anaesthetic used, should be taken into account.

Levobupivacaine solutions are contra-indicated in patients with a known hypersensitivity to levobupivacaine, local anaesthetics of the amide type or any of the excipients (see section 4.8).

Levobupivacaine solutions are contra-indicated for intravenous regional anaesthesia (Bier's block).

Levobupivacaine solutions are contra-indicated in patients with severe hypotension such as cardiogenic or hypovolaemic shock.

Levobupivacaine solutions are contra-indicated for use in paracervical block in obstetrics (see section 4.6).

4.4 Special Warnings And Precautions For Use

All forms of local and regional anaesthesia with levobupivacaine should be performed in well-equipped facilities and administered by staff trained and experienced in the required anaesthetic techniques and able to diagnose and treat any unwanted adverse effects that may occur.

Levobupivacaine can cause acute allergic reactions, cardiovascular effects and neurological damage, see section 4.8.

Levobupivacaine should be used with caution for regional anaesthesia in patients with impaired cardiovascular function e.g. serious cardiac arrhythmias.

The introduction of local anesthetics via either intrathecal or epidural administration into the central nervous system in patients with preexisting CNS diseases may potentially exacerbate some of these disease states. Therefore, clinical judgment should be exercised when contemplating epidural or intrathecal anesthesia in such patients.

This medicinal product contains 3.6 mg/ml sodium in the bag or ampoule solution to be taken into consideration by patients on a controlled sodium diet.

Epidural Anesthesia

During epidural administration of levobupivacaine, concentrated solutions (0.5-0.75%) should be administered in incremental doses of 3 to 5 ml with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. When a large dose is to be injected, e.g. in epidural block, a test dose of 3-5 ml lidocaine with adrenaline is recommended. An inadvertent intravascular injection may then be recognised by a temporary increase in heart rate and accidental intrathecal injection by signs of a spinal block. Syringe aspirations should also be performed before and during each supplemental injection in continuous (intermittent) catheter techniques. An intravascular injection is still possible even if aspirations for blood are negative. During the administration of epidural anesthesia, it is recommended that a test dose be administered initially and the effects monitored before the full dose is given.

Epidural anaesthesia with any local anaesthetic may cause hypotension and bradycardia. All patients must have intravenous access established. The availability of appropriate fluids, vasopressors, anaesthetics with anticonvulsant properties, myorelaxants, and atropine, resuscitation equipment and expertise must be ensured (see section 4.9).

Major regional nerve blocks

The patient should have I.V. fluids running via an indwelling catheter to assure a functioning intravenous pathway. The lowest dosage of local anesthetic that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should be used when feasible.

Use in Head and Neck Area

Small doses of local anesthetics injected into the head and neck area, including retrobulbar, dental and stellate ganglion blocks, may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. The injection procedures require the utmost care. Reactions may be due to intraarterial injection of the local anesthetic with retrograde flow to the cerebral circulation. They may also be due to puncture of the dural sheath of the optic nerve during retrobulbar block with diffusion of any local anesthetic along the subdural space to the midbrain. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available.

Use in Ophthalmic Surgery

Clinicians who perform retrobulbar blocks should be aware that there have been reports of respiratory arrest following local anaesthetic injection. Prior to retrobulbar block, as with all other regional procedures, the immediate availability of equipment, drugs, and personnel to manage respiratory arrest or depression, convulsions, and cardiac stimulation or depression should be assured. As with other anaesthetic procedures, patients should be constantly monitored following ophthalmic blocks for signs of these adverse reactions.

Special populations

Debilitated, elderly or acutely ill patients: levobupivacaine should be used with caution in debilitated, elderly or acutely ill patients (see section 4.2).

Hepatic impairment: since levobupivacaine is metabolised in the liver, it should be used cautiously in patients with liver disease or with reduced liver blood flow e.g. alcoholics or cirrhotics (see section 5.2).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In vitro studies indicate that the CYP3A4 isoform and CYP1A2 isoform mediate the metabolism of levobupivacaine. Although no clinical studies have been conducted, metabolism of levobupivacaine may be affected by CYP3A4 inhibitors eg: ketoconazole, and CYP1A2 inhibitors eg: methylxanthines.

Levobupivacaine should be used with caution in patients receiving anti-arrhythmic agents with local anaesthetic activity, e.g., mexiletine, or class III anti-arrhythmic agents since their toxic effects may be additive.

No clinical studies have been completed to assess levobupivacaine in combination with adrenaline.

4.6 Pregnancy And Lactation

Pregnancy

Levobupivacaine solutions are contraindicated for use in paracervical block in obstetrics. Based on experience with bupivacaine foetal bradycardia may occur following paracervical block (see section 4.3).

For levobupivacaine, there are no clinical data on first trimester-exposed pregnancies. Animal studies do not indicate teratogenic effects but have shown embryo-foetal toxicity at systemic exposure levels in the same range as those obtained in clinical use (see section 5.3). The potential risk for human is unknown. Levobupivacaine should therefore not be given during early pregnancy unless clearly necessary.

Nevertheless, to date, the clinical experience of bupivacaine for obstetrical surgery (at the term of pregnancy or for delivery) is extensive and has not shown a foetotoxic effect.

Lactation

Levobupivacaine excretion in breast milk is unknown. However, levobupivacaine is likely to be poorly transmitted in the breast milk, as for bupivacaine. Thus breast feeding is possible after local anaesthesia.

4.7 Effects On Ability To Drive And Use Machines

Levobupivacaine can have a major influence on the ability to drive or use machines. Patients should be warned not to drive or operate machinery until all the effects of the anaesthesia and the immediate effects of surgery are passed.

4.8 Undesirable Effects

The adverse drug reactions for Chirocaine are consistent with those known for its respective class of medicinal products. The most commonly reported adverse drug reactions are hypotension, nausea, anaemia, vomiting, dizziness, headache, pyrexia, procedural pain, back pain and foetal distress syndrome in obstetric use (see table below).

Adverse reactions reported either spontaneously or observed in clinical trials are depicted in the following table Within each system organ class, the adverse drug reactions are ranked under headings of frequency, using the following convention: very common (

System Organ Class

Frequency

Adverse Reaction

Blood and lymphatic system disorders

Very Common

Anaemia

Immune system disorders

Not known

Not known

Allergic reactions (in serious cases anaphylactic shock)

Hypersensitivity

Nervous system disorders

Common

Common

Not known

Not known

Not known

Not known

Not known

Not known

Dizziness

Headache

Convulsion

Loss of consciousness

Somnolence

Syncope

Paraesthesia

Paraplegia

Eye disorders

Not known

Vision blurred

Cardiac disorders

Not known

Not known

Not known

Not known

Not known

Atrioventricular block

Cardiac arrest

Ventricular tachyarrhythmia

Tachycardia

Bradycardia

Vascular disorders

Very common

Hypotension

Respiratory, thoracic and mediastinal disorders

Not known

Not known

Not known

Not known

Respiratory arrest

Laryngeal oedema

Apnoea

Sneezing

Gastrointestinal disorders

Very Common

Common

Not known

Nausea

Vomiting

Hypoasthesia oral

Loss of sphincter control

Skin and subcutaneous tissue disorders

Not known

Not known

Not known

Not known

Not known

Angioedema

Urticaria

Pruritus

Hyperhidrosis

Erythema

Musculoskeletal and connective tissue disorders

Common

Not known

Not known

Back pain

Muscle twitching

Muscular weakness

Renal and urinary disorders

Not known

Bladder dysfunction

Pregnancy, puerperium and perinatal conditions

Common

Foetal distress syndrome

General disorders and administration site conditions

Common

Pyrexia

Investigations

Not known

Not known

Cardiac output decreased

Electrocardiogram change

Injury, poisoning and procedural complications

Common

Procedural pain

Adverse reactions with local anaesthetics of the amide type are rare, but they may occur as a result of overdosage or unintentional intravascular injection and may be serious.

Cross-sensitivity among members of the amide-type local anesthetic group have been reported (see section 4.3).

Accidental intrathecal injection of local anaesthetics can lead to very high spinal anaesthesia.

Cardiovascular effects are related to depression of the conduction system of the heart and a reduction in myocardial excitability and contractility. Usually these will be preceded by major CNS toxicity, i.e. convulsions, but in rare cases, cardiac arrest may occur without prodromal CNS effects.

Neurological damage is a rare but well recognised consequence of regional and particularly epidural and spinal anaesthesia. It may be due to direct injury to the spinal cord or spinal nerves, anterior spinal artery syndrome, injection of an irritant substance or an injection of a non-sterile solution. Rarely, these may be permanent.

4.9 Overdose

Accidental intravascular injection of local anaesthetics may cause immediate toxic reactions. In the event of overdose, peak plasma concentrations may not be reached until 2 hours after administration depending upon the injection site and, therefore, signs of toxicity may be delayed. The effects of the drug may be prolonged.

Systemic adverse reactions following overdose or accidental intravascular injection reported with long acting local anaesthetic agents involve both CNS and cardiovascular effects.

CNS Effects

Convulsions should be treated immediately with intravenous thiopentone or diazepam titrated as necessary. Thiopentone and diazepam also depress central nervous system, respiratory and cardiac function. Therefore their use may result in apnoea. Neuro-muscular blockers may be used only if the clinician is confident of maintaining a patent airway and managing a fully paralysed patient.

If not treated promptly, convulsions with subsequent hypoxia and hypercarbia plus myocardial depression from the effects of the local anaesthetic on the heart, may result in cardiac arrhythmias, ventricular fibrillation or cardiac arrest.

Cardiovascular Effects

Hypotension may be prevented or attenuated by pre-treatment with a fluid load and/or the use of vasopressors. If hypotension occurs it should be treated with intravenous crystalloids or colloids and/or incremental doses of a vasopressor such as ephedrine 5-10 mg. Any coexisting causes of hypotension should be rapidly treated.

If severe bradycardia occurs, treatment with atropine 0.3 - 1.0 mg will normally restore the heart rate to an acceptable level.

Cardiac arrhythmia should be treated as required and ventricular fibrillation should be treated by cardioversion.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Local anaesthetics, amide

ATC Code N01B B10

Levobupivacaine is a long acting local anaesthetic and analgesic. It blocks nerve conduction in sensory and motor nerves largely by interacting with voltage sensitive sodium channels on the cell membrane, but also potassium and calcium channels are blocked. In addition, levobupivacaine interferes with impulse transmission and conduction in other tissues where effects on the cardiovascular and central nervous systems are most important for the occurrence of clinical adverse reactions.

The dose of levobupivacaine is expressed as base, whereas, in the racemate bupivacaine the dose is expressed as hydrochloride salt. This gives rise to approximately 13% more active substance in levobupivacaine solutions compared to bupivacaine. In clinical studies at the same nominal concentrations levobupivacaine showed similar clinical effect to bupivacaine.

In a clinical pharmacology study using the ulnar nerve block model, levobupivacaine was equipotent with bupivacaine.

5.2 Pharmacokinetic Properties

In human studies, the distribution kinetics of levobupivacaine following i.v. administration are essentially the same as bupivacaine. The plasma concentration of levobupivacaine following therapeutic administration depends on dose and, as absorption from the site of administration is affected by the vascularity of the tissue, on route of administration.

There are no relevant data in patients with hepatic impairment (see section 4.4).

There are no data in patients with renal impairment. Levobupivacaine is extensively metabolised and unchanged levobupivacaine is not excreted in urine.

Plasma protein binding of levobupivacaine in man was evaluated in vitro and was found to be> 97% at concentrations between 0.1 and 1.0 ?g/ml.

In a clinical pharmacology study where 40 mg levobupivacaine was given by intravenous administration, the mean half-life was approximately 80 + 22 minutes, Cmax 1.4 + 0.2 ?g/ml and AUC 70 + 27 ?g•min/ml.

The mean Cmax and AUC(0-24h) of levobupivacaine were approximately dose-proportional following epidural administration of 75 mg (0.5%) and 112.5 mg (0.75%) and following doses of 1 mg/kg (0.25%) and 2 mg/kg (0.5%) used for brachial plexus block. Following epidural administration of 112.5 mg (0.75%) the mean Cmax and AUC values were 0.58 µg/ml and 3.56?µg•h/ml respectively.

The mean total plasma clearance and terminal half-life of levobupivacaine after intravenous infusion were 39 litres/hour and 1.3 hours, respectively. The volume of distribution after intravenous administration was 67 litres.

Levobupivacaine is extensively metabolised with no unchanged levobupivacaine detected in urine or faeces. 3-hydroxylevobupivacaine, a major metabolite of levobupivacaine, is excreted in the urine as glucuronic acid and sulphate ester conjugates. In vitro studies showed that CYP3A4 isoform and CYP1A2 isoform mediate the metabolism of levobupivacaine to desbutyl-levobupivacaine and 3-hydroxylevobupivacaine respectively. These studies indicate that the metabolism of levobupivacaine and bupivacaine are similar.

Following intravenous administration, recovery of levobupivacaine was quantitative with a mean total of about 95% being recovered in urine (71%) and faeces (24%) in 48 hours.

There is no evidence of in vivo racemisation of levobupivacaine.

5.3 Preclinical Safety Data

In an embryo-foetal toxicity study in rats, an increased incidence of dilated renal pelvis, dilated ureters, olfactory ventricle dilatation and extra thoraco-lumbar ribs was observed at systemic exposure levels in the same range as those obtained at clinical use. There were no treatment-related malformations.

Levobupivacaine was not genotoxic in a standard battery of assays for mutagenicity and clastogenicity. No carcinogenicity testing has been conducted.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium Chloride

Sodium Hydroxide

Hydrochloric acid

Water for Injections

6.2 Incompatibilities

Levobupivacaine may precipitate if diluted with alkaline solutions and should not be diluted or co-administered with sodium bicarbonate injections. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf Life

Shelf life as packaged for sale: 3 years

Shelf life after first opening: The product should be used immediately

Shelf life after dilution in sodium chloride solution 0.9%: Chemical and physical in-use stability has been demonstrated for 7 days at 20-22°C. Chemical and physical in-use stability with clonidine, morphine or fentanyl has been demonstrated for 40 hours at 20-22°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

6.4 Special Precautions For Storage

Polypropylene ampoules: polypropylene ampoules do not require any special storage conditions.

For storage conditions of the reconstituted medicinal product, see section 6.3.

6.5 Nature And Contents Of Container

Chirocaine is available in two presentations;

10 ml polypropylene ampoule in packs of 5, 10 & 20

10 ml polypropylene ampoule, in sterile blister packs of 5, 10 & 20

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

For single use only. Discard any unused solution.

The solution/dilution should be inspected visually prior to use. Only clear solutions without visible particles should be used.

A sterile blister container should be chosen when a sterile ampoule surface is required. Ampoule surface is not sterile if sterile blister is pierced.

Dilutions of levobupivacaine standard solutions should be made with sodium chloride 9 mg/ml (0.9%) solution for injection using aseptic techniques.

Clonidine 8.4 ?g/ml, morphine 0.05 mg/ml and fentanyl 4 ?g/ml have been shown to be compatible with levobupivacaine in sodium chloride 9 mg/ml (0.9%) solution for injection.

7. Marketing Authorisation Holder

Abbott Laboratories Ltd

Abbott House

Vanwall Business Park

Vanwall Road

Maidenhead

Berkshire

SL6 4XE

United Kingdom

8. Marketing Authorisation Number(S)

PL 00037/0301

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 06th January 2000

Date of last renewal: 18th December 2008

10. Date Of Revision Of The Text

2nd July 2010

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Chirocaine 2.5mg / ml solution for injection / concentrate for solution for infusion

1. Name Of The Medicinal Product

Chirocaine 2.5 mg/ml solution for injection/concentrate for solution for infusion.

2. Qualitative And Quantitative Composition

One ml contains 2.5 mg levobupivacaine as levobupivacaine hydrochloride.

Each ampoule contains 25 mg in 10 ml.

Excipients: 3.6mg/ml of sodium per ampoule.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection/concentrate for solution for infusion.

Clear colourless solution.

4. Clinical Particulars 4.1 Therapeutic Indications

Adults

Surgical anaesthesia

- Major, e.g. epidural (including for caesarean section), intrathecal, peripheral nerve block.

- Minor, e.g. local infiltration, peribulbar block in ophthalmic surgery.

Pain management

- Continuous epidural infusion, single or multiple bolus epidural administration for the management of pain especially post-operative pain or labour analgesia.

Children

Analgesia (ilioinguinal/iliohypogastric blocks).

4.2 Posology And Method Of Administration

Levobupivacaine should be administered only by, or under the supervision of, a clinician having the necessary training and experience.

The table below is a guide to dosage for the more commonly used blocks. For analgesia (e.g. epidural administration for pain management), the lower concentrations and doses are recommended. Where profound or prolonged anaesthesia is required with dense motor block (e.g. epidural or peribulbar block), the higher concentrations may be used. Careful aspiration before and during injection is recommended to prevent intravascular injection.

Aspiration should be repeated before and during administration of a bolus dose, which should be injected slowly and in incremental doses, at a rate of 7.5–30 mg/min, while closely observing the patient's vital functions and maintaining verbal contact.

If toxic symptoms occur, the injection should be stopped immediately.

Maximum dose

The maximum dosage must be determined by evaluating the size and physical status of the patient, together with the concentration of the agent and the area and route of administration. Individual variation in onset and duration of block does occur. Experience from clinical studies shows onset of sensory block adequate for surgery in 10-15 minutes following epidural administration, with a time to regression in the range of 6-9 hours.

The recommended maximum single dose is 150 mg.Where sustained motor and sensory block are required for a prolonged procedure, additional doses may be required. The maximum recommended dose during a 24 hour period is 400 mg. For post-operative pain management, the dose should not exceed 18.75 mg/hour.

Obstetrics

For caesarean section, higher concentrations than the 5.0 mg/ml solution should not be used (See section 4.3). The maximum recommended dose is 150 mg.

For labour analgesia by epidural infusion, the dose should not exceed 12.5 mg/hour.

Children

In children, the maximum recommended dose for analgesia (ilioinguinal/iliohypogastric blocks) is 1.25 mg/kg/side.

The safety and efficacy of levobupivacaine in children for other indications have not been established.

Special populations

Debilitated, elderly or acutely ill patients should be given reduced doses of levobupivacaine commensurate with their physical status.

In the management of post-operative pain, the dose given during surgery must be taken into account.

There are no relevant data in patients with hepatic impairment (see sections 4.4 and 5.2).

Table of Doses

 

Concentration (mg/ml)1

Dose

Motor Block

Surgical Anaesthesia

     

Epidural (slow) bolus2 for surgery

- Adults

 

5.0-7.5

 

10-20 ml (50-150 mg)

 

Moderate to complete

Epidural slow injection3 for Caesarean Section

5.0

15-30 ml (75-150 mg)

Moderate to complete

Intrathecal

5.0

3 ml (15 mg)

Moderate to complete

Peripheral Nerve

Ilioinguinal/Iliohypogastric blocks in children <12 years

2.5-5.0

2.5-5.0

1-40 ml (2.5-150 mg max.)

0.25-0.5 ml/kg (0.625-2.5 mg/kg)

Moderate to complete

Not applicable

Ophthalmic (peribulbar block)

7.5

5–15 ml (37.5-112.5 mg)

Moderate to complete

Local Infiltration

- Adults

 

2.5

 

1-60 ml (2.5-150 mg max.)

 

Not applicable

Pain Management4

Labour Analgesia (epidural bolus5)

 

2.5

 

6-10 ml (15-25 mg)

 

Minimal to moderate

Labour Analgesia (epidural infusion)

1.256

4-10 ml/h (5-12.5 mg/h)

Minimal to moderate

Post-operative pain

1.256

2.5

10-15ml/h (12.5-18.75mg/h)

5-7.5ml/h (12.5 –18.75mg/h)

Minimal to moderate

1 Levobupivacaine solution for injection/concentration for solution for infusion is available in 2.5, 5.0 and 7.5 mg/ml solutions.

2 Spread over 5 minutes (see also text).

3 Given over 15-20 minutes.

4 In cases where levobupivacaine is combined with other agents e.g. opioids in pain management, the levobupivacaine dose should be reduced and use of a lower concentration (e.g. 1.25 mg/ml) is preferable.

5 The minimum recommended interval between intermittent injections is 15 minutes.

6 For information on dilution, see section 6.6.

4.3 Contraindications

General contra-indications related to regional anaesthesia, regardless of the local anaesthetic used, should be taken into account.

Levobupivacaine solutions are contra-indicated in patients with a known hypersensitivity to levobupivacaine, local anaesthetics of the amide type or any of the excipients (see section 4.8).

Levobupivacaine solutions are contra-indicated for intravenous regional anaesthesia (Bier's block).

Levobupivacaine solutions are contra-indicated in patients with severe hypotension such as cardiogenic or hypovolaemic shock.

Levobupivacaine solutions are contra-indicated for use in paracervical block in obstetrics (see section 4.6).

4.4 Special Warnings And Precautions For Use

All forms of local and regional anaesthesia with levobupivacaine should be performed in well-equipped facilities and administered by staff trained and experienced in the required anaesthetic techniques and able to diagnose and treat any unwanted adverse effects that may occur.

Levobupivacaine can cause acute allergic reactions, cardiovascular effects and neurological damage, see section 4.8.

Levobupivacaine should be used with caution for regional anaesthesia in patients with impaired cardiovascular function e.g. serious cardiac arrhythmias.

The introduction of local anesthetics via either intrathecal or epidural administration into the central nervous system in patients with preexisting CNS diseases may potentially exacerbate some of these disease states. Therefore, clinical judgment should be exercised when contemplating epidural or intrathecal anesthesia in such patients.

This medicinal product contains 3.6 mg/ml sodium in the bag or ampoule solution to be taken into consideration by patients on a controlled sodium diet.

Epidural Anesthesia

During epidural administration of levobupivacaine, concentrated solutions (0.5-0.75%) should be administered in incremental doses of 3 to 5 ml with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. When a large dose is to be injected, e.g. in epidural block, a test dose of 3-5 ml lidocaine with adrenaline is recommended. An inadvertent intravascular injection may then be recognised by a temporary increase in heart rate and accidental intrathecal injection by signs of a spinal block.

Syringe aspirations should also be performed before and during each supplemental injection in continuous (intermittent) catheter techniques. An intravascular injection is still possible even if aspirations for blood are negative. During the administration of epidural anesthesia, it is recommended that a test dose be administered initially and the effects monitored before the full dose is given.

Epidural anaesthesia with any local anaesthetic may cause hypotension and bradycardia. All patients must have intravenous access established. The availability of appropriate fluids, vasopressors, anaesthetics with anticonvulsant properties, myorelaxants, and atropine, resuscitation equipment and expertise must be ensured (see section 4.9).

Major regional nerve blocks

The patient should have I.V. fluids running via an indwelling catheter to assure a functioning intravenous pathway. The lowest dosage of local anesthetic that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should be used when feasible.

Use in Head and Neck Area

Small doses of local anesthetics injected into the head and neck area, including retrobulbar, dental and stellate ganglion blocks, may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. The injection procedures require the utmost care. Reactions may be due to intraarterial injection of the local anesthetic with retrograde flow to the cerebral circulation. They may also be due to puncture of the dural sheath of the optic nerve during retrobulbar block with diffusion of any local anesthetic along the subdural space to the midbrain. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available.

Use in Ophthalmic Surgery

Clinicians who perform retrobulbar blocks should be aware that there have been reports of respiratory arrest following local anaesthetic injection. Prior to retrobulbar block, as with all other regional procedures, the immediate availability of equipment, drugs, and personnel to manage respiratory arrest or depression, convulsions, and cardiac stimulation or depression should be assured. As with other anesthetic procedures, patients should be constantly monitored following ophthalmic blocks for signs of these adverse reactions.

Special populations

Debilitated, elderly or acutely ill patients: levobupivacaine should be used with caution in debilitated, elderly or acutely ill patients (see section 4.2).

Hepatic impairment: since levobupivacaine is metabolised in the liver, it should be used cautiously in patients with liver disease or with reduced liver blood flow e.g. alcoholics or cirrhotics (see section 5.2).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In vitro studies indicate that the CYP3A4 isoform and CYP1A2 isoform mediate the metabolism of levobupivacaine. Although no clinical studies have been conducted, metabolism of levobupivacaine may be affected by CYP3A4 inhibitors eg: ketoconazole, and CYP1A2 inhibitors eg: methylxanthines.

Levobupivacaine should be used with caution in patients receiving anti-arrhythmic agents with local anaesthetic activity, e.g., mexiletine, or class III anti-arrhythmic agents since their toxic effects may be additive.

No clinical studies have been completed to assess levobupivacaine in combination with adrenaline.

4.6 Pregnancy And Lactation

Pregnancy

Levobupivacaine solutions are contraindicated for use in paracervical block in obstetrics. Based on experience with bupivacaine foetal bradycardia may occur following paracervical block (see section 4.3).

For levobupivacaine, there are no clinical data on first trimester-exposed pregnancies. Animal studies do not indicate teratogenic effects but have shown embryo-foetal toxicity at systemic exposure levels in the same range as those obtained in clinical use (see section 5.3). The potential risk for human is unknown. Levobupivacaine should therefore not be given during early pregnancy unless clearly necessary.

Nevertheless, to date, the clinical experience of bupivacaine for obstetrical surgery (at the term of pregnancy or for delivery) is extensive and has not shown a foetotoxic effect.

Lactation

Levobupivacaine excretion in breast milk is unknown. However, levobupivacaine is likely to be poorly transmitted in the breast milk, as for bupivacaine. Thus breast feeding is possible after local anaesthesia.

4.7 Effects On Ability To Drive And Use Machines

Levobupivacaine can have a major influence on the ability to drive or use machines. Patients should be warned not to drive or operate machinery until all the effects of the anaesthesia and the immediate effects of surgery are passed.

4.8 Undesirable Effects

The adverse drug reactions for Chirocaine are consistent with those known for its respective class of medicinal products. The most commonly reported adverse drug reactions are hypotension, nausea, anaemia, vomiting, dizziness, headache, pyrexia, procedural pain, back pain and foetal distress syndrome in obstetric use (see table below).

Adverse reactions reported either spontaneously or observed in clinical trials are depicted in the following table. Within each system organ class, the adverse drug reactions are ranked under headings of frequency, using the following convention: very common (

System Organ Class

Frequency

Adverse Reaction

Blood and lymphatic system disorders

Very Common

Anaemia

Immune system disorders

Not known

Not known

Allergic reactions (in serious cases anaphylactic shock)

Hypersensitivity

Nervous system disorders

Common

Common

Not known

Not known

Not known

Not known

Not known

Not known

Dizziness

Headache

Convulsion

Loss of consciousness

Somnolence

Syncope

Paraesthesia

Paraplegia

Eye disorder

Not known

Vision blurred

Cardiac disorders

Not known

Not known

Not known

Not known

Not known

Atrioventricular block

Cardiac arrest

Ventricular tachyarrhythmia

Tachycardia

Bradycardia

Vascular disorders

Very common

Hypotension

Respiratory, thoracic and mediastinal disorders

Not known

Not known

Not known

Not known

Respiratory arrest

Laryngeal oedema

Apnoea

Sneezing

Gastrointestinal disorders

Very Common

Common

Not known

Nausea

Vomiting

Hypoaesthesia oral

Loss of sphincter control

Skin and subcutaneous tissue disorders

Not known

Not known

Not known

Not known

Not known

Angioedema

Urticaria

Pruritus

Hyperhidrosis

Erythema

Musculoskeletal and connective tissue disorders

Common

Not known

Not known

Back pain

Muscle twitching

Muscular weakness

Renal and urinary disorders

Not known

Bladder dysfunction

Pregnancy, puerperium and perinatal conditions

Common

Foetal distress syndrome

General disorders and administration site conditions

Common

Pyrexia

Investigations

Not known

Not known

Cardiac output decreased

Electrocardiogram change

Injury, poisoning and procedural complications

Common

Procedural pain

Adverse reactions with local anaesthetics of the amide type are rare, but they may occur as a result of overdosage or unintentional intravascular injection and may be serious.

Cross-sensitivity among members of the amide-type local anesthetic group have been reported (see section 4.3).

Accidental intrathecal injection of local anaesthetics can lead to very high spinal anaesthesia.

Cardiovascular effects are related to depression of the conduction system of the heart and a reduction in myocardial excitability and contractility. Usually these will be preceded by major CNS toxicity, i.e. convulsions, but in rare cases, cardiac arrest may occur without prodromal CNS effects.

Neurological damage is a rare but well recognised consequence of regional and particularly epidural and spinal anaesthesia. It may be due to direct injury to the spinal cord or spinal nerves, anterior spinal artery syndrome, injection of an irritant substance or an injection of a non-sterile solution. These may result in localised areas of paraesthesia or anaesthesia, motor weakness, loss of sphincter control and paraplegia. Rarely, these may be permanent.

4.9 Overdose

Accidental intravascular injection of local anaesthetics may cause immediate toxic reactions. In the event of overdose, peak plasma concentrations may not be reached until 2 hours after administration depending upon the injection site and, therefore, signs of toxicity may be delayed. The effects of the drug may be prolonged.

Systemic adverse reactions following overdose or accidental intravascular injection reported with long acting local anaesthetic agents involve both CNS and cardiovascular effects.

CNS Effects

Convulsions should be treated immediately with intravenous thiopentone or diazepam titrated as necessary. Thiopentone and diazepam also depress central nervous system, respiratory and cardiac function. Therefore their use may result in apnoea. Neuro-muscular blockers may be used only if the clinician is confident of maintaining a patent airway and managing a fully paralysed patient.

If not treated promptly, convulsions with subsequent hypoxia and hypercarbia plus myocardial depression from the effects of the local anaesthetic on the heart, may result in cardiac arrhythmias, ventricular fibrillation or cardiac arrest.

Cardiovascular Effects

Hypotension may be prevented or attenuated by pre-treatment with a fluid load and/or the use of vasopressors. If hypotension occurs it should be treated with intravenous crystalloids or colloids and/or incremental doses of a vasopressor such as ephedrine 5-10 mg. Any coexisting causes of hypotension should be rapidly treated.

If severe bradycardia occurs, treatment with atropine 0.3-1.0 mg will normally restore the heart rate to an acceptable level.

Cardiac arrhythmia should be treated as required and ventricular fibrillation should be treated by cardioversion.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Local anaesthetics, amide

ATC Code N01B B10

Levobupivacaine is a long acting local anaesthetic and analgesic. It blocks nerve conduction in sensory and motor nerves largely by interacting with voltage sensitive sodium channels on the cell membrane, but also potassium and calcium channels are blocked. In addition, levobupivacaine interferes with impulse transmission and conduction in other tissues where effects on the cardiovascular and central nervous systems are most important for the occurrence of clinical adverse reactions.

The dose of levobupivacaine is expressed as base, whereas, in the racemate bupivacaine the dose is expressed as hydrochloride salt. This gives rise to approximately 13% more active substance in levobupivacaine solutions compared to bupivacaine. In clinical studies at the same nominal concentrations levobupivacaine showed similar clinical effect to bupivacaine.

In a clinical pharmacology study using the ulnar nerve block model, levobupivacaine was equipotent with bupivacaine.

5.2 Pharmacokinetic Properties

In human studies, the distribution kinetics of levobupivacaine following i.v. administration are essentially the same as bupivacaine. The plasma concentration of levobupivacaine following therapeutic administration depends on dose and, as absorption from the site of administration is affected by the vascularity of the tissue, on route of administration.

There are no relevant data in patients with hepatic impairment (see section 4.4).

There are no data in patients with renal impairment. Levobupivacaine is extensively metabolised and unchanged levobupivacaine is not excreted in urine.

Plasma protein binding of levobupivacaine in man was evaluated in vitro and was found to be> 97% at concentrations between 0.1 and 1.0 ?g/ml.

In a clinical pharmacology study where 40 mg levobupivacaine was given by intravenous administration, the mean half-life was approximately 80 + 22 minutes, Cmax 1.4 + 0.2 ?g/ml and AUC 70 + 27 ?g•min/ml.

The mean Cmax and AUC(0-24h) of levobupivacaine were approximately dose-proportional following epidural administration of 75 mg (0.5%) and 112.5 mg (0.75%) and following doses of 1 mg/kg (0.25%) and 2 mg/kg (0.5%) used for brachial plexus block. Following epidural administration of 112.5 mg (0.75%) the mean Cmax and AUC values were 0.58 µg/ml and 3.56?µg•h/ml respectively.

The mean total plasma clearance and terminal half-life of levobupivacaine after intravenous infusion were 39 litres/hour and 1.3 hours, respectively. The volume of distribution after intravenous administration was 67 litres.

Levobupivacaine is extensively metabolised with no unchanged levobupivacaine detected in urine or faeces. 3-hydroxylevobupivacaine, a major metabolite of levobupivacaine, is excreted in the urine as glucuronic acid and sulphate ester conjugates. In vitro studies showed that CYP3A4 isoform and CYP1A2 isoform mediate the metabolism of levobupivacaine to desbutyl-levobupivacaine and 3-hydroxylevobupivacaine respectively.These studies indicate that the metabolism of levobupivacaine and bupivacaine are similar.

Following intravenous administration, recovery of levobupivacaine was quantitative with a mean total of about 95% being recovered in urine (71%) and faeces (24%) in 48 hours.

There is no evidence of in vivo racemisation of levobupivacaine.

5.3 Preclinical Safety Data

In an embryo-foetal toxicity study in rats, an increased incidence of dilated renal pelvis, dilated ureters, olfactory ventricle dilatation and extra thoraco-lumbar ribs was observed at systemic exposure levels in the same range as those obtained at clinical use. There were no treatment-related malformations.

Levobupivacaine was not genotoxic in a standard battery of assays for mutagenicity and clastogenicity. No carcinogenicity testing has been conducted.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium Chloride

Sodium Hydroxide

Hydrochloric acid

Water for Injections

6.2 Incompatibilities

Levobupivacaine may precipitate if diluted with alkaline solutions and should not be diluted or co-administered with sodium bicarbonate injections. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf Life

Shelf life as packaged for sale: 3 years

Shelf life after first opening: The product should be used immediately

Shelf life after dilution in sodium chloride solution 0.9%: Chemical and physical in-use stability has been demonstrated for 7 days at 20-22°C. Chemical and physical in-use stability with clonidine, morphine or fentanyl has been demonstrated for 40 hours at 20-22°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

6.4 Special Precautions For Storage

Polypropylene ampoules: polypropylene ampoules do not require any special storage conditions.

For storage conditions of the reconstituted medicinal product, see section 6.3.

6.5 Nature And Contents Of Container

Chirocaine is available in two presentations;

10 ml polypropylene ampoule in packs of 5, 10 & 20

10 ml polypropylene ampoule, in sterile blister packs of 5, 10 & 20

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

For single use only. Discard any unused solution.

The solution/dilution should be inspected visually prior to use. Only clear solutions without visible particles should be used.

A sterile blister container should be chosen when a sterile ampoule surface is required. Ampoule surface is not sterile if sterile blister is pierced.

Dilutions of levobupivacaine standard solutions should be made with sodium chloride 9 mg/ml (0.9%) solution for injection using aseptic techniques.

Clonidine 8.4 ?g/ml, morphine 0.05 mg/ml and fentanyl 4 ?g/ml have been shown to be compatible with levobupivacaine in sodium chloride 9 mg/ml (0.9%) solution for injection.

7. Marketing Authorisation Holder

Abbott Laboratories Ltd

Abbott House

Vanwall Business Park

Vanwall Road

Maidenhead

Berkshire

SL6 4XE

United Kingdom

8. Marketing Authorisation Number(S)

PL 00037/0300

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 06 January 2000

Date of last renewal: 18th December 2008

10. Date Of Revision Of The Text

02nd July 2010

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Fabrazyme 5 mg, powder for concentrate for solution for infusion

Fabrazyme 5 mg powder for concentrate for solution for infusion

Agalsidase beta

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Fabrazyme is and what it is used for 2. Before you use Fabrazyme 3. How to use Fabrazyme 4. Possible side effects 5. How to store Fabrazyme 6. Further information What Fabrazyme Is And What It Is Used For

Fabrazyme is used as enzyme replacement therapy in Fabry disease, where the level of ?-galactosidase enzyme activity is absent or lower than normal. If you suffer from Fabry disease a fat substance, called globotriaosylceramide (GL-3), is not removed from the cells of your body and starts to accumulate in the walls of the blood vessels of your organs.

Fabrazyme is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease.

Before You Use Fabrazyme Do not use Fabrazyme

If you have experienced an allergic anaphylactic reaction to agalsidase beta or if you are allergic (hypersensitive) to any of the other ingredients of Fabrazyme.

Take special care with Fabrazyme

If you are treated with Fabrazyme, you may develop infusion associated reactions. An infusion-associated reaction is any side effect occurring during the infusion or until the end of the infusion day (See 4 “Possible Side Effects”). If you experience a reaction like this, you should tell your doctor immediately. You may need to be given additional medicines to prevent such reactions from occurring.

Different groups of patients using Fabrazyme

The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly.

Using other medicines

There are no known interactions with other medicinal products. Fabrazyme should not be administered with chloroquine, amiodarone, benoquin or gentamicin due to a theoretical risk of decreased agalsidase beta activity. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using Fabrazyme with food and drink

Interactions with food and drink are unlikely.

Pregnancy and breast-feeding

Use of Fabrazyme during pregnancy is not recommended. There is no experience with the use of Fabrazyme in pregnant women. Fabrazyme may get into breast milk. Use of Fabrazyme during breast-feeding is not recommended. Ask your doctor or pharmacist for advice before taking this medicine.

How To Use Fabrazyme

Fabrazyme is given through a drip into a vein (by intravenous infusion). It is supplied as a powder which will be mixed with sterile water before it is given (see information for Health Care Professionals)

Fabrazyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Fabry disease.

The recommended dose of Fabrazyme for adults and children 8 – 16 years is 1 mg/kg body weight, once every 2 weeks. No changes in dose are necessary for patients with kidney disease.

If you use more Fabrazyme than you should

There are no cases of overdose of Fabrazyme reported. Doses up to 3 mg/kg body weight have shown to be safe.

If you forget to use Fabrazyme

If you have missed an infusion of Fabrazyme, please contact your doctor.

Possible Side Effects

Like all medicines, Fabrazyme can cause side effects, although not everybody gets them.

In clinical studies side effects were mainly seen while patients were being given the medicine or shortly after. If you experience any serious side effect or side effects not listed, please tell your doctor immediately.

In clinical trials the following side effects were reported:

Very common (occurring in more than 1 in 10 patients):

chills fever headache abnormal touch feeling (pins and needles) nausea vomiting feeling cold

Common (occurring in 1 in 100 to 1 in 10 patients):

chest pain difficulty in breathing pallor itching abnormal tear secretion feeling weak tinnitus nasal congestion diarrhoea redness muscle pain increased blood pressure sudden swelling of the face or throat oedema in extremities vertigo stomach discomfort muscle spasms sleepiness increased heart beat abdominal pain back pain rash low heart rate lethargy syncope cough abdominal discomfort swelling face joint pain decreased blood pressure chest discomfort face oedema exacerbated difficulty in breathing muscle tightness fatigue flushing pain throat tightness dizziness palpitations decreased sensitivity to pain burning sensation wheezing urticaria pain at the extremities nasopharyngitis hot flush feeling hot hyperthermia decreased mouth sensitivity musculoskeletal stiffness

Uncommon (occurring in 1 in 1000 to 1 in 100 patients):

tremor red eyes ear pain throat pain fast breathing itchy rash feeling hot and cold difficulty swallowing infusion site pain infusion site reaction itching eyes ear swelling bronchospasm runny nose heart burn skin discomfort musculoskeletal pain rhinitis influenza-like illness malaise low heart rate due to conduction disturbances increased sensitivity to pain upper respiratory tract congestion red rash (mottled purplish) skin discoloration coldness of the extremities injection site blood clotting skin discoloration oedema

Unknown frequency

Serious allergic reactions serious inflammation of the vessels lower blood oxygen levels

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Fabrazyme

Keep out of the reach and sight of children.

Unopened vials

Store in a refrigerator (2 °C – 8 °C).

Do not use Fabrazyme after the expiry date which is stated on the labelling after the letters ‘EXP’.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Fabrazyme contains The active substance is agalsidase beta, one vial contains 5 mg. Other ingredients are: Mannitol Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate. What Fabrazyme looks like and contents of the pack

Fabrazyme is supplied as a white to off-white powder. After reconstitution it is a clear, colourless liquid, free from foreign matter. The reconstituted solution must be further diluted. Package sizes: 1, 5 and 10 vials per carton. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder

Genzyme Europe B.V. Gooimeer 10 NL-1411DD Naarden The Netherlands

Manufacturer

Genzyme Ltd. 37 Hollands Road Haverhill Suffolk CB9 8PU United Kingdom

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom/Ireland Genzyme Therapeutics Ltd. United Kingdom Tel: +44 1865 405200

This leaflet was last approved in 01/2010

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu. There are also links to other websites about rare diseases and treatments.

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Noradrenaline (Norepinephrine) 1:1000 or Levophed

1. Name Of The Medicinal Product

Noradrenaline (Norepinephrine) 1:1000 or Levophed

concentrate for solution for infusion

2. Qualitative And Quantitative Composition

Noradrenaline Tartrate 2 mg/ml

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Concentrate for solution for infusion

4. Clinical Particulars 4.1 Therapeutic Indications

Norepinephrine 1:1000 is recommended for use as an emergency measure in the restoration of blood pressure in cases of acute hypotension.

4.2 Posology And Method Of Administration

Route of Administration:

For intravenous use.

Route and method of infusion:

Norepinephrine 1:1000 should be administered in a diluted solution via a central venous catheter.

The infusion should be at a controlled rate using either a syringe pump or an infusion pump or a drip counter.

Dilution instructions:

Norepinephrine 1:1000 should be diluted either with dextrose 5%, or with isotonic dextrose saline.

Adults:

Either add 2 ml of Norepinephrine 1:1000 to 48 ml 5% dextrose for administration by syringe pump, or add 20 ml of Norepinephrine 1:1000 to 480 ml 5% dextrose for administration by drip counter.

In both cases the final concentration of the infusion solution is 80 mg/litre norepinephrine tartrate, which is equivalent to 40 mg/litre norepinephrine base. If other dilutions are used check the calculation carefully before starting treatment.

Initial rate of infusion:

The initial rate of infusion should be between 10 ml/hour and 20 ml/hour (0.16 ml/min to 0.33 ml/min). This is equivalent to 0.8 mg/hr to 1.6 mg/hr norepinephrine tartrate (or 0.4 mg/hr to 0.8 mg/hr norepinephrine base).

Titration of dose:

Once an infusion of norepinephrine has been established the dose should be titrated according to the pressor effect observed. There is great individual variation in the dose required to attain and maintain normotension. The aim should be to establish a low normal systolic blood pressure (100-120 mm Hg) or to achieve an adequate mean arterial blood pressure (greater than 80 mm Hg).

Duration of Treatment and Monitoring:

Norepinephrine should be continued for as long as vasoactive drug support is indicated. The patient should be monitored carefully for the duration of norepinephrine therapy.

Elderly.

As for adults but see Precautions.

Children:

Not recommended.

4.3 Contraindications

The use of pressor amines during cyclopropane or halothane anaesthesia may cause serious cardiac arrhythmias. Because of the possibility of increasing the risk of ventricular fibrillation, norepinephrine should be used with caution in patients receiving these or any other cardiac sensitising agent or who exhibit profound hypoxia or hypercarbia.

Particular caution should be observed in patients with coronary, mesenteric or peripheral vascular thrombosis because norepinephrine may increase the ischemia and extend the area of infarction. Similar caution should be observed in patients with hypotension following myocardial infarction and in patients with Prinzmetal's variant angina.

4.4 Special Warnings And Precautions For Use

Norepinephrine should be used only in conjunction with appropriate blood volume replacement. When infusing norepinephrine, the blood pressure and rate of flow should be checked frequently to avoid hypertension. Extravasation of the solution may cause local tissue necrosis. The infusion site should be checked frequently. If extravasation occurs, the area should be infiltrated with phentolamine without delay.

It has been suggested that phentolamine may be added directly to the infusion flask to act as an antidote against sloughing without affecting the vasopressor activity of norepinephrine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Norepinephrine should be used with extreme caution in patients receiving monoamine oxidase inhibitors or tricyclic antidepressants because severe, prolonged hypertension may result. The elderly may be especially sensitive to the effects of norepinephrine.

4.6 Pregnancy And Lactation

Norepinephrine may impair placental perfusion and induce foetal bradycardia. It may also exert a contractile effect on the pregnant uterus and lead to foetal asphyxia in late pregnancy. These possible risks to the foetus should therefore be weighed against the potential benefit to the mother.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Hypertension may occur, which may be associated with bradycardia as well as headache and peripheral ischemia, including gangrene of the extremities. Cardiac arrhythmias may arise when norepinephrine is used in conjunction with cardiac sensitising agents, and may be more likely in patients with hypoxia or hypercarbia. Prolonged administration may result in plasma volume depletion.

4.9 Overdose

Overdosage may result in severe hypertension, reflex bradycardia, marked increase in peripheral resistance and decreased cardiac output. These may be accompanied by violent headache, photophobia, retrosternal pain, pallor, intense sweating and vomiting. In the event of overdosage, treatment should be withdrawn and appropriate corrective treatment initiated.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Adrenergic and dopaminergic agents, ATC code: C01CA03

The vascular effects of norepinephrine in the doses usually used clinically result from the simultaneous stimulation of alpha and beta adrenergic receptors in the heart and vascular system. Except in the heart, its action is predominantly on the alpha receptors. This results in an increase in the force (and in the absence of vagal inhibition) in the rate of myocardial contraction. Peripheral resistance increases and diastolic and systolic pressures are raised.

5.2 Pharmacokinetic Properties

Up to 16% of an intravenous dose is excreted unchanged in the urine with methylated and deaminated metabolites in free and conjugated forms.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium Chloride

Water for Injections.

This medicinal product contains sodium

? 2 ml container contains 0.29 mmol (or 6.7 mg) sodium per container.

? 4 ml container contains 0.58 mmol (or 13.3 mg) sodium per container.

? 20 ml container contains 2.9 mmol (or 67 mg) sodium per container.

To be taken into consideration by patients on a controlled sodium diet.

6.2 Incompatibilities

Infusion solutions containing norepinephrine tartrate have been reported to be incompatible with the following substances: alkalis and oxidising agents, barbiturates, chlorpheniramine, chlorothiazide, nitrofurantoin, novobiocin, phenytoin, sodium bicarbonate, sodium iodide, streptomycin.

6.3 Shelf Life

18 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Keep the container in the outer carton.

6.5 Nature And Contents Of Container

2ml, 4ml and 20ml ampoules packed in boxes of 5.

6.6 Special Precautions For Disposal And Other Handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Hospira Enterprises BV.

Randstad 22-11, 1316 BN Almere,

The Netherlands

8. Marketing Authorisation Number(S)

PL 23061/0006

9. Date Of First Authorisation/Renewal Of The Authorisation

1 July 2005

10. Date Of Revision Of The Text

October 2010

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Zinacef

ZINACEF 1.5 g, 750 mg and 250 mg

cefuroxime sodium powder for injection

Please read this leaflet carefully before starting to take your medicine. Keep it safe, as you may want to read it again. This leaflet contains important information about Zinacef injection. If you want to know more about your illness or your medicine, ask your pharmacist or doctor.

What is Zinacef?

Zinacef contains cefuroxime, which is an antibiotic belonging to the cephalosporin class. Antibiotics are used to kill the bacteria or “germs” which cause infections.

What Zinacef contains

Each vial contains:

The active ingredient - cefuroxime 250 mg or 750 mg or 1.5 g (as sodium salt).

Other ingredients - none.

Zinacef is supplied in single vials of cefuroxime 250 mg, 750 mg or 1.5 g.

Product licence holder and manufacturer Product licence held by Glaxo Operations UK Ltd. trading as GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT Manufactured by GlaxoSmithKline Manufacturing S.p.A. Verona Italy What Zinacef does

This medicine is used to treat infections of the airways; ear, nose and throat; urinary tract; bones and joints; pelvis; blood and wounds; gonorrhoea and meningitis.

Your doctor has decided to give you Zinacef because you have an infection or to protect you from infection before an operation or during dialysis. Sometimes Zinacef is used at the same time as other antibiotics and the correct dose is checked by blood tests.

Before having Zinacef Make sure your doctor knows: if you think you may be pregnant if you are breast-feeding if you have been told that you are allergic to Zinacef, cefuroxime or other antibiotics e.g. penicillin if you have been told that your kidneys are not working as well as they should be if you are taking a diuretic such as furosemide if you are taking an aminoglycoside type antibiotic or any other antibiotics. You and your doctor should also know that: if your urine is tested for sugar, Zinacef does not normally cause a false positive result as occurs with some other cephalosporin antibiotics if you have any blood tests, Zinacef can cause changes to the results.

Like other medicines used to treat meningitis, Zinacef may take a while to clear the body of all the meningitis infection. Because of this, hearing loss caused by meningitis has occurred in a few patients after using Zinacef to treat the disease.

Dosage and administration

The correct dose of Zinacef will be decided by your doctor and depends on the type of infection and your weight and age. Zinacef will usually be given by a doctor or nurse either directly into a vein or into a muscle. In some cases, it may be added to a “drip” intravenous infusion. Zinacef is made up by adding the following amount of sterile water or other recommended diluting solution.

Vial Size 250mg Intramuscular injection (suspension): 1ml Intravenous injection (solution): 2ml Intravenous infusion (solution): - Vial Size 750mg Intramuscular injection (suspension): 3ml Intravenous injection (solution): 6ml Intravenous infusion (solution): - Vial Size 1.5g Intramuscular injection (suspension): - Intravenous injection (solution): 15ml Intravenous infusion (solution): - Vial Size 1.5g infusion Intramuscular injection (suspension): - Intravenous injection (solution): - Intravenous infusion (solution): 50ml

The usual adult dose is from 750 mg to 1.5 g three times a day: bigger or more frequent doses are sometimes needed. The duration of treatment depends on the type of infection. In special cases, just one 1.5 g dose is sufficient.

To treat pneumonia in adults, the usual dose of Zinacef is 1.5 g, twice a day for 2 to 3 days, followed by a 7 day course of the oral form of Zinacef, called Zinnat (cefuroxime axetil).

To treat a sudden worsening of chronic bronchitis, the usual dose of Zinacef is 750 mg, twice a day for 2 to 3 days, followed by a 5 to 7 day course of Zinnat.

The duration of your treatment with Zinacef or Zinnat will depend on how severe your infection is and how well you are responding to the treatment.

For infants and children, the dose is based on body weight and is usually between 30 mg to 100 mg per kilogram daily divided into three or four separate doses. For newborn children the dose is as for infants and children, but is divided into 2 or 3 doses.

The daily dose depends on whether it is a simple or complicated infection and on whether other antibiotics are being used at the same time.

For patients with kidney problems the dose of Zinacef will be reduced.

Your medication will usually be given to you by a health professional. However if you think you may have missed a dose or have received too much medicine please tell your doctor or nurse.

Zinacef Side Effects

Along with its needed effects, a medicine may cause unwanted effects. Most people given Zinacef find it causes no problems.

A few people can be allergic to antibiotics, if any of the following rare side effects appear soon after having your injection, tell your doctor immediately:

sudden wheeziness, chest tightness, pain or collapse, as these may be symptoms of an acute allergic reaction to your medicine. The more common side effects of Zinacef that could happen to between in 1 in 10 and 1 in 100 people taking it include: changes to “blood counts” or tests used to measure the functioning of organs in the body such as the liver pain or inflammation at the site of injection (thrombophlebitis). Uncommon side effects that could happen to between 1 in 100 and 1 in 1,000 people taking Zinacef include: skin lumps or hives skin rash (red spots), itchiness diarrhoea or vomiting. Rare side effects that could happen to between 1 in 1,000 and 1 in 10,000 people include: as with other antibiotics after long courses of treatment, thrush in the vagina or mouth can occur easy bruising (thrombocytopenia) fever. Very rare side effects that could happen to less 1 in 10,000 taking Zinacef include: swelling of eyelids, face or lips severe diarrhoea from colitis (lower end of the bowel inflamed) kidney inflammation blistering or peeling skin.

If you feel unwell or have any unusual discomfort you do not understand, tell the doctor as soon as possible.

Storage

If you keep the vials at home, keep them away from heat and light which could spoil them. As with all medicines, keep Zinacef vials safely away from children. Store any unopened vials at room temperature below 25°C (77°F). Store reconstituted vials in a fridge at 2-8°C for no longer than 24 hours. Do not autoclave (a method of sterilization often used in hospitals).

What to do with any unused medication

If you are at home and your doctor stops your treatment, return any unused Zinacef vials to a pharmacist for disposal. Only keep your medication if your doctor tells you to. Do not use the unopened vials after the expiry date on the label or carton.

Further information

Remember this medicine is for you. Only a doctor can prescribe it for you.

This leaflet does not tell you everything about your medication. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

You may be able to find out more about prescribed medicines from books in public libraries.

Leaflet last updated 3 May 2006

The information provided applies only to Zinacef

Zinacef and Zinnat are registered trademarks of the GlaxoSmithKline group of companies

© 2006 GlaxoSmithKline group of companies

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Maalox Concentrate

Pronunciation: a-LOO-min-uhm/mag-NEE-zee-uhm
Generic Name: Aluminum/Magnesium
Brand Name: Examples include Alamag and Maalox
Maalox Concentrate is used for:

Treating acid indigestion, heartburn, and sour stomach. It may also be used for other conditions as determined by your doctor.

Maalox Concentrate is an antacid. It works by neutralizing acid in the stomach.

Do NOT use Maalox Concentrate if: you are allergic to any ingredient in Maalox Concentrate you are also taking citrate salts (found in some calcium supplements, antacids, and laxatives)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Maalox Concentrate:

Some medical conditions may interact with Maalox Concentrate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have Alzheimer disease, appendicitis, diarrhea, a stomach blockage, kidney problems, or an ileostomy if you have recently had stomach bleeding

Some MEDICINES MAY INTERACT with Maalox Concentrate. Tell your health care provider if you are taking any other medicines, especially any of the following:

Cation exchange resins (eg, sodium polystyrene sulfonate) and citrate salts (found in some calcium supplements, antacids, and laxatives) because they may increase the actions and the risk of Maalox Concentrate's side effects Anticoagulants (eg, warfarin), quinidine, or sulfonylureas (eg, glyburide) because their actions and the risk of their side effects may be increased Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), bisphosphonates (eg, risedronate), cephalosporins (eg, cephalexin), corticosteroids (eg, hydrocortisone), cyclosporine, delavirdine, digoxin, imidazoles (eg, ketoconazole), mycophenolate, penicillamine, quinolones (eg, ciprofloxacin), tetracyclines (eg, doxycycline), or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Maalox Concentrate, especially when taken at the same time as Maalox Concentrate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Maalox Concentrate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Maalox Concentrate:

Use Maalox Concentrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Maalox Concentrate by mouth with or without food. Shake well before each use. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose. Do not use Maalox Concentrate within 2 hours before or after taking a beta-blocker (eg, propranolol), bisphosphonate (eg, risedronate), cephalosporin (eg, cephalexin), corticosteroid (eg, hydrocortisone), delavirdine, digoxin, imidazole (eg, ketoconazole), penicillamine, or sulfonylurea (eg, glyburide) because their effectiveness may be decreased by Maalox Concentrate. If you miss a dose of Maalox Concentrate and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Maalox Concentrate.

Important safety information: Do NOT take more than the recommended dose or take the maximum dose for longer than 2 weeks without checking with your doctor. If your symptoms do not get better within 2 weeks or if they get worse, or if you experience black, tarry stools or vomit that looks like coffee grounds, check with your doctor. Maalox Concentrate has aluminum and magnesium in it. Before you begin taking any new prescription or over-the-counter medicine, read the ingredients to see has aluminum or magnesium in it too. If it does or if you are not sure, check with your doctor or pharmacist. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Maalox Concentrate while you are pregnant. If you are or will be breast-feeding while you use Maalox Concentrate, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Maalox Concentrate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); loss of appetite; muscle weakness; nausea; slow reflexes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Maalox Concentrate:

Store Maalox Concentrate between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Maalox Concentrate out of the reach of children and away from pets.

General information: If you have any questions about Maalox Concentrate, please talk with your doctor, pharmacist, or other health care provider. Maalox Concentrate is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Maalox Concentrate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Maalox resources Maalox Use in Pregnancy & BreastfeedingMaalox Drug InteractionsMaalox Support Group0 Reviews for Maalox - Add your own review/rating Compare Maalox with other medications Duodenal UlcerErosive EsophagitisGERDIndigestionStress Ulcer ProphylaxisZollinger-Ellison Syndrome

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Potassium Chloride Solution

Pronunciation: po-TAS-ee-um KLOR-ide
Generic Name: Potassium Chloride
Brand Name: Generic only. No brands available.

Injectable potassium chloride products in strengths of 1.5 mEq and 2 mEq per mL must be diluted before injecting into the vein. Instruct patients that injection of potassium concentrate may cause instant death. However, injectable potassium chloride products in strengths of 0.1, 0.2, 0.3, and 0.4 mEq per mL are intended for use with a calibrated infusion device and do not require dilution.

Potassium Chloride Solution is used for:

Treating and preventing potassium deficiency where oral doseforms are not possible.

Potassium Chloride Solution is an injectable potassium supplement. It works by restoring the potassium level in your body if your potassium level is low.

Do NOT use Potassium Chloride Solution if: you are allergic to any ingredient in Potassium Chloride Solution you are taking a potassium-sparing diuretic (eg, triamterene) you have a high blood potassium level or kidney failure

Contact your doctor or health care provider right away if any of these apply to you.

Before using Potassium Chloride Solution:

Some medical conditions may interact with Potassium Chloride Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a high acidity of your body fluids (acidosis), adrenal gland problems, diarrhea, or kidney problems

Some MEDICINES MAY INTERACT with Potassium Chloride Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

Aldosterone blockers (eg, spironolactone), angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or potassium-sparing diuretics (eg, triamterene) because the risk of high blood potassium levels may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Potassium Chloride Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Potassium Chloride Solution:

Use Potassium Chloride Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Potassium Chloride Solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Potassium Chloride Solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Potassium Chloride Solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not use Potassium Chloride Solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Potassium Chloride Solution MUST be diluted before use. It is very important to carefully check that the right amount of medicine is drawn into the syringe before injecting the medicine into its diluent solution. If this solution is given by way of a pumping device, be sure to stop the pumping action before the container runs dry or air embolism may occur. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Potassium Chloride Solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Potassium Chloride Solution.

Important safety information: Check with your doctor before you use a salt substitute or a product that has potassium in it. Too much or too little potassium can adversely affect your heart. Be sure that your health care provider and pharmacist are aware of any heart medicines you are taking. Lab tests, including electrolyte monitoring and kidney function, may be performed while you use Potassium Chloride Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Potassium Chloride Solution with caution in the ELDERLY; they may be more sensitive to its effects. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Potassium Chloride Solution while you are pregnant. It is not known if Potassium Chloride Solution is found in breast milk. If you are or will be breast-feeding while you use Potassium Chloride Solution, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Potassium Chloride Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; fever; infection at the injection site; nausea; vein irritation; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; chest pain; confusion; heart problems; irregular heartbeat; low blood pressure; muscle weakness; numbness or tingling in your hands or feet; stomach pain; vomit that looks like coffee grounds; weak or heavy legs; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Potassium Chloride side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; fast, slow, or irregular heartbeat; limp muscles; listlessness; muscle weakness or paralysis; slow or difficult breathing.

Proper storage of Potassium Chloride Solution:

Store Potassium Chloride Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Potassium Chloride Solution out of the reach of children and away from pets.

General information: If you have any questions about Potassium Chloride Solution, please talk with your doctor, pharmacist, or other health care provider. Potassium Chloride Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Potassium Chloride Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Potassium Chloride resources Potassium Chloride Side Effects (in more detail)Potassium Chloride Use in Pregnancy & BreastfeedingDrug ImagesPotassium Chloride Drug InteractionsPotassium Chloride Support Group5 Reviews for Potassium Chloride - Add your own review/rating Compare Potassium Chloride with other medications HypokalemiaPrevention of Hypokalemia

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Alamag Concentrate

Pronunciation: a-LOO-min-uhm/mag-NEE-zee-uhm
Generic Name: Aluminum/Magnesium
Brand Name: Examples include Alamag and Maalox
Alamag Concentrate is used for:

Treating acid indigestion, heartburn, and sour stomach. It may also be used for other conditions as determined by your doctor.

Alamag Concentrate is an antacid. It works by neutralizing acid in the stomach.

Do NOT use Alamag Concentrate if: you are allergic to any ingredient in Alamag Concentrate you are also taking citrate salts (found in some calcium supplements, antacids, and laxatives)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Alamag Concentrate:

Some medical conditions may interact with Alamag Concentrate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have Alzheimer disease, appendicitis, diarrhea, a stomach blockage, kidney problems, or an ileostomy if you have recently had stomach bleeding

Some MEDICINES MAY INTERACT with Alamag Concentrate. Tell your health care provider if you are taking any other medicines, especially any of the following:

Cation exchange resins (eg, sodium polystyrene sulfonate) and citrate salts (found in some calcium supplements, antacids, and laxatives) because they may increase the actions and the risk of Alamag Concentrate's side effects Anticoagulants (eg, warfarin), quinidine, or sulfonylureas (eg, glyburide) because their actions and the risk of their side effects may be increased Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), bisphosphonates (eg, risedronate), cephalosporins (eg, cephalexin), corticosteroids (eg, hydrocortisone), cyclosporine, delavirdine, digoxin, imidazoles (eg, ketoconazole), mycophenolate, penicillamine, quinolones (eg, ciprofloxacin), tetracyclines (eg, doxycycline), or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Alamag Concentrate, especially when taken at the same time as Alamag Concentrate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Alamag Concentrate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Alamag Concentrate:

Use Alamag Concentrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Alamag Concentrate by mouth with or without food. Shake well before each use. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose. Do not use Alamag Concentrate within 2 hours before or after taking a beta-blocker (eg, propranolol), bisphosphonate (eg, risedronate), cephalosporin (eg, cephalexin), corticosteroid (eg, hydrocortisone), delavirdine, digoxin, imidazole (eg, ketoconazole), penicillamine, or sulfonylurea (eg, glyburide) because their effectiveness may be decreased by Alamag Concentrate. If you miss a dose of Alamag Concentrate and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Alamag Concentrate.

Important safety information: Do NOT take more than the recommended dose or take the maximum dose for longer than 2 weeks without checking with your doctor. If your symptoms do not get better within 2 weeks or if they get worse, or if you experience black, tarry stools or vomit that looks like coffee grounds, check with your doctor. Alamag Concentrate has aluminum and magnesium in it. Before you begin taking any new prescription or over-the-counter medicine, read the ingredients to see has aluminum or magnesium in it too. If it does or if you are not sure, check with your doctor or pharmacist. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Alamag Concentrate while you are pregnant. If you are or will be breast-feeding while you use Alamag Concentrate, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Alamag Concentrate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); loss of appetite; muscle weakness; nausea; slow reflexes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Alamag side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Alamag Concentrate:

Store Alamag Concentrate between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Alamag Concentrate out of the reach of children and away from pets.

General information: If you have any questions about Alamag Concentrate, please talk with your doctor, pharmacist, or other health care provider. Alamag Concentrate is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Alamag Concentrate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Alamag resources Alamag Side Effects (in more detail)Alamag Use in Pregnancy & BreastfeedingAlamag Drug InteractionsAlamag Support Group0 Reviews for Alamag - Add your own review/rating Compare Alamag with other medications Duodenal UlcerErosive EsophagitisGERDIndigestionStress Ulcer ProphylaxisZollinger-Ellison Syndrome

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Alamag Concentrate

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