isosulfan blue Subcutaneous

eye-soe-SUL-fan BLOO

Commonly used brand name(s)

In the U.S.

Lymphazurin

In Canada

Lymphazurin 1%

Available Dosage Forms:

Solution

Therapeutic Class: Diagnostic Agent, Lymphatic Visualization

Uses For isosulfan blue

Isosulfan blue injection is used as an aid in a procedure called lymphography (medical imaging procedure) to test how well your lymphatic system is working in certain parts of your body. It is a blue dye that works by staining the lymph nodes and lymph vessels. This creates a contrast between the lymph nodes and vessels and helps your doctor check for serious medical problems such as lymphedema, chyluria (lymph in the urine), chylous ascites (lymph in the stomach), chylothorax (lymph in the chest), cancer of the lymph nodes, or other problems of the lymphatic system.

isosulfan blue is available only with your doctor's prescription.

Before Using isosulfan blue

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For isosulfan blue, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to isosulfan blue or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of isosulfan blue injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of isosulfan blue injection in geriatric patients.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of isosulfan blue. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma, history of—Use with caution. May be more likely to experience side effects. Proper Use of isosulfan blue

A doctor will give you isosulfan blue in a hospital. isosulfan blue is given as a shot under your skin.

Precautions While Using isosulfan blue

It is very important that your doctor check your progress closely while you are receiving isosulfan blue. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

isosulfan blue may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have cold clammy skin; confusion; dizziness; lightheadedness; a skin rash; itching; shortness of breath; sweating; swelling of the face, tongue, and throat; or trouble with breathing after you get the injection.

Make sure your doctor knows if you have had an allergic reaction to any dye or medicine given during a test or procedure.

Make sure any doctor or dentist who treats you knows that you are using isosulfan blue. isosulfan blue may affect the results of certain medical tests.

isosulfan blue may cause your urine to turn blue for up to 24 hours after you receive isosulfan blue. Talk to your doctor if you have any questions.

isosulfan blue Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common Cold, clammy skin confusion cough difficulty with swallowing dizziness fast heartbeat fast, weak pulse hives or welts itching large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs lightheadedness puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue redness of the skin shortness of breath skin rash sweating tightness in the chest troubled breathing unusual tiredness or weakness wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known Blue discoloration of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: isosulfan blue Subcutaneous side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More isosulfan blue Subcutaneous resources Isosulfan blue Subcutaneous Side Effects (in more detail)Isosulfan blue Subcutaneous Use in Pregnancy & BreastfeedingIsosulfan blue Subcutaneous Support Group0 Reviews for Isosulfan blue Subcutaneous - Add your own review/rating Compare isosulfan blue Subcutaneous with other medications Diagnosis and Investigation

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Ibuflam Lichtenstein may be available in the countries listed below.

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Ibuprofen is reported as an ingredient of Ibuflam Lichtenstein in the following countries:

Germany

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Ibuleve Gel 50g

Information for the user

IBULEVETM GEL

ibuprofen 5% w/w

Read all of this leaflet carefully before using this product.

Keep this leaflet. You may need to read it again.

Ask your doctor or pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do not improve after a few weeks.

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

In this leaflet: 1. What Ibuleve is and what it is used for 2. Before you use Ibuleve 3. How to use Ibuleve 4. Possible side effects 5. How to store Ibuleve 6. Further information What Ibuleve Is And What It Is Used For Ibuleve is an anti-inflammatory painkiller applied to, and absorbed through, the skin. It is for the treatment of the following conditions involving the musculoskeletal system: backache rheumatic or muscular pain sprains strains neuralgia. It is also for pain relief in common arthritic conditions. Ibuleve is recommended for use by adults, the elderly and children over the age of 12 years. Children under the age of 12 may also use it if recommended by their doctor. The active ingredient in this product is ibuprofen. This is one of a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen works by: relieving pain reducing swelling and inflammation. Before You Use Ibuleve Do not use Ibuleve: if you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of Ibuleve listed in section 6; if you are asthmatic, or suffer from rhinitis (allergic runny nose) or urticaria (hives) and have ever had a bad reaction to aspirin, ibuprofen or other NSAIDs in the past; if you are pregnant or breast-feeding; on broken, damaged, infected or diseased skin.

Before applying this product for the first time, make sure it is suitable for you to use:

Because Ibuleve is delivered through the skin, directly over the painful area, there is less risk of the complications that sometimes occur when ibuprofen (or a similar anti-inflammatory painkiller) is taken by mouth. However, in rare cases you may be at risk:

if you have a stomach ulcer (also called a peptic or gastric ulcer); if you have ever had kidney problems; if you have ever had asthma; if you have ever had a bad reaction to aspirin or ibuprofen taken by mouth.

If any of the above apply to you, only use this product on advice from your doctor or pharmacist.

Take special care when using this product: Use it only on the skin. Do not use it on children under 12 years old unless advised by a doctor. Do not apply it to broken or irritated skin. Keep the gel away from the eyes, nose and mouth. Using other medicines Interaction between Ibuleve and blood pressure lowering drugs and anticoagulants is possible, in theory, although very unlikely. If you would like more advice about this, speak to your doctor or pharmacist. If you are also taking aspirin or other NSAIDs by mouth, discuss this beforehand with your doctor or pharmacist because these may increase the risk of undesirable effects. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including other medicines obtained without prescription. Pregnancy and breast-feeding

You should not use Ibuleve if you are pregnant or breast-feeding.

Driving and using machinery

Using this product is not known to affect your ability to drive or use machinery.

Important information about one of the ingredients of Ibuleve

The product contains a small amount of propylene glycol. This ingredient may cause skin irritation in a small number of people who are intolerant to it. If your doctor has told you that you have an intolerance to propylene glycol, please talk to your doctor before using this product.

How To Use Ibuleve Before using this tube of gel for the first time, open it as follows: Unscrew the cap, turn it upside down and then use the sharp point of the cap to pierce the membrane in the neck of the tube. The tube squeezer key:

To make Ibuleve easier and more economical to use, a tube squeezer key has been provided. Once fitted to the tube, simply turning the key will dispense the gel more easily for patients who experience difficulties in squeezing tubes.For economy, the key will also help expel the last few grams of Ibuleve when the tube is nearly empty.

To fit the tube squeezer key: Ensure that the tube nozzle has been pierced using the point of the cap. Slide the slit of the key over the folded end of the tube. Carefully turn the key to roll up the tube until the required amount of gel has been expelled. Always replace the cap after use, leaving the key in place on the end of the tube. To use the gel (for adults, the elderly and children over 12 years old): Use the gel up to three times a day, or as often as advised by your doctor. Lightly apply the gel to intact skin over the painful area. Apply only enough gel to thinly cover the affected area, then massage gently until absorbed. Wash hands after use, unless treating them. Carry on using the gel in this way until your condition gets better (you may find you need to use it for a few weeks, and your doctor may want you to continue using it for longer than this). If your symptoms worsen or continue for more than a few weeks, discuss this with your doctor before continuing treatment. If the gel comes into contact with broken skin or gets into the eyes, nose or mouth The product may cause irritation if it comes into contact with broken skin or gets into the eyes, nose or mouth. If this happens, rinse the affected areas with plenty of water. If rinsing one eye, take care to avoid washing product into the other eye. If irritation persists, tell your doctor or pharmacist. If the gel is accidentally swallowed Symptoms may include headache, vomiting, drowsiness and low blood pressure. If you experience any of these symptoms contact a doctor or hospital straight away. If you forget to use this product

Do not worry if you occasionally forget to use this product, just carry on using it when you remember.

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

Possible Side Effects

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

Occasionally, mild skin rashes, itching or irritation can sometimes occur at the site of application.

If this is unacceptable, or persists, stop using the product and tell your doctor or pharmacist.

Very rarely, the following side effects can happen with ibuprofen, although these are extremely uncommon with products such as Ibuleve that are applied to the skin.

If you experience any of the following, stop using Ibuleve immediately and tell your doctor: Allergic reactions (particularly in people who have a history of asthma or allergic problems), such as: unexplained runny nose and watery eyes, or, in more serious cases asthma or aggravated asthma involving breathing difficulties, wheezing or chest tightness; generalised allergic skin reactions involving itch, swelling, inflammation, redness and perhaps blistering and light sensitivity; other more serious generalised allergic reactions possibly involving unexplained nausea and vomiting, swollen eyes, face or tongue, difficulty swallowing, dizziness or light-headedness.Unconsciousness could perhaps occur in the most serious cases. Kidney problems (particularly in people who have a history of kidney disease), such as: decreased urine volume; loss of appetite / weight loss; swelling to abdomen. Problems with the digestive system (particularly in people who have a history of stomach ulcers etc), such as: stomach pain; heartburn / indigestion.

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 Ibuleve Keep it out of the reach and sight of children. Always replace the cap tightly after use. Do not store the product above 25°C. Do not use after the expiry date shown on the fold of the tube and the carton. The expiry date refers to the last day of that month. 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 About Ibuleve What Ibuleve contains:

The active ingredient is ibuprofen (5% w/w).

The other ingredients are industrial methylated spirit, carbomers, propylene glycol, diethylamine and purified water.

What Ibuleve looks like and contents of the pack The product is a clear, colourless gel that contains no fragrance. The gel is available in tubes containing 30g, 50g and 100g. The 50g and 100g packs also contain a tube key. The Marketing Authorisation holder is Diomed Developments Limited Tatmore Place Gosmore Hitchin Herts SG4 7QR UK The Manufacturer is DDD Limited 94 Rickmansworth Road Watford Herts WD18 7JJ UK The Distributor is DDD Limited 94 Rickmansworth Road Watford Herts WD18 7JJ UK

This leaflet was last approved in June 2008.

To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge: 0800 198 5000 (UK only).

Please be ready to give the following information: Ibuleve 00173/0060.

This is a service provided by the Royal National Institute of Blind People (RNIB).

KD8/08/1

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Insulin Penmix 50 may be available in the countries listed below.

Ingredient matches for Insulin Penmix 50 Insulin Injection, Biphasic Isophane

Insulin Injection, Biphasic Isophane human (a derivative of Insulin Injection, Biphasic Isophane) is reported as an ingredient of Insulin Penmix 50 in the following countries:

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Imdur
Generic Name: isosorbide mononitrate Dosage Form: tablet, extended releaseImdur®

Improvil

Improvil may be available in the countries listed below.

Ingredient matches for Improvil Ethinylestradiol

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Australia Norethisterone

Norethisterone is reported as an ingredient of Improvil in the following countries:

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Ibuprofeno MK may be available in the countries listed below.

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Ibuprofen is reported as an ingredient of Ibuprofeno MK in the following countries:

Belize Colombia Costa Rica Dominican Republic Ecuador El Salvador Guatemala Honduras Nicaragua Panama

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Ifa Acxion

Ifa Acxion may be available in the countries listed below.

Ingredient matches for Ifa Acxion Phentermine

Phentermine hydrochloride (a derivative of Phentermine) is reported as an ingredient of Ifa Acxion in the following countries:

Mexico

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Ipran

Ipran may be available in the countries listed below.

Ingredient matches for Ipran Escitalopram

Escitalopram is reported as an ingredient of Ipran in the following countries:

Chile Ecuador

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Isormol

Isormol may be available in the countries listed below.

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Isosorbide Mononitrate is reported as an ingredient of Isormol in the following countries:

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Innohep 20,000 IU / ml and Innohep syringe 20,000 IU / ml
1. Name Of The Medicinal Product

innohep® 20,000 IU/ml and innohep® Syringe 20,000 IU/ml

2. Qualitative And Quantitative Composition

Tinzaparin sodium 20,000 anti-Factor Xa IU/ml

3. Pharmaceutical Form

Solution for injection

4. Clinical Particulars 4.1 Therapeutic Indications

Treatment of deep vein thrombosis and of pulmonary embolus.

4.2 Posology And Method Of Administration

Administration is by subcutaneous injection only.

Adults:

175 anti-Factor Xa IU/kg bodyweight once daily, for at least 6 days and until adequate oral anti-coagulation is established. There is no need to monitor the anticoagulant activity of innohep®.

Patients with renal impairment:

Caution is recommended when treating patients with renal impairment (see Section 4.4, Special warnings and precautions for use). Monitoring of anti-factor Xa activity should be considered in patients with severe renal impairment (creatinine clearance < 30 ml/min); however, available evidence suggests that no dose reduction is needed in patients with creatinine clearance levels down to 20 ml/min.

Elderly:

Renal function should be assessed, for example with the Cockcroft-Gault formula, to estimate creatinine clearance levels. No dose reduction is needed in elderly patients with normal renal function (see Section 4.4, Special warnings and precautions for use).

Children:

There is no experience of use in children.

4.3 Contraindications

• Known hypersensitivity to constituents.

• Current or history of heparin-induced thrombocytopenia.

• Generalised or local haemorrhagic tendency, including uncontrolled severe hypertension, severe liver insufficiency, active peptic ulcer, acute or subacute septic endocarditis, intracranial haemorrhage, or injuries and operations on the central nervous system, eyes and ears, and in women with abortus imminens.

• The innohep® 20,000 IU/ml vial formulation contains 10 mg/ml of the preservative benzyl alcohol. This formulation must not be given to premature babies or neonates.

The innohep® 20,000 IU/ml syringe formulation does not contain the preservative benzyl alcohol.

• An epidural anaesthesia during birth in pregnant women treated with low molecular weight heparin is contraindicated (see section 4.6).

• In patients receiving heparin for treatment rather than prophylaxis, locoregional anaesthesia in elective surgical procedures is contraindicated because the use of heparin may be very rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis.

4.4 Special Warnings And Precautions For Use

Care should be taken when innohep® is administered to patients with increased risk of bleeding complications.

In patients undergoing peridural or spinal anaesthesia or spinal puncture, the prophylactic use of heparin may be very rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis. The risk is increased by the use of a peridural or spinal catheter for anaesthesia, by the concomitant use of drugs affecting haemostasis such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors or anticoagulants, and by traumatic or repeated puncture.

In decision making on the interval between the last administration of heparin at prophylactic doses and the placement or removal of a peridural or spinal catheter, the product characteristics and the patient profile should be taken into account. Subsequent dose should not take place before at least four hours have elapsed. Re-administration should be delayed until the surgical procedure is completed.

Should a physician decide to administer anti-coagulation in the context of peridural or spinal anaesthesia, extreme vigilance and frequent monitoring must be exercised to detect any signs and symptoms of neurologic impairment, such as back pain, sensory and motor deficits and bowel or bladder dysfunction. Patients should be instructed to inform immediately a nurse or a clinician if they experience any of these.

innohep® should not be administered by intramuscular injection due to the risk of haematoma.

Due to increased bleeding risk care should be taken when giving concomitant intramuscular injections, lumbar puncture and similar procedures.

innohep® should be used with caution in patients with hypersensitivity to heparin or to other low molecular weight heparins.

As there is a risk of antibody-mediated heparin-induced thrombocytopenia, platelet counts should be measured in patients receiving heparin treatment for longer than 5 days and the treatment should be stopped immediately in those who develop thrombocytopenia.

As with other low molecular weight heparins, in some patients undergoing surgical procedures (especially orthopaedic) or presenting with a concomitant inflammatory process, the administration of innohep® has coincided with an asymptomatic increase of platelet count, which in many cases subsided during continued administration. If an increase in platelet count occurs, evaluation of the benefit/risk of continuing therapy for that patient should be made.

Renal impairment (also see Section 4.2, Posology and method of administration): Caution is recommended in the treatment of patients with renal impairment. Monitoring of anti Xa activity should be considered in patients with severe renal impairment (creatinine clearance < 30 ml/min).

Caution is recommended in the treatment of elderly patients with renal impairment. Renal function should be assessed in all elderly patients. Monitoring of anti-factor Xa activity should be considered in patients with severe renal impairment (creatinine clearance < 30 ml/min).

For some patients with pulmonary embolism (e.g. those with severe haemodynamic instability) alternative treatment, such as surgery or thrombolysis, may be indicated.

Heparin can suppress adrenal secretion of aldosterone leading to hyperkalaemia, particularly in patients such as those with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, a raised plasma potassium or taking potassium-sparing drugs. The risk of hyperkalaemia appears to increase with duration of therapy but is usually reversible. Plasma potassium should be measured in patients at risk before starting heparin therapy and monitored regularly thereafter particularly if treatment is prolonged beyond about 7 days.

The innohep® 20,000 IU/ml syringe and vial formulations contain sodium metabisulphite (E223). This may rarely cause severe hypersensitivity reactions and bronchospasm.

The innohep® 20,000 IU/ml vial formulation contains the preservative benzyl alcohol 10 mg/ml. This should be administered with caution to infants and children up to 3 years old, as there is a risk that benzyl alcohol may cause toxic reactions and allergic reactions (anaphylactoid) in this age group (see section 4.3 for premature babies and neonates).

Drugs affecting platelet function or the coagulation system should in general not be given concomitantly with innohep® (see section 4.5).

Prosthetic heart valves:

There have been no adequate studies to assess the safe and effective use of tinzaparin sodium in preventing valve thrombosis in patients with prosthetic heart valves; therefore no dosage recommendations can be given. High doses of tinzaparin sodium (175 IU/kg) may not be sufficient prophylaxis to prevent valve thrombosis in patients with prosthetic heart valves. The use of tinzaparin sodium cannot be recommended for this purpose.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The anticoagulant effect of innohep® may be enhanced by concomitant medication with other drugs affecting platelet function or the coagulation system, e.g. platelet aggregation inhibitors, thrombolytic agents, salicylates, non-steroidal anti-inflammatory drugs, vitamin K antagonists, dextrans, activated protein C.

4.6 Pregnancy And Lactation

Pregnancy

No transplacental passage of innohep® was found (assessed by anti-Factor Xa and anti-Factor IIa activity) in patients given a dose of 35 to 40 anti-Factor Xa IU/kg in the second trimester of pregnancy. In rabbits, no transplacental passage of anti-Factor Xa or anti-Factor IIa activity was observed after doses of 1750 anti-Factor Xa IU/kg. Toxicological studies in rats have shown no embryotoxic or teratogenic effects, although a lower birthweight was found.

Although these animal studies show no hazard, as a precaution innohep® should not be used in pregnancy unless no safer alternative is available.

As benzyl alcohol may cross the placenta, the use of innohep® formulations containing benzyl alcohol should be avoided during pregnancy.

The use of innohep® in women with abortus imminens is contraindicated (see section 4.3).

Prosthetic heart valves:

Therapeutic failures and maternal death have been reported in pregnant women with prosthetic heart valves on full anti-coagulant doses of low molecular weight heparins. In the absence of clear dosing, efficacy and safety information in this circumstance, tinzaparin sodium is not recommended for use in pregnant women with prosthetic heart valves.

Lactation

It is not known whether innohep® is excreted in breast milk. However, patients are advised to stop breast-feeding while receiving innohep®.

4.7 Effects On Ability To Drive And Use Machines

innohep® has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable Effects

Based on reports from clinical trials the frequency rate of all adverse reactions is 17.6%. The most frequently reported undesirable effects are bleeding events, injection site reactions, various skin reactions, reversible thrombocytopenia, allergic reactions, headache and reversible increase in liver enzymes.

Based on pooled study results, from a clinical trial programme where 3167 patients received innohep®, local reactions following subcutaneous administration such as irritation, bruising, pain and ecchymosis were identified in approximately 3.7% of patients. The overall bleeding risk was approximately 11% while the risk of major bleeding was approximately 0.5%. Reversible thrombocytopenia was seen in approximately 0.6% of patients.

A list of undesirable effects is given below. Where frequencies are given, these are based on the clinical trial data, using the stated frequency classification. Where the term 'Not known' is given, these effects are derived from spontaneous reports.

Frequency classification:

Very common

>1/10

Common

>1/100 and <1/10

Uncommon

>1/1,000 and <1/100

Rare

>1/10,000 and <1/1,000

Very rare

<1/10,000

• Blood and lymphatic system disorders

 

Uncommon:

Thrombocytopenia (type I).

Not known:

Heparin induced thrombocytopenia (HIT), probably of an immuno-allergic nature (see Section 4.4). In some cases, Heparin induced thrombocytopenia has been accompanied by venous or arterial thrombi.

 

Increase in platelet count, asymptomatic and reversible (see section 4.4).

Class effect:

Valve thrombosis in patients with prosthetic heart valves has been reported rarely in patients receiving low molecular weight heparins, usually associated with inadequate dosing (see Section 4.4).

• Immune system disorders

 

Uncommon:

Allergic reactions (of all types and severities have been reported).

• Metabolism and nutrition disorders

 

Not known:

Hypoaldosteronism associated with hyperkalaemia and metabolic acidosis, especially in patients with renal impairment and diabetes mellitus (see Section 4.4).

• Nervous system disorders

 

Uncommon:

Headache.

• Vascular disorders

 

Very common:

Haemorrhage. Haemorrhagic complications may affect any organ, and may have different degrees of severity. In some cases haemorrhage has resulted in death or permanent disability. Haemorrhagic complications can occur in particular when high doses are administered. Anaemia can occur as a consequence of haemorrhage.

Not known:

Epidural and spinal haematoma (see Section 4.4).

• Hepatobiliary disorders

 

Uncommon:

Raised transaminases. These increases are reversible after drug withdrawal.

Not known:

Raised gamma-GT.

• Skin and subcutaneous tissue disorder

 

Uncommon:

Rash (such as erythematous or maculopapular), pruritus, urticaria.

Rare:

Skin necrosis.

Not known:

Angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome.

• Musculoskeletal and connective tissue disorders

 

Not known:

Osteoporosis has been reported in connection with long-term treatment with heparin.

• Reproductive system and breast disorders

 

Not known:

Priapism.

• General disorders and administration site conditions

 

Common:

Injection site reactions (local irritation, pain, bruising, ecchymosis).

4.9 Overdose

Overdose of innohep® may be complicated by haemorrhage. With recommended dosages there should be no need for an antidote but in the event of accidental administration of an overdose, the effect of innohep® can be reversed by intravenous administration of 1% protamine sulphate solution.

The dose of protamine sulphate required for neutralisation should be accurately determined by titrating with the patient's plasma.

Studies in healthy volunteers indicate that 65-80% of the anti-Xa activity is neutralised by protamine sulphate 1 mg/100 anti-Xa IU of innohep®. A return of innohep® anti-Xa, anti-IIa and APTT activities are seen 3 hours after its reversal probably due to continuous absorption of innohep® from the s.c. depot. It may therefore be necessary to give protamine sulphate intermittently or as a continuous infusion to achieve and maintain neutralisation of s.c. innohep® for at least 24 hours. Potential side-effects of protamine sulphate must be considered and patients carefully observed.

Transfusion of fresh plasma may be used, if necessary. Plasma anti-Factor Xa and anti-Factor IIa activity should be measured during the management of overdose situations.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

innohep® is an antithrombotic agent. It potentiates the inhibition of several activated coagulation factors, especially Factor Xa, its activity being mediated via antithrombin III.

5.2 Pharmacokinetic Properties

The pharmacokinetics/pharmacodynamic activity of innohep® is monitored by anti-Factor Xa activity. Following subcutaneous injection of innohep®, anti-Factor Xa activity reaches a maximum at 4-6 hours (peak anti-Factor Xa activity, after administration of 175 anti-Factor Xa IU/kg bodyweight once daily, is approximately 0.5-1.0 IU/ml). Detectable anti-Factor Xa activity persists for 24 hours.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

innohep® 20,000 IU/ml:

Sodium metabisulphite

Benzyl alcohol

Sodium hydroxide

Water for injections

innohep® Syringe 20,000 IU/ml:

Sodium metabisulphite

Sodium hydroxide

Water for injections

6.2 Incompatibilities

innohep® should be given by subcutaneous injection. It should not be mixed with any other injection.

6.3 Shelf Life

innohep® 20,000 IU/ml:

2 years.

innohep® Syringe 20,000 IU/ml:

3 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

innohep® 20,000 IU/ml:

2 ml glass vial containing 20,000 anti-Factor Xa IU/ml in packs of 1 vial.

innohep® Syringe 20,000 IU/ml:

A prefilled variable dose graduated syringe with needle safety device containing:

0.5 ml (10,000 anti-Factor Xa IU)

0.7 ml (14,000 anti-Factor Xa IU)

0.9 ml (18,000 anti-Factor Xa IU)

in packs of 2 and 6 syringes

6.6 Special Precautions For Disposal And Other Handling

innohep® 20,000 IU/ml:

The vial should be discarded 14 days after first use.

innohep® Syringe 20,000 IU/ml:

Contains no bactericide, any portion of the contents not used at once should be discarded together with the syringe.

7. Marketing Authorisation Holder

LEO Laboratories Limited

Longwick Road

Princes Risborough

Bucks HP27 9RR

8. Marketing Authorisation Number(S)

innohep® 20,000 IU/ml

PL 00043/0192

innohep® Syringe 20,000 IU/ml

PL 00043/0197

9. Date Of First Authorisation/Renewal Of The Authorisation

innohep® 20,000 IU/ml

18 October 1994

innohep® Syringe 20,000 IU/ml

3 October 1996

10. Date Of Revision Of The Text

1 September 2011

LEGAL CATEGORY

POM

Itraspor

Itraspor may be available in the countries listed below.

Ingredient matches for Itraspor Itraconazole

Itraconazole is reported as an ingredient of Itraspor in the following countries:

Greece Turkey

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Indatab

Indatab may be available in the countries listed below.

Ingredient matches for Indatab Indapamide

Indapamide is reported as an ingredient of Indatab in the following countries:

Vietnam

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Intergonan

Intergonan may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Intergonan Gonadotrophin, Serum

Gonadotrophin, Serum is reported as an ingredient of Intergonan in the following countries:

Germany Portugal

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Isoket Retard

Isoket Retard may be available in the countries listed below.

Ingredient matches for Isoket Retard Isosorbide Dinitrate

Isosorbide Dinitrate is reported as an ingredient of Isoket Retard in the following countries:

Germany Ireland Luxembourg Sri Lanka

International Drug Name Search

Inatal Advance

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins) Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Inatal Advance (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin. What should I discuss with my healthcare provider before taking prenatal vitamins? Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding. How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

What should I avoid while taking prenatal vitamins? Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin. Prenatal vitamins side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

upset stomach;

headache; or

unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

diuretics (water pills);

heart or blood pressure medications;

tretinoin (Vesanoid);

isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

This list is not complete and other drugs may interact with prenatal vitamins. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Inatal Advance resources Inatal Advance Use in Pregnancy & BreastfeedingInatal Advance Drug InteractionsInatal Advance Support Group0 Reviews for Inatal Advance - Add your own review/rating Inatal Advance Prescribing Information (FDA) Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer) CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer) CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer) CitraNatal Assure Prescribing Information (FDA) CitraNatal Harmony Prescribing Information (FDA) Concept DHA Prescribing Information (FDA) Docosavit Prescribing Information (FDA) Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer) Folbecal MedFacts Consumer Leaflet (Wolters Kluwer) Folcal DHA Prescribing Information (FDA) Folcaps Care One Prescribing Information (FDA) Gesticare DHA Prescribing Information (FDA) Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer) Inatal Ultra Prescribing Information (FDA) Multi-Nate DHA Prescribing Information (FDA) Multi-Nate DHA Extra Prescribing Information (FDA) MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer) Natelle One Prescribing Information (FDA) Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer) Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer) OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer) Paire OB Plus DHA Prescribing Information (FDA) PreNexa Prescribing Information (FDA) PreNexa MedFacts Consumer Leaflet (Wolters Kluwer) PreferaOB Prescribing Information (FDA) Prenatal Plus Prescribing Information (FDA) Prenatal Plus Iron Prescribing Information (FDA) Prenate Elite tablets Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer) Prenate Elite Prescribing Information (FDA) Prenate Essential Prescribing Information (FDA) PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer) PrimaCare ONE capsules PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer) Renate DHA Prescribing Information (FDA) Se-Natal 19 Prescribing Information (FDA) Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Tandem DHA Prescribing Information (FDA) Tandem OB Prescribing Information (FDA) TriAdvance Prescribing Information (FDA) Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer) Triveen-PRx RNF Prescribing Information (FDA) UltimateCare ONE NF Prescribing Information (FDA) Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer) Vinate AZ Prescribing Information (FDA) Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer) Zatean-CH Prescribing Information (FDA) Compare Inatal Advance with other medications Vitamin/Mineral Supplementation during Pregnancy/Lactation Where can I get more information? Your pharmacist can provide more information about prenatal vitamins.

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