Ceplene 0.5 mg / 0.5 ml solution for injection

1. Name Of The Medicinal Product

Ceplene 0.5 mg/0.5 ml solution for injection

2. Qualitative And Quantitative Composition

One vial of 0.5 ml of solution contains 0.5 mg of histamine dihydrochloride.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection.

Clear, colourless aqueous solution.

4. Clinical Particulars 4.1 Therapeutic Indications

Ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (IL-2). The efficacy of Ceplene has not been fully demonstrated in patients older than age 60.

4.2 Posology And Method Of Administration

Ceplene maintenance therapy should be administered following completion of consolidation therapy in patients concomitantly treated with IL-2 under the supervision of a physician experienced in the management of acute myeloid leukaemia.

For dosing instructions for Ceplene in combination with IL-2, see posology below.

Interleukin-2 (IL-2)

IL-2 is administered twice daily as a subcutaneous injection 1 to 3 minutes prior to the administration of Ceplene; each dose of IL-2 is 16 400 IU/kg (1µg/kg).

Interleukin-2 (IL-2) is commercially available as a recombinant IL-2; aldesleukin. The reconstitution, dilution, dispensing and storage directions below are specific to aldesleukin.

Dispensing Instructions for IL-2 (aldesleukin)

IL-2 (aldesleukin) should be aseptically reconstituted, diluted and dispensed in capped polypropylene tuberculin syringes by the pharmacy based on the individual patient's weight (see administration chart for aldesleukin below) at the recommended dose of 16 400 IU/kg (1 µ?g/kg). Up to two weeks supply of pre-filled capped tuberculin syringes may be provided to patients for home administration, with instructions that the syringes be stored under refrigeration at 2°– 8°C prior to administration.

Studies have shown chemical stability and sterility of diluted aldesleukin (dispensed in capped polypropylene tuberculin syringes) for up to three weeks when prepared in a controlled aseptic environment and stored under refrigeration at 2°– 8°C.

NOTE: Dispensing of aldesleukin must be carried out under controlled aseptic conditions.

Initial Reconstitution: Each vial of aldesleukin (1.3 mg / vial) is reconstituted aseptically with 1.2 mL Water for Injections (see commercially available aldesleukin Summary of Product Characteristics). Direct the diluent against the side of the vial to avoid excessive foaming. Gently swirl to facilitate complete dissolution of the powder. Do NOT shake the vial during the entire reconstitution process. The resulting solution contains 22 x 10 6 IU (1,300µg) of aldesleukin per 1.2 ml.

Subsequent Dilution to 200 µg/ml: The entire contents of the reconstituted vial (1.2ml) is then further diluted aseptically with 5.3ml Dextrose 5% w/v Solution for Injection to a total volume of 6.5 ml providing a final concentration of 200µg/ml (3.3 x 106 IU/ml) of IL-2 (aldesleukin).

Dispensing of dilute IL-2 (Aldesleukin) for each patient: The diluted IL-2 (aldesleukin) is aseptically drawn up into sterile polypropylene tuberculin syringes and capped for each patient at 1 µg/kg dose, with a minimum standard dosage volume of 0.25 ml (50 µg) and a maximum dose of 0.5 ml (100 µg). Dosing volumes based on patient weight are provided in Table 1 below. This table also provides the volume required if a 20 % dose reduction is prescribed.

Table 1: Administration Chart for IL-2 (aldesleukin)

Patient Weight

(kg)

Standard Dosage

(µg)

Injection Volume*

(ml)

20% Dose Reduction Injection Volume

(ml)**

50

0.25

0.20

>50 to

60

0.30

0.25

>60 to

70

0.35

0.30

>70 to

80

0.40

0.30

>80 to

90

0.45

0.35

>90 to

100

0.50

0.40

>100

100

0.50

0.40

*Injection volume rounded up to the nearest 0.05ml

** Injection volumes based on 20 % reductions are rounded thus actual dose reductions vary from 15%-25%

Ceplene

0.5 ml solution is sufficient for a single dose (see section 6.6).

Ceplene is administered 1 to 3 minutes after each injection of IL-2. Each 0.5 ml Ceplene dose is injected slowly, over 5-15 minutes.

Treatment cycles

Ceplene and IL-2 are administered for 10 treatment cycles: each cycle consists of a treatment period of 21 days (3 weeks) followed by a three-week or six-week treatment-free period.

For cycles 1-3, each cycle consists of 3 weeks of treatment, followed by a 3-week treatment free period. For cycles 4-10, each cycle consists of 3 weeks of treatment, followed by a 6-week treatment-free period.

The recommended dosing regimen is presented in Tables 2 and 3.

Table 2: For treatment cycles 1-3 with Ceplene and IL-2

Week number (w)*

Treatment*

   

Cycle 1

Cycle 2

Cycle 3

 

w.1 to w.3

(Days 1-21)

w.7 to w.9

(Days 1-21)

w.13 to w.15

(Days 1-21)

IL-2 16 400 IU/kg followed by 0.5 ml Ceplene. Twice daily.

w.4 to w.6

w.10 to w.12

w.16 to w.18

Treatment-free (3 weeks)

*see dose modification for provisions for the modification to dose and dosage schedule

Table 3: For treatment cycles 4-10 with Ceplene and IL-2, same as for Table 2 above, with the exception of number of cycles and duration of rest periods

Week number (w)*

Treatment*

           

Cycles

             

4

5

6

7

8

9

10

 

w.19 to w.21

w.28 to w.30

w.37 to w.39

w.46 to w.48

w.55- to w.57

w.64 to w.66

w.73 to w.75

IL-2 16 400 IU/kg followed by 0.5 ml Ceplene. Twice daily

w.22 to w.27

w.31 to w.36

w.40 to w.45

w.49 to w.54

w.58 to w.63

w.67 to w.72

w.76 to w.81

Treatment-free (6 weeks)

*see dose modification for provisions for the modification to dose and dosage schedule

Dose modification

Patients should be monitored for the expected symptomatic adverse reactions and laboratory changes associated with this treatment. Doses of Ceplene and IL-2 should be modified as necessary based on individual patient tolerance to treatment. It is recommended that dose modifications be addressed early in treatment. The dose reductions can be temporary or permanent.

Should Ceplene related toxicities occur (such as hypotension, headache), the injection time can be increased from 5 minutes to a maximum of duration of 15 minutes.

For patients experiencing grade 1 toxicity events:

No altered dose recommendations with the exception of grade 1 neurologic toxicity and grade 1 generalised toxic dermatitis. For the dose recommendations for these grade 1 toxicity events refer to the relevant sections below:

For patients experiencing grade 1-4 neurologic toxicity

-for grade 1 to 3 toxicity, treatment should be discontinued until grade 0 toxicity event has been achieved. Treatment should then be resumed at a 20% dose reduction for both Ceplene and IL-2.

-for grade 4 toxicity, discontinuation of treatment should be considered.

For patients experiencing grade 1-4 generalised toxic dermatitis

-for grade 1 toxicity, the treatment should be delayed for 48 hours or until all symptoms have been resolved. Treatment should then be resumed using the full dose of Ceplene, but reducing the IL-2 dose by 20%.

-for grade 2 toxicity, the IL-2 dose should be reduced 50% and only increased to full dose if the symptoms do not reappear. Ceplene and IL-2 doses should be separated by 60 minutes, which should be maintained throughout treatment.

-for grade 3 and 4 toxicity, treatment should be discontinued and not resumed until events have been resolved. Treatment should only be resumed after consideration of risk – benefit to the patient.

For patients experiencing grade 2 (including cardiac function, renal, hepatic) toxicity:

- treatment should be discontinued until the event has returned to grade 1

- the time of injection of the dose of Ceplene should be extended to a maximum of 15 minutes.

- for cardiac, hepatic or renal toxicities the dose should be reduced by 20% for both Ceplene and IL-2.

For patients experiencing grade 3 and 4 (including hypotension, arrhythmia) toxicities:

- treatment should be discontinued until the event is resolved. A maximum delay of one treatment cycle can be considered for the resolution of grade 3 and 4 events.

For persistent hypotension, headache, arrhythmia, cardiac, hepatic and renal toxicities:

- the time of injection of the dose of Ceplene should be extended to a maximum of 15 minutes.

- the dose amount of both Ceplene and IL-2 should be reduced by 20%.

Fever

- IL-2 can be discontinued for 24 hours and then restarted at a 20% dose reduction level.

Abnormal WBC counts

- the dose of IL-2 can be reduced by 20% for the remaining duration of the treatment course and if abnormal WBC counts re-occur during the following cycle a permanent IL-2 reduction is recommended.

Localised toxic dermatitis

- treatment should be discontinued until symptoms resolved. Treatment can be resumed by administering Ceplene at the full dose and IL-2 at 50%.

Special populations

Renal impairment:

Patients with renal impairment may be more sensitive to the blood pressure lowering effects of Ceplene. Although the degree of renal impairment has no demonstrable effect on the pharmacokinetic disposition of Ceplene, caution is warranted when Ceplene is administered to patients with severe renal impairment. However, no Ceplene dose reduction is normally required in renally impaired patients.

Hepatic impairment:

Ceplene should be used with caution in patients with moderate to severe hepatic impairment (see section 5.2). Plasma Ceplene levels are higher in patients with moderate and severe liver impairment, and these patient groups tend to experience more tachycardia and lower blood pressure after Ceplene dosing than do patients with normal or mildly affected liver function. Plasma drug levels were not predictive of adverse effects, however, and effects did not correlate closely with drug exposure. Dose reduction of Ceplene is normally not required in hepatically impaired patients, but caution should be used in these patients.

Paediatric Population:

Ceplene is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy in this age group (see section 5.1 and 5.2).

Method of administration

For subcutaneous use only.

One to 3 minutes after the subcutaneous administration of IL-2 has been completed, Ceplene should be administered by slow subcutaneous injection at a rate not to exceed 0.1 ml (0.1 mg histamine dihydrochloride) per minute. The usual time for administering a 0.5 ml Ceplene dose is 5 minutes. To reduce potential adverse reactions, the administration time may be lengthened to a maximum of 15 minutes, see below. Ceplene can be administered via an ambulatory infusion syringe pump or by controlled manual subcutaneous injection by syringe with a timer.

The first dose of Ceplene and IL-2 on day 1 of the initiation of the first cycle of treatment should be administered in the clinic under direct supervision by a physician. Patient monitoring on day 1 should include vital signs, including pulse, blood pressure and respiratory rate. If the patient experiences a significant change in vital signs, the physician should evaluate the status of the patient and continue to monitor vital signs; these patients should be monitored during subsequent treatments.

Subsequent injections of Ceplene may be self-administered at home by a patient who demonstrates a good understanding of necessary precautions and who has demonstrated adequate injection skills.

Injections should be preferably administered in a supervised setting in the presence of an adult family member, friend, or other care provider who is capable of responding appropriately should signs or symptoms of hypotension occur.

The preferred injection areas are the thighs and the abdomen. Ceplene should not be injected into the same anatomic region as IL-2.

The twice daily dosing of IL-2 and Ceplene should be separated by a minimum of 6 hours. Patients should remain at rest for 20 minutes after injection of Ceplene.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients.

• Patients with significantly compromised cardiac function, e.g., NYHA Class III/IV.

• Patients receiving systemic steroid therapy, clonidine and H2 blocking agents.

• Patients who have received an allogenic stem cell transplant.

• During pregnancy.

• During breast feeding.

4.4 Special Warnings And Precautions For Use

Ceplene should be administered 1 to 3 minutes after IL-2 administration, and not concomitantly.

• Rapid subcutaneous injection or injection into a vascular space may result in severe hypotension, tachycardia, or syncope.

Treatment with Ceplene in conjunction with IL-2 should be used with caution in patients with poorly compensated cardiac function. Patients with cardiac disease should be evaluated for ventricular ejection fraction and wall function by echocardiography or nuclear medicine stress test and then treated with caution.

• Patients should be monitored during treatment for possible clinical complications due to hypotension or hypovolaemia. Ceplene should be administered in the clinic under supervision of the physician on day 1 of the initial treatment cycle. Patient monitoring on day 1 should include vital signs, including pulse, blood pressure and respiratory rate.

• Patient monitoring during subsequent treatment days or cycles should be performed as long as the patient continues to experience significant changes in vital signs during administration of Ceplene. If significant hypotension or related symptoms are observed in subsequent treatment cycles, dose reduction should be initiated and if required, administered in hospital until responses to treatment allow for home administration.

• Caution should be used for patients with any of the following: symptomatic peripheral arterial disease, past or present peptic or oesophageal ulcer disease with a history of bleeding, clinically significant renal disease and stroke within the last 12 months. Where appropriate, consideration should be made to providing concomitant treatment with a proton pump inhibitor.

• Patients with clinically significant infection requiring the use of antibiotics, antifungals, or antivirals, or who have completed prior anti-infectious therapy within 14 days of starting treatment should be treated with caution unless the use of antibiotics and antivirals were for prophylaxis purposes.

• Patients with a prior history of autoimmune disease (including systemic lupus, inflammatory bowel disease, psoriasis and rheumatoid arthritis) should be treated with caution.

• Monitoring of laboratory test results is recommended including standard haematological and blood chemistry tests.

• Patients receiving the following medicinal products should be treated with caution (see section 4.5)

-Beta-blockers or other anti

-H1 blocking agents and neuroleptics (anti-psychotics) with H1 receptor blocking properties.

-Tricyclic anti-depressants that may have H1 and H2 receptor blocking properties.

-Monoamine oxidase inhibitors and anti-malarial and anti-trypanosomal agents.

-Neuromuscular blocking agents, narcotic analgesics, and various contrast media.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

While posology differs, when Ceplene is used in conjunction with IL-2, physicians should also refer to the SmPC for IL-2 and observe the respective medical product interactions.

H2 receptor antagonists with imidazole structures similar to histamine, e.g., cimetidine, systemic steroids and clonidine, must not be used during treatment with Ceplene (see section 4.3).

Beta-blockers and other anti-hypertensive agents should be used with caution during treatment with Ceplene. Concurrent administration of medicinal products with cardiotoxicity or blood pressure lowering effects may increase the toxicity of Ceplene.

H1 receptor blocking antihistamines or neuroleptics (anti-psychotics) with H1 receptor blocking properties that might decrease efficacy of Ceplene should be avoided.

Tricyclic anti-depressants may have H1 and H2 receptor blocking properties and should be avoided.

Monoamine oxidase inhibitors, anti-malarial, and anti-trypanosomal active substances may alter the metabolism of Ceplene and should be avoided (see section 4.4).

It has been noted that neuromuscular blocking agents, narcotic analgesics, and various contrast media can induce the release of endogenous histamine; therefore in patients undergoing diagnostic or surgical procedures, the additive effect of Ceplene treatment should be considered prior to the procedure (see section 4.4).

4.6 Pregnancy And Lactation

For Ceplene, no clinical data on exposed pregnancies are available. Animal studies showed reproductive toxicity but only at maternotoxic doses, and did not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Section 5.3). Ceplene in conjunction with IL-2 must not be used during pregnancy.

It is unknown whether histamine is excreted in human breast milk. The excretion of histamine in milk has not been studied in animals, but at maternotoxic doses in rats, offspring showed slight toxicity during early lactation (see Section 5.3). Ceplene in conjunction with IL-2 must not be used during breast-feeding.

No clinical data are available on the effects of Ceplene on fertility. Animal studies revealed no adverse effects on fertility apart from a slight reduction in implantations and viable foetuses (see section 5.3). Women of childbearing potential and sexually active men must use effective methods of contraception during treatment with Ceplene and IL-2.

Refer to the IL-2 SmPC for information on pregnancy and lactation with IL-2.

4.7 Effects On Ability To Drive And Use Machines

Ceplene has minor or moderate influence on the ability to drive and use machines. Administration of Ceplene can cause hypotension and may result in dizziness, light-headedness and blurred vision. Patients should not drive or operate machines for at least 1 hour after receiving Ceplene.

4.8 Undesirable Effects

Acute Myeloid Leukaemia

Adverse reactions were reported to be at least possibly related to IL-2 and Ceplene treatment in almost all patients in studies in acute myeloid leukaemia (AML).

The most common adverse reactions experienced by 30% or more of patients receiving IL-2 and Ceplene (listed in descending order of frequency) were: flushing, headache, fatigue, injection site granuloma, pyrexia and injection site erythema.

The adverse reactions occurring in at least 5% of patients considered at least possibly related to the treatment of low-dose IL-2 with Ceplene in AML studies (n=196 for the IL-2 and Ceplene treatment arm) are listed below by body system organ, class and frequency. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as very common (

Blood and lymphatic system disorders

Very common: eosinophilia, thrombocytopenia

Metabolism and nutrition disorders

Common: anorexia

Psychiatric disorders

Common: insomnia

Nervous system disorders

Very common: headache, dizziness, dysgeusia

Cardiac disorders

Very common: tachycardia

Common: palpitations

Vascular disorders

Very common: flushing, hypotension

Respiratory, thoracic, and mediastinal disorders

Very common: cough, dyspnoea

Common: nasal congestion

Gastrointestinal disorders

Very common: nausea, dyspepsia, diarrhoea.

Common: vomiting, upper abdominal pain, dry mouth

Skin and subcutaneous tissue disorders

Very common: rash

Common: erythema, increased sweating, night sweats, pruritus

Musculoskeletal and connective tissue disorders

Very common: arthralgia, myalgia

Common: limb pain, back pain

General disorders and administration site conditions

Very common: injection site granuloma, fatigue, pyrexia, injection site erythema, feeling hot, injection site reaction, injection site pruritus, influenza like illness, rigors, injection site inflammation, injection site pain

Common: injection site urticaria, injection site bruising, injection site rash, injection site swelling, weakness, chest pain

Other oncology (advanced tumour) studies

Ceplene and low dose IL-2 have been investigated in other clinical studies at different doses (1.0 mg histamine dihydrochloride twice a day) and with different dose regimens of low-dose IL-2 and interferon-alfa. The following adverse events, not listed above, were reported in at least 5% of patients and as at least possibly related to the study medicine:

Blood and lymphatic system disorders

Common: anaemia

Skin and subcutaneous tissue disorders

Very common: dry skin

Ear and labyrinth disorders

Common: vertigo

Endocrine disorders

Common: acquired hypothyroidism

Metabolism and nutrition disorders

Very common: decreased appetite

Common: dehydration

Psychiatric disorders

Very common: anxiety

Common: depression

Nervous system disorders

Common: paraesthesia

Vascular disorders

Common: hot flushes

Respiratory, thoracic, and mediastinal disorders

Common: wheezing

Gastrointestinal disorders

Common: constipation, abdominal distention, stomatitis

General disorders and administration site conditions

Very common: malaise, oedema peripheral, weight decreased

Common: injection site fibrosis, pain

4.9 Overdose

Administration of Ceplene or IL-2 by rapid infusion or into vascular spaces, at higher doses than the approved ones, may exaggerate the adverse reactions associated with Ceplene.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Other cytokines and immunomodulators; ATC code: L03AX14.

Ceplene/IL-2 is an immunotherapy which aims to induce immune-mediated destruction of residual myeloid leukaemic cells and thereby to prevent relapse of leukaemia. The role of Ceplene is to protect lymphocytes, in particular NK cells and T cells, which are responsible for the immune-mediated destruction of residual leukaemic cells. The role of IL-2 is to promote the functions of NK cells and T cells by activating the anti-leukaemic properties of these cells and by expanding these cell populations by inducing cell cycle proliferation. The mechanism by which Ceplene improves the anti-leukaemic function of lymphocytes in AML is not completely established; it is considered to be by inhibition of reactive oxygen species (ROS or “oxygen free radicals”), which are synthesised by monocytes/macrophages and granulocytes. ROS are known to limit the anti-leukaemic effects of lymphocyte activators such as IL-2, by triggering dysfunction and death by apoptosis in NK cells and T cells. Ceplene inhibits NAPDH oxidase which initiates the formation and release of ROS from phagocytes. By inhibiting oxidase function and reducing ROS production, Ceplene protects IL-2-activated NK cells and T cells from oxygen free radical-induced inhibition and apoptosis. The concomitant administration of Ceplene and IL-2 therefore aims to optimise the anti-leukaemic functions of NK cells and T cells.

There have been 2 clinical studies to evaluate the use of Ceplene in the maintenance of remission in adult AML patients. Study AML-1 was exploratory, enrolling 39 AML patients in remission to determine the dose and feasibility of Ceplene administered together with IL-2. Results of this pilot study were used to design and implement a multi-national phase 3 trial. The randomised phase 3 trial (0201) compared Ceplene+IL-2 treatment to no treatment in 261 patients in first remission (CR1) and in another 59 patients in subsequent remission after relapse (CR>1). For CR1 patients, the median duration of leukaemia-free survival increased from 291 days (9.7 months) to 450 days (15 months) after Ceplene/IL-2 versus no maintenance treatment (ITT, p=0.01. n=261). The number of CR1 patients remaining leukaemia-free for 3 years was 40% after Ceplene+IL-2 versus 26% in patients not receiving this treatment (p=0.01).

This medicinal product has been authorised under “Exceptional circumstances”. This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product. The European Medicines Agency will review any new information which may become available every year and this SPC will be updated as necessary.

5.2 Pharmacokinetic Properties

Histamine is rapidly absorbed after subcutaneous injection. Maximum plasma concentration is reached approximately 10 minutes after end of subcutaneous infusion. Histamine concentrations and PK were highly variable across studies, as well as within the normal volunteer and patient groups. Patients showed a higher degree of variability with respect to systemic exposure as compared to healthy subjects.

Histamine is eliminated by metabolism in kidney, liver and other tissues. The main enzymes involved in the metabolism of histamine are HNMT (histamine-N-methyltransferase) and DAO (diamine oxidase). The metabolites are mainly excreted in urine. The mean half-life was 0.75 to 1.5 hours in patients.

There are no significant effects of age or weight on the pharmacokinetic properties of histamine. Clearance of Ceplene is almost twice as high in females resulting in considerably lower systemic exposure than in males.

It is not known whether histamine crosses the placenta.

Renal impairment

The pharmacokinetics of histamine are similar in healthy volunteers with normal renal function compared to volunteers with mild, moderate, or severe renal impairment. In subjects with severe renal impairment, there were decreases in systolic and diastolic blood pressure at plasma histamine concentrations which caused no appreciable decrease in blood pressure in other subjects. Thus, subjects with severe renal impairment may be more sensitive to the blood pressure lowering effects of exogenously administered histamine than subjects with normal renal function or subjects with mild or moderate renal impairment. Although the degree of renal impairment has little effect on the PK disposition of histamine, caution should be used in the administration of histamine to patients with severe renal impairment.

Hepatic impairment

A study was performed to measure the PK of histamine in normal volunteers compared to patients with mild, moderate, and severe hepatic impairment. There were no clinically significant differences in safety parameters or in pharmacodynamics. Plasma histamine concentrations were highly variable and were considerably higher in the groups of patients with moderate or severe hepatic impairment (medians 10 and 5 times the normal volunteers respectively). Patients with all degrees of hepatic impairment may have tachycardia or hypotension for 30-60 minutes after Ceplene+IL-2 administration.

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated-dose toxicity, local tolerance and genotoxicity. Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to clinical use. No carcinogenicity studies have been performed on Ceplene.

Histamine dihydrochloride was not teratogenic in rats or rabbits at doses resulting in several hundred-fold greater systemic exposures than the clinical exposure. In female rats dosed before mating to gestation day 7, slightly reduced numbers of implantations and viable foetuses were found, but without any dose-response and within the range of historical control data. In the peri-post natal development study, high doses of histamine dihydrochloride caused maternal toxicity, and the offspring showed toxicity during lactation (fewer live pups at day 21 compared to lactation at day 4) but not after weaning.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium chloride

Sodium hydroxide (for pH adjustment)

Hydrochloric acid (for pH adjustment)

Water for injections

6.2 Incompatibilities

In the absence of compatibility studies this medicinal product should not be mixed with other medicinal products, diluents or infusion solutions.

6.3 Shelf Life

Unopened vials: 3 years

6.4 Special Precautions For Storage

Ceplene

Do not freeze.

Interleukin-2 (IL-2; aldesleukin)

Diluted IL-2 (aldesleukin) dispensed in capped polypropylene tuberculin syringes is to be stored in the refrigerator at 2– 8°C.

6.5 Nature And Contents Of Container

2 ml type I glass vial, with bromobutyl rubber stopper and flip-off aluminium over seal, containing 0.5 ml of solution (0.70 ml including overfill).

Each carton contains 14 vials.

6.6 Special Precautions For Disposal And Other Handling

Ceplene

The vials contain 0.5 ml of solution (0.70 ml including overfill) to facilitate the dose extraction of a single 0.5 ml dose.

Patients are provided with capped polypropylene syringes and instructed to extract 0.5 ml of solution into the syringe.

The solution should be visually inspected for particulate matter and discolouration prior to administration. The solution must be clear and colourless.

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

Interleukin-2 ( IL-2; aldesleukin)

Dilute IL-2 dispensed in capped polypropylene tuberculin syringes is to be prepared by the Pharmacy in a controlled aseptic environment and stored in a refrigerator at 2°– 8° C.

When reconstituted and diluted according to the directions in Section 4.2, stability of dilute IL-2 (aldesleukin) in capped polypropylene tuberculin syringes has been demonstrated for up to 21 days when stored at refrigerated temperatures (2°C - 8°C).

Please see Section 4.2 for IL-2 dispensing instructions.

7. Marketing Authorisation Holder

EpiCept GmbH

Goethestrasse 4

D-80336 M?nchen

Germany

8. Marketing Authorisation Number(S)

EU/1/08/477/001

9. Date Of First Authorisation/Renewal Of The Authorisation

07/10/2008

10. Date Of Revision Of The Text

January 2011

Read More:

Adrenocortical Insufficiency Medications

Definition of Adrenocortical Insufficiency:

Loss, to varying degrees, of adrenocortical function.

Synonym: hypocorticoidism.

Drugs associated with Adrenocortical Insufficiency

The following drugs and medications are in some way related to, or used in the treatment of Adrenocortical Insufficiency. 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 Adrenocortical Insufficiency

Micromedex Care Notes:

Addison's DiseaseSecondary Adrenal Insufficiency

Medical Encyclopedia:

Exogenous adrenal insufficiency
Drug List:A-HydrocortAristocortBaycadronClinacort-InjectionClinalog-InjectionCortefCortrosynDe-Sone-La-InjectionDecadronDeltasoneDexacen-4-InjectionDexacort-Phosphate-In-TurbinaireDexamethasone-IntensolDexasone-InjectionDexasone-La-InjectionDexpak-Tablets-Dose-PackHydrocortoneKen-Jec-40-InjectionKenalog-40-SuspensionMeticortenSolu-Cortef-SolutionSolurex-InjectionSolurex-La-InjectionSterapredSterapred-DsTac-3-InjectionTriam-ForteTriamcot-InjectionTriamonide-40-InjectionU-Tri-Lone-InjectionZema-Pak-10-Day

Read More:

Adrenogenital Syndrome Medications

Definition of Adrenogenital Syndrome: Congenital adrenal hyperplasia refers to a group of inherited disorders relating to the adrenal glands, characterized by a deficiency in the hormones cortisol and aldosterone and an overproduction of androgen. More...

Drugs associated with Adrenogenital Syndrome

The following drugs and medications are in some way related to, or used in the treatment of Adrenogenital Syndrome. 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 Adrenogenital Syndrome

Medical Encyclopedia:

Congenital adrenal hyperplasia
Drug List: A-Methapred-Solution Baycadron De-Sone-La-Injection Decadron Deltasone Depo-Medrol-Suspension Dexacen-4-Injection Dexacort-Phosphate-In-Turbinaire Dexamethasone-Intensol Dexasone-Injection Dexasone-La-Injection Dexpak-Tablets-Dose-Pack Florinef Florinef-Acetate Medrol Medrol-Dosepak Methylprednisolone-Dose-Pack Meticorten Solu-Medrol-Solution Solurex-Injection Solurex-La-Injection Sterapred Sterapred-Ds Zema-Pak-10-Day

Read More:

Addison's Disease Medications

Definition of Addison's Disease: A rare endocrine disease that results from the underproduction of aldosterone and cortisol

Drugs associated with Addison's Disease

The following drugs and medications are in some way related to, or used in the treatment of Addison's Disease. 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 Addison's Disease

Micromedex Care Notes:

Addison's Disease Secondary Adrenal Insufficiency

Medical Encyclopedia:

Addison's disease
Drug List: A-Hydrocort Baycadron Cortef De-Sone-La-Injection Decadron Dexacen-4-Injection Dexacort-Phosphate-In-Turbinaire Dexamethasone-Intensol Dexasone-Injection Dexasone-La-Injection Dexpak-Tablets-Dose-Pack Florinef Florinef-Acetate Hydrocortone Solu-Cortef-Solution Solurex-Injection Solurex-La-Injection Zema-Pak-10-Day

Read More:

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

Read More:

Bursitis Medications

Definition of Bursitis: Bursitis involves the inflammation of the fluid-filled sac (bursa) that lies between tendon and skin and/or between tendon and bone. The condition may be acute or chronic.

Drugs associated with Bursitis

The following drugs and medications are in some way related to, or used in the treatment of Bursitis. 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 Bursitis

Medical Encyclopedia:

Bursitis

Harvard Health Guide:

Symptoms and treatment for Bursitis
Drug List: Aflaxen Aleve All-Day-Pain-Relief All-Day-Relief Anaprox Anaprox-Ds Aristocort Aspercreme-Cream Baycadron Celestone-Solution Celestone-Soluspan Clinacort-Injection Clinalog-Injection Comfort-Pac-With-Naproxen Cortone-Acetate De-Sone-La-Injection Decadron Deltasone Dexacen-4-Injection Dexacort-Phosphate-In-Turbinaire Dexamethasone-Intensol Dexasone-Injection Dexasone-La-Injection Dexpak-Tablets-Dose-Pack Ec-Naprosyn-Enteric-Coated-Tablets Indocin Indocin-Iv Indocin-Sr-Sustained-Release-Capsules Ken-Jec-40-Injection Kenalog-10-Suspension Kenalog-40-Suspension Leader-Naproxen-Sodium Meticorten Midol-Extended-Relief Myoflex-Cream Naprelan-Sustained-Release-Tablets Naprosyn Solurex-Injection Solurex-La-Injection Sterapred Sterapred-Ds Tac-3-Injection Triam-Forte Triamcot-Injection Triamonide-40-Injection U-Tri-Lone-Injection Zema-Pak-10-Day

Read More:

Bacteremia Medications

Definition of Bacteremia: The presence of viable bacteria circulating in the bloodstream.

Drugs associated with Bacteremia

The following drugs and medications are in some way related to, or used in the treatment of Bacteremia. 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 Bacteremia

Medical Encyclopedia:

Septicemia
Drug List: Amikin Amikin-Pediatric Azactam Cefizox Cefobid Ceptaz Cipro Cipro-I-V Cipro-Xr-Extended-Release-Tablets Claforan Cleocin Cleocin-Hcl Cleocin-Pediatric-Suspension Cleocin-Phosphate-Iv Cubicin Flagyl Flagyl-375 Flagyl-I-V Fortaz Garamycin-Solution Lyphocin Maxipime Metro Nallpen-Injection Nebcin Primaxin-Im Primaxin-Iv Rocephin Synercid Tazicef Timentin Tobi-Solution Unipen-Injection Vancocin Vancocin-Hcl Vancocin-Hcl-Pulvules Zosyn Zyvox

Read More:

Synovitis Medications

Definition of Synovitis:

Inflammation of a synovial membrane. It is usually painful, particularly on motion and is characterised by a fluctuating swelling due to effusion within a synovial sac.

Synovitis is qualified as fibrinous, gonorrhoeal, hyperplastic, lipomatous, metritic, puerperal, rheumatic, scarlatinal, syphilitic, tuberculous, urethral, etc.

Drugs associated with Synovitis

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

Drug List: Aristocort Baycadron Clinacort-Injection Clinalog-Injection De-Sone-La-Injection Decadron Deltasone Dexacen-4-Injection Dexacort-Phosphate-In-Turbinaire Dexamethasone-Intensol Dexasone-Injection Dexasone-La-Injection Dexpak-Tablets-Dose-Pack Ken-Jec-40-Injection Kenalog-10-Suspension Kenalog-40-Suspension Meticorten Solurex-Injection Solurex-La-Injection Sterapred Sterapred-Ds Tac-3-Injection Triam-Forte Triamcot-Injection Triamonide-40-Injection U-Tri-Lone-Injection Zema-Pak-10-Day

Read More:

Meningitis, Listeriosis Medications

Drugs associated with Meningitis, Listeriosis

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

Drug List: Baycadron De-Sone-La-Injection Decadron Dexacen-4-Injection Dexacort-Phosphate-In-Turbinaire Dexamethasone-Intensol Dexasone-Injection Dexasone-La-Injection Dexpak-Tablets-Dose-Pack Solurex-Injection Solurex-La-Injection Zema-Pak-10-Day

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

Read More:

Lichen Simplex Chronicus Medications

Definition of Lichen Simplex Chronicus: Lichen simplex chronicus is a skin disorder characterized by chronicitching and scratching. The persistent scratching causes formation of thick, leathery hyperpigmented skin.

Drugs associated with Lichen Simplex Chronicus

The following drugs and medications are in some way related to, or used in the treatment of Lichen Simplex Chronicus. 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 Lichen Simplex Chronicus

Medical Encyclopedia:

Lichen simplex chronicus
Drug List: Aloquin-Gel Aristocort-Forte Aristospan-Suspension Clinacort-Injection Clinalog-Injection Ken-Jec-40-Injection Kenalog-10-Suspension Kenalog-40-Suspension Prudoxin-Topical Tac-3-Injection Triam-Forte Triamcot-Injection Triamonide-40-Injection U-Tri-Lone-Injection Zonalon-Cream

Read More:

Dacarbazine 200 mg, powder for solution for injection (Hospira UK Ltd)

DACARBAZINE 200 mg POWDER FOR SOLUTION FOR INJECTION

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.

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

In this leaflet: 1. What Dacarbazine Powder for Solution for Injection is and what it is used for 2. Before you use Dacarbazine Powder for Solution for Injection 3. How to use Dacarbazine Powder for Solution for Injection 4. Possible side effects 5. How to store Dacarbazine Powder for Solution for Injection 6. Further information What Dacarbazine Powder For Solution For Injection Is And What It Is Used For

Dacarbazine Powder for Solution for Injection is an anti-cancer medicine, in the form of a powder for solution for injection. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.

Dacarbazine Powder for Solution for Injection may be used for the treatment of some types of cancer, for example: metastatic malignant melanoma (a type of skin cancer that has spread) and Hodgkin’s disease and some types of cancer in soft tissues.

Before You Use Dacarbazine Powder For Solution For Injection Do not use Dacarbazine Powder for Solution for Injection if you have shown signs of hypersensitivity (severe allergy) to dacarbazine on previous occasions if you have severe liver or kidney diseases in combination with yellow fever vaccine and some other types of vaccines (live attenuated) in combination with phenytoin (a medicine used to prevent convulsions). Taking/using other medicines

Special care should be taken if you are taking other medicinal products which could interact with Dacarbazine:

ciclosporin or tacrolimus (medicines used after having a transplant) fotemustine (a medicine used in cancer treatment) medicines which could damage your liver warfarin (a medicine used to thin the blood). Your doctor may need to do your blood test (INR) more often

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

Do not use Dacarbazine:

if you are pregnant or trying to become pregnant if you are breast feeding Driving and using machines

Dacarbazine may influence the ability to drive or operate machinery because of nausea and vomiting or rare adverse reactions affecting the nervous system.

Important information about one of the ingredients of Dacarbazine Powder for Solution for Injection

This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium free’.

How To Use Dacarbazine Powder For Solution For Injection

This medicinal product is for intravenous use (injection into a vein).

Your treatment will usually be given to you in hospital.

You will be given Dacarbazine as an infusion (slow injection via a drip) into a vein or a slow intravenous injection(injection into a vein).

Tell your doctor or nurse at once if you notice any pain at the injection site during or shortly after treatment. Pain around the injection site could mean the needle has not been properly inserted into the vein.

The dose of dacarbazine will depend on the illness for which you are being treated. The dose is calculated according to your body surface area (expressed as mg/m2).

Depending on your illness, dosing is typically between 200 and 850 mg/m2 of dacarbazine.

As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much. However, tell your doctor or pharmacist if you have any concerns.

Possible Side Effects

Like all medicines Dacarbazine Powder for Solution for Injection can have side effects although not everybody gets them.

If any of the following happen, tell your doctor immediately: severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth and throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.

This is a very serious side effect. You may need urgent medical attention. This very serious side effect is rare.

If you experience any of the following tell your doctor as soon as possible:

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

pallor (anaemia) loss of appetite nausea/vomiting

Uncommon (Less than 1 in 100 patients but more than 1 in 1000):

confusion fits (seizures) numbness of the skin or pins and needles sensation in the face (paraesthesia) headache blurred vision facial flushing hair loss (alopecia) transient rash an influenza (‘flu’) type syndrome of fever, muscle pain (myalgia) and generally feeling unwell (malaise) which may start approximately one week after treatment and may last for up to three weeks tiredness and weakness (lethargy)

Rare (less than 1 in 1000 patients but more than 1 in 10,000)

diarrhoea bruising increased sensitivity of the skin to sunlight (photosensitivity)

Very rare (less than 1 in 10,000)

redness of the skin/rash itching

Blood samples will be taken to check for changes in blood cells levels, which is a common side effect of Dacarbazine treatment. Blood and urine tests will be performed to check for changes in kidney function. Blood tests may be performed to check that your liver is working properly. Kidney and liver problems are uncommon.

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

HOW TO STORE DACARBAZINE 200 mg POWDER FOR SOLUTION FOR INJECTION

Keep out of the reach and sight of children

The vials should be stored at 2 - 8°C with the vials kept in the outer carton (in order to protect from light).

This medicine should not be used after the expiry date printed on the vial label.

Further Information What Dacarbazine Powder for Solution for Injection contains

The medicine is presented in glass containers called vials containing 200 mg dacarbazine. Each pack contains 1 vial.

The active substance is dacarbazine The other ingredients are citric acid monohydrate, mannitol and sodium hydroxide What Dacarbazine Powder for Solution for Injection looks like and contents of the pack

The powder is a white or pale yellow solid.

The vial containing the powder is a glass container with a rubber stopper.

Each single-dose vial contains 200 mg of Dacarbazine. When reconstituted each ml of solution contains 10 mg of dacarbazine.

The 200 mg presentation of Dacarabazine is sold in packs containing 1 vial of powder

Marketing Authorisation Holder and Manufacturer

The Marketing authorisation holder and company responsible for batch release in the European Union is

Mayne Pharma Plc Queensway Royal Leamington Spa Warwickshire CV31 3RW UK

The Manufacturer is

Mayne Pharma Pty Ltd Lexia Place Mulgrave Victoria 3170 Australia

This leaflet was last approved in

08/2006

Read More:

Brucellosis Medications

Definition of Brucellosis: Brucellosis is a disease caused by contact with animals carrying the Brucella bacteria.

Drugs associated with Brucellosis

The following drugs and medications are in some way related to, or used in the treatment of Brucellosis. 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 Brucellosis

Medical Encyclopedia:

Brucellosis
Drug List: Ala-Tet Chloromycetin-Oral-Intravenous-Injection Chloromycetin-Sodium-Succinate Doryx-Delayed-Release-Capsules Doxy-100 Doxy-200 Garamycin-Solution Monodox Ocudox-Convenience-Kit Oraxyl Sumycin Vibra-Tabs Vibramycin

Read More:

Hemolytic Anemia Medications

Definition of Hemolytic Anemia: Hemolytic anemia is a condition of an inadequate number of circulating red blood cells (anemia), caused by premature destruction of red blood cells. There are a number of specific types of hemolytic anemia which are described individually.

Drugs associated with Hemolytic Anemia

The following drugs and medications are in some way related to, or used in the treatment of Hemolytic Anemia. 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 Hemolytic AnemiaAutoimmune Hemolytic Anemia (4 drugs) G-6-PD Deficiency (0 drugs) Learn more about Hemolytic Anemia

Micromedex Care Notes:

Erythroblastosis FetalisHemolytic AnemiaJaundice In NewbornsRh Factor Incompatibility

Medical Encyclopedia:

Congenital spherocytic anemiaDrug-induced immune hemolytic anemiaHemolytic anemiaHemolytic anemia caused by chemicals and toxinsIron deficiency anemiaNewborn jaundiceRh incompatibility

Harvard Health Guide:

Symptoms and treatment for Hemolytic Anemia
Drug List:AristocortBaycadronClinacort-InjectionClinalog-InjectionCortone-AcetateDe-Sone-La-InjectionDecadronDexacen-4-InjectionDexacort-Phosphate-In-TurbinaireDexamethasone-IntensolDexasone-InjectionDexasone-La-InjectionDexpak-Tablets-Dose-PackKen-Jec-40-InjectionKenalog-40-SuspensionSolurex-InjectionSolurex-La-InjectionTac-3-InjectionTriam-ForteTriamcot-InjectionTriamonide-40-InjectionU-Tri-Lone-InjectionZema-Pak-10-Day

Read More:

Opiate Adjunct Medications

Drugs associated with Opiate Adjunct

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

Drug List: Adgan-Injection Anergan-50-Injection Antinaus-50-Injection Phenadoz-Rectal Phenergan Promethegan-Rectal

Read More:

Ethanolamine Oleate Injection BP (UCB Pharma Ltd)

1. Name Of The Medicinal Product

Ethanolamine Oleate Injection (monoethanolamine oleate). Solution for injection.

2. Qualitative And Quantitative Composition

Oleic acid 4.23% w/v

Ethanolamine 0.910% w/v

For excipients see 6.1.

3. Pharmaceutical Form

Solution for injection.

5 ml neutral glass ampoule containing a clear solution.

4. Clinical Particulars 4.1 Therapeutic Indications

The injection is recommended for use as a sclerosing agent in the treatment of small, uncomplicated varicose veins in the lower extremities.

4.2 Posology And Method Of Administration

Ethanolamine Oleate is administered by slow intravenous injection.

Adults Including The Elderly

The product is used only as a sclerosant and injected directly into the varicose vein. A dose of 2 to 5ml, divided between 3 or 4 sites, administered by slow injection into empty isolated segments of vein.

Children

The product is not recommended for use in children.

4.3 Contraindications

Inability to walk, acute phlebitis, oral contraceptive use, obese legs, known hypersensitivity to Ethanolamine Oleate or benzyl alcohol. Superficial thrombophlebitis and deep vein thrombosis in the region of the varicose veins. Marked arterial, cardiac or renal disease. Uncontrolled metabolic disorders such as diabetes mellitus. Patients with local or systemic infections.

4.4 Special Warnings And Precautions For Use

Care should be taken to ensure that the injection does not leak into perivenous tissue which could cause sloughing, ulceration and in severe cases, necrosis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Safety during pregnancy has not been established. Use in pregnancy is not recommended.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Burning, cramping sensation, urticaria. Allergic reactions and anaphylaxis have been reported following use of sclerosing agents.

4.9 Overdose

Acute nephrotoxicity has been reported in two patients given 15-20ml of a solution containing 5% Ethanolamine with 2% Benzl Alcohol.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code: C05B B 01; sclerosing agent for local injection.

Ethanolamine Oleate is an irritant. An injection of Ethanolamine Oleate into a vein irritates the intimal endothelium resulting in the formation of a thrombus. The thrombus occludes the vein and fibrous tissue develops resulting in a permanent obliteration of the vein.

5.2 Pharmacokinetic Properties

Ethanolamine Oleate is a locally acting agent. Absorption from the site of administration is not anticipated as its mode of action is to cause a permanent obstruction in the vein.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Benzyl alcohol

Water for Injection

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

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

6.5 Nature And Contents Of Container

5 ml Neutral Glass (Type 1) Ampoules.

6.6 Special Precautions For Disposal And Other Handling

The product is used only as a sclerosant and injected directly into the varicose vein.

7. Marketing Authorisation Holder

UCB Pharma Limited

208 Bath Road

Slough

Berkshire

SL1 3WE

UK

8. Marketing Authorisation Number(S)

PL 0039/5671R

9. Date Of First Authorisation/Renewal Of The Authorisation

27 March 1987 / 26 May 1994 / 27 May 1999

10. Date Of Revision Of The Text

June 2005

Read More:

Uveitis, Posterior Medications

Drugs associated with Uveitis, Posterior

The following drugs and medications are in some way related to, or used in the treatment of Uveitis, Posterior. 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 Uveitis, Posterior Infectious Posterior Uveitis (0 drugs) Learn more about Uveitis, Posterior

Medical Encyclopedia:

Uveitis
Drug List: Baycadron De-Sone-La-Injection Decadron Deltasone Dexacen-4-Injection Dexacort-Phosphate-In-Turbinaire Dexamethasone-Intensol Dexasone-Injection Dexasone-La-Injection Dexpak-Tablets-Dose-Pack Meticorten Ozurdex Solurex-Injection Solurex-La-Injection Sterapred Sterapred-Ds Zema-Pak-10-Day

Read More:

Synvisc Solution

Pronunciation: HIGH-lan
Generic Name: Hylan
Brand Name: Synvisc
Synvisc Solution is used for:

Treating pain associated with osteoarthritis of the knee.

Synvisc Solution is a visco supplement. It works by replacing the viscous or "thick" fluid naturally found in joints. The viscous fluid is needed to coat and protect the cartilage and joint of the knee, which lessens the pain of osteoarthritis.

Do NOT use Synvisc Solution if: you are allergic to any ingredient in Synvisc Solution you have an infection where Synvisc Solution will be injected

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

Before using Synvisc Solution:

Some medical conditions may interact with Synvisc 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 skin disease if you have an allergy to bird proteins, feathers, or eggs if you have blood flow problems

Some MEDICINES MAY INTERACT with Synvisc Solution. However, no specific interactions with Synvisc Solution are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Synvisc 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 Synvisc Solution:

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

Synvisc Solution comes with an additional patient leaflet. Read it carefully and reread it each time you get Synvisc Solution refilled. Synvisc Solution is administered as an injection at your doctor's office, hospital, or clinic. Do not miss your doctor appointments while you are taking Synvisc Solution. If you must miss an appointment, notify your doctor as soon as possible. Do not miss your doctor appointments while you are taking Synvisc Solution. If you must miss an appointment, notify your doctor as soon as possible. If you miss a dose of Synvisc Solution, contact your doctor right away.

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

Important safety information: It may take several injections for Synvisc Solution to work fully. Complete the full treatment course, even if you are already feeling better. Avoid strenuous activities or prolonged weight-bearing activities, such as jogging or tennis, after receiving an injection. Use Synvisc Solution with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Synvisc Solution during pregnancy. It is unknown if Synvisc Solution is excreted in breast milk. If you are or will be breast-feeding while you are using Synvisc Solution, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Synvisc 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:

Knee pain or swelling after injection.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); ankle swelling; bruising; calf cramping; fast heartbeat; fever; hemorrhoids; muscle pain; nausea; persistent pain, redness, or swelling at injection site; sweating.

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: Synvisc 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 Synvisc Solution:

Synvisc Solution is usually handled and stored by a health care provider. Keep Synvisc Solution, as well as needles and syringes, out of the reach of children and away from pets.

General information: If you have any questions about Synvisc Solution, please talk with your doctor, pharmacist, or other health care provider. Synvisc 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 Synvisc 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 Synvisc resources Synvisc Side Effects (in more detail) Synvisc Use in Pregnancy & Breastfeeding Synvisc Drug Interactions Synvisc Support Group 6 Reviews for Synvisc - Add your own review/rating Compare Synvisc with other medications Osteoarthritis

Read More:

Meningitis, Haemophilus influenzae Medications

Drugs associated with Meningitis, Haemophilus influenzae

The following drugs and medications are in some way related to, or used in the treatment of Meningitis, Haemophilus influenzae. 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 Meningitis, Haemophilus influenzaeHaemophilus influenzae Prophylaxis (12 drugs)
Drug List:BaycadronDe-Sone-La-InjectionDecadronDexacen-4-InjectionDexacort-Phosphate-In-TurbinaireDexamethasone-IntensolDexasone-InjectionDexasone-La-InjectionDexpak-Tablets-Dose-PackGantrisin-SuspensionGantrisin-PediatricSolurex-InjectionSolurex-La-InjectionTruxazoleZema-Pak-10-Day

Read More:

Mountain Sickness / Altitude Sickness Medications

Definition of Mountain Sickness / Altitude Sickness: Acute mountain sickness is an illness that can affect mountain climbers, hikers, skiers, or travelers who ascend too rapidly to high altitude (typically above 8,000 feet or 2,400 meters). This is especially for persons who normally reside at or near sea level.

Drugs associated with Mountain Sickness / Altitude Sickness

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

Drug List:BaycadronDe-Sone-La-InjectionDecadronDexacen-4-InjectionDexacort-Phosphate-In-TurbinaireDexamethasone-IntensolDexasone-InjectionDexasone-La-InjectionDexpak-Tablets-Dose-PackDiamoxDiamox-Sequels-Sustained-Release-CapsulesSolurex-InjectionSolurex-La-InjectionZema-Pak-10-Day

Read More:

Mountain Sickness / Altitude Sickness Medications

---

Related Posts Ceplene 0.5 mg 0.5 ml solution for injection:

• Heparin sodium 25 000 I.U. ml solution for injection or concentrate for solution for infusion with preservative
• Heparin calcium 25 000 I.U. ml Solution for injection or concentrate for solution for infusion
• Chirocaine 5mg ml solution for injection concentrate for solution for infusion
• Chirocaine 2.5mg ml solution for injection concentrate for solution for infusion
• Naropin 10 mg ml solution for injection
• Cytarabine Injection Solution
• Naropin 7.5 mg ml solution for injection
• Carnitor 1 g Solution for Injection
• Sodiofolin 50 mg ml solution for injection
• Magnevist 2mmol l solution for injection