Drug Class Description
Interferons (rbe).

Generic Name
Interferon alfa-2a - hepatitis

Drug Description
Each cartridge contains 18 Million International Units interferon alfa-2a* per 0.6 millilitres** (18MIU/0.6ml). * produced in Escherichia coli by recombinant DNA technology.**Contains volume overagesExcipients recognized to have a known effect:Benzyl alcohol (10mg/1ml)

Presentation
Solution for injection in cartridge.Solution is clear and colourless to light yellow.

Indications
Roferon-A is indicated for the treatment of:- Hairy cell leukaemia.- AIDS patients with progressive, asymptomatic Kaposi's sarcoma who have a CD4 count> 250/mm3.- Chronic phase Philadelphia-chromosome positive chronic myelogenous leukaemia.-A is not an alternative treatment for CML patients who have an HLA-identical relative and for whom allogeneic bone marrow transplantation is planned or possible in the immediate future. It is still unknown whether Roferon-A can be considered as a treatment with a curative potential in this indication.- Cutaneous T-cell lymphoma. Interferon alfa-2a (Roferon-A) may be active in patients who have progressive disease and who are refractory to, or unsuitable for, conventional therapy.- Adult patients with histologically proven chronic hepatitis B who have markers for viral replication, i.e., those who are positive for HBV DNA or HBeAg.- Adult patients with histologically proven chronic hepatitis C who are positive for HCV antibodies or HCV RNA and have elevated serum alanine aminotransferase (ALT) without liver decompensation. The efficacy of interferon alfa-2a in the treatment of hepatitis C is enhanced when combined with ribavirin. Roferon-A should be given alone mainly in case of intolerance or contraindication to ribavirin.- Follicular non-Hodgkin's lymphoma.- Advanced renal cell carcinoma.- Patients with AJCC stage II malignant melanoma (Breslow tumour thickness> 1.5 mm, no lymph node involvement or cutaneous spread) who are free of disease after surgery.

Adult Dosage
The prescribed strength should correspond with the recommended dose for each individual indication.- HAIRY CELL LEUKAEMIAInitial dosage:Three million IU daily, given by subcutaneous injection for 16 24 weeks. If intolerance develops, either the daily dose should be lowered to 1.5 million IU or the schedule changed to three times per week, or both.Maintenance dosage:Three million IU, given three times per week by subcutaneous injection. If intolerance develops, the dose should be lowered to 1.5 million IU three times per week.Duration of treatment:Patients should be treated for approximately six months before the physician decides whether to continue treatment in responding patients or to discontinue treatment in non-responding patients. Patients have been treated for up to 20 consecutive months. The optimal duration of Roferon-A treatment for hairy cell leukaemia has not been determined.The minimum effective dose of Roferon-A in hairy cell leukaemia has not been established.- AIDSRELATED KAPOSI'S SARCOMARoferon-A is indicated for the treatment of AIDS patients with progressive, asymptomatic Kaposi's sarcoma who have a CD4 count> 250/mm3. AIDS patients with CD4 counts < 250/mm3, or those with a history of opportunistic infections or constitutional symptoms, are unlikely to respond to Roferon-A therapy and therefore should not be treated. The optimal posology has not yet been well established.Roferon-A should not be used in conjunction with protease inhibitors. With the exception of zidovudine, there is a lack of safety data for the combination of Roferon-A with reverse transcriptase inhibitors.Initial dosage:Roferon-Ashould be given by subcutaneous injection, and escalated to at least 18 million IU daily and if possible to 36 million IU daily for a total of ten to twelve weeks in patients of 18 years or older. The recommended escalation schedule is as follows:days 133 million IU dailydays 469 million IU dailydays 7918 million IU daily and, if tolerated, increase to:days 108436 million IU dailyMaintenance dosage:Roferon-A should be given by subcutaneous injection three times per week at the maximum dose which is acceptable to the patient, but not exceeding 36 million IU.Patients with AIDSrelated Kaposi's sarcoma treated with 3 million IU of Roferon-A given daily showed a lower response rate than those treated with the recommended dosage.Duration of treatment:The evolution of lesions should be documented to determine response to therapy. Patients should be treated for a minimum of 10 weeks and preferably for at least twelve weeks before the physician decides whether to continue treatment in responding patients or to discontinue treatment in nonresponding patients. Patients generally showed evidence of response after approximately three months of therapy. Patients have been treated for up to 20 consecutive months. If a response to treatment occurs, treatment should continue at least until there is no further evidence of tumour. The optimal duration of Roferon-A treatment for AIDSrelated Kaposi's sarcoma has not been determined.Note:Lesions of Kaposi's sarcoma frequently reappear when Roferon-A treatment is discontinued.- CHRONIC MYELOGENOUS LEUKAEMIARoferon-A is indicated for the treatment of patients with chronic phase Philadelphia-chromosome positive chronic myelogenous leukaemia. Roferon-A is not an alternative treatment for CML patients who have an HLA-identical relative and for whom allogeneic bone marrow transplantation is planned or possible in the immediate future.Roferon-A produces haematological remissions in 60% of patients with chronic phase CML, independent of prior treatment. Two thirds of these patients have complete haematological responses which occur as late as 18 months after treatment start.In contrast to cytotoxic chemotherapy, interferon alfa-2a is able to generate sustained, ongoing cytogenetic responses beyond 40 months. It is still unkown whether Roferon-A can be considered as a treatment with a curative potential in this indication.Dosage:It is recommended that Roferon-A should be given by subcutaneous injection for eight to 12 weeks to patients 18 years or more. The recommended schedule is:Days 1-33 million IU dailyDays 4-66 million IU dailyDays 7-849 million IU dailyDuration of treatment:Patients should be treated for a minimum of eight weeks, preferably for at least twelve weeks before the physician decides whether or not to continue treatment in responding patients or to discontinue treatment in patients not showing any changes in haematological parameters. Responding patients should be treated until complete haematological response is achieved or for a maximum of 18 months. All patients with complete haematologic responses should continue treatment with 9 million IU daily (optimum) or 9 million IU three times a week (minimum) in order to achieve a cytogenetic response in the shortest possible time. The optimal duration of Roferon-A treatment for chronic myelogenous leukaemia has not been determined, although cytogenetic responses have been observed two years after treatment start.The safety, efficacy and optimal dosage of Roferon-A in children with CML has not yet been established.- CUTANEOUS T-CELL LYMPHOMA (CTCL)Interferon alfa-2a (Roferon-A) may be active in patients with progressive cutaneous T-cell lymphoma and who are refractory to, or unsuitable for conventional therapy.The optimal dosage has not been established.Initial dosage:Roferon-A should be given by subcutaneous injection, and escalated to 18 million IU daily for a total of 12 weeks in patients of 18 years or older. The recommended escalation schedule is as follows:Days 1 to 3;3 million IU dailyDays 4 to 6;9 million IU dailyDays 7 to 84;18 million IU dailyMaintenance dosage:Roferon-A should be given by subcutaneous injection three times per week at the maximum dose which is acceptable to the patient, but not exceeding 18 million IU.Duration of treatment:Patients should be treated for a minimum of eight weeks and preferably for at least twelve weeks before the physician decides whether to continue treatment in responding patients or to discontinue treatment in non-responding patients. Minimum treatment duration in responding patients should be 12 months in order to maximise the chance to achieve a complete response and improve the chance for a prolonged response. Patients have been treated for up to 40 consecutive months. The optimal duration of Roferon-A treatment for cutaneous T-cell lymphoma has not been determined.Warning:Objective tumor responses have not been observed in approximately 40% of patients with CTCL. Partial responses are usually seen within 3 months and complete responses within 6 months, although it may occasionally take more than one year to reach the best response.- CHRONIC HEPATITIS BRoferon-A is indicated for the treatment of adult patients with histologically proven chronic hepatitis B who have markers for viral replication, i.e., those who are positive for HBV DNA or HBeAg.Dosage recommendation:The optimal schedule of treatment has not been established yet. The dose is usually in the range of 2.5 million IU to 5.0 million IU/m2 body surface administered subcutaneously three times per week for a period of 4 to 6 months.The dosage may be adjusted accordingto the patient's tolerance to the medication. If no improvement has been observed after 3-4 months of treatment, discontinuation of therapy should be considered.Children: up to 10 million IU/m2 has been safely administered to children with chronic hepatitis B. However efficacy of therapy has not been demonstrated.- CHRONIC HEPATITIS CROFERON-A IN COMBINATION WITH RIBAVIRINRELAPSED PATIENTSRoferon-A is given in combination with ribavirin for adult patients with chronic hepatitis C who have previously responded to interferon alpha monotherapy, but who have relapsed after treatment was stopped.Dosage:Roferon-A: 4.5 MIU 3 times per week by subcutaneous injection for a period of 6 month.Dosage of Ribavirin:Ribavirin dose: 1000 mg to 1200 mg/day in two divided doses (once in the morning with breakfast and once with the evening meal). Please refer to the SmPC for ribavirin for further details on the posology and method of administration of ribavirin.NAÏVE PATIENTSThe efficacy of interferon alfa-2a in the treatment of hepatitis C is enhanced when combined with ribavirin. Roferon-A should be given alone mainly in case of intolerance or contraindication to ribavirin.Dosage:Roferon-A: 3 to 4.5 MIU 3 times per week by subcutaneous injection for a period of at least 6 months. Treatment should be continued for an additional 6 months in patients who have negative HCV RNA at month 6, and are infected with genotype 1 and have high pretreatment viral load.Dosage of Ribavirin:see aboveOther negative prognostic factors (age> 40 years, male gender, bridging fibrosis) should be taken into account in order to extend therapy to 12 months.Patients who failed to show a virologic response after 6 months of treatment (HCV-RNA below lower limit of detection) do generally not become sustained virologic responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).Roferon-A monotherapyRoferon-A monotherapy should be given mainly in case of intolerance or contraindication to ribavirin.Initial dosage:Roferon-Ashould be administered at a dose of 3 to 6 million IU by subcutaneous injection three times a week for six months as induction therapy, patient tolerance permitting. In patients who fail to respond after three to four months of treatment, discontinuation of Roferon-A should be considered.Maintenance dosage:Patients whose serum ALT has normalized and/or HCV RNA has become undetectable require maintenance therapy with 3 million IU Roferon-A three times a week for an additional six months or longer to consolidate the complete response. The optimal duration of treatment has not yet been determined but a therapy of at least 12 months is advised.Note: The majority of patients who relapse after adequate treatment with Roferon-A alone do so within four months of the end of treatment.- FOLLICULAR NON-HODGKINS LYMPHOMARoferon-A prolongs disease-free and progression-free survival when used as adjunctive treatment to CHOP-like chemotherapy regimens in patients with advanced (high tumour burden) follicular non-Hodgkin's lymphoma. However, the efficacy of adjunctive interferon alfa-2a treatment on overall long-term survival of these patients has not yet been established.Dosage Recommendation:Roferon-Ashould be administered concomitantly to a conventional chemotherapy regimen (such as the combination of cyclophosphamide, prednisone, vincristine and doxorubicin) according to a schedule such as 6 million IU/m2 given subcutaneously from day 22 to day 26 of each 28-day cycle.- ADVANCED RENAL CELL CARCINOMATherapy with Roferon-A in combination with vinblastine induces overall response rates of approximately 17-26%, delays disease progression, and prolongs overall survival in patients with advanced renal cell carcinoma.Dosage recommendation:Roferon-A should be given by subcutaneous injection at a dose of 3 million IU three times weekly for one week, 9 million IU three times weekly for the following week and 18 million IU three times weekly thereafter. Concomitantly vinblastine should be given intravenously according to the manufacturer's instructions at a dose of 0.1 mg/kg once every 3 weeks.If the Roferon-A dosage of 18 million IU three times per week is not tolerated the dose may be reduced to 9 million IU three times per week.Treatment should be given for a minimum of three months, up to a maximum of 12 months or until the development of progressive disease. Patients who achieve a complete response may stop treatment three months after the response is established.- SURGICALLY RESECTED MALIGNANT MELANOMA.Adjuvant therapy with a low dose of Roferon-A prolongs disease-free interval in patients with no nodal or distant metastases following resection of a melanoma (tumour thickness> 1.5 mm).Dosage recommendation:Roferon-A should be administered subcutaneously at a dose of 3 million IU three times a week for 18 months, starting no later than six weeks post surgery. If intolerance develops, the dose should be lowered to 1.5 million IU three times a week.

Child Dosage
Not recommended.

Contra Indications
Roferon-A is contraindicated in patients with:1) A history of hypersensitivity to recombinant interferon alfa-2a or to any of the excipients,2) Patients with severe pre-existing cardiac disease or with any history of cardiac illness. No direct cardiotoxic effect has been demonstrated, but it is likely that acute, selflimiting toxicities (i.e., fever, chills) frequently associated with administration of Roferon-A may exacerbate pre-existing cardiac conditions,3) Severe renal, hepatic or myeloid dysfunction,4) Uncontrolled seizure disorders and/or compromised central nervous system function,5) Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver,6) Chronic hepatitis who are being or have recently been treated with immunosuppressive agents,7) Benzyl alcohol, which is an excipient in Roferon-A solution for injection has on rare occasions been associated with potentially fatal toxicities and anaphylactoid reactions in children up to 3 years old. Therefore, Roferon-A solution for injection should not be used in premature babies, neonates, infants or children up to 3 years old. Roferon-A solution contains 10 mg / ml Benzyl alcohol.Combination therapy with ribavirin: Also see ribavirin labelling if interferon alfa-2a is to be administered in combination with ribavirin in patients with chronic hepatitis C.

Special Precautions
Roferon-A should be administered under the supervision of a qualified physician experienced in the management of the respective indication. Appropriate management of the therapy and its complications is possible only when adequate diagnostic and treatment facilities are readily available.Patients should be informed not only of the benefits of therapy but also that they will probably experience adverse reactions.Hypersensitivity: If a hypersensitivity reaction occurs during treatment with Roferon-A or in the combination therapy with ribavirin, treatment has to be discontinued and appropriate medical therapy has to be instituted immediately. Transient rashes do not necessitate interruption of treatment.In transplant patients (e.g., kidney or bone marrow transplant) therapeutic immunosuppression may be weakened because interferons also exert an immunostimulatory action.Fever/Infections: While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever, particularly serious infections (bacterial, viral, fungal) must be ruled out, especially in patients with neutropenia. Serious infections (bacterial, viral, fungal) have been reported during treatment with alfa interferons including Roferon-A. Appropriate anti-infective therapy should be started immediately and discontinuation of therapy should be considered.Psychiatric: Severe psychiatric adverse reactions may manifest in patients receiving therapy with interferons, including Roferon-A. Depression, suicidal ideation, suicidal attempt, and suicide may occur in patients with and without previous psychiatric illness. Physicians should monitor all patients treated with Roferon-A for evidence of depression. Physicians should inform patients of the possible development of depression prior to initiation of therapy, and patients should report any sign or symptom of depression immediately. Psychiatric intervention and/or drug discontinuation should be considered in such cases.Ophthalmologic: As with other interferons, retinopathy including retinal haemorrhages, cotton wool spots, papilloedema, retinal artery or vein thrombosis and optic neuropathy which may result in loss of vision, have been reported after treatment with Roferon-A. Any patient complaining of decrease or loss of vision must have an eye examination. Because these ocular events may occur in conjunction with other disease states, a visual examination prior to initiation of Roferon-A monotherapy or in the combination therapy with ribavirin is recommended in patients with diabetes mellitus or hypertension. Roferon-A monotherapy or the combination therapy with ribavirin should be discontinued in patients who develop new or worsening ophthalmologic disorders.Endocrine: Hyperglycemia has been observed rarely in patients treated with Roferon-A. All patients who develop symptoms of hyperglycemia should have their blood glucose measured and followed-up accordingly. Patients with diabetes mellitus may require adjustment of their antidiabetic regimen.When mild to moderate renal, hepatic or myeloid dysfunction is present, close monitoring of these functions is required.Hepatic function: In rare cases interferon alpha has been suspected of causing an exacerbation of an underlying autoimmune disease in hepatitis patients. Therefore, when treating hepatitis patients with a history of autoimmune disease caution is recommended. If a deterioration in liver function in these patients develops a determination of autoimmune antibodies should be considered. If necessary treatment should be discontinued.Bone marrow suppression: Extreme caution should be exercised when administering Roferon-A to patients with severe myelosuppression as it has a suppressive effect on the bone marrow, leading to a fall in the white blood count, particularly granulocytes, platelet count and, less commonly, hemoglobin concentration. This can lead to an increased risk of infection or of haemorrhage. It is important to monitor closely these events in patients and periodic complete blood counts should be performed during the course of Roferon-Atreatment, both prior to therapy and at appropriate periods during therapy.Autoimmune: The development of different auto-antibodies has been reported during treatment with alpha interferons. Clinical manifestations of autoimmune disease during interferon therapy occur more frequently in subjects predisposed to the development of autoimmune disorders. In patients with an underlying or clinical history of auto-immune disorders, monitoring of symptoms suggestive of these disorders, as well as measurement of auto antibodies and TSH level, is recommended.The use of Roferon-A in children is not recommended as the safety and effectiveness of Roferon-A in children have not been established.Efficacy in patients with chronic hepatitis B or C who are on hemodialysis or have hemophilia or are coinfected with human immunodeficiency virus has not been demonstrated.This product contains less than 1 mmol sodium (23 mg) per 0.6 ml, i.e. essentially 'sodium-free'.Combination therapy with ribavirin: Also see ribavirin labelling if interferon alfa-2a is to be administered in combination with ribavirin in patients with chronic hepatitis C.Patients co-infected with HIV and receiving Highly Active Anti-Retroviral Therapy (HAART) may be at increased risk of developing lactic acidosis. Caution should be used when adding Roferon-A and ribavirin to HAART therapy (see ribavirin SPC).Co-infected patients with advanced cirrhosis receiving HAART may be at increased risk of hepatic decompensation and death. Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset.

Interactions
Since alphainterferons alter cellular metabolism, the potential to modify the activity of other drugs exists. In a small study, Roferon-A was shown to have an effect on specific microsomal enzyme systems. The clinical relevance of these findings is unknown.Alphainterferons may affect the oxidative metabolic process; this should be borne in mind when prescribing concomitant therapy with drugs metabolised by this route. However, as yet no specific information is available.Roferon-A has been reported to reduce the clearance of theophylline.As Roferon-A may affect central nervous system functions, interactions could occur following concurrent administration of centrallyacting drugs. The neurotoxic, haematotoxic or cardiotoxic effects of previously or concurrently administered drugs may be increased by interferons.Combination therapy with ribavirin: Also see ribavirin labelling if interferon alfa-2a is to be administered in combination with ribavirin in patients with chronic hepatitis C

Adverse Reactions
Combination therapy with ribavirin: Also see ribavirin labeling if interferon alfa-2a is to be administered in combination with ribavirin in patients with chronic hepatitis C.The following data on adverse reactions are based on information derived from the treatment of cancer patients with a wide variety of malignancies and often refractory to previous therapy and suffering from advanced disease, patients with chronic hepatitis B, and patients with chronic hepatitis C.Approximately two thirds of cancer patients experienced anorexia and one half nausea. Cardiovascular and pulmonary disorders were seen in about one fifth of cancer patients and consisted of transient hypotension, hypertension, edema, cyanosis, arrhythmias, palpitations and chest pain. Most cancer patients received doses that were significantly higher than the dose now recommended and may explain the higher frequency and severity of adverse reactions in this patient group compared with patients with hepatitis B where adverse reactions are usually transient, and patients return to pre-treatment status within 1 to 2 weeks after the end of therapy. Cardiovascular disorders were very rarely seen in patients with hepatitis B. In hepatitis B patients, changes in transaminases usually signal an improvement in the clinical state of the patient.The majority of the patients experienced flulike symptoms such as fatigue, pyrexia, rigors, decreased appetite, myalgia, headache, arthralgia and diaphoresis. These acute sideeffects can usually be reduced or eliminated by concurrent administration of paracetamol and tend to diminish with continued therapy or dose modification although continuing therapy can lead to lethargy, asthenia and fatigue.Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness:Body SystemVery common(1/10)Common(1/100to <1/10)Uncommon(1/1 000to 1/100)Rare(1/10 000to 1/1 000)Very rare(1/10 000)Infections and infestationsPneumoniaHerpes simplex1Blood and lymphatic system disorders2LeukopeniaThrombocytopeniaAnemiaAgranulocytosisHemolytic anemiaIdiopathic thrombocytopenic purpuraImmune system disordersAutoimmune disorderAcute hypersensivity reactions3SarcoidosisEndocrine disordersHypothyroidismHyperthyroidismThyroid dysfunctionMetabolism and nutrition disordersAnorexiaNauseaInconsequential hypocalcemiaDehydrationElectrolyte imbalanceDiabete mellitusHyperglycemiaHyper-triglyceridemiaHyperlipidemiaPsychiatric disordersDepressionAnxietyMental status changesConfusional stateAbnormal behaviorNervousnessMemory impairmentSleep disorderSuicideSuicide attemptSuicidal ideationNervous system disordersHeadacheDysgeusiaNeuropathyDizzinessHypoasthesiaParasthesiaTremorSomnolenceComaCerebrovascular accidentConvulsionsTransient erectile dysfunctionEncephalopathyEye disordersVisual disturbanceConjunctivitisIschemic retinopathyRetinal artery thrombosisOptic neuropathyRetinal hemorrhageRetinal vein thrombosisRetinal exudatesRetinopathyPapilledemaEar and labyrinth disordersVertigoCardiac disordersArrhythmias4PalpitationsCyanosisCardiorespiratory arrestMyocardial infarctionCongestive heart failurePulmonary edemaVascular disordersHypertensionHypotensionVasculitisRespiratory, thoracic and mediastinal disordersDyspneaCoughGastrointestinal disordersDiarrheaVomitingAbdominal painNauseaDry mouthPancreatitisIntestinal hypermotilityConstipationDyspepsiaFlatulenceReactivation of peptic ulcergastrointestinal bleeding (non life threatening)Hepato-biliary disordersHepatic failureHepatitisHepatic dysfunctionSkin and subcutaneous tissue disordersAlopecia5Sweating increasedPsoriasis6PruritusRashDry skinEpistaxisMucosal drynessRhinorrheaMusculoskeletal, connective tissue and bone disordersMyalgiaArthralgiaSystemic lupuserythematosusArthritisRenal and urinary disordersProteinuriaIncreased cell count in urineAcute renal failure7Renal impairmentGeneral disorders and administration site conditionsFlu like illnessAppetite decreasedPyrexiaRigorsFatigueChest painEdemaInjection site necrosisInjection site reactionInvestigationsWeight lossIncreased ALTIncreased transaminaseIncreased blood alkaline phosphataseIncreased blood creatinineIncreased blood ureaIncreased blood bilirubinIncreased blood uric acidIncreased blood LDH1 (including exacerbations of herpes labialis)2In myelosuppressed patients, thrombocytopenia and decreased haemoglobin occurred more frequently. Recovery of severe haematological deviations to pre-treatment levels usually occurred within seven to ten days after discontinuing Roferon-A treatment.3(e.g. urticaria, angioedema, bronchospasm and anaphylaxis)4including atrioventricular block5(reversible upon discontinuation; increased hair loss may continue for several weeks after end of treatment)6exacerbation of, or provocation of psoriasis7(mainly in cancer patients with renal disease)Rarely, alpha interferons including Roferon-A used alone or in combination with ribavirin, may be associated with pancytopenia, and very rarely, aplastic anemia has been reported.Neutralizing antibodies to interferons may form in some patients. In certain clinical conditions (cancer, systemic lupus erythematosus, herpes zoster) antibodies to human leukocyte interferon may also occur spontaneously in patients who have never received exogenous interferons. The clinical significance of the development of antibodies has not been fully clarified.In clinical trials where lyophilised Roferon-A which had been stored at 25°C was used, neutralizing antibodies to Roferon-A have been detected in approximately one fifth of patients. In patients with hepatitis C, a trend for responding patients who develop neutralizing antibodies to lose response while still on treatment and to lose it earlier than patients who do not develop such antibodies, has been seen. No other clinical sequelae of the presence of antibodies to Roferon-A have been documented. The clinical significance of the development of antibodies has not been fully clarified.No data on neutralizing antibodies yet exist from clinical trials in which lyophilized Roferon-A or Roferon-A solution for injection which is stored at 4°C has been used. In a mouse model, the relative immunogenicity of lyophilized Roferon-A increases with time when the material is stored at 25°C - no such increase in immunogenicity is observed when lyophilised Roferon-A is stored at 4°C, the recommended storage conditions.

Manufacturer
Roche

Drug Availability
(POM)

Updated
24 June 2009