Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - interferon alfa-2b -

Australia - English - Department of Health (Therapeutic Goods Administration)

biogen australia pty ltd - interferon beta-1a, quantity: 60 microgram/ml - injection, solution - excipient ingredients: arginine hydrochloride; polysorbate 20; sodium acetate; water for injections; glacial acetic acid - avonex is indicated for the treatment of patients with relapsing forms of multiple sclerosis (ms). avonex is indicated in patients who have experienced a single demyelinating event and are at risk of developing clinically definite ms based on the presence of brain mri abnormalities characteristic of ms. avonex 60 mcg is indicated for the treatment of secondary progressive ms in patients in whom relapse is still a feature of disease. avonex 60 mcg should not be initiated in patients with secondary progressive ms who have not experienced relapse in the previous 12 months.

United States - English - NLM (National Library of Medicine)

merck sharp & dohme corp. - peginterferon alfa-2b (unii: g8rgg88b68) (peginterferon alfa-2b - unii:g8rgg88b68) - peginterferon alfa-2b 40 ug in 0.1 ml - sylatron™ is an alpha interferon indicated for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. sylatron is contraindicated in patients with: - a history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b - autoimmune hepatitis - hepatic decompensation (child-pugh score >6 [class b and c]) risk summary based on findings from animal studies, sylatron can cause embryo-fetal harm when administered to a pregnant woman. available human data with sylatron use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. administration of nonpegylated interferon alfa-2b was abortifacient in rhesus monkeys at doses approximately 13 times higher than the recommended dose of 6 mcg/kg/week (see data ). in the u.s. general population, the estimated background risk of major birth defects and miscarriage is 2-4% and

United States - English - NLM (National Library of Medicine)

horizon therapeutics usa, inc. - interferon gamma-1b (unii: 21k6m2i7ag) (interferon gamma-1b - unii:21k6m2i7ag) - interferon gamma-1b 100 ug in 0.5 ml - - actimmune is indicated for reducing the frequency and severity of serious infections associated with chronic granulomatous disease (cgd). - actimmune is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (smo). actimmune is contraindicated in patients who develop or have known hypersensitivity to interferon gamma, e. coli derived products, or any component of the product. risk summary there are no adequate and well-controlled studies in pregnant women. actimmune should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. animal data actimmune has shown an increased incidence of abortions in primates when given from gestation day 20 to 80 in doses approximately 100 times the human dose. a study in pregnant primates treated with subcutaneous doses 2 – 100 times the human dose failed to demonstrate teratogenic activity for actimmune. female mice treated subcutaneously with recombinant murine ifn-interferon gamma (rmuifn-gamma) at 280 times the maximum recommended clinical dose of actimmune from shortly after birth through puberty but not during pregnancy had offspring which exhibited decreased body weight during the lactation period. the clinical significance of this finding observed following treatment of mice with rmuifn-gamma is uncertain. for lower doses, there is no evidence of maternal toxicity, embryotoxicity, fetotoxicity or teratogenicity in preclinical studies. risk summary it is not known whether actimmune is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from actimmune, a decision should be made whether to discontinue nursing or to discontinue the drug, dependent upon the importance of the drug to the mother. infertility based on the information available, it cannot be excluded that the presence of higher levels of interferon gamma may impair male fertility and that in certain cases of female infertility increased levels of interferon gamma may have played a role [see nonclinical toxicology (13.1) ]. in younger patients, the long-term effect on fertility is also not known. the safety and effectiveness of actimmune has been established in pediatric patients aged 1 year and older in cgd patients and 1 month and older in smo patients [see clinical studies (14)]. there are no data available for pediatric patients below the age of 1 month. clinical studies of actimmune did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

echo therapeutics pty ltd - peginterferon alfa-2a, quantity: 180 microgram - injection, solution - excipient ingredients: acetic acid; water for injections; sodium acetate; sodium chloride; polysorbate 80; benzyl alcohol - chronic hepatitis c (chc): the combination of pegasys and copegus is indicated for the treatment of chronic heptitis c in patients who have received no prior interferon therapy (treatment naive patients) and patients who have failed previous treatment with interferon alfa (pegylated or non-pegylated) alone or in combination therapy with ribavirin. the combination of pegasys and copegus is also indicated for the treatment of chronic hepatitis c in patients with clinically stable human immunodeficiency virus (hiv) co-infection who have previously not received interferon therapy. pegasys monotherapy is indicated for the for the treatment of chronic heptitis c in treatment naive patients (see dosage and administration; chronic hepatitis c: treatment naive patients). patients must be 18 years of age or older and have compensated liver disease. chronic hepatitis b (chb): pegasys is indicated for the treatment of chronic heptitis b in adult patients with evidence of viral replication and liver inflammation and compensated liver disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

echo therapeutics pty ltd - peginterferon alfa-2a, quantity: 135 microgram - injection, solution - excipient ingredients: water for injections; sodium acetate; acetic acid; polysorbate 80; sodium chloride; benzyl alcohol - chronic hepatitis c (chc): the combination of pegasys and copegus is indicated for the treatment of chronic heptitis c in patients who have received no prior interferon therapy (treatment naive patients) and patients who have failed previous treatment with interferon alfa (pegylated or non-pegylated) alone or in combination therapy with ribavirin. the combination of pegasys and copegus is also indicated for the treatment of chronic hepatitis c in patients with clinically stable human immunodeficiency virus (hiv) co-infection who have previously not received interferon therapy. pegasys monotherapy is indicated for the for the treatment of chronic heptitis c in treatment naive patients (see dosage and administration; chronic hepatitis c: treatment naive patients). patients must be 18 years of age or older and have compensated liver disease. chronic hepatitis b (chb): pegasys is indicated for the treatment of chronic heptitis b in adult patients with evidence of viral replication and liver inflammation and compensated liver disease.

Canada - English - Health Canada

biogen canada inc - peginterferon beta-1a; peginterferon beta-1a - kit - 63mcg; 94mcg - peginterferon beta-1a 63mcg; peginterferon beta-1a 94mcg - interferons

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - peginterferon alfa-2b - hepatitis c, chronic - immunostimulants, - adults (tritherapy)pegintron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy.please refer to the ribavirin and boceprevir summaries of product characteristics (smpcs) when pegintron is to be used in combination with these medicines.adults (bitherapy and monotherapy)pegintron is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv.pegintron in combination with ribavirin (bitherapy) is indicated for the treatment of chc infection in adult patients who are previously untreated including patients with clinically stable hiv co-infection and in adult patients who have failed previous treatment with interferon-alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon-alpha monotherapy.interferon monotherapy, including pegintron, is indicated mainly in case of intolerance or contraindication to ribavirin.please refer to the ribavirin smpc when pegintron is to be used in combination with ribavirin.paediatric population (bitherapy)pegintron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have chc, previously untreated, without liver decompensation, and who are positive for hcv-rna.when deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. the decision to treat should be made on a case-by-case basis.please refer to the ribavirin smpc for capsules or oral solution when pegintron is to be used in combination with ribavirin.

Israel - English - Ministry of Health

bayer israel ltd - interferon beta 1b - powder and solvent for solution for injection - interferon beta 1b 0.3 mg/vial - interferon beta-1b - interferon beta-1b - use in ambulatory patients with relapsing-remitting multiple sclerosis (rrms) and relapsing progressive m.s. to reduce the frequency of clinical exacerbations. treatment of secondary progressive (sp) form of multiple sclerosis. treatment of patients who have experienced a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, including the prescence of mri abnormalities characteristic of m.s. and if they are determined to be at high risk of developing clinically definite multiple sclerosis.

European Union - English - EMA (European Medicines Agency)

merck sharp dohme ltd  - peginterferon alfa-2b - hepatitis c, chronic - immunostimulants, - adults (tritherapy)viraferonpeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy.please refer to the ribavirin and boceprevir summaries of product characteristics (smpcs) when viraferonpeg is to be used in combination with these medicines.adults (bitherapy and monotherapy)viraferonpeg is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv.viraferonpeg in combination with ribavirin (bitherapy) is indicated for the treatment of chc infection in adult patients who are previously untreated including patients with clinically stable hiv co-infection and in adult patients who have failed previous treatment with interferon alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon alpha monotherapy.interferon monotherapy, including viraferonpeg, is indicated mainly in case of intolerance or contraindication to ribavirin.please refer to the ribavirin smpc when viraferonpeg is to be used in combination with ribavirin.paediatric population (bitherapy)viraferonpeg is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents, who have chronic hepatitis c, previously untreated, without liver decompensation, and who are positive for hcv-rna.when deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. the decision to treat should be made on a case-by-case basis.please refer to the ribavirin smpc for capsules or oral solution when viraferonpeg is to be used in combination with ribavirin.