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

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)

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

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)

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

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)

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

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

merck sharp & dohme llc - interferon alfa-2b (unii: 43k1w2t1m6) (interferon alfa-2b - unii:43k1w2t1m6) - interferon alfa-2b 38 ug in 1 ml - intron® a is indicated for the treatment of patients 18 years of age or older with hairy cell leukemia. intron a is indicated as adjuvant to surgical treatment in patients 18 years of age or older with malignant melanoma who are free of disease but at high risk for systemic recurrence, within 56 days of surgery. intron a is indicated for the initial treatment of clinically aggressive (see clinical pharmacology ) follicular non-hodgkin's lymphoma in conjunction with anthracycline-containing combination chemotherapy in patients 18 years of age or older. efficacy of intron a therapy in patients with low-grade, low-tumor burden follicular non-hodgkin's lymphoma has not been demonstrated. intron a is indicated for intralesional treatment of selected patients 18 years of age or older with condylomata acuminata involving external surfaces of the genital and perianal areas (see dosage and administration ). the use of this product in adolescents has not been studied. intron a is indicated for the treatment of select

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

merck sharp & dohme corp. - peginterferon alfa-2b (unii: g8rgg88b68) (interferon alfa-2b - unii:43k1w2t1m6) - peginterferon alfa-2b 50 ug in 0.5 ml - pegintron® , as part of a combination regimen, is indicated for the treatment of chronic hepatitis c (chc) in patients with compensated liver disease. - pegintron in combination with ribavirin and an approved hepatitis c virus (hcv) ns3/4a protease inhibitor is indicated in adult patients with hcv genotype 1 infection (see labeling of the specific hcv ns3/4a protease inhibitor for further information). - pegintron in combination with ribavirin is indicated in patients with genotypes other than 1, pediatric patients (3-17 years of age), or in patients with genotype 1 infection where use of an hcv ns3/4a protease inhibitor is not warranted based on tolerability, contraindications or other clinical factors. pegintron monotherapy should only be used in the treatment of chc in patients with compensated liver disease if there are contraindications to or significant intolerance of ribavirin and is indicated for use only in previously untreated adult patients. combination therapy provides substantially better respons

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.