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. - interferon alfa-2b - carcinoid tumor; leukemia, hairy cell; lymphoma, follicular; hepatitis b, chronic; hepatitis c, chronic; leukemia, myelogenous, chronic, bcr-abl positive; melanoma; multiple myeloma - immunostimulants, - chronic hepatitis btreatment of adult patients with chronic hepatitis b associated with evidence of hepatitis-b viral replication (presence of dna of hepatitis-b virus (hbv-dna) and hepatitis-b antigen (hbeag), elevated alanine aminotransferase (alt) and histologically proven active liver inflammation and / or fibrosis.chronic hepatitis cbefore initiating treatment with introna, consideration should be given to the results from clinical trials comparing introna with pegylated interferon.adult patientsintrona is indicated for the treatment of adult patients with chronic hepatitis c who have elevated transaminases without liver decompensation and who are positive for hepatitis-c virus-rna (hcv-rna).the best way to use introna in this indication is in combination with ribavirin.children three years of age and older and adolescentsintrona 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, not previously treated, 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 resulted in reduced final adult height in some patients.the decision to treat should be made on a case-by-case basis.hairy-cell leukaemiatreatment of patients with hairy cell leukaemia.chronic myelogenous leukaemiamonotherapytreatment of adult patients with philadelphia-chromosome- or bcr/abl-translocation-positive chronic myelogenous leukaemia.clinical experience indicates that a haematological and cytogenetic major / minor response is obtainable in the majority of patients treated. a major cytogenetic response is defined by < 34 % ph+ leukaemic cells in the bone marrow, whereas a minor response is ≥ 34 %, but < 90 % ph+ cells in the marrow.combination therapythe combination of interferon alfa-2b and cytarabine (ara-c) administered during the first 12 months of treatment has been demonstrated to significantly increase the rate of major cytogenetic responses and to significantly prolong the overall survival at three years when compared to interferon alfa-2b monotherapy.multiple myelomaas maintenance therapy in patients who have achieved objective remission (more than 50% reduction in myeloma protein) following initial induction chemotherapy.current clinical experience indicates that maintenance therapy with interferon alfa-2b prolongs the plateau phase; however, effects on overall survival have not been conclusively demonstrated.follicular lymphomatreatment of high-tumour-burden follicular lymphoma as adjunct to appropriate combination induction chemotherapy such as a chop-like regimen. high tumour burden is defined as having at least one of the following: bulky tumour mass (> 7 cm), involvement of three or more nodal sites (each > 3 cm), systemic symptoms (weight loss > 10 %, pyrexia > 38°c for more than eight days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia.carcinoid tumourtreatment of carcinoid tumours with lymph node or liver metastases and with 'carcinoid syndrome'.malignant melanomaas adjuvant therapy in patients who are free of disease after surgery but are at high risk of systemic recurrence, e.g. patients with primary or recurrent (clinical or pathological) lymph-node.