IntronA European Union - English - EMA (European Medicines Agency)

introna

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.

PEGASYS peginterferon alfa-2a 180 micrograms/0.5mL injection pre-filled syringe Australia - English - Department of Health (Therapeutic Goods Administration)

pegasys peginterferon alfa-2a 180 micrograms/0.5ml injection pre-filled syringe

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.

PEGASYS peginterferon alfa-2a 135 micrograms/0.5mL injection pre-filled syringe Australia - English - Department of Health (Therapeutic Goods Administration)

pegasys peginterferon alfa-2a 135 micrograms/0.5ml injection pre-filled syringe

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.