Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
interferon alfa-2b
Merck Sharp & Dohme B.V.
L03AB05
interferon alfa-2b
Immunostimulants,
Carcinoid Tumor; Leukemia, Hairy Cell; Lymphoma, Follicular; Hepatitis B, Chronic; Hepatitis C, Chronic; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Melanoma; Multiple Myeloma
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.
Revision: 34
Withdrawn
2000-03-09
143 B. PACKAGE LEAFLET Medicinal Product no longer authorised 144 PACKAGE LEAFLET: INFORMATION FOR THE USER INTRONA 3 MILLION IU/0.5 ML SOLUTION FOR INJECTION OR INFUSION i nterferon alfa -2b READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What IntronA is and what it is used for 2. What you need to know before you use IntronA 3. How to use IntronA 4. Possible side effects 5. How to store IntronA 6. Contents of the pack and other information 1. WHAT INTRONA IS AND WHAT IT IS USED FOR IntronA (interferon alfa - 2b) modifies the response of the body's immune system to help fight infections and severe diseases. IntronA is used in adult patients to treat certain disorders that affec t the blood, bone marrow, lymph glands, or skin and may extend into the body. Included are hairy cell leukaemia, chronic myelogenous leukaemia, multiple myeloma, follicular lymphoma, carcinoid tumour, and malignant melanoma. IntronA is also used in adult patients for the treatment of chronic hepatitis B or C, which are viral infections of the liver. IntronA is used in combination with ribavirin in children 3 years of age and older and adolescents who have previously untreated chronic hepatitis C. 2. WH AT YOU NEED TO KNOW BEFORE YOU USE INTRONA DO NOT USE INTRONA - if you are allergic to interferon or any of the other ingredients of this medicine (listed in section 6). - if you have severe heart disease. - if you have poor kidney or liver function. - if you have advanced decompensated (uncontrolled) liver disease. Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal Product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT IntronA 3 million IU/0.5 mL solution for injection or infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of solution for injection or infusion contains 3 million IU of recombinant interferon alfa -2b produced in E. coli by recombinant DNA technology, in 0.5 mL of solution. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection or infusion. Clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chronic hepatitis B Treatment of adult patients with chronic hepatitis B associated with evide nce 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 C Before initiating treatment with IntronA, consideration should be given to the results from clinical trials comparing IntronA with pegylated interferon (see section 5.1). Adult patients IntronA is indicated for the treatment of adult patients with chronic hepati tis C who have elevated transaminases without liver decompensation and who are positive for hepatitis C virus RNA (HCV- RNA) (see section 4.4). The best way to use IntronA in this indication is in combination with ribavirin. Children 3 years of age and ol der and adolescents IntronA is indicated, in a combination regimen with ribavirin, for the treatment of children 3 years of age and older and adolescents, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are posit ive 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 mad e on a case by case basis (see section 4.4). Hairy cell leukaemia Treatment of Pročitajte cijeli dokument