Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
interferon alfa-2b
Schering-Plough Europe
L03AB05
interferon alfa-2b
Immunostimulants,
Hepatitis C, Chronic; Hepatitis B, Chronic
Chronic Hepatitis B: Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/or fibrosis.Chronic Hepatitis C:Adult patients:IntronA is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see section 4.4).The best way to use IntronA in this indication is in combination with ribavirin.Chidren and adolescents:IntronA is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA. The decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral load. The expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).
Revision: 11
Withdrawn
2000-03-09
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Viraferon 1 million IU/ml powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of powder contains 1 million IU of interferon alfa-2b produced in _E.coli_ by recombinant DNA technology. After reconstitution, 1 ml contains 1 million IU of interferon alfa-2b. _ _ For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection _ _ White to cream coloured powder. Clear and colourless solvent. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chronic Hepatitis B : Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/or fibrosis. Chronic Hepatitis C: _Adult patients: _ Viraferon is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see section 4.4). The best way to use Viraferon in this indication is in combination with ribavirin. _Chidren and adolescents: _ Viraferon is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA. The decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral load. The expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTR Đọc toàn bộ tài liệu
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Viraferon 1 million IU/ml powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of powder contains 1 million IU of interferon alfa-2b produced in _E.coli_ by recombinant DNA technology. After reconstitution, 1 ml contains 1 million IU of interferon alfa-2b. _ _ For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection _ _ White to cream coloured powder. Clear and colourless solvent. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chronic Hepatitis B : Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/or fibrosis. Chronic Hepatitis C: _Adult patients: _ Viraferon is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see section 4.4). The best way to use Viraferon in this indication is in combination with ribavirin. _Chidren and adolescents: _ Viraferon is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA. The decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral load. The expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTR Đọc toàn bộ tài liệu