Ülke: Avrupa Birliği
Dil: İngilizce
Kaynak: EMA (European Medicines Agency)
Ribavirin
BioPartners GmbH
J05AB04
ribavirin
Antivirals for systemic use
Hepatitis C, Chronic
Ribavirin BioPartners is indicated for the treatment of chronic hepatitis-C-virus (HCV) infection in adults, children three years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. Ribavirin monotherapy must not be used. There is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b).Naïve patientsAdult patientsRibavirin BioPartners is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid (HCV-RNA) (see section 4.4)Children three years of age and older and adolescentsRibavirin BioPartners is intended for use, in a combination regimen with interferon alfa-2b, for the treatment of children three years of age and older and adolescents, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for HCV-RNA.When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4).Previous-treatment-failure patientsAdult patientsRibavirin BioPartners is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alfa monotherapy but who have subsequently relapsed (see section 5.1).
Revision: 2
Withdrawn
2010-04-06
33 B. PACKAGE LEAFLET Medicinal product no longer authorised 34 PACKAGE LEAFLET: INFORMATION FOR THE USER RIBAVIRIN BIOPARTNERS 200 MG FILM-COATED TABLETS ribavirin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Ribavirin BioPartners is and what it is used for 2. Before you take Ribavirin BioPartners 3. How to take Ribavirin BioPartners 4. Possible side effects 5. How to store Ribavirin BioPartners 6. Further information 1. WHAT RIBAVIRIN BIOPARTNERS IS AND WHAT IT IS USED FOR Ribavirin BioPartners contains the active ingredient ribavirin. Ribavirin BioPartners stops the multiplication of many types of viruses, including hepatitis C virus. Ribavirin BioPartners must not be used without interferon alfa-2b, i.e. Ribavirin BioPartners must not be used alone. _Previously untreated patients_ : The combination of Ribavirin BioPartners with interferon alfa-2b is used to treat patients 3 years of age and older who have chronic hepatitis C (HCV) infection, except genotype 1. For children and adolescents weighing less than 47 kg a solution formulation is available. _Previously treated adult patients_ : The combination of Ribavirin BioPartners with interferon alfa-2b is used to treat adult patients with chronic hepatitis C, who have previously responded to a treatment with an alpha interferon alone, but whose condition has recurred. There is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e., not alfa-2b). 2. BEFORE YOU TAKE RIBAVIRIN BIOPARTNERS Ribavirin BioPartners is not recommended for use in patients under the age of 3 years. DO N Belgenin tamamını okuyun
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Ribavirin BioPartners 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Ribavirin BioPartners film-coated tablet contains 200 mg of ribavirin. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Round, white, biconvex film-coated tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ribavirin BioPartners is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3 years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. Ribavirin monotherapy must not be used. There is no safety or efficacy information on the use of Ribavirin with other forms of interferon (i.e., not alfa-2b). Naïve patients _Adult patients: _ Ribavirin BioPartners is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid HCV-RNA (see section 4.4). _Children 3 years of age and older and adolescents:_ Ribavirin BioPartners is intended for use, in a combination regimen with interferon alfa-2b, for the treatment of children 3 years of age and older and adolescents, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for HCV-RNA. When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4). Previous treatment failure patients _Adult patients:_ Ribavirin BioPartners is indicated, in combination with interferon alfa-2b, for the treatmen Belgenin tamamını okuyun