Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Ribavirin
Mylan S.A.S
J05AB04
ribavirin
Antivirals for systemic use
Hepatitis C, Chronic
Ribavirin Mylan is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (three years of age and older) and adolescents). 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).Please refer also to the interferon alfa-2b summary of product characteristics (SmPC) for prescribing information particular to that product.Naïve patientsAdult patientsRibavirin Mylan 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 serum hepatitis-C-virus (HCV) RNA.Children and adolescentsRibavirin Mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents three years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for serum 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).Previously treatment-failure patientsAdult patientsRibavirin Mylan 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 alpha monotherapy but who have subsequently relapsed.
Revision: 10
Withdrawn
2010-06-10
44 B. PACKAGE LEAFLET 45 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RIBAVIRIN MYLAN 200 MG HARD CAPSULES ribavirin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Ribavirin Mylan is and what it is used for 2. What you need to know before you take Ribavirin Mylan 3. How to take Ribavirin Mylan 4. Possible side effects 5. How to store Ribavirin Mylan 6. Contents of the pack and other information 1. WHAT RIBAVIRIN MYLAN IS AND WHAT IT IS USED FOR Ribavirin Mylan contains the active substance ribavirin. This medicine stops the multiplication of hepatitis C virus. Ribavirin Mylan must not be used without interferon alfa-2b, i.e. Ribavirin Mylan must not be used alone. Depending on the genotype of the hepatitis C virus that you have, your doctor may choose to treat you with a combination of this medicine with other medicines. There may be some further treatment limitations if you have or have not been previously treated for chronic hepatitis C infection. Your doctor will recommend the best course of therapy. The combination of Ribavirin Mylan and other medicines is used to treat adult patients who have chronic hepatitis C (HCV). _Previously untreated patients_ : The combination of Ribavirin Mylan with interferon alfa-2b is used in paedriatic patientes (children 3 years of age and older) who have chronic hepatitis C (HCV) infection. For paediatric patients (children and adolescents) weighing less than 47 kg a solution formulation is available. _Previously treated adult patients_ : The Lesen Sie das vollständige Dokument
1 _ _ _ _ _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ribavirin Mylan 200 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 200 mg of ribavirin. Excipient with known effect: each hard capsule contains 15 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. White opaque body imprinted "riba/200" in green and a white opaque cap imprinted "riba/200" in green. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ribavirin Mylan is indicated for the treatment of chronic hepatitis C (CHC) and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (3 years of age and older) and adolescents). 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). Please refer also to the interferon alfa-2b Summary of Product Characteristics (SmPC) for prescribing information particular to that product. Naïve patients _Adult Patients (18 years of age or older)_ : Ribavirin Mylan 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 serum HCV-RNA (see section 4.4). _Paediatric patients (children 3 years of age and older and adolescents):_ Ribavirin Mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy can induce a growth inhibition that may be irreversible in some patients. The decision to treat should be made Lesen Sie das vollständige Dokument