Land: Den europeiske union
Språk: engelsk
Kilde: EMA (European Medicines Agency)
Ribavirin
Merck Sharp and Dohme B.V
J05AP01
ribavirin
Antivirals for systemic use, Antivirals for treatment of HCV infections
Hepatitis C, Chronic
Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation.
Revision: 39
Withdrawn
1999-05-06
65 PACKAGE LEAFLET: INFORMATION FOR THE USER REBETOL 200 MG HARD CAPSULES ribavirin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Ke ep this leaflet. You may need to read it again. - If you have any further questions, ask your d octor, pharmacist or nurse. - This medicine has bee n prescribed for you only. Do not pass it on to others. It ma y harm them, even if their signs of illness are the s ame as yours. - If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side ef fects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Re betol is and what it is used for 2. What you need to know before you use Rebetol 3. How to use Rebetol 4. Possible side effects 5. How to store R ebetol 6. Contents of the pack and other informat ion 1. WHAT REBETOL IS AND WHAT IT IS USED FOR Rebetol contains the active substance ribavirin. This medicine s tops the multiplication of hepatitis C virus. Rebetol must not be used alone. Depending on t he genotype of the hepatitis C virus that you hav e, your doc tor 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 pre viously treated for chronic he patitis C infection. Your doctor will recommend t he best course of therapy. T he combination of Rebetol and other medicines is used to treat adult patients who have chronic hepatitis C (HCV). Rebetol may be used in paediatric patients (children 3 years of age and older and adoles cents) who are not previously treat ed and without severe liver disease. For paediatric patients ( children and adolescents ) weighing less than 47 kg a solution formulation is available. If yo u have an y further questions on the use of this medicine, ask yo ur doctor or pharmacist. 2. WHAT YOU NEED TO KNOW B EFORE YOU USE REBETOL DO NOT TAKE REBETOL Do not take Rebetol i f any of the following apply to you or the chil Les hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Rebetol 200 mg hard capsu les 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each har d capsule contains 200 mg of ribavirin. Excipient with known eff ect Each hard capsule contains 40 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule) White, opaque and imprinted w ith blue ink. 4. CLIN ICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rebetol is indicated in com bination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1). Rebetol is indicated in com bination with other me d icinal products for the treatment of chronic hepatitis C (CHC) for paediat ric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation (see sections 4.2, 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tre atment should be initiated , and monitored, by a physici an experienced in the management of chronic hepatitis C. Posology Rebetol must be used in combinat ion therapy as described in section 4.1. Please refer to th e corresponding Summar y of Product Charact eristics (SmPC) of medicinal products used in combinati on with Rebetol for additional prescribing information particular to that product and for further do sage recommendations on co - administration with Rebetol. Re betol capsules are to b e administered oral ly each day in two divided doses (morning and evening) with food. Adults The recommended dose and duration of Rebetol depends on patient ’s weight and on the medicinal product that is used in combination . Please refer to the corresponding SmPC of medicina l products used in combina tion with Rebetol. In the ca ses in which no specific dose recommendation is made, the following dose should be used: Patient weight: < 75 kg =1,000 mg and > 75 kg = 1,200 mg. Medicinal product no longer authorised 3 Paediatric popul Les hele dokumentet