Ország: Európai Unió
Nyelv: angol
Forrás: EMA (European Medicines Agency)
Boceprevir
Merck Sharp Dohme Ltd
J05AE
boceprevir
Antivirals for systemic use
Hepatitis C, Chronic
Victrelis is indicated for the treatment of chronic hepatitis-C (CHC) genotype-1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
Revision: 22
Withdrawn
2011-07-18
51 B. PACKAGE LEAFLET Medicinal product no longer authorised 52 PACKAGE LEAFLET: INFORMATION FOR THE USER VICTRELIS 200 MG HARD CAPSULES boceprevir 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 or pharmacist. This medicine has been prescribed for you. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Victrelis is and what it is used for 2. What you need to know before you take Victrelis 3. How to take Victrelis 4. Possible side effects 5. How to store Victrelis 6. Contents of the pack and other information 1. WHAT VICTRELIS IS AND WHAT IT IS USED FOR WHAT VICTRELIS IS Victrelis contains the active ingredient boceprevir which helps to fight against hepatitis C infection by stopping the virus multiplying. Victrelis must always be used together with two other medicines. These are called peginterferon alfa and ribavirin. Victrelis must not be used by itself. WHAT VICTRELIS IS USED FOR Victrelis, in combination with peginterferon alfa and ribavirin, is used for chronic hepatitis C virus infection in adults (also called HCV infection). Victrelis may be used in adults who are previously untreated for HCV infection or who have previously used medicines called ‘interferons’ and ‘pegylated interferons’. HOW VICTRELIS WORKS Victrelis inhibits the direct replication of the virus and contributes in this way to lowering the amount of hepatitis C virus in your body. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VICTRELIS DO NOT TAKE VICTRELIS IN COMBINATION WITH PEGINTERFERON ALFA AND RIBAVIRIN IF YOU: are ALLERGIC to boceprevir or any of the other ingredients of this medicine (listed in section 6) a Olvassa el a teljes dokumentumot
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Victrelis 200 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 200 mg of boceprevir. Excipient with known effect Each capsule contains 56 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Each capsule has a yellowish-brown, opaque cap with an "MSD" logo imprinted in red ink and off- white, opaque body with the code "314" imprinted in red ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Victrelis is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy (see sections 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Victrelis should be initiated and monitored by a physician experienced in the management of chronic hepatitis C. Posology Victrelis must be administered in combination with peginterferon alfa and ribavirin. The Summary of Product Characteristics of peginterferon alfa and ribavirin (PR) must be consulted prior to initiation of therapy with Victrelis. The recommended dose of Victrelis is 800 mg administered orally three times daily (TID) with food (a meal or light snack). Maximum daily dose of Victrelis is 2,400 mg. Administration without food could be associated with a net loss of efficacy due to sub-optimal exposure. _Patients without cirrhosis who are previously untreated or who have failed previous therapy _ The following dosing recommendations differ for some subgroups from the dosing studied in the Phase 3 trials (see section 5.1). Medicinal product no longer authorised 3 Table 1 Duration of therapy using Response-Guided Therapy (RGT) guidelines in patients without cirrhosis who are previously untreated or who have failed previous therapy to interferon and ribavir Olvassa el a teljes dokumentumot