Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
telaprevir
Janssen-Cilag International N.V.
J05AE
telaprevir
Antivirals for systemic use
Hepatitis C, Chronic
Incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype-1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis):who are treatment naïve;who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.
Revision: 19
Withdrawn
2011-09-19
54 B. PACKAGE LEAFLET Medicinal product no longer authorised 55 PACKAGE LEAFLET: INFORMATION FOR THE USER INCIVO 375 MG FILM-COATED TABLETS telaprevir This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What INCIVO is and what it is used for 2. What you need to know before you take INCIVO 3. How to take INCIVO 4. Possible side effects 5. How to store INCIVO 6. Contents of the pack and other information 1. WHAT INCIVO IS AND WHAT IT IS USED FOR INCIVO acts against the virus that causes hepatitis C infection and is used to treat chronic hepatitis C infection in adult patients (aged 18–65 years) in combination with peginterferon alfa and ribavirin. INCIVO contains a substance called telaprevir and belongs to a group of medicines called ‘NS3-4A protease inhibitors’. The NS3-4A protease inhibitor reduces the amount of hepatitis C virus in your body. INCIVO must not be taken alone and must be taken in combination with peginterferon alfa and ribavirin to be sure your treatment works. INCIVO can be used for patients with chronic hepatitis C infection who have never been treated before or can be used in patients with chronic hepatitis C infection who have been treated previously with an interferon-based regimen. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INCIVO DO NOT TAKE INCIVO if yo Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT INCIVO 375 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 375 mg of telaprevir. Excipient: 2.3 mg of sodium per film-coated tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Yellow caplet shaped tablets of approximately 20 mm in length, marked with “T375” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INCIVO, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis): - who are treatment-naïve; - who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders (see sections 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with INCIVO should be initiated and monitored by a physician experienced in the management of chronic hepatitis C. Posology INCIVO, 1,125 mg (three 375 mg film-coated tablets) should be taken orally twice daily (b.i.d.) with food. Alternatively, 750 mg (two 375 mg tablets) can be taken orally every 8 hours (q8h) with food. The total daily dose is 6 tablets (2,250 mg). Taking INCIVO without food or without regard to the dosing interval may result in decreased plasma concentrations of telaprevir which could reduce the therapeutic effect of INCIVO. INCIVO should be administered in conjunction with ribavirin and either peginterferon alfa-2a or -2b. Please consult sections 4.4 and 5.1 regarding the selection of peginterferon alfa-2a or -2b. For spe Aqra d-dokument sħiħ