Ülke: Avrupa Birliği
Dil: İngilizce
Kaynak: EMA (European Medicines Agency)
simeprevir
Janssen-Cilag International NV
J05AE14
simeprevir
Antivirals for systemic use
Hepatitis C, Chronic
Olysio is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients.For hepatitis C virus (HCV) genotype specific activity.
Revision: 13
Withdrawn
2014-05-14
47 B. PACKAGE LEAFLET Medicinal product no longer authorised 48 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OLYSIO 150 MG HARD CAPSULES simeprevir 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 OLYSIO is and what it is used for 2. What you need to know before you take OLYSIO 3. How to take OLYSIO 4. Possible side effects 5. How to store OLYSIO 6. Contents of the pack and other information 1. WHAT OLYSIO IS AND WHAT IT IS USED FOR WHAT OLYSIO IS - OLYSIO contains the active substance ‘simeprevir’. It acts against the virus that causes hepatitis C infection, called ‘hepatitis C virus’ (HCV). - OLYSIO must not be used by itself. OLYSIO must always be used as part of a course of treatment with other medicines for treating chronic hepatitis C infection. It is therefore important that you also read the package leaflets that are provided with these other medicines before you start taking OLYSIO. If you have any further questions about any of these medicines, ask your doctor or pharmacist. WHAT OLYSIO IS USED FOR OLYSIO is used with other medicines to treat chronic (long-term) hepatitis C infection in adults. HOW OLYSIO WORKS OLYSIO helps to fight against hepatitis C infection by preventing HCV from multiplying. When used together with other medicines to treat chronic h Belgenin tamamını okuyun
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 OLYSIO 150 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains simeprevir sodium equivalent to 150 mg of simeprevir. Excipient with known effect: each capsule contains 78.4 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule) White gelatin capsule of approximately 22 mm in length, marked with “TMC435 150” in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OLYSIO is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with OLYSIO should be initiated and monitored by a physician experienced in the management of CHC. Posology The recommended dosage of OLYSIO is one capsule of 150 mg once daily, taken with food. OLYSIO must be used in combination with other medicinal products for the treatment of CHC (see section 5.1). When considering OLYSIO combination treatment with peginterferon alfa and ribavirin in HCV genotype 1a patients, patients should be tested for the presence of virus with the NS3 Q80K polymorphism before starting treatment (see section 4.4). Refer also to the Summary of Product Characteristics of the medicinal products that are used in combination with OLYSIO. The recommended co-administered medicinal product(s) and treatment duration for OLYSIO combination therapy are provided in tables 1 and 2. Medicinal product no longer authorised 3 TABLE 1: RECOMMENDED TREATMENT DURATION FOR Belgenin tamamını okuyun