Χώρα: Ευρωπαϊκή Ένωση
Γλώσσα: Αγγλικά
Πηγή: EMA (European Medicines Agency)
Sofosbuvir, velpatasvir, voxilaprevi
Gilead Sciences Ireland UC
J05A
sofosbuvir, velpatasvir, voxilaprevi
Antivirals for systemic use
Hepatitis C, Chronic
Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged 12 years and older and weighing at least 30 kg. (see sections 4.2, 4.4 and 5.1).
Revision: 16
Authorised
2017-07-26
43 B. PACKAGE LEAFLET 44 PACKAGE LEAFLET: INFORMATION FOR THE USER VOSEVI 400 MG/100 MG/100 MG FILM-COATED TABLETS VOSEVI 200 MG/50 MG/50 MG FILM-COATED TABLETS sofosbuvir/velpatasvir/voxilaprevir 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 Vosevi is and what it is used for 2. What you need to know before you take Vosevi 3. How to take Vosevi 4. Possible side effects 5. How to store Vosevi 6. Contents of the pack and other information IF VOSEVI HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL THE INFORMATION IN THIS LEAFLET IS ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD” INSTEAD OF “YOU”). 1. WHAT VOSEVI IS AND WHAT IT IS USED FOR Vosevi is a medicine that contains the active substances sofosbuvir, velpatasvir and voxilaprevir in a single tablet. It is given to treat a chronic (long-term) viral infection of the liver called hepatitis C in patients aged 12 years and older and weighing at least 30 kg. The active substances in this medicine work together by blocking three different proteins that the hepatitis C virus needs to grow and reproduce itself, causing the infection to be eliminated from the body. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VOSEVI DO NOT TAKE VOSEVI • IF YOU ARE ALLERGIC to sofosbuvir, velpatasvir, voxilaprevir or any of the other ingredients of this medicine (listed in section 6 of this leaflet). If this applies to you, DO NOT TAKE VOSEVI AND TELL YOUR DOCTOR IMMEDIATELY. • IF YOU ARE CURRENTLY TAKING ANY OF THE FOLLOWING MEDICINES Διαβάστε το πλήρες έγγραφο
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Vosevi 400 mg/100 mg/100 mg film-coated tablets Vosevi 200 mg/50 mg/50 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Vosevi 400 mg/100 mg/100 mg film-coated tablets Each film-coated tablet contains 400 mg sofosbuvir, 100 mg velpatasvir and 100 mg voxilaprevir. Excipients with known effect Each film-coated tablet contains 111 mg of lactose (as monohydrate). Vosevi 200 mg/50 mg/50 mg film-coated tablets Each film-coated tablet contains 200 mg sofosbuvir, 50 mg velpatasvir and 50 mg voxilaprevir. Excipients with known effect Each film-coated tablet contains 55 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Vosevi 400 mg/100 mg/100 mg film-coated tablets Beige, capsule-shaped, film-coated tablet of dimensions 10 mm x 20 mm, debossed with “GSI” on one side and “3” on the other side. Vosevi 200 mg/50 mg/50 mg film-coated tablets Beige, oval-shaped, film-coated tablet of dimensions 8 mm x 15 mm, debossed with “GSI” on one side and “SVV” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged 12 years and older and weighing at least 30 kg (see sections 4.2, 4.4 and 5.1). 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Vosevi treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection. Posology The recommended dose of Vosevi in patients aged 12 years and older and weighing at least 30 kg is one 400 mg/100 mg/100 mg tablet or two 200 mg/50 mg/50 mg tablets, taken orally, once daily with food (see section 5.2). The recommended durations of treatment applicable to all HCV genotypes are shown in Table 1. TABLE 1: RECOMMENDED TREATMENT DURATIONS FOR VOSEVI FOR ALL HCV GENOTYPES IN PATIENTS 12 YEARS AND OLDER AND WEIGHING AT LEAST 30 KG PATIENT POPULATION TREATMENT DUR Διαβάστε το πλήρες έγγραφο