Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
GILEAD SCIENCES ISRAEL LTD
J05AP56
FILM COATED TABLETS
VOXILAPREVIR 100 MG; VELPATASVIR 100 MG; SOFOSBUVIR 400 MG
PER OS
Required
GILEAD SCIENCES IRELAND UC, IRELAND
SOFOSBUVIR, VELPATASVIR AND VOXILAPREVIR
Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults.
2023-02-28
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ (PRODUCTS) REGULATIONS - 1986 This medicine is to be supplied by doctor’s prescription only VOSEVI ® Film-coated tablets ACTIVE INGREDIENTS: Each tablet contains – sofosbuvir 400 mg velpatasvir 100 mg voxilaprevir 100 mg INACTIVE AND ALLERGENIC SUBSTANCES : see section 6 _“Additional information_ ”. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This leaflet contains essential information about this medicine. 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 it seems that their medical condition is similar to yours. 1. WHAT IS VOSEVI INTENDED FOR? Vosevi is given to adults of 18 years and older to treat a chronic (long-term) viral infection of the liver called hepatitis C. THERAPEUTIC GROUP: • VELPATASVIR, VOXILAPREVIR AND SOFOSBUVIR are direct-acting antivirals. Vosevi is a medicine that contains the active substances sofosbuvir, velpatasvir and voxilaprevir in a single tablet. 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. BEFORE TAKING VOSEVI . X . DO NOT TAKE THIS MEDICINE 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. HEPATITIS B VIRUS REACTIVATION: BEFORE STARTING TREATMENT WITH VOSEVI, YOUR HEALTHCARE PROVIDER WILL DO BLOOD TESTS TO CHECK FOR HEPATITIS B VIRUS INFECTION. IF YOU HAVE OR HAD IN THE PAST AN INFECTION WITH HEPATITIS B VIRUS, TREATMENT WITH VOSEVI MIGHT CAUSE REACTIVATION OF HEPATITIS B, WHICH IN SOME CASES MIGHT BE FATAL OR CAUSE SERIOUS LIVER PROBLEMS (SUCH AS LIVER FAILURE). REACTIVATION O Lesen Sie das vollständige Dokument
1 VOSEVI ® (SOFOSBUVIR, VELPATASVIR, VOXILAPREVIR) FILM-COATED TABLETS 1. NAME OF THE MEDICINAL PRODUCT Vosevi ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 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. 4. CLINICAL PARTICULARS WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV TEST ALL PATIENTS FOR EVIDENCE OF CURRENT OR PRIOR HEPATITIS B VIRUS (HBV) INFECTION BEFORE INITIATING TREATMENT WITH VOSEVI. HBV REACTIVATION HAS BEEN REPORTED IN HCV/HBV COINFECTED PATIENTS WHO WERE UNDERGOING OR HAD COMPLETED TREATMENT WITH HCV DIRECT ACTING ANTIVIRALS (DAA) AND WERE NOT RECEIVING HBV ANTIVIRAL THERAPY. SOME CASES HAVE RESULTED IN FULMINANT HEPATITIS, HEPATIC FAILURE, AND DEATH. MONITOR HCV/HBV COINFECTED PATIENTS FOR HEPATITIS FLARE OR HBV REACTIVATION DURING HCV TREATMENT AND POST-TREATMENT FOLLOW-UP. INITIATE APPROPRIATE PATIENT MANAGEMENT FOR HBV INFECTION AS CLINICALLY INDICATED _[SEE SPECIAL WARNINGS AND PRECAUTIONS FOR USE (SECTION 4.4)]_ . 4.1 THERAPEUTIC INDICATIONS Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1). 2 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 is one tablet, 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 PATIENT POPULATION TREATMENT DURATION DAA naïve patients without cirrhosi Lesen Sie das vollständige Dokument