国家: 以色列
语言: 英文
来源: Ministry of Health
SOFOSBUVIR; VELPATASVIR
GILEAD SCIENCES ISRAEL LTD
J05AX15
FILM COATED TABLETS
VELPATASVIR 100 MG; SOFOSBUVIR 400 MG
PER OS
Required
GILEAD SCIENCES IRELAND UC, IRELAND
SOFOSBUVIR
Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults.
2022-03-31
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ (PRODUCTS) REGULATIONS - 1986 This medicine is to be supplied by doctor’s prescription only EPCLUSA ® Film-coated tablets ACTIVE INGREDIENTS: Each tablet contains – sofosbuvir 400 mg velpatasvir 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. Keep this leaflet. You may need to read it again. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. If you experience any side effects, talk to your doctor or pharmacist. Even if you experience any side effects that are not listed in this leaflet (see section 4). This medicine is intended for adults aged 18 years and over. HEPATITIS B VIRUS REACTIVATION: BEFORE STARTING TREATMENT WITH EPCLUSA, 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 EPCLUSA MIGHT CAUSE REACTIVATION OF HEPATITIS B, WHICH IN SOME CASES MIGHT BE FATAL OR CAUSE SERIOUS LIVER PROBLEMS (SUCH AS LIVER FAILURE). REACTIVATION OF HEPATITIS B CAN OCCUR DURING TREATMENT OR AT THE END OF TREATMENT WITH EPCLUSA. IF YOU ARE AT RISK OF HEPATITIS B REACTIVATION YOU MUST BE MONITORED CLOSELY DURING AND AFTER TREATMENT WITH EPCLUSA. FOR MORE INFORMATION ABOUT THE SIDE EFFECTS, SEE SECTION 4. 1. WHAT IS EPCLUSA INTENDED FOR? Epclusa is given to treat a chronic (long-term) viral infection of the liver called hepatitis C in adults of 18 years and older. THERAPEUTIC GROUP: • VELPATASVIR AND SOFOSBUVIR are direct-acting antivirals for systemic use. The medicine Epclusa is a single tablet regimen that contains the following two active substances: 阅读完整的文件
1 EPCLUSA ® (SOFOSBUVIR / VELPATASVIR) FILM-COATED TABLETS 1. NAME OF THE MEDICINAL PRODUCT Epclusa ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg sofosbuvir and 100 mg velpatasvir. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Pink, diamond-shaped, film-coated tablet of dimensions 20 mm x 10 mm, debossed on one side with “GSI” and “7916” 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 EPCLUSA. HBV REACTIVATION HAS BEEN REPORTED IN HCV/HBV COINFECTED PATIENTS WHO WERE UNDERGOING OR HAD COMPLETED TREATMENT WITH HCV DIRECT ACTING ANTIVIRALS 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 Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Epclusa treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection. Posology The recommended dose of Epclusa is one tablet, taken orally, once daily with or without food (see section 5.2). 2 TABLE 1: RECOMMENDED TREATMENT AND DURATION FOR ALL HCV GENOTYPES PATIENT POPULATION A TREATMENT AND DURATION Patients without cirrhosis and patients with compensated cirrhosis Epclusa for 12 weeks Addition of ribavirin may be considered for genotype 3 infected patients with compensated cirrhosis (see section 5.1.) Patients with decompensated cirrhosis Ep 阅读完整的文件