País: Israel
Língua: inglês
Origem: Ministry of Health
SOFOSBUVIR
GILEAD SCIENCES ISRAEL LTD
J05AX15
FILM COATED TABLETS
SOFOSBUVIR 400 MG
PER OS
Required
GILEAD SCIENCES IRELAND UC, IRELAND
SOFOSBUVIR
Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.For hepatitis C virus (HCV) genotype specific activity, see physician leaflet .
2015-08-12
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 THIS MEDICINE IS TO BE SUPPLIED BY DOCTOR’S PRESCRIPTION ONLY SOVALDI ® SOFOSBUVIR 400 MG FILM - COATED TABLETS ACTIVE INGREDIENTS: Each tablet contains – SOFOSBUVIR 400 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 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. This medicine is intended for adults aged 18 years and over. HEPATITIS B VIRUS REACTIVATION: BEFORE STARTING TREATMENT WITH SOVALDI, YOUR HEALTHCARE PROVIDER WILL DO BLOOD TESTS TO CHECK FOR HEPATITIS B VIRUS INFECTION. IF YOU HAVE OR HAD IN THE PAST INFECTION WITH HEPATITIS B VIRUS, SOVALDI MIGHT CAUSE REACTIVATION OF HEPATITIS B, WHICH IN SOME CASES MIGHT BY 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 SOVALDI. IF YOU ARE AT RISK OF HEPATITIS B REACTIVATION DURING OR AFTER TREATMENT WITH SOVALDI, YOU MUST BE CLOSELY MONITORED. 1. WHAT IS SOVALDI INTENDED FOR? Sovaldi contains the active substance sofosbuvir which is given to treat hepatitis C virus infection in adults of 18 years and older. Hepatitis C is a virus that infects the liver. This medicine works by lowering the amount of hepatitis C virus in your body and removing the virus from your blood over a period of time. Sovaldi is always taken with other medicines to treat hepatitis C. It will not work on its own. It is c Leia o documento completo
1 THE FORMAT OF THIS LEAFLET WAS DEFINED BY THE MINISTRY OF HEALTH AND ITS CONTENT WAS CHECKED AND APPROVED BY THE MINISTRY OF HEALTH IN JANUARY 2018 AND UPDATED ACCORDING TO THE GUIDELINES OF THE MINISTRY OF HEALTH IN SEPTEMBER 2019. SOVALDI ® SOFOSBUVIR 400 MG FILM - COATED TABLETS 1. NAME OF THE MEDICINAL PRODUCT Sovaldi ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg of sofosbuvir. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Yellow, capsule-shaped, film-coated tablet of dimensions 20 mm x 9 mm, debossed on one side with “GSI” and “7977” 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 SOVALDI. 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. 4.1 THERAPEUTIC INDICATIONS Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (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 Sovaldi treatment should be initiated and monitored by a physician experienced in the management of patients with CHC. 2 Posology The recommended dose is one 400 mg tablet, taken orally, once daily with food (see section 5.2). Sovaldi should be used in combination with other medicinal products. Monotherapy of Sovaldi is not recommended (see section 5.1). R Leia o documento completo