Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
LEDIPASVIR; SOFOSBUVIR
GILEAD SCIENCES ISRAEL LTD
J05AP51
FILM COATED TABLETS
LEDIPASVIR 90 MG; SOFOSBUVIR 400 MG
PER OS
Required
GILEAD SCIENCES IRELAND UC, IRELAND
SOFOSBUVIR AND LEDIPASVIR
Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adults.
2021-04-30
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ (PRODUCTS) REGULATIONS - 1986 This medicine is to be supplied by doctor’s prescription only HARVONI ® Film-coated tablets ACTIVE INGREDIENTS : Each tablet contains – ledipasvir 90 mg 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. 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. This medicine is intended for adults aged 18 years and over. 1. WHAT IS THE MEDICINE INTENDED FOR Harvoni is indicated to treat chronic (long-term) hepatitis C virus infection in adults. THERAPEUTIC GROUP: • LEDIPASVIR AND SOFOSBUVIR are antivirals which suppress the hepatitis C virus. Harvoni is a medicine that contains the active substances ledipasvir and sofosbuvir in a single tablet. Hepatitis C is a virus that infects the liver. The active substances ledipasvir and sofosbuvir work together by blocking two different proteins that the virus needs to grow and reproduce itself, allowing the infection to be permanently eliminated from the body. Harvoni is sometimes taken with another medicine, ribavirin. It is very important that you also read the leaflets for the other medicines that you will be taking with Harvoni. If you have any questions about your medicines, please ask your doctor or pharmacist. HEPATITIS B VIRUS REACTIVATION: BEFORE STARTING TREATMENT WITH HARVONI, YOUR HEALTHCARE PROVIDER WILL DO BLOOD TESTS TO CHECK FOR HEPATITIS B VIRUS INFECTION. IF YOU HAVE OR HAD IN Прочитайте повний документ
Page 1 of 39 HARVONI ® (LEDIPASVIR/SOFOSBUVIR) FILM-COATED TABLETS 1. NAME OF THE MEDICINAL PRODUCT Harvoni ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir. Excipients with known effect Each film-coated tablet contains 157 mg of lactose (as monohydrate) and 47 micrograms of sunset yellow FCF. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Orange, diamond-shaped, film-coated tablet of dimensions of approximately 19 mm x 10 mm, debossed with “GSI” on one side and “7985” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Harvoni is indicated 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. 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 HARVONI. 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)]._ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Harvoni treatment should be initiated and monitored by a physician experienced in the management of patients with CHC. Posology The recommended dose of Harvoni is one tablet once daily with or without food (see section 5.2). TABLE 1: RECOMMENDED TREATMENT DURATION FOR HARVONI AND THE RECOMMENDED USE OF CO-ADMINISTERED RIBAVIRIN FOR CERTAIN SUBGROUPS PATIENT POPULATION * TREATMENT Прочитайте повний документ