Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
ledipasvir, Sofosbuvir
Gilead Sciences Ireland UC
J05AX65
ledispavir, sofosbuvir
Antivirals for systemic use
Hepatitis C, Chronic
Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.
Revision: 28
Authorised
2014-11-17
93 B. PACKAGE LEAFLET 94 PACKAGE LEAFLET: INFORMATION FOR THE USER HARVONI 90 MG/400 MG FILM-COATED TABLETS HARVONI 45 MG/200 MG FILM-COATED TABLETS ledipasvir/sofosbuvir 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 Harvoni is and what it is used for 2. What you need to know before you take Harvoni 3. How to take Harvoni 4. Possible side effects 5. How to store Harvoni 6. Contents of the pack and other information IF HARVONI HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL THE INFORMATION IN THIS LEAFLET IS APPLICABLE TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD” INSTEAD OF “YOU”). 1. WHAT HARVONI IS AND WHAT IT IS USED FOR Harvoni is a medicine that contains the active substances ledipasvir and sofosbuvir. Harvoni is given to treat chronic (long-term) hepatitis C virus infection in ADULTS and CHILDREN 3 YEARS OF AGE AND OLDER. Hepatitis C is a virus that infects the liver. The active substances in the medicine 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HARVONI DO NOT TAKE HARVONI • IF YOU ARE ALLERGIC to ledipasvir, sofosbuvir or any of the other in Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Harvoni 90 mg/400 mg film-coated tablets Harvoni 45 mg/200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Harvoni 90 mg/400 mg film-coated tablets 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. Harvoni 45 mg/200 mg film-coated tablets Each film-coated tablet contains 45 mg ledipasvir and 200 mg sofosbuvir. Excipients with known effect Each film-coated tablet contains 78 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Harvoni 90 mg/400 mg film-coated tablets 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. Harvoni 45 mg/200 mg film-coated tablets White, capsule-shaped, film-coated tablet of dimensions of approximately 14 mm x 7 mm, debossed with “GSI” on one side and “HRV” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (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 Harvoni treatment should be initiated and monitored by a physician experienced in the management of patients with CHC. 3 Posology The recommended dose of Harvoni in adults is 90 mg/400 mg once daily with or without food (see section 5.2). The recommended dose of Harvoni in paediatric patients aged 3 years and above is based on weight (as detailed in Table 2) and can be taken with or without food (see section 5.2). A granule formulation of Harvoni is available for the treatment of chronic HCV-infection in paediatric patients aged 3 years and above havin Lestu allt skjalið