Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
elbasvir, grazoprevir
Merck Sharp & Dohme B.V.
J05AP54
elbasvir, grazoprevir
Direct acting antivirals, Antivirals for systemic use, , Antivirals for treatment of HCV infections
Hepatitis C, Chronic
ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (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: 12
Authorised
2016-07-22
45 B. PACKAGE LEAFLET 46 PACKAGE LEAF LET: IN FORMATION FOR THE U SER ZEPATIER 50 MG/100 MG FILM- COATED TABLETS elbasvir/grazoprevir READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING TH IS MEDICINE B ECAUSE IT CONTAINS IMPORTANT INFORMATI ON FOR YOU. Keep th is leaflet. You may need to read it again. If you have any fur ther questions, ask your doctor or pharmacist. This medicine has been pres cribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness a re the same a s yours. If you get any s ide effects, talk to your doctor or p harmaci st. This includes a ny p ossible side effects not lis ted in this leaflet. Se e section 4. WHAT IS IN THIS LEAFLET 1. What ZEPATIER is and what it is used for 2. What you need to know befo re you take ZEPATIER 3. How to take ZEPATIER 4. Possible side effects 5. How to store ZEPATIER 6. Contents of the pack and other information 1. WHAT ZEPATIER IS AND WHAT IT IS USED FOR WHAT ZEPATIER IS ZEPATIER is an antiviral medicine that contains the acti ve substances elbas vir and grazoprevir. WHAT ZEPATIER IS USED FOR ZEPATIER is used to treat long-term hepatitis C infection in adult s and children aged 12 years and older who weigh at least 30 kilograms. HOW ZEPATIER WORKS Hepatitis C is a virus that infects the liver. The ac tive substances in the medi cine work together by blocking two different pro teins that the hepatitis C virus needs to grow and reproduce. This allows the infection to be permanently removed from the body. ZEPATIER is sometimes taken with ano ther medicine , ribavirin. It is very imp ortant that yo u also read the leaflets for the o ther medicines that you will be t aking with ZEPATIER. If you have any questions about your medicines, please ask your doctor or pharmacist. 2. WHAT YOU NEED TO KNOW BEFORE YOU TA KE ZEPATIER DO NOT TAKE ZEPATIER IF : you are allergic to elbasvir, grazopre vir or any of the other ingredien ts of this medicine (listed in section 6) you have certain moderate or severe Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACT ERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ZEPATIER 50 mg/100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COM POSITION Each film- coated tablet con tains 50 mg elbasvir and 100 mg grazoprevir. Excipie nts with known effect Each film-coated tablet contains 87.02 mg of lactose (as monohydrate) and 69.85 mg of sodium. For the fu ll list of excipients, see section 6.1. 3. PHA RMACEUT ICAL FORM Film-coated tablet. Beige, oval tablet of dimensions 21 mm x 10 mm debossed with “770” on one side an d plain on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICAT IONS ZEPATIER i s indicated for the treatment of chro nic hepatitis C (C HC) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (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 ZEPATIER treatment should b e initiated and monitored by a physician experienced in the management of patients with CHC. Posology The recommended dose is one tablet once daily. Recommended reg imens and treatm ent durations are provided in Table 1 below (see section s 4.4 and 5.1): 3 TABLE 1: RECOMMENDED ZEPA TIER THERAPY FOR TREATMENT OF CHRONIC HEPATITIS C INFECTION IN PATIENTS WITH OR WITHOUT C OMPENSATED C IRRHOSIS (CHILD - PUGH A ONLY) HCV GENOTYP E TREATMENT AND DURATION 1a ZEPATIER for 12 weeks ZEPATIER for 16 weeks plus r ibavirin A should be consid ered in patients with baseline HCV RNA level >800,000 IU/ mL and/or the presence of specific NS5A polymorphism s causing at least a 5 -fold reduction in activit y of elbasvir to minimi s e the risk of treatment failure (see section 5.1). 1b ZEPATIER for 12 weeks 4 ZEPATIER for 12 weeks ZEPATIER for 16 weeks plus ribavirin A should be considered in pa tients with baseline HCV RNA level >800,000 IU/mL to minimise the risk of treatment failure (see section 5.1) . A In the adult clinical studies, the dose of ribavirin was weight-based (< 66 kg Aqra d-dokument sħiħ