Země: Evropská unie
Jazyk: angličtina
Zdroj: myHealthbox
Daclatasvir Dihydrochloride
Bristol-Myers Squibb Pharma EEIG
J05AX14
Daclatasvir
60 mg
Film-coated tablet (tablet)
Oral use
28 (calendar pack), 28 x 1 tablet
Subject to medical prescription
Bristol-Myers Squibb
Direct-acting antiviral
Hepatitis C, Chronic
Indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults
Authorized
2014-08-23
71 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DAKLINZA 60 MG FILM-COATED TABLETS daclatasvir This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 Daklinza is and what it is used for 2. What you need to know before you take Daklinza 3. How to take Daklinza 4. Possible side effects 5. How to store Daklinza 6. Contents of the pack and other information 1. WHAT DAKLINZA IS AND WHAT IT IS USED FOR Daklinza contains the active ingredient daclatasvir. It is used to treat adults with hepatitis C, an infectious disease that affects the liver, caused by the hepatitis C virus. This medicine works by stopping the hepatitis C virus from multiplying and infecting new cells. This lowers the amount of hepatitis C virus in your body and removes the virus from your blood over a period of time. Daklinza must always be used together with other medicines against hepatitis C infection and must never be used by itself. It is very important that you also read the package leaflets for the other medicines that you will be taking with Daklinza. If you have any questions about your medicines, please ask your doctor or pharma Přečtěte si celý dokument
27 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Daklinza 60 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 60 mg daclatasvir. Excipient(s) with known effect: Each 60-mg film-coated tablet contains 116 mg of lactose (as anhydrous). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Light green biconvex pentagonal of dimensions 9.1 mm x 8.9 mm, debossed tablet with “BMS” on one side and “215” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1). For HCV genotype specific activity, see sections 4.4 and 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Daklinza should be initiated and monitored by a physician experienced in the management of chronic hepatitis C. Posology The recommended dose of Daklinza is 60 mg once daily, to be taken orally with or without meals. Daklinza must be administered in combination with other medicinal products. The Summary of Product Characteristics for the other medicinal products in the regimen should also be consulted before initiation of therapy with Daklinza. Recommended regimens and treatment duration are provided in Table 1 below (see sections 4.4 and 5.1): 28 TABLE 1: RECOMMENDED REGIMENS AND TREATMENT DURATION FOR DAKLINZA COMBINATION THERAPY HCV GENOTYPE AND PATIENT POPULATION* TREATMENT DURATION Genot Přečtěte si celý dokument