Страна: Европейский союз
Язык: английский
Источник: EMA (European Medicines Agency)
dasabuvir sodium
AbbVie Ltd
J05AP09
dasabuvir
Antivirals for systemic use,
Hepatitis C, Chronic
Exviera 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.,
Revision: 14
Authorised
2015-01-14
57 B. PACKAGE LEAFLET 58 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EXVIERA 250 MG FILM-COATED TABLETS dasabuvir 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 Exviera is and what it is used for 2. What you need to know before you take Exviera 3. How to take Exviera 4. Possible side effects 5. How to store Exviera 6. Contents of the pack and other information 1. WHAT EXVIERA IS AND WHAT IT IS USED FOR Exviera is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus). It contains the active substance dasabuvir. Exviera works by stopping the hepatitis C virus from multiplying and infecting new cells, thus clearing the virus from your blood over a period of time. Exviera tablets do not work on their own. They are always taken with another antiviral medicine containing ombitasvir/paritaprevir/ritonavir. Some patients may also take an antiviral medicine called ribavirin. Your doctor will talk with you about which of these medicines to take with Exviera. It is very important that you also read the package leaflets for the other antiviral medicines that you take with Exviera. If you have any questions about your medicines, please ask your doctor or pharmacist. 2. W Прочитать полный документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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 Exviera 250 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate). Excipient with known effect: each film-coated tablet contains 44.94 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Beige, ovaloid, film-coated tablets with dimensions of 14.0 mm x 8.0 mm and debossed on one side with ‘AV2’. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Exviera 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 Treatment with Exviera should be initiated and monitored by a physician experienced in the management of chronic hepatitis C. Posology The recommended dose of dasabuvir is 250 mg (one tablet) twice daily (morning and evening). Exviera must not be administered as monotherapy. Exviera should be used in combination with other medicinal products for the treatment of HCV (see section 5.1). Refer to the Summary of Product Characteristics of the medicinal products that are used in combination with Exviera. The recommended co-administered medicinal product(s) and treatment duration for Exviera combination therapy are provided in table 1. 3 TABLE 1. RECOMMENDED CO-ADMINISTERED MEDICINAL PRODUCT(S) AND TREATMENT DURATION FOR EXVIERA BY PATIENT POPULATION PATIENT POPULATION TREATMENT* DURATION GENOTYPE 1B, WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS Exviera + ombitasvir/paritaprevir/ritonavir 12 weeks 8 w Прочитать полный документ