Quốc gia: Hà Lan
Ngôn ngữ: Tiếng Hà Lan
Nguồn: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ENTECAVIR 1-WATER SAMENSTELLING overeenkomend met ; ENTECAVIR
Aliud Pharma GmbH & Co. KG Gottlieb-Daimler-Strasse 19 89150 LAICHINGEN (DUITSLAND)
J05AF10
ENTECAVIR 1-WATER COMPOSITION corresponding to ; ENTECAVIR
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Entecavir
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYSORBAAT 80 (E 433); TITAANDIOXIDE (E 171);
2017-04-20
PACKAGE LEAFLET: INFORMATION FOR THE USER ENTECAVIR ALIUD PHARMA GMBH 0,5 MG, FILMOMHULDE TABLETTEN ENTECAVIR ALIUD PHARMA GMBH 1 MG, FILMOMHULDE TABLETTEN Entecavir 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 Entecavir ALIUD PHARMA GmbH is and what it is used for 2. What you need to know before you take Entecavir ALIUD PHARMA GmbH 3. How to take Entecavir ALIUD PHARMA GmbH 4. Possible side effects 5. How to store Entecavir ALIUD PHARMA GmbH 6. Contents of the pack and other information 1. WHAT ENTECAVIR ALIUD PHARMA GMBH IS AND WHAT IT IS USED FOR ENTECAVIR ALIUD PHARMA GMBH TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT CHRONIC (LONG TERM) HEPATITIS B VIRUS (HBV) INFECTION IN ADULTS. Entecavir ALIUD PHARMA GmbH can be used in people whose liver is damaged but still functions properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease). ENTECAVIR ALIUD PHARMA GMBH TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM) HBV INFECTION IN CHILDREN AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS. Entecavir ALIUD PHARMA GmbH can be used in children whose liver is damaged but still functions properly (compensated liver disease). Infection by the hepatitis B virus can lead to damage to the liver. Entecavir ALIUD PHARMA GmbH reduces the amount of virus in your body, and improves the condition of the liver. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENTECAVIR ALIUD PHARMA GMBH DO NOT TAKE ENTECAVIR ALIUD PHARMA GMBH - if you are a Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Entecavir ALIUD PHARMA GmbH 0,5 mg, filmomhulde tabletten Entecavir ALIUD PHARMA GmbH 1 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION0.5 mg film-coated tablets Each tablet contains 0.5 mg entecavir (as monohydrate). Đọc toàn bộ tài liệu1 mg film-coated tablets Each tablet contains 1 mg entecavir (as monohydrate). Excipients with known effect: Each 0.5 mg film-coated tablet contains 120.97 mg lactose monohydrate. Each 1 mg film-coated tablet contains 241.94 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). 0.5 mg film-coated tablets White oval shaped tablet with a size of about10.1 mm x 3.7 mm with break line on both sides. 1 mg film-coated tablets Pink oval shaped tablet with a size of about 12.8 mm x 4.8 mm with break line on both sides. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS ADULT INDICATION Treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with: − compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. − decompensated liver disease (see section 4.4) For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B, see sections 4.2, 4.4 and 5.1. PAEDIATRIC POPULATION Treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to 18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to