国: オランダ
言語: オランダ語
ソース: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ENTECAVIR 1-WATER 0,5 mg/stuk SAMENSTELLING overeenkomend met ; ENTECAVIR 0,47 mg/stuk
Vocate Pharmaceuticals SA 150 Gounari street 16674 GLYFADA (GRIEKENLAND)
J05AF10
ENTECAVIR 1-WATER 0,5 mg/stuk SAMENSTELLING overeenkomend met ; ENTECAVIR 0,47 mg/stuk
Filmomhulde tablet
CALCIUMCARBONAAT (E 170) ; CARMELLOSE NATRIUM (E 466) ; CITROENZUUR 1-WATER (E 330) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; POLYSACCHARIDEN VAN SOJA ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171), CALCIUMCARBONAAT (E 170) ; CARMELLOSE NATRIUM (E 466) ; CITROENZUUR 1-WATER (E 330) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; POLYSACCHARIDEN VAN SOJA ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Entecavir
Hulpstoffen: CALCIUMCARBONAAT (E 170); CARMELLOSE NATRIUM (E 466); CITROENZUUR 1-WATER (E 330); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MACROGOL 400; MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMSTEARYLFUMARAAT; POLYSACCHARIDEN VAN SOJA; POLYSORBAAT 80 (E 433); TITAANDIOXIDE (E 171);
2018-04-12
1 B. PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER ENTECAVIR VOCATE 0,5 MG, FILMOMHULDE TABLETTEN ENTECAVIR VOCATE 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 Vocate is and what it is used for 2. What you need to know before you take Entecavir Vocate 3. How to take Entecavir Vocate 4. Possible side effects 5. How to store Entecavir Vocate 6. Contents of the pack and other information 1. WHAT ENTECAVIR VOCATE IS AND WHAT IT IS USED FOR ENTECAVIR VOCATE TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT CHRONIC (LONG TERM) HEPATITIS B VIRUS (HBV) INFECTION IN ADULTS. Entecavir Vocate 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 VOCATE TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM) HBV INFECTION IN CHILDREN AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS. ENTECAVIR VOCATE 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 Vocate 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 VOCATE DO NOT TAKE ENTECAVIR VOCATE • IF YOU ARE ALLERGIC (HYPERSENSITIVE) to entecavir or any of the other ingredients of this medicine (listed in section 6). WARNING AN 完全なドキュメントを読む
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Entecavir Vocate 0,5 mg, filmomhulde tabletten Entecavir Vocate 1 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Entecavir Vocate 0.5 mg film-coated tablets Each tablet contains 0.5 mg entecavir (as monohydrate). Entecavir Vocate 1 mg film-coated tablets Each tablet contains 1 mg entecavir (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Entecavir Vocate 0.5 mg film-coated tablets White to off white, triangle shaped, approx. 8.7 x 8.40 mm, biconvex film- coated tablets debossed with ‘J' on one side and ‘110’ on other side. Entecavir Vocate 1 mg film-coated tablets Pink, triangle shaped, approx. 11.0 x 10.60 mm, biconvex film - coated tablets debossed with 'J' on one side and '111' on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Entecavir Vocate is indicated for the 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. Entecavir Vocate is also indicated for the 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 initiate treatment in paediatric patients, see sections 4.2, 4.4, and 5.1. 4.2 POSOLOGY AND 完全なドキュメントを読む