Riik: Holland
keel: hollandi
Allikas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ENTECAVIR 1-WATER 1,1 mg/stuk SAMENSTELLING overeenkomend met ; ENTECAVIR 1 mg/stuk
Pharmaceutical Works Polpharma S.A. 19, Pelplinska Street 83-200 STAROGARD GDANSKI (POLEN)
J05AF10
ENTECAVIR 1-WATER 1,1 mg/stuk SAMENSTELLING overeenkomend met ; ENTECAVIR 1 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; 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), 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);
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Entecavir Polpharma 0,5 mg, filmomhulde tabletten Entecavir Polpharma 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 Polpharma is and what it is used for 2. What you need to know before you take Entecavir Polpharma 3. How to take Entecavir Polpharma 4. Possible side effects 5. How to store Entecavir Polpharma 6. Contents of the pack and other information 1. WHAT ENTECAVIR POLPHARMA IS AND WHAT IT IS USED FOR ENTECAVIR POLPHARMA ARE ANTI-VIRAL MEDICINES, USED TO TREAT CHRONIC (LONG TERM) HEPATITIS B VIRUS (HBV) INFECTION IN ADULTS. Entecavir Polpharma 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 POLPHARMA ARE ALSO USED TO TREAT CHRONIC (LONG TERM) HBV INFECTION IN CHILDREN AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS. Entecavir Polpharma 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 Polpharma 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 POLPHARMA DO NOT TAKE ENTECAVIR POLPHARMA: - if you are allergic to entecavir or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Tal Lugege kogu dokumenti
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 . NAME OF THE MEDICINAL PRODUCT Entecavir Polpharma 0,5 mg, filmomhulde tabletten Entecavir Polpharma 1 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Entecavir Polpharma 0.5 mg, film-coated tablets Each tablet contains 0.5 mg entecavir (as monohydrate). Excipient with known effect: lactose. Each tablet contains 120.97 mg lactose. Entecavir Polpharma 1 mg, film-coated tablets Each tablet contains 1 mg entecavir (as monohydrate). Excipient with known effect: lactose. Each tablet contains 241.94 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Entecavir Polpharma 0.5 mg, film-coated tablets White, 10.1 mm x 3.7 mm +/- 0.2 mm, oval shaped tablet with break line on both sides. The tablet can be divided into equal doses. Entecavir Polpharma 1 mg, film-coated tablets Pink, 12.8 mm x 4.8 mm +/- 0.2 mm, oval shaped tablet with break line on both sides. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULT INDICATION Entecavir Polpharma 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. 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 2 serum ALT levels, or histological evidence of moderate to severe inflam Lugege kogu dokumenti