Pajjiż: Olanda
Lingwa: Olandiż
Sors: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ENTECAVIR 1-WATER 0,53 mg/stuk SAMENSTELLING overeenkomend met ; ENTECAVIR 0,5 mg/stuk
Krka d.d., Novo mesto Smarjeska cesta 6 8501 NOVO MESTO (SLOVENIË)
J05AF10
ENTECAVIR 1-WATER 0,53 mg/stuk SAMENSTELLING overeenkomend met ; ENTECAVIR 0,5 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; 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); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); POLYSORBAAT 80 (E 433); TITAANDIOXIDE (E 171);
1900-01-01
1.3.1 Entecavir SPC, Labeling and Package Leaflet NL-Netherlands PI_Text009649_2 - Updated: Page 27 of 31 PACKAGE LEAFLET: INFORMATION FOR THE USER ENTECAVIR KRKA 0,5 MG FILMOMHULDE TABLETTEN ENTECAVIR KRKA 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 Krka is and what it is used for 2. What you need to know before you take Entecavir Krka 3. How to take Entecavir Krka 4. Possible side effects 5. How to store Entecavir Krka 6. Contents of the pack and other information 1. WHAT ENTECAVIR KRKA IS AND WHAT IT IS USED FOR ENTECAVIR KRKA TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT CHRONIC (LONG TERM) HEPATITIS B VIRUS (HBV) INFECTION IN ADULTS. Entecavir Krka 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 KRKA TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM) HBV INFECTION IN CHILDREN AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS. Entecavir Krka 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 Krka 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 KRKA DO NOT TAKE ENTECAVIR KRKA: - IF YOU ARE ALLERGIC (HYPERSENSITIVE) to entecavir or any of the other ingredients of thi Aqra d-dokument sħiħ
1.3.1 Entecavir SPC, Labeling and Package Leaflet NL-Netherlands PI_Text038430_1 - Updated: Page 1 of 20 1. NAME OF THE MEDICINAL PRODUCT Entecavir Krka 0,5 mg filmomhulde tabletten Entecavir Krka 1 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 0.5 mg entecavir (as monohydrate). Each film-coated tablet contains 1 mg entecavir (as monohydrate). Excipient(s) with known effect Each 0.5 mg film-coated tablet contains 120.5 mg lactose monohydrate. Each 1 mg film-coated tablet contains 241.0 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) White triangular shaped film coated tablets debossed 'A' on one side and '88' on the other side of 8.7 x 8.4 mm. Pink triangular shaped film coated tablets debossed 'A' on one side and '89' on the other side of 10.9 x 10.5 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULT INDICATIONis 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. Aqra d-dokument sħiħis 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 se