מדינה: הולנד
שפה: הולנדית
מקור: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ENTECAVIR 1-WATER 1,06 mg/stuk SAMENSTELLING overeenkomend met ; ENTECAVIR 1 mg/stuk
Fomed Pharmaceuticals SL Gabriel Garcia Marquez 4, Las Rozas MADRID (SPANJE)
J05AF10
ENTECAVIR 1-WATER 1,06 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) ; 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) ; 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); TITAANDIOXIDE (E 171);
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ENTECAVIR FOMED 0,5 MG FILMOMHULDE TABLETTEN ENTECAVIRFOMED1 MG FILMOMHULDETABLETTEN 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 EntecavirFomed is and what it is used for 2. What you need to know before you take EntecavirFomed 3. How to take EntecavirFomed 4. Possible side effects 5. How to store EntecavirFomed 6. Contents of the pack and other information 1. WHAT ENTECAVIRFOMED IS AND WHAT IT IS USED FOR ENTECAVIRFOMED TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT CHRONIC (LONG TERM) HEPATITIS B VIRUS (HBV) INFECTION IN ADULTS.EntecavirFomed 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). ENTECAVIRFOMED TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM) HBV INFECTION IN CHILDREN AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS.EntecavirFomed 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. EntecavirFomed reduces the amount of virus in your body, and improves the condition of the liver. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENTECAVIRFOMED DO NOT TAKE ENTECAVIRFOMED IF YOU ARE ALLERGIC (HYPERSENSITIVE) to entecavir or any of the other ingredients of this medicine (listed in section 6). WARNING AND PRECAUTIONS Talk to your doctor or pharmacist before tak קרא את המסמך השלם
1. NAME OF THE MEDICINAL PRODUCT ENTECAVIR FOMED 0,5 MG FILMOMHULDE TABLETTEN ENTECAVIR FOMED 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). Excipients 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 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 initiate treatment in paediatric patients, see sections 4.2, 4.4, and 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of chronic hepati קרא את המסמך השלם