Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
ENTECAVIR HYDRATE
PharOS – Pharmaceutical Oriented Services Limited Lesvou str. (end), Thesi Loggos, Industrial Zone, 144 52 Metamorfossi Attikis,, Greece
J05AF10
ENTECAVIR HYDRATE 0.5 mg
FILM-COATED TABLET
ENTECAVIR HYDRATE 0.5 mg
POM
ANTIVIRALS FOR SYSTEMIC USE
Withdrawn
2017-05-18
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER ENTECAVIR PHAROS 0.5 MG FILM-COATED TABLETS ENTECAVIR PHAROS 1 MG FILM-COATED TABLETS 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 PharOS is and what it is used for 2. What you need to know before you take Entecavir PharOS 3. How to take Entecavir PharOS 4. Possible side effects 5. How to store Entecavir PharOS 6. Contents of the pack and other information 1. WHAT ENTECAVIR PHAROS IS AND WHAT IT IS USED FOR ENTECAVIR PHAROS TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT CHRONIC (LONG TERM) HEPATITIS B VIRUS (HBV) INFECTION IN ADULTS. Entecavir PharOS 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 PHAROS TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM) HBV INFECTION IN CHILDREN AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS. Entecavir PharOS 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 PharOS 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 PHAROS DO NOT TAKE ENTECAVIR PHAROS IF YOU ARE ALLERGIC (HYPERSENSITIVE) to entecavir or any of the other ingredients of this medicine (listed in section 6). WARNING AND PRECAUTIONS Tal Baca dokumen lengkap
Page 1 of 22 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Entecavir PharOS 0.5 mg film-coated tablets Entecavir PharOS 1 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Entecavir PharOS 0.5 mg film-coated tablets Each film-coated tablet contains 0.5 mg entecavir (as monohydrate). Entecavir PharOS 1 mg film-coated tablets Each film-coated tablet contains 1 mg entecavir (as monohydrate). Excipients with known effect: Each 0.5 mg tablet contains 108 mg lactose (as monohydrate). Each 1 mg tablet contains 216 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Entecavir PharOS 0.5 mg film-coated tablets White to off-white and triangular-shaped film-coated tablet with “0.5” debossed on one side and plain on the other, with dimensions 8.4 mm x 8.7 mm. Entecavir PharOS 1 mg film-coated tablets Pink and triangular-shaped film coated tablet with “1” debossed on one side and plain on the other, with dimensions 10.6 mm x 11.0 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 Page 2 of 22 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 t Baca dokumen lengkap