国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Entecavir monohydrate
Bristol-Myers Squibb Pharmaceuticals Ltd
J05AF10
Entecavir monohydrate
1mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05030301; GTIN: 5012712003687
PACKAGE LEAFLET: INFORMATION FOR THE USER BARACLUDE 0.5 MG FILM-COATED TABLETS BARACLUDE 1 MG FILM-COATED TABLETS BARACLUDE 0.05 MG/ML ORAL SOLUTION 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 Baraclude is and what it is used for 2. What you need to know before you take Baraclude 3. How to take Baraclude 4. Possible side effects 5. How to store Baraclude 6. Contents of the pack and other information 1. WHAT BARACLUDE IS AND WHAT IT IS USED FOR BARACLUDE TABLETS AND ORAL SOLUTION ARE ANTI-VIRAL MEDICINES, USED TO TREAT CHRONIC (LONG TERM) HEPATITIS B VIRUS (HBV) INFECTION IN ADULTS. Baraclude 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). BARACLUDE TABLETS AND ORAL SOLUTION ARE ALSO USED TO TREAT CHRONIC (LONG TERM) HBV INFECTION IN CHILDREN AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS. Baraclude 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. Baraclude reduces the amount of virus in your body, and improves the condition of the liver. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BARACLUDE DO NOT TAKE BARACLUDE 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 ta 完全なドキュメントを読む
OBJECT 1 BARACLUDE 0.5 MG FILM COATED TABLETS Summary of Product Characteristics Updated 07-Apr-2016 | Bristol-Myers Squibb Pharmaceuticals limited 1. Name of the medicinal product Baraclude 0.5 mg film-coated tablets Baraclude 1 mg film-coated tablets 2. Qualitative and quantitative composition Baraclude 0.5 mg film-coated tablets Each tablet contains 0.5 mg entecavir (as monohydrate). Baraclude 1 mg film-coated tablets Each tablet contains 1 mg entecavir (as monohydrate). Excipients with known effect: Each 0.5 mg film-coated tablet contains 120.5 mg lactose. Each 1 mg film-coated tablet contains 241 mg lactose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet (tablet) Baraclude 0.5 mg film-coated tablets White to off-white and triangular-shaped tablet with BMS debossed on one side and 1611 on the other. Baraclude 1 mg film-coated tablets Pink and triangular-shaped tablet with BMS debossed on one side and 1612 on the other. 4. Clinical particulars 4.1 Therapeutic indications Baraclude 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. Baraclude 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 r 完全なドキュメントを読む