Country: ইউরোপীয় ইউনিয়ন
ভাষা: ইংরেজি
সূত্র: EMA (European Medicines Agency)
Entecavir
Accord Healthcare S.L.U.
J05AF10
entecavir
Antivirals for systemic use
Hepatitis B, Chronic
Entecavir Accord is indicated for the treatment of chronic hepatitis B virus (HBV) infection 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. , 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. Entecavir Accord is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to
Revision: 5
Authorised
2017-09-25
37 B. PACKAGE LEAFLET 38 PACKAGE LEAFLET: INFORMATION FOR THE USER ENTECAVIR ACCORD 0.5 MG FILM-COATED TABLETS ENTECAVIR ACCORD 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 Accord is and what it is used for 2. What you need to know before you take Entecavir Accord 3. How to take Entecavir Accord 4. Possible side effects 5. How to store Entecavir Accord 6. Contents of the pack and other information 1. WHAT ENTECAVIR ACCORD IS AND WHAT IT IS USED FOR ENTECAVIR ACCORD TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT CHRONIC (LONG TERM) HEPATITIS B VIRUS (HBV) INFECTION IN ADULTS. Entecavir Accord 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 ACCORD TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM) HBV INFECTION IN CHILDREN AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS. Entecavir Accord 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 Accord 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 ACCORD DO NOT TAKE ENTECAVIR ACCORD - IF YOU ARE ALLERGIC (HYPERSENSITIVE) to entecavir or any of the other ingredients of this medicine (listed in section 6). WARNING AND PRECAUTIONS সম্পূর্ণ নথি পড়ুন
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Entecavir Accord 0.5 mg film-coated tablets Entecavir Accord 1 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Entecavir Accord 0.5 mg film-coated tablets Each tablet contains entecavir monohydrate equivalent to 0.5 mg entecavir . Entecavir Accord 1 mg film-coated tablets Each tablet contains entecavir monohydrate equivalent to 1 mg entecavir. Excipients with known effect Each 0.5 mg film-coated tablet contains 26 mg soy polysaccharides. Each 1 mg film-coated tablet contains 52 mg soy polysaccharides. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Entecavir Accord 0.5 mg film-coated tablets White to off white, triangle shaped, biconvex film-coated tablets debossed with ‘J' on one side and ‘110’ on other side. Dimension: Length 8.70 mm ± 0.20 mm, width 8.40 mm ± 0.20 mm and thickness 3.40 mm ± 0.30 mm. Entecavir Accord 1 mg film-coated tablets Pink, triangle shaped, biconvex film-coated tablets debossed with 'J' on one side and '111' on other side. Dimension: Length 11.00 mm ± 0.20 mm, width 10.60 mm ± 0.20 mm and thickness 4.20 mm ± 0.30 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Entecavir Accord 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) 3 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. Entecavir Accord is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric সম্পূর্ণ নথি পড়ুন