Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Entecavir monohydrate
Dr Reddy's Laboratories (UK
J05AF10
Entecavir monohydrate
500microgram
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05030301
PACKAGE LEAFLET: INFORMATION FOR THE USER ENTECAVIR 0.5 MG FILM-COATED TABLETS ENTECAVIR 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 is and what it is used for 2. What you need to know before you take Entecavir 3. How to take Entecavir 4. Possible side effects 5. How to store Entecavir 6. Contents of the pack and other information 1. WHAT ENTECAVIR IS AND WHAT IT IS USED FOR ENTECAVIR TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT CHRONIC (LONG TERM) HEPATITIS B VIRUS (HBV) INFECTION IN ADULTS. Entecavir 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 TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM) HBV INFECTION IN CHILDREN AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS. Entecavir 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 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 DO NOT TAKE ENTECAVIR - if you are allergic to entecavir or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Entecavir - IF YOU HAVE EVER HAD PROBLEMS WITH YOUR KIDNEYS , tell your doctor. This is impo Belgenin tamamını okuyun
OBJECT 1 ENTECAVIR DR. REDDY'S 0.5 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 08-May-2017 | Dr. Reddy's Laboratories (UK) Ltd 1. Name of the medicinal product Entecavir Dr. Reddy's 0.5 mg Film-Coated Tablets 2. Qualitative and quantitative composition Each tablet contains entecavir monohydrate corresponding to 0.5 mg entecavir. Excipients with known effect: Each 0.5 mg film-coated tablet contains 121 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet (tablet). White oval shaped tablet with a size of about 10.1 mm x 3.7 mm with break line on both sides. The tablet can be divided into equal halves. 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 hepatitis B infection. Posology _Compensated liver disease_ _Nucleoside naïve patients: _the recommended dose in Belgenin tamamını okuyun