국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ENTECAVIR MONOHYDRATE
CAMBER LABORATORIES SDN. BHD.
ENTECAVIR MONOHYDRATE
10x10'stablet Tablets; 10 x 10'stablet Tablets
Hetero Labs Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ TECAVIR 0.5 (ENTECAVIR TABLETS 0.5MG) TECAVIR 1 (ENTECAVIR TABLETS 1MG)_ _ Entecavir (0.5mg, 1mg) 1 WHAT IS IN THIS LEAFLET 1. What TECAVIR is used for 2. How TECAVIR works 3. Before you use TECAVIR 4. How to use TECAVIR 5. While you using it 6. Side effects 7. Storage and Disposal of TECAVIR 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number 1. WHAT TECAVIR_ _IS USED FOR Entecavir tablets is 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). 2. HOW TECAVIR_ _WORKS 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. 3. BEFORE YOU USE TECAVIR - _When you must not use it_ If you are allergic to entecavir or any of the other ingredients of this medicine _Pregnancy and lactation _ Do not take TECAVIR if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take TECAVIR if you are breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine. - Before you start to use it You should not take this medication if you are allergic to entecavir, or if you also have HIV (human immunodeficiency virus) that is not being treated. If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before you take entecavir, tell your doctor if you are allergic to any drugs, or if you have: • HIV or AIDS; • kidney disease; • liver disease; or • if you have had a liver transplant. Some people have developed a life- threatening condition called lactic acidosis (excess of lactic acid in your blood) while taking entecavir. Symptoms such as nausea, vomiting and stomach 전체 문서 읽기
TECAVIR 0.5/1 Entecavir Tablets 0.5mg and 1mg Font size: 7 NAME OF THE PRODUCT TECAVIR 0.5 (Entecavir Tablets 0.5 mg) / TECAVIR 1 (Entecavir Tablets 1 mg NAME AND STRENGTH OF ACTIVE INGREDIENT TECAVIR 0.5 (Entecavir Tablets 0.5 mg) Each film-coated tablet contains: Entecavir Tablets 0.5 mg TECAVIR 1 (Entecavir Tablets 1 mg) Each film-coated tablet contains: Entecavir Tablets 1 mg DOSAGE FORM Oral dosage form, tablet PRODUCT DESCRIPTION TECAVIR 0.5 (Entecavir Tablets 0.5 mg) White to off white, triangle shaped, biconvex film- coated tablets debossed with 'J' on one side and '110' on other side. TECAVIR 1 (Entecavir Tablets 1 mg) Pink, triangle shaped, biconvex, film-coated tablets, debossed with 'J' on one side and '111' on the other side. PHARMACODYNAMICS/PHARMACOKINETICS PHARMACODYNAMICS Pharmacotherapeutic group: antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors. MECHANISM OF ACTION Entecavir, a guanosine nucleoside analogue with activity against HBV polymerase, is efficiently phosphorylated to the active triphosphate (TP) form, which has an intracellular half-life of 15 hours. By competing with the natural substrate deoxyguanosine TP, entecavir-TP functionally inhibits the 3 activities of the viral polymerase: (1) priming of the HBV polymerase, (2) reverse transcription of the negative strand DNA from the pregenomic messenger RNA, and (3) synthesis of the positive strand HBV DNA. The entecavir-TP Ki for HBV DNA polymerase is 0.0012 μM. Entecavir-TP is a weak inhibitor or cellular DNA polymerases α, β, and δ with Ki values of 18 to 40 µM . In addition, high exposures of entecavir had no relevant adverse effects on γ polymerase or mitochondrial DNA synthesis in HepG2 cells (Ki > 160 μM). ANTIVIRAL ACTIVITY Entecavir inhibited HBV DNA synthesis (50% reduction, EC 50 ) at a concentration of 0.004 μMin human HepG2 cells transfected with wild-type HBV. The median EC 50 value for entecavir against lamivudine- resistant HBV (rtL180M, rtM204V) was 0.026 μM (range 0.010–0 전체 문서 읽기