Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Entecavir Monohydrate
HOVID BERHAD
Entecavir Monohydrate
30 Tablets
RA Chem Pharma Ltd
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ HOVID ENTECAVIR TABLETS Entecavir tablets 0.5mg (0.5mg), Entecavir tablets 1.0mg (1 mg) 1 WHAT IS IN THIS LEAFLET 1. What Hovid Entecavir is used for 2. How Hovid Entecavir works 3. Before you use Hovid Entecavir 4. How to use Hovid Entecavir 5. While you are using Hovid Entecavir 6. Side effects 7. Storage and Disposal of Hovid Entecavir 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT HOVID ENTECAVIR IS USED FOR Hovid Entecavir is indicated for the treatment of chronic hepatitis B (HBV) infection in adult: whose liver is damaged but still functions properly (compensated liver disease) whose liver is damaged and does not function properly (decompensated liver disease). HOW HOVID ENTECAVIR WORKS Infection by the hepatitis B virus can lead to damage to the liver. Hovid Entecavir reduces the amount of virus in your body, and improves the condition of the liver. BEFORE YOU USE HOVID ENTECAVIR _- When you must not use it _ Do not take this medicine if: you are allergic (hypersensitive) to entecavir or any of the other ingredients of this medicine you are HIV/HBV co-infected patient and also not receiving highly active antiretroviral therapy (HAART). you are pregnant or planning to become pregnant, unless considered essential by the physician. It has not been demonstrated that Hovid Entecavir is safe to use during pregnancy you are breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine. It is not known whether entecavir, the active ingredient in Hovid Entecavir, is excreted in human breast milk. Hovid Entecavir is not recommended for children below the age of 16 years. _-Before you start to use it_ _ _ Inform and discuss with your doctor or pharmacist if: you have ever had problems with your kidneys you have a transplanted liver your liver does not function properly (decompensated liver disease) you have any other allergies or health problem you have Leggi il documento completo
VIENT03-var (MY) DESCRIPTION HOVID ENTECAVIR TABLETS 0.5 MG White triangular shaped film-coated tablets debossed ‘A’ on one side and ‘88’ on the other side. HOVID ENTECAVIR TABLETS 1 MG Pink triangular shaped film-coated tablets debossed 'A' on one side and '89' on other side. COMPOSITION HOVID ENTECAVIR TABLETS 0.5 MG Each tablet contains 0.5 mg Entecavir. HOVID ENTECAVIR TABLETS 1 MG Each tablet contains 1 mg Entecavir. PHARMACODYNAMICS Entecavir is 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 of cellular DNA polymerases α, β, and δ with K i 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 (K i > 160 µM). PHARMACOKINETICS ABSORPTION Entecavir is rapidly absorbed with peak plasma concentrations occurring between 0.5-1.5 hours. The absolute bioavailability has not been determined. Based on urinary excretion of unchanged drug, the bioavailability has been estimated to be at least 70%. There is a dose- proportionate increase in C max and AUC values following multiple doses ranging from 0.1-1 mg. Steady-state is achieved between 6-10 days after once daily dosing with approximately 2 times accumulation. C max and C min at steady-state are 4.2 and 0.3 ng/ml, respectively, for a dose of 0.5 mg, and 8.2 and 0.5 ng/ml, respectively, for 1 mg. DISTRIBUTION The estimated volume of distribution for entecavir is in excess of total body water. Protein binding to human seru Leggi il documento completo