Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ENTECAVIR MONOHYDRATE
MEDISPEC (M) SDN.BHD
ENTECAVIR MONOHYDRATE
3 x 10 Tablets
2ND PLANT STANDARD CHEM & PHARM CO LTD
HEPURI F.C. TABLETS 0.5MG ® Entecavir 0.5mg _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Hepuri _ is used for 2. How _Hepuri _ works 3. Before you use _Hepuri_ 4. How to use _Hepuri_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Hepuri_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _HEPURI _IS USED FOR Entecavir is used to treat chronic hepatitis B virus (HBV) infection in adults with compensated or decompensated liver disease or with HIV/HBV co- infection who have received prior lamivudine therapy. HOW _HEPURI _WORKS Entecavir is an antiviral medication. Entecavir prevents certain virus cells from multiplying in your body BEFORE YOU USE _HEPURI_ - _ When you must not use it_ You should not take this medication if you are allergic to entecavir, or any other ingredients of _Hepuri._ _Pregnancy and lactation_ Do not take _Hepuri _ if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take _Hepuri _ if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _ Before you start to use it_ Before you take entecavir, tell your doctor if: You have liver disease You have kidney disease You are suffered from HIV or AIDS You have lever transplant You are infected with hepatitis C or D You are lactose intolerance - _ Taking other medicines_ Tell your doctor if you use any other medicines, including medicines purchased without a prescription from a pharmacy, supermarket, or health food store. Before taking entecavir, tell your doctor if you are using any of the following drugs: Lamivudine Adefovir dipivoxil Enofovir disoproxil HOW TO USE _HEPURI_ - _ How much to use_ Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet. If you do not understand the instructions on the label, ask your doctor or pharmacist for help. Compensated liver disease _Nucleoside naive patien Leggi il documento completo
Hepuri F.C. Tablet 0.5mg (Entecavir) 1. NAME AND DOSAGE FORM OF PRODUCT : Hepuri F.C. Tablet 0.5mg (Entecavir) 2. NAME AND STRENGTH OF ACTIVE INGREDIENT : Each tablet contains Entecavir monohydrate 0.53mg 3. DESCRIPTION : It occurs as a white tablet; film coated, triangular-shaped tablet, branded “948” on one side and “STD” on the other surface. 4. THERAPEUTIC CLASS : Antivirals 5. INDICATIONS : Entecavir are indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum alanine aminotransferases (ALT or AST) or histological active disease. This indication is based on the reported histologic, virologic, biochemical, and serological response in: a) nucleoside-treatment naive and lamivudine-resistant adult patient with HBeAg positive and HBeAg negative HBV infection with compensated liver disease b) adult patent with chronic HBV infection and decompensated liver disease c) adult patient with HIV/HBV co-infection who have received prior lamivudine therapy. 6. DOSAGE AND ADMINISTRATION : Compensated liver disease _Nucleoside naive patients_ : The recommended dose of Entecavir is 0.5mg orally once daily with or without food. _Lamivudine-refractory patients (i.e. history of hepatitis B viremia while receiving lamivudine _ _therapy or known lamivudine resistance [LVDr, commonly called YMDD] mutations):_ The recommended dose is 1mg once daily. Entecavir should be taken orally, on an empty stomach (empty means at least 2 hours before and at least 2 hours after a meal). Decompensated liver disease The recommended dose for patients with decompensated liver disease is 1 mg once daily, which must be taken on an empty stomach (empty means at least 2 hours before and at least 2 hours after a meal). Special Populations _Patients with renal impairment_ Entecavir is predominantly eliminated by the kidney. The clearance of entecavir decreases with impaired (decreasing) creatinine clearance. Dosage adjustment o Leggi il documento completo