Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Glecaprevir; Pibrentasvir
ABBVIE SDN BHD
Glecaprevir; Pibrentasvir
21 Tablets; 84 Tablets
Fournier Laboratories Ireland Limited
_Consumer Medication Information Leaflet (RiMUP)_ MAVIRET FILM-COATED TABLETS Glecaprevir 100mg/Pibrentasvir 40mg _____________________________________________________________________________________ ______________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What Maviret is used for 2. How Maviret works 3. Before you take Maviret 4. How to take Maviret 5. While you are using Maviret 6. Side effects of Maviret 7. Storage and disposal of Maviret 8. Product description 9. Manufacturer and Registration Holder 10. Date of revision WHAT MAVIRET IS USED FOR Maviret is an antiviral medicine used to treat adults and adolescents (12 to less than 18 years old) with long-term (‘chronic’) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus). HOW MAVIRET WORKS Maviret works by stopping the hepatitis C virus from multiplying and infecting new cells. This allows the infection to be eliminated from the body BEFORE YOU TAKE MAVIRET _When you must not take Maviret _ DO NOT TAKE MAVIRET IF: you are allergic to glecaprevir, pibrentasvir or any of the other ingredients of this medicine (listed under PRODUCT DESCRIPTION section). you have severe liver problems other than from hepatitis C. you are taking the following medicines: atazanavir (for HIV infection) atorvastatin or simvastatin (to lower blood cholesterol) carbamazepine, phenobarbital, phenytoin, primidone (normally used for epilepsy) dabigatran etexilate (to prevent blood clots) ethinyl oestradiol- containing medicines (such as contraception medicines, including vaginal rings and tablets) rifampicin (for infections) St. John’s wort (_Hypericum _ _perforatum_), (herbal remedy used for mild depression). If you are not sure, talk to your doctor or pharmacist before taking Maviret. _Before you start taking _ _Maviret _ YOU MUST TELL YOUR HEALTHCARE PROVIDER ABOUT ALL YOUR MEDICAL CONDITIONS, INCLUDING IF YOU: • have liver problems other than hepatitis C i Baca dokumen lengkap
MAVIRET (GLECAPREVIR 100MG/ PIBRENTASVIR 40MG) FILM COATED TABLETS PACKAGE INSERT PRODUCT NAME GENERIC NAME: Glecaprevir 100mg/Pibrentasvir 40mg TRADE NAMES Maviret DESCRIPTION Pink, oblong, biconvex, film-coated tablet of dimensions 18.8 mm x 10.0 mm, debossed on one side with ‘NXT’. Maviret is a fixed-dose combination tablet containing glecaprevir and pibrentasvir for oral administration. Glecaprevir is a HCV NS3/4A PI, and pibrentasvir is a HCV NS5A inhibitor. Glecaprevir/Pibrentasvir Film-Coated Immediate Release Tablets Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. Glecaprevir and pibrentasvir are presented as a fixed-dose combination, immediate release bilayer tablet. Glecaprevir The chemical name of glecaprevir is (3a_R_,7_S_,10_S_,12_R_,21_E_,24a_R_)-7-_tert_-butyl-_N_-{(1_R_,2_R_)-2- (difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro- 5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1_H_,10_H_-9,12- methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10- carboxamide hydrate. The molecular formula is C 38 H 46 F 4 N 6 O 9 S (anhydrate) and the molecular weight for the drug substance is 838.87 g/mol (anhydrate). Glecaprevir is a white to off-white crystalline powder with a solubility of less than 0.1 to 0.3 mg/mL across a pH range of 2–7 at 37°C and is practically insoluble in water, but is sparingly soluble in ethanol. Pibrentasvir The chemical name of pibrentasvir is Methyl {(2_S_,3_R_)-1-[(2_S_)-2-{5-[(2_R_,5_R_)-1-{3,5-difluoro-4- [4-(4-fluorophenyl)piperidin-1-yl]phenyl}-5-(6-fluoro-2-{(2_S_)-1-[_N_-(methoxycarbonyl)-_O_- methyl-L-threonyl]pyrrolidin-2-yl}-1_H_-benzimidazol-5-yl)pyrrolidin-2-yl]-6-fluoro-1_H_- benzimidazol-2-yl}pyrrolidin-1-yl]-3-methoxy-1-oxobutan-2-yl}carbamate. The molecular formula is C 57 H 65 F 5 N 10 O 8 and the molecular weight for the drug substance is 1113.18 g/mol. Pibrentasvir is a white to off-white to light yellow crystalline powder with a solubility of less than 0. Baca dokumen lengkap