Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
entecavir, Quantity: 0.5 mg
Alphapharm Pty Ltd
entecavir monohydrate
Tablet, film coated
Excipient Ingredients: lactose monohydrate; crospovidone; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; macrogol 400
Oral
30
(S4) Prescription Only Medicine
Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults 16 years or older with evidence of active liver inflammation. This indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment na?ve and lamividine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease.
Visual Identification: A white, film-coated, round, biconvex, beveled edge tablet debossed with 'M' on one side of the tablet and 'EV1' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-04-18
AUSTRALIAN PRODUCT INFORMATION ENTECAVIR MYLAN _entecavir (as monohydrate) film coated tablets _ 1 NAME OF THE MEDICINE Entecavir (as monohydrate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ENTECAVIR MYLAN tablet contains 0.5 mg or 1 mg of entecavir (as monohydrate). Excipients with known effects: sugars (as lactose). For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM ENTECAVIR MYLAN 0.5 mg : A white, film-coated, round, biconvex, beveled edge tablet debossed with ‘M’ on one side of the tablet and ‘EV1’ on the other side. ENTECAVIR MYLAN 1 mg : A white, film-coated, round, biconvex, beveled edge tablet debossed with ‘M’ on one side of the tablet and ‘EV2’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults 16 years or older with evidence of active liver inflammation. This indication is based on histologic, virologic, biochemical and serological responses in nucleoside- treatment naïve and lamivudine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease. 4.2 DOSE AND METHOD OF ADMINISTRATION RECOMMENDED DOSAGE Entecavir should be taken orally, on an empty stomach (at least 2 hours after a meal and at least 2 hours before the next meal). The recommended oral dose of entecavir in adults and adolescents older than 16 years is 0.5 mg once daily. For lamivudine-refractory patients [history of hepatitis B viremia while receiving lamivudine therapy or known lamivudine resistance (LVD R commonly called YMDD mutations)], the recommended dose is 1 mg once daily. RENAL IMPAIRMENT In patients with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased (see section 5.1 PHARMACOKINETIC PROPERTIES: Special Populations). Dosage adjustment of entecavir is recommended for patients with creatinine clearance <50 mL/min, including patients on haemodialysis or Прочитать полный документ