Details

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• Registration Number (MAL): MAL18116080AZ.

• Manufacturer: 2nd Plant, Standard Chem & Pharm Co. Ltd., Tainan City, Taiwan.

Content

• Active Ingredient: Entecavir monohydrate 0.53 mg per tablet.

• Formulation: Film-coated, triangular-shaped tablet imprinted with “948” on one side and “STD” on the other.

Indications

Hepuri F.C. 0.5mg is indicated for:

• Treatment of chronic hepatitis B virus (HBV) infection in adults with evidence of active viral replication and either persistent elevations in serum alanine aminotransferases (ALT or AST) or histological active disease.

• Nucleoside-naive and lamivudine-resistant adult patients with HBeAg positive and HBeAg negative HBV infection with compensated liver disease.

• Adult patients with chronic HBV infection and decompensated liver disease.

• Adult patients with HIV/HBV co-infection who have received prior lamivudine therapy

Instructions

• Dosage:

  • For compensated liver disease in nucleoside-naive patients: 0.5 mg orally once daily with or without food.

  • For lamivudine-refractory patients: 1 mg once daily on an empty stomach (at least 2 hours before and 2 hours after a meal).

  • For decompensated liver disease: 1 mg once daily on an empty stomach.

• Administration: Swallow the tablet whole with water. Do not chew or crush.

• Storage: Store below 30°C in a dry place. Keep out of reach of children.