Details

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Manufacturer
Novartis Pharmaceutical Manufacturing LLC(SLOVENIA)
Registraction Number
MAL20026063AZ

Here’s the information about Entecavir Sandoz® Film-Coated Tablet 0.5mg:

Content

Active Ingredient: Entecavir monohydrate (0.5 mg per tablet), an antiviral medication.
Excipients: Includes lactose monohydrate and other stabilizing agents.

Indication

Used for the treatment of chronic hepatitis B virus (HBV) infection in adults with:
Evidence of active viral replication.
Persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Instruction

Dosage:
For nucleoside-naïve patients: 0.5 mg once daily.
For lamivudine-refractory patients: 1 mg once daily.
Take on an empty stomach (at least 2 hours before or after a meal).
Administration:
Administer orally with water.
Follow the prescribed dosage and schedule strictly.
Precautions:
Avoid use in patients with hypersensitivity to entecavir or its excipients.
Dosage adjustments may be required for patients with renal impairment.
Monitor for potential side effects such as headache, fatigue, or gastrointestinal discomfort.