ENTECAVIR Alvogen 0.5mg x 30 tabl
ENTECAVIR Alvogen 0.5mg x 30 tabl
Treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with:
- compensated liver disease and evidence of active viral replication, persistent elevation of serum alanine aminotransferase (ALT) levels, and histological evidence of active inflammation and/or fibrosis.
- decompensated liver disease (see section 4.4)
For both compensated and decompensated liver disease, this indication is based on data from a clinical study in nucleoside-naïve patients with HBeAg positive and HBeAg negative HBV infection. For patients with lamivudine-refractory hepatitis B, see sections 4.2, 4.4. and 5.1.
Pediatric population
Treatment of chronic HBV infection in nucleoside-naïve paediatric patients aged 2 to 18 years with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels or histological evidence of moderate to severe inflammation and/or fibrosis. For decision to initiate treatment in paediatric patients see sections 4.2, 4.4 and 5.1.
Composition:
Entecavir (as monohydrate)
