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Entec

Entec Indications/Uses

entecavir

Manufacturer:

Berlin Pharm

Distributor:

Berlin Pharm

Marketer:

Berlin Pharm
Full Prescribing Info
Indications/Uses
Entecavir is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see Pharmacology: Pharmacodynamics under Actions) in adults with compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis; decompensated liver disease (see Precautions).
For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B, see Dosage & Administration, Precautions and Pharmacology: Pharmacodynamics under Actions.
Entecavir is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to <18 years of age 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. With respect to the decision to initiate treatment in paediatric patients, see Dosage & Administration, Precautions and Pharmacology: Pharmacodynamics under Actions.
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