Human medicines European public assessment report (EPAR): Baraclude, entecavir, Date of authorisation: 26/06/2006, Revision: 28, Status: Authorised

Treatment with Baraclude should be started by a doctor with experience in the management of chronic hepatitis B.

Baraclude is taken once a day. For adults with compensated liver disease, the dose depends on whether or not the patient has been previously treated with a medicine in the same group as Baraclude (a nucleoside analogue, such as lamivudine). Patients who have not been treated before with a nucleoside analogue receive a 0.5 mg dose, while those who have received lamivudine before but whose infection is no longer responding to it are given a 1 mg dose. The 0.5 mg dose can be taken with or without food, but the 1 mg dose must be taken at least 2 hours before or 2 hours after a meal. The treatment duration is determined by how the patient responds.

The 1 mg daily dose is also used in adults with decompensated liver disease and stopping treatment is not recommended in these patients.

When treatment is considered appropriate in children, the dose depends on their body weight. Children weighing less than 32.6 kg should be given the oral solution, while those weighing 32.6 kg and above can also be given the 0.5 mg tablets. For more information on the use of the medicine in children, see the summary of product characteristics (also part of the EPAR).