TENOFOVIR DISOPROXIL Zentiva 245mg x 30 tabl
HIV-1 infection Tenofovir disoproxil Zentiva, in combination with other antiretroviral medicinal products, is indicated for the treatment of HIV-1 infected adults. In adults, the demonstrated benefit of tenofovir disoproxil treatment in HIV-1 infection is based on the results of a study in treatment-naïve patients, including patients with high viral loads (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly triple therapy) in antiretroviral therapy-experienced patients who experienced early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml). Tenofovir disoproxil Zentiva is also indicated for the treatment of HIV-1 infected adolescents aged 12 to < 18 years in whom the use of first-line agents is precluded due to NRTI resistance or toxicity. The choice of Tenofovir disoproxil Zentiva for the treatment of HIV-1 infected patients with prior antiretroviral therapy should be based on individual viral resistance testing and/or prior treatment history. Hepatitis B infection Tenofovir disoproxil Zentiva is indicated for the treatment of chronic hepatitis B in adults with: - compensated liver disease, evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1). - proven lamivudine-resistant hepatitis B virus (see sections 4.8 and 5.1). - decompensated liver disease (see sections 4.4, 4.8 and 5.1). Tenofovir disoproxil Zentiva is indicated for the treatment of chronic hepatitis B in adolescents aged 12 to < 18 years with: - compensated liver disease and evidence of immunologically active disease, i.e. active viral replication and persistently elevated serum ALT levels or histological evidence of moderate to severe inflammation and/or fibrosis. For the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.Tenofovir disoproxil (as tenofovir disoproxil phosphate) 245 mg
