| Condition / İndication (Şart / Edikasyon): | HIV 1 infection, , Viread 123 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 17 kg to less than 22 kg., The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients.Hepatitis B infection, , Viread 123 mg film coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 17 kg to less than 22 kg, with, , compensated liver disease and evidence of immune active disease, i.e. 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 sections 4.2, 4.4, 4.8 and 5.1., HIV 1 infection, , Viread 163 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 22 kg to less than 28 kg., The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients.Hepatitis B infection, , Viread 163 mg film coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 22 kg to less than 28 kg, with:, , compensated liver disease and evidence of immune active disease, i.e. 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 sections 4.2, 4.4, 4.8 and 5.1., HIV 1 infection, , Viread 204 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 28 kg to less than 35 kg., The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients.Hepatitis B infection, , Viread 204 mg film coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 28 kg to less than 35 kg, with:, , compensated liver disease and evidence of immune active disease, i.e. 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 sections 4.2, 4.4, 4.8 and 5.1., HIV 1 infection, , Viread 245 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected adults., In adults, the demonstration of the benefit of Viread in HIV 1 infection is based on results of one study in treatment naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml)., Viread 245 mg film coated tablets are also indicated for the treatment of HIV 1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years., The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients.Hepatitis B infection, , Viread 245 mg film coated tablets are indicated for the treatment of chronic hepatitis B in adults with:, , compensated liver disease, with 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)., evidence of lamivudine resistant hepatitis B virus (see sections 4.8 and 5.1)., decompensated liver disease (see sections 4.4, 4.8 and 5.1)., Viread 245 mg film coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with:, , compensated liver disease and evidence of immune active disease, i.e. 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 sections 4.2, 4.4, 4.8 and 5.1., HIV 1 infection, , Viread 33 mg/g granules are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, from 2 to < 6 years of age, and above 6 years of age for whom a solid dosage form is not appropriate., Viread 33 mg/g granules are also indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected adults for whom a solid dosage form is not appropriate., In adults, the demonstration of the benefit of Viread in HIV 1 infection is based on results of one study in treatment naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml)., The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients., , Hepatitis B infection, Viread 33 mg/g granules are indicated for the treatment of chronic hepatitis B in adults for whom a solid dosage form is not appropriate with:, , compensated liver disease, with 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)., evidence of lamivudine resistant hepatitis B virus (see sections 4.8 and 5.1)., decompensated liver disease (see sections 4.4, 4.8 and 5.1)., , Viread 33 mg/g granules are also indicated for the treatment of chronic hepatitis B in paediatric patients2 to < 18 years of age for whom a solid dosage form is not appropriate with:, , compensated liver disease and evidence of immune active disease, i.e. 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 sections 4.2, 4.4, 4.8 and 5.1., | First Published (İlk Yayın Tarihi): | 19.07.2018 |
