Viread 33 mg/g granules

Each scoop delivers one gram of granules which contains 33 mg of tenofovir disoproxil (as fumarate).

Excipient with known effect: One gram of granules contains 622 mg mannitol.

For the full list of excipients, see section 6.1.

Granules.

White, taste masked, coated granules.

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 adolescents 12 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, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis (see sections 4.4, 4.8 and 5.1).