Viread 163 mg film-coated tablets
Each film-coated tablet contains 163 mg of tenofovir disoproxil (as fumarate).
Excipient with known effect: Each tablet contains 109 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
Film-coated tablet (tablet).
White, round-shaped, film-coated tablets, 10.7 mm in diameter, debossed on one side with “GILEAD” and on the other side with “200”.
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.
Therapy should be initiated by a physician experienced in the management of HIV infection.
Posology
The recommended dose for HIV-1 infected paediatric patients aged 6 to < 12 years weighing 22 kg to < 28 kg who are able to swallow film-coated tablets is one 163 mg tablet once daily taken orally with food.
Please refer to the Summaries of Product Characteristics for Viread 123 mg and 204 mg film-coated tablets for the treatment of HIV-1 infected paediatric patients aged 6 to < 12 years weighing 17 kg to < 22 kg and 28 kg to < 35 kg, respectively.
Viread is also available as 33 mg/g granules for use in HIV-1 infected paediatric patients aged 2 to < 12 years who weigh < 17 kg or who are unable to swallow film-coated ta
