lunes, 23 de febrero de 2009

EPARs - Reyataz/ATAZANAVIR



FICHA FARMACOLÓGICA de ATAZANAVIR. Contiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Cerasale. Febrero 2009.

EPARs for authorised medicinal products for human use - Reyataz

Active Substance
Atazanavir sulphate
International Nonproprietary Name or Common Name
Atazanavir sulphate
Pharmaco-therapeutic Group
Protease inhibitor
ATC Code
J05A E08

Therapeutic Indication
REYATAZ is indicated for the treatment of HIV-1 infected adults in combination with other antiretroviral medicinal products.

In antiretroviral treatment experienced patients, the demonstration of efficacy is based on a study comparing REYATAZ 300 mg once daily in combination with ritonavir 100 mg once daily with lopinavir/ritonavir, each regimen in combination with tenofovir. Based on available virological and clinical data, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations). The choice of REYATAZ in treatment experienced patients should be based on individual viral resistance testing and the patient’s treatment history.

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