EPARs - Prezista/Darunavir

EPARs for authorised medicinal products for human use - Prezista

FICHA FARMACOLÓGICA de darunavir. 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.


Active Substance
darunavir
International Nonproprietary Name or Common Name
darunavir
Pharmaco-therapeutic Group
Antivirals for systemic use
ATC Code
J05AE10
Therapeutic Indication
PREZISTA, co-administered with 100 mg ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in treatment experienced adult patients, including those that have been highly pre treated.

In deciding to initiate treatment with

PREZISTA co-administered with 100 mg ritonavir careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.
PREZISTA 400 mg, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in antiretroviral therapy (ART) naïve adults.