jueves, 19 de marzo de 2009

EPARs - Aptivus/Tripanavir

FICHA FARMACOLÓGICA de tripanavir. 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. Marzo 19, 2009.

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EPARs for authorised medicinal products for human use - Aptivus

Active Substance
International Nonproprietary Name or Common Name
Pharmaco-therapeutic Group
Protease inhibitors
ATC Code
J05A E09

Therapeutic Indication:
APTIVUS, co-administered with low dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors.

This indication is based on the results of two phase III studies, performed in highly pre-treated patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors (see details of resistance profile of patients' HIV at baseline in section 5.1).

In deciding to initiate treatment with APTIVUS, co-administered with low dose 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 APTIVUS. Initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to APTIVUS, co-administered with low dose ritonavir.

Date of issue of Marketing Authorisation valid throughout the European Union
25 October 2005

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