Indications : התוויות

1 INDICATIONS AND USAGE
Prezista 400mg, Prezista 600mg, Prezista 800mg:
Adult patients:
Prezista, co-administered with ritonavir (Prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV -1) infection for patients over 18 years of age.

Prezista 75mg, Prezista 150mg:
Adult patients:
Prezista, co-administered with ritonavir (Prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV -1) infection.
This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from 2 controlled phase 3 trials of 48 weeks duration in antiretroviral treatment - naive and treatment-experienced patients and 2 controlled phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients .

Pediatric patients:
Prezista, co-administered with ritonavir (Prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in treatment-experienced pediatric patients 6 years of age and older .
This indication is based on 24 Week analyses of plasma HIV-1 RNA levels and CD4+ cell counts from an open- label phase 2 trial in antiretroviral treatment-experienced pediatric patients 6 to < 18 years of age.
In treatment-experienced adult and pediatric, the following points should be considered when initiating therapy with Prezista/rtv:
- Treatment history and, when available, genotypic or phenotypic testing, should guide the use of Prezista/rtv.
- The use of other active agents with Prezista/rtv is associated with a greater likelihood of treatment response.