FICHA FARMACOLÓGICA de abacavir (as sulphate) and lamivudine. 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. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. JULIO 18, 2009.-
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EPARs for authorised medicinal products for human use - Kivexa
Active Substance
Abacavir (as sulphate) and lamivudine
International Nonproprietary Name or Common Name
Abacavir/Lamivudine
Pharmaco-therapeutic Group
Antivirals for treatment of HIV infections, combinations
ATC Code
J05AR02
Therapeutic Indication:
Kivexa is a fixed-dose combination of two nucleoside analogues (abacavir and lamivudine). It is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age. The demonstration of the benefit of the combination abacavir/lamivudine as a once daily regimen in antiretroviral therapy, is mainly based on results of one study performed in primarily asymptomatic treatment-naïve adult patients (see sections 4.4 and 5.1).
Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available in these patients, based on the treatment history and resistance testing (see section 4.4 and 4.8).
Date of issue of Marketing Authorisation valid throughout the European Union
17 December 2004
Orphan medicinal product designation date
Not applicable
EPARs for authorised medicinal products for human use
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