EPARs - Ziagen//abacavir sulfate

FICHA FARMACOLÓGICA de abacavir sulfate. 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. ABRIL 29, 2009.-

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EPARs for authorised medicinal products for human use - Ziagen

Active Substance
abacavir sulfate
International Nonproprietary Name or Common Name
abacavir sulfate
Pharmaco-therapeutic Group
Nucleoside reverse transcriptase inhibitors
ATC Code
J05A F06

Therapeutic Indication:
Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.

The demonstration of the benefit of Ziagen is mainly based on results of studies performed with a twice daily regimen, in treatment-naïve adult patients on combination therapy (see section 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
8 July 1999