viernes, 23 de octubre de 2009

ribavirin - EPARs for human use - Rebetol



FICHA FARMACOLÓGICA de ribavirin 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. OCTUBRE 23, 2009.

abrir aquí para acceder al documento EMEA completo:
EPARs for authorised medicinal products for human use - Rebetol

Active Substance
ribavirin
International Nonproprietary Name or Common Name
ribavirin
Pharmaco-therapeutic Group
Direct acting antivirals, nucleosides and nucleotides (excl. reverse transcriptase inhibitors)
ATC Code
J05A B04

Therapeutic Indication:
Rebetol is indicated for the treatment of chronic hepatitis C virus (HCV) infection and must only be used as part of a combination regimen with peginterferon alfa-2b (adults) or interferon alfa-2b (adults, children 3-years of age and older and adolescents). Rebetol monotherapy must not be used.

There is no safety or efficacy information on the use of Rebetol with other forms of interferon (i.e., not alfa-2b).

Naïve patients

Adult patients: Rebetol is indicated, in combination with interferon alfa-2b or peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum hepatitis C viral ribonucleic acid (HCV-RNA). In combination with peginterferon alfa-2b also patients with clinically stable HIV co-infection are included (see section 4.4).

Children and adolescents: Rebetol is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children 3 years of age and older and adolescents, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA.
The decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral load. The expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).


Previously treated patients

Adult patients: Rebetol is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed. Rebetol is indicated, in combination with peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have failed previous treatment with interferon alpha (pegylated or nonpegylated) alone or in combination with ribavirin (see section 5.1).

Date of issue of Marketing Authorisation valid throughout the European Union
7 May 1999

Orphan medicinal product designation date
Not applicable

EPARs for authorised medicinal products for human use

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