lunes, 9 de noviembre de 2009

filgrastim - EPARs for human use - Filgrastim Hexal



FICHA FARMACOLÓGICA de filgrastim 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. NOVIEMBRE 09, 2009.

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

Active Substance
filgrastim
International Nonproprietary Name or Common Name
filgrastim
Pharmaco-therapeutic Group
Colony stimulating factors
ATC Code
L03AA02

Therapeutic Indication:
-Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.

-Mobilisation of peripheral blood progenitor cells (PBPC).

-In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of [<]/= 0.5 x 10E9/l, and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection related events.

-Treatment of persistent neutropenia (ANC) [<][/= 1.0 x 10E9/l] in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.

Date of issue of Marketing Authorisation valid throughout the European Union
06 February 2009

Orphan medicinal product designation date
Not applicable

EPARs for authorised medicinal products for human use

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