Epoetin zeta - EPARs for human use

FICHA FARMACOLÓGICA de Epoetin zeta Contiene la Monografía en distintos idiomas (de la Unión 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. FEBRERO 03, 2010.-

abrir aquí para acceder al documento EMEA completo:
http://www.emea.europa.eu/humandocs/Humans/EPAR/silapo/silapo.htm

Active Substance
epoetin zeta
International Nonproprietary Name or Common Name
epoetin zeta
Pharmaco-therapeutic Group
Antianaemic preparations, erythropoietin
ATC Code
B03XA01

Therapeutic Indication:
- Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:

- Treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis (See section 4.4).

- Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis (See section 4.4).

- Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre‑existing anaemia at the start of chemotherapy).

- Silapo can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).

Date of issue of Marketing Authorisation valid throughout the European Union
18 December 2007

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use