EPARs human use - Epoetin alfa Hexal//recombinant human erythropoietin alfa

FICHA FARMACOLÓGICA de recombinant human erythropoietin alfa. 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. JUNIO 19, 2009.-

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EPARs for authorised medicinal products for human use - Epoetin alfa Hexal

Active Substance
recombinant human erythropoietin alfa
International Nonproprietary Name or Common Name
recombinant human erythropoietin alfa
Pharmaco-therapeutic Group
Other antianemic preparations
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 paediatric and adult 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).

Epoetin alfa HEXAL 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 (haemoglobin (Hb) 10 – 13 g/dl [6.2 – 8.1 mmol/l], 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).

Epoetin alfa HEXAL can be used to reduce exposure to allogeneic blood transfusions in adult non‑iron deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (e.g. Hb 10 - 13 g/dl) who do not have an autologous predonation programme available and with an expected blood loss of 900 to 1800 ml.

Date of issue of Marketing Authorisation valid throughout the European Union
28 August 2007

Orphan medicinal product designation date
Not applicable