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Product No EMEA/H/C/000727
Brand Name Abseamed
Nonproprietary Name epoetin alfa
API epoetin alfa
ATC Code B03XA01
Indications 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; treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. 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). Abseamed 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). Abseamed 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.
Orphan Drug no
Generics no
Marketing Authorization Holder Medice Arzneimittel Pütter GmbH & Co. KG
Status Authorised
Authorization Date 2007-08-28
Version 15
Condition Approval no
Exceptions no
Biosimilar yes
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