Page 3 - 09 EMA
P. 3
nti sul mercato) da EMA1
ndication
Treatment of diabetes mellitus in adults, adolescents and children aged
2 years and above.
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
ymphoma 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
ncrease the yield of autologous blood from patients in a predonation
programme. Its use in this indication must be balanced against the
eported risk of thromboembolic events. Treatment should only be given
o 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
r insufficient when the scheduled major elective surgery requires a
arge volume of blood (4 or more units of blood for females or 5 or more
-2-
ndication
Treatment of diabetes mellitus in adults, adolescents and children aged
2 years and above.
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
ymphoma 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
ncrease the yield of autologous blood from patients in a predonation
programme. Its use in this indication must be balanced against the
eported risk of thromboembolic events. Treatment should only be given
o 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
r insufficient when the scheduled major elective surgery requires a
arge volume of blood (4 or more units of blood for females or 5 or more
-2-
