Data from EMA (European Medicines Agency) - Curated by Marshall Pearce - Last updated 10 November 2017

Indication(s)

Binocrit is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF):

- in adults and children aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis.
- in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients.

Binocrit is indicated in adults 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) for the treatment of anaemia and reduction of transfusion requirements.

Binocrit is indicated in adults in a predonation programme to increase the yield of autologous blood.
Treatment should only be given to patients with moderate anaemia (haemoglobin [Hb] concentration range between 10 to 13 g/dl [6.2 to 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).

Binocrit is indicated for non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions. Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dl or 6.2 to 8.1 mmol/l) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1,800 ml).

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Category Value
Agency product number EMEA/H/C/000725
Orphan designation No
Date First Approved 28-08-2007
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Sandoz GmbH