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Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1325900
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Name of medicinal product:
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ABSEAMED
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Active substances:
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ATC code:
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B03XA01
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Dosage form:
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solution for injection in pre-filled syringe
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Route of administration:
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intravenous use; subcutaneous use
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Strengh:
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4000RÜ 0.4ml
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Amount in package:
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0.4ml 6TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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Abseamed 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 (see section 4.4).
- in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients (see section 4.4).
Abseamed 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.
Abseamed 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).
Abseamed 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). Abseamed is indicated for the treatment of symptomatic anaemia (haemoglobin concentration of <= 10 g/dl) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (< 200 mU/ml).
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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Package information leaflet (PIL):
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EST
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Labelling:
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Last imported to Estonia:
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Never imported to Estonia
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Marketing authorization holder:
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Medice Arzneimittel Puetter GmbH & Co. KG
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Marketing authorization number:
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EU/1/07/412
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Marketing authorization issued on:
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August 28, 2007
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Centralised
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Reference price:
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Under reference price:
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Reference price of daily dose:
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Entry/Changing date:
September 21, 2018
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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