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Product class:
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Medicinal product with marketing authorization
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Medicinal product class:
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Human medicine
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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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Strength:
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30000RÜ 0.75ml
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Legal status for supply*:
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Subject to medicinal prescription
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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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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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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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November 26, 2009
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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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Assessment report:
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Package code
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Name of medicinal product
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Dosage form
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Package
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Legal status
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Reimbursements
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Reference price
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Last imported
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PƤritolumaa
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Additional information
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1454778
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ABSEAMED
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solution for injection in pre-filled syringe
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30000RÜ 0.75ml 0.75ml 1TK
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Prescription
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1454789
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ABSEAMED
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solution for injection in pre-filled syringe
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30000RÜ 0.75ml 0.75ml 6TK
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Prescription
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1646580
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ABSEAMED
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solution for injection in pre-filled syringe
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30000RÜ 0.75ml 0.75ml 4TK
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Prescription
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Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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