Abseamed

RSS

epoetin alfa

Authorised
This medicine is authorised for use in the European Union.

Overview

Abseamed is a medicine used for the following:

  • to treat anaemia (low red blood cell counts) that is causing symptoms in patients with chronic kidney failure (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems;
  • to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce the need for blood transfusions;
  • to increase the amount of blood that can be taken in adult patients with moderate anaemia and normal blood iron levels who are going to have an operation and donate their own blood before surgery (autologous blood transfusion);
  • to reduce the need for blood transfusions in adults with moderate anaemia who are about to undergo major orthopaedic (bone) surgery, such as hip surgery. It is used in patients with normal blood iron levels who could experience complications from a blood transfusion, if they do not donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood;
  • to treat anaemia in adults with myelodysplastic syndromes (conditions in which the production of healthy blood cells is defective). Abseamed is used when patients are at low or intermediate risk of developing acute myeloid leukaemia and have low levels of the natural hormone erythropoietin.

Abseamed contains the active substance epoetin alfa and is a ‘biosimilar medicine’. This means that Abseamed is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Abseamed is Eprex/Erypo.

This EPAR was last updated on 03/10/2018

Authorisation details

Product details
Name
Abseamed
Agency product number
EMEA/H/C/000727
Active substance
epoetin alfa
International non-proprietary name (INN) or common name
epoetin alfa
Therapeutic area (MeSH)
  • Anemia
  • Kidney Failure, Chronic
  • Cancer
Anatomical therapeutic chemical (ATC) code
B03XA01
Biosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Medice Arzneimittel Pütter GmbH Co. KG
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
28/08/2007
Contact address
Kuhloweg 37-39
D-58638 Iserlohn
Germany

Product information

31/08/2018 Abseamed - EMEA/H/C/000727 - WS/1406

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTIANEMIC PREPARATIONS

Therapeutic indication

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.

Assessment history

How useful was this page?

Add your rating