Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Medice Arzneimittel Pรผtter GmbH & Co. KG, Kuhloweg 37, D-58638, Iserlohn, Germany
Abseamed 1,000 IU/0.5 mL solution for injection in a pre-filled syringe.
Abseamed 2,000 IU/1 mL solution for injection in a pre-filled syringe.
Abseamed 3,000 IU/0.3 mL solution for injection in a pre-filled syringe.
Abseamed 4,000 IU/0.4 mL solution for injection in a pre-filled syringe.
Abseamed 5,000 IU/0.5 mL solution for injection in a pre-filled syringe.
Abseamed 6,000 IU/0.6 mL solution for injection in a pre-filled syringe.
Abseamed 7,000 IU/0.7 mL solution for injection in a pre-filled syringe.
Abseamed 8,000 IU/0.8 mL solution for injection in a pre-filled syringe.
Abseamed 9,000 IU/0.9 mL solution for injection in a pre-filled syringe.
Abseamed 10,000 IU/1 mL solution for injection in a pre-filled syringe.
Abseamed 20,000 IU/0.5 mL solution for injection in a pre-filled syringe.
Abseamed 30,000 IU/0.75 mL solution for injection in a pre-filled syringe.
Abseamed 40,000 IU/1 mL solution for injection in a pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection in a pre-filled syringe (injection). Clear, colourless solution. |
Abseamed 1,000 IU/0.5 mL solution for injection in a pre-filled syringe: Each mL of solution contains 2,000 IU of epoetin alfa* corresponding to 16.8 micrograms per mL
A pre-filled syringe of 0.5 mL contains 1,000 international units (IU) corresponding to 8.4 micrograms epoetin alfa. *
Abseamed 2,000 IU/1 mL solution for injection in a pre-filled syringe: Each mL of solution contains 2,000 IU of epoetin alfa* corresponding to 16.8 micrograms per mL
A pre-filled syringe of 1 mL contains 2,000 international units (IU) corresponding to 16.8 micrograms epoetin alfa. *
Abseamed 3,000 IU/0.3 mL solution for injection in a pre-filled syringe: Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
A pre-filled syringe of 0.3 mL contains 3,000 international units (IU) corresponding to 25.2 micrograms epoetin alfa. *
Abseamed 4,000 IU/0.4 mL solution for injection in a pre-filled syringe: Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
A pre-filled syringe of 0.4 mL contains 4,000 international units (IU) corresponding to 33.6 micrograms epoetin alfa. *
Abseamed 5,000 IU/0.5 mL solution for injection in a pre-filled syringe: Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
A pre-filled syringe of 0.5 mL contains 5,000 international units (IU) corresponding to 42.0 micrograms epoetin alfa. *
Abseamed 6,000 IU/0.6 mL solution for injection in a pre-filled syringe: Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
A pre-filled syringe of 0.6 mL contains 6,000 international units (IU) corresponding to 50.4 micrograms epoetin alfa. *
Abseamed 7,000 IU/0.7 mL solution for injection in a pre-filled syringe: Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
A pre-filled syringe of 0.7 mL contains 7,000 international units (IU) corresponding to 58.8 micrograms epoetin alfa. *
Abseamed 8,000 IU/0.8 mL solution for injection in a pre-filled syringe: Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
A pre-filled syringe of 0.8 mL contains 8,000 international units (IU) corresponding to 67.2 micrograms epoetin alfa. *
Abseamed 9,000 IU/0.9 mL solution for injection in a pre-filled syringe: Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
A pre-filled syringe of 0.9 mL contains 9,000 international units (IU) corresponding to 75.6 micrograms epoetin alfa. *
Abseamed 10,000 IU/1 mL solution for injection in a pre-filled syringe: Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
A pre-filled syringe of 1 mL contains 10,000 international units (IU) corresponding to 84.0 micrograms epoetin alfa. *
Abseamed 20,000 IU/0.5 mL solution for injection in a pre-filled syringe: Each mL of solution contains 40,000 IU of epoetin alfa* corresponding to 336.0 micrograms per mL
A pre-filled syringe of 0.5 mL contains 20,000 international units (IU) corresponding to 168.0 micrograms epoetin alfa. *
Abseamed 30,000 IU/0.75 mL solution for injection in a pre-filled syringe: Each mL of solution contains 40,000 IU of epoetin alfa* corresponding to 336.0 micrograms per mL
A pre-filled syringe of 0.75 mL contains 30,000 international units (IU) corresponding to 252.0 micrograms epoetin alfa. *
Abseamed 40,000 IU/1 mL solution for injection in a pre-filled syringe: Each mL of solution contains 40,000 IU of epoetin alfa* corresponding to 336.0 micrograms per mL
A pre-filled syringe of 1 mL contains 40,000 international units (IU) corresponding to 336.0 micrograms epoetin alfa. *
* Produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology
For the full list of excipients, see section 6.1.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.
| Active Ingredient | Description | |
|---|---|---|
| Epoetin alfa |
Epoetin alfa is a glycoprotein hormone produced primarily by the kidney in response to hypoxia and is the key regulator of red blood cell (RBC) production. Epoetin alfa is involved in all phases of erythroid development, and has its principal effect at the level of erythroid precursors. |
| List of Excipients |
|---|
|
Sodium dihydrogen phosphate dihydrate |
Pre-filled syringes (glass type I), with or without a needle safety guard, with plunger stopper (Teflon-faced rubber) sealed in a blister.
Abseamed 1,000 IU/0.5 mL solution for injection in a pre-filled syringe: Each syringe contains 0.5 mL of solution for injection.
Pack of 1 or 6 syringes.
Abseamed 2,000 IU/1 mL solution for injection in a pre-filled syringe: Each syringe contains 1 mL of solution for injection.
Pack of 1 or 6 syringes.
Abseamed 3,000 IU/0.3 mL solution for injection in a pre-filled syringe: Each syringe contains 0.3 mL of solution for injection.
Pack of 1 or 6 syringes.
Abseamed 4,000 IU/0.4 mL solution for injection in a pre-filled syringe: Each syringe contains 0.4 mL of solution for injection.
Pack of 1 or 6 syringes.
Abseamed 5,000 IU/0.5 mL solution for injection in a pre-filled syringe: Each syringe contains 0.5 mL of solution for injection.
Pack of 1 or 6 syringes.
Abseamed 6,000 IU/0.6 mL solution for injection in a pre-filled syringe: Each syringe contains 0.6 mL of solution for injection.
Pack of 1 or 6 syringes.
Abseamed 7,000 IU/0.7 mL solution for injection in a pre-filled syringe: Each syringe contains 0.7 mL of solution for injection.
Pack of 1 or 6 syringes.
Abseamed 8,000 IU/0.8 mL solution for injection in a pre-filled syringe: Each syringe contains 0.8 mL of solution for injection.
Pack of 1 or 6 syringes.
Abseamed 9,000 IU/0.9 mL solution for injection in a pre-filled syringe: Each syringe contains 0.9 mL of solution for injection.
Pack of 1 or 6 syringes.
Abseamed 10,000 IU/1 mL solution for injection in a pre-filled syringe: Each syringe contains 1 mL of solution for injection.
Pack of 1 or 6 syringes.
Abseamed 20,000 IU/0.5 mL solution for injection in a pre-filled syringe: Each syringe contains 0.5 mL of solution for injection.
Pack of 1, 4 or 6 syringes.
Abseamed 30,000 IU/0.75 mL solution for injection in a pre-filled syringe: Each syringe contains 0.75 mL of solution for injection.
Pack of 1, 4 or 6 syringes.
Abseamed 40,000 IU/1 mL solution for injection in a pre-filled syringe: Each syringe contains 1 mL of solution for injection.
Pack of 1, 4 or 6 syringes.
ฮot all pack sizes may be marketed.
Medice Arzneimittel Pรผtter GmbH & Co. KG, Kuhloweg 37, D-58638, Iserlohn, Germany
Abseamed 1,000 IU/0.5 mL solution for injection in a pre-filled syringe:
EU/1/07/412/001
EU/1/07/412/002
EU/1/07/412/027
EU/1/07/412/028
Abseamed 2,000 IU/1 mL solution for injection in a pre-filled syringe:
EU/1/07/412/003
EU/1/07/412/004
EU/1/07/412/029
EU/1/07/412/030
27Abseamed 3,000 IU/0.3 mL solution for injection in a pre-filled syringe:
EU/1/07/412/005
EU/1/07/412/006
EU/1/07/412/031
EU/1/07/412/032
Abseamed 4,000 IU/0.4 mL solution for injection in a pre-filled syringe:
EU/1/07/412/007
EU/1/07/412/008
EU/1/07/412/033
EU/1/07/412/034
Abseamed 5,000 IU/0.5 mL solution for injection in a pre-filled syringe:
EU/1/07/412/009
EU/1/07/412/010
EU/1/07/412/035
EU/1/07/412/036
Abseamed 6,000 IU/0.6 mL solution for injection in a pre-filled syringe:
EU/1/07/412/011
EU/1/07/412/012
EU/1/07/412/037
EU/1/07/412/038
Abseamed 7,000 IU/0.7 mL solution for injection in a pre-filled syringe:
EU/1/07/412/017
EU/1/07/412/018
EU/1/07/412/039
EU/1/07/412/040
Abseamed 8,000 IU/0.8 mL solution for injection in a pre-filled syringe:
EU/1/07/412/013
EU/1/07/412/014
EU/1/07/412/041
EU/1/07/412/042
Abseamed 9,000 IU/0.9 mL solution for injection in a pre-filled syringe:
EU/1/07/412/019
EU/1/07/412/020
EU/1/07/412/043
EU/1/07/412/044
Abseamed 10,000 IU/1 mL solution for injection in a pre-filled syringe:
EU/1/07/412/015
EU/1/07/412/016
EU/1/07/412/045
EU/1/07/412/046
Abseamed 20,000 IU/0.5 mL solution for injection in a pre-filled syringe:
EU/1/07/412/021
EU/1/07/412/022
EU/1/07/412/047
EU/1/07/412/053
EU/1/07/412/048
Abseamed 30,000 IU/0.75 mL solution for injection in a pre-filled syringe:
EU/1/07/412/023
EU/1/07/412/024
EU/1/07/412/049
EU/1/07/412/054
EU/1/07/412/050
Abseamed 40,000 IU/1 mL solution for injection in a pre-filled syringe:
EU/1/07/412/025
EU/1/07/412/026
EU/1/07/412/051
EU/1/07/412/055
EU/1/07/412/052
Date of first authorisation: 28 August 2007
Date of latest renewal: 18 June 2012
| Drug | Countries | |
|---|---|---|
| ABSEAMED | Austria, Cyprus, Germany, Estonia, Croatia, Ireland, Lithuania, Poland |
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