Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Ratiopharm GmbH, Graf-Arco-Straße 3, 89079 Ulm, Germany
Ratiograstim 30 MIU/0.5 mL solution for injection/infusion.
Ratiograstim 48 MIU/0.8 mL solution for injection/infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection/infusion. Clear, colourless solution. |
Each mL of solution for injection/infusion contains 60 million international units [MIU] (600 µg) of filgrastim.
Ratiograstim 30 MIU/0.5 mL solution for injection/infusion: Each pre-filled syringe contains 30 MIU (300 µg) of filgrastim in 0.5 mL solution for injection/infusion.
Ratiograstim 48 MIU/0.8 mL solution for injection/infusion: Each pre-filled syringe contains 48 MIU (480 µg) of filgrastim in 0.8 mL solution for injection/infusion.
Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor) is produced in Escherichia coli K802 by recombinant DNA technology.
Excipient with known effect: Each mL of solution contains 50 mg of sorbitol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Filgrastim |
Filgrastim causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes. |
| List of Excipients |
|---|
|
Acetic acid, glacial |
Type I glass pre-filled syringe with a permanently attached stainless steel needle with or without safety device to prevent needle stick injury and re-use.
Ratiograstim 30 MIU/0.5 mL solution for injection/infusion: Packs containing 1, 5 or 10 pre-filled syringes with 0.5 mL solution or multipacks containing 10 (2 packs of 5) pre-filled syringes with 0.5 mL solution.
Ratiograstim 48 MIU/0.8 mL solution for injection/infusion: Packs containing 1, 5 or 10 pre-filled syringes with 0.8 mL solution or multipacks containing 10 (2 packs of 5) pre-filled syringes with 0.8 mL solution.
Not all pack sizes may be marketed.
Ratiopharm GmbH, Graf-Arco-Straße 3, 89079 Ulm, Germany
Ratiograstim 30 MIU/0.5 mL solution for injection/infusion:
EU/1/08/444/001
EU/1/08/444/002
EU/1/08/444/003
EU/1/08/444/004
EU/1/08/444/009
EU/1/08/444/010
Ratiograstim 48 MIU/0.8 mL solution for injection/infusion:
EU/1/08/444/005
EU/1/08/444/006
EU/1/08/444/007
EU/1/08/444/008
EU/1/08/444/011
EU/1/08/444/012
Date of first authorisation: 15 September 2008
Date of latest renewal: 19 July 2013
| Drug | Countries | |
|---|---|---|
| RATIOGRASTIM | Germany, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland |
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