Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Fresenius Kabi Deutschland GmbH, Else-Kroener Strasse 1, 61352 Bad Homburg v.d.Hoehe, Germany
Stimufend 6 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear, colourless solution for injection. |
Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection. The concentration is 10 mg/mL based on protein only**.
* Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
** The concentration is 20 mg/mL if the PEG moiety is included.
The potency of this product should not be compared to the potency of another pegylated or nonpegylated protein of the same therapeutic class. For more information, see section 5.1.
Excipients with known effect: Each pre-filled syringe contains 30 mg sorbitol (E420) (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pegfilgrastim |
Pegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance. Pegfilgrastim and filgrastim have been shown to have identical modes of action, causing a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes. |
| List of Excipients |
|---|
|
Sodium acetate |
Pre-filled syringe (Type I glass), with a bromobutyl fluorotec stopper, stainless steel needle, needle cap and an automatic needle guard.
The needle cap of the pre-filled syringe contains dry natural rubber (a derivative of latex) (see section 4.4).
Each pre-filled syringe contains 0.6 mL of solution for injection.
Pack size of one pre-filled syringe, in a blistered packaging.
Fresenius Kabi Deutschland GmbH, Else-Kroener Strasse 1, 61352 Bad Homburg v.d.Hoehe, Germany
EU/1/22/1632/001
| Drug | Countries | |
|---|---|---|
| STIMUFEND | Austria, Estonia, France, Croatia, Italy, Lithuania, Poland |
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