STIMUFEND Solution for injection Ref.[49775] Active ingredients: Pegfilgrastim

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Fresenius Kabi Deutschland GmbH, Else-Kroener Strasse 1, 61352 Bad Homburg v.d.Hoehe, Germany

Product name and form

Stimufend 6 mg solution for injection in pre-filled syringe.

Pharmaceutical Form

Solution for injection (injection).

Clear, colourless solution for injection.

Qualitative and quantitative composition

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
Sorbitol (E420)
Polysorbate 20
Glacial acetic acid
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Fresenius Kabi Deutschland GmbH, Else-Kroener Strasse 1, 61352 Bad Homburg v.d.Hoehe, Germany

Marketing authorization dates and numbers

EU/1/22/1632/001

Drugs

Drug Countries
STIMUFEND Estonia, Lithuania, Poland

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