PELMEG Solution for injection Ref.[27666] Active ingredients: Pegfilgrastim

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW

Product name and form

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

Pharmaceutical Form

Solution for 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

Excipient with known effect:

Each pre-filled syringe contains 30 mg sorbitol (E420).

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
Water for injections
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)

* Sodium acetate is prepared by mixing sodium acetate trihydrate and acetic acid.

Pack sizes and marketing

Pre-filled syringe (Type I glass), with a bromobutyl rubber stopper and a stainless steel needle with an automatic needle guard.

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

Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW

Marketing authorization dates and numbers

PLGB 16950/0388

Date of first authorisation: 20 November 2018

Drugs

Drug Countries
PELMEG Austria, Cyprus, Estonia, Spain, Finland, France, Lithuania, Netherlands, Poland, Romania, United Kingdom

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