Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW
Pelmeg 6 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for 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
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* * Sodium acetate is prepared by mixing sodium acetate trihydrate and acetic acid. |
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.
Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW
PLGB 16950/0388
Date of first authorisation: 20 November 2018
| Drug | Countries | |
|---|---|---|
| PELMEG | Austria, Cyprus, Estonia, Spain, Finland, France, Lithuania, Netherlands, Poland, Romania, United Kingdom |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
