Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: ERA Consulting GmbH, Lange Strasse 70, 29664 Walsrode, Germany, Tel: +49 (0) 5161 9890 0, Fax: +49 (0) 5161 9890 18, E-mail: EUAgent@eraconsulting.com
UDENYCA 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 content only**.
* The active substance is a covalent conjugate of filgrastim produced in Escherichia coli cells by recombinant DNA technology with polyethylene glycol (PEG).
** The concentration is 20 mg/ml if the PEG moiety is included.
The potency of this medicinal product should not be compared to the potency of another pegylated or non-pegylated 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.
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 trihydrate (for pH adjustment) |
Pre-filled syringe, with a coated bromobutyl rubber stopper and a stainless steel needle with automatic needle guard.
Each pre-filled syringe contains 0.6 ml of solution for injection.
Pack size: Each carton contains 1 pre-filled syringe with an automatic needle guard blistered in a plastic tray.
ERA Consulting GmbH, Lange Strasse 70, 29664 Walsrode, Germany, Tel: +49 (0) 5161 9890 0, Fax: +49 (0) 5161 9890 18, E-mail: EUAgent@eraconsulting.com
EU/1/18/1303/001
Date of first authorisation: 21 September 2018
| Drug | Countries | |
|---|---|---|
| UDENYCA | Estonia, Lithuania, Poland, United States |
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