Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Mylan S.A.S., 117 allée des Parcs, 69800, Saint-Priest, France
Fulphila 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 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 (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 formed by titrating glacial acetic acid with sodium hydroxide. |
Pre-filled syringe (Type I glass), with a fluorotec-coated bromobutyl rubber stopper and a stainless steel needle with or without an automatic needle guard.
Pack size of one pre-filled syringe, in blistered packaging.
Mylan S.A.S., 117 allée des Parcs, 69800, Saint-Priest, France
EU/1/18/1329/001 1 pre-filled syringe
EU/1/18/1329/002 1 pre-filled syringe with needle guard
Date of first authorisation: 20 November 2018
| Drug | Countries | |
|---|---|---|
| FULPHILA | Austria, Australia, Brazil, Canada, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, New Zealand, Poland, Romania, United States |
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