Source: European Medicines Agency (EU) Revision Year: 2012 Publisher: Regeneron UK Limited, 40 Bank Street, E14 5DS, London, United Kingdom
Rilonacept Regeneron 80 mg/ml powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection. The powder is white to off-white. The solvent is a clear colourless solution. |
Each vial of powder contains 220 mg of rilonacept. After reconstitution, each ml of solution contains 80 mg rilonacept.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Rilonacept |
Rilonacept is a dimeric fusion protein which binds to and blocks the activity of the cytokine IL-1 and binds both IL-1β and IL-1α. Rilonacept is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) with severe symptoms. |
| List of Excipients |
|---|
|
Powder: Glycine Solvent: Water for injections |
Powder vial: 20 ml clear type I glass vial with rubber stopper and lacquered flip-off aluminium seal containing 220 mg rilonacept.
Solvent vial: LDPE vials containing 5 ml water for injections
Each pack contains:
4 vials of powder for solution for injection
4 vials of solvent
8 disposable 3 ml syringes
8 disposable 27 gauge, ½-inch needles
Regeneron UK Limited, 40 Bank Street, E14 5DS, London, United Kingdom
EU/1/09/582/001
Date of first authorisation: 23 October 2009
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