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Refrigerated Storage
Enbrel
PfizerIn the event of an inadvertent temperature excursion the following data may be used:
Enbrel is licensed for storage at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again.
For 25mg and 50mg Enbrel pre-filled syringe and pen, in-house stability data shows:
- the product is stable for 7 days when exposed to 40°C
- the product is stable for 1 month when exposed to 25°C
- the product is stable for 30 months when exposed to 3 temperature cycles of -20°C for 3 days followed by 3 days at 30°C then storage at 5°C. During the last month of study, the product was stored at 25°C.
For 10mg and 25mg Enbrel powder and solvent for solution for injection, in-house stability data shows:
- the product is stable for 12 months when exposed to 25°C
- the product is stable for 6 months when exposed to storage at 40°C
- the product is stable for 48 months when exposed to 3 temperature cycles of -20°C for 4 days followed by 4 days at 30°C then storage at 5°C. During the last month of study, the product was stored at 25°C.
Benepali
BiogenIn the event of an inadvertent temperature excursion the following data may be used:
Benepali may be stored at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again. Benepali should be discarded if not used within four weeks of removal from refrigeration.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk