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32455711000001105

Refrigerated Storage

ImlygicAmgen Ltd

Amgen Ltd
Imlygic
106 and 108 plaque forming units (PFU)/mL; solution for injection

In the event of an inadvertent temperature excursion the following data may be used:
Imlygic is to be stored at freezing temperatures (≤-18°C). If thawed, Imlygic is stable when stored at temperatures of 2°C up to 25°C protected from light in its original vial, in a syringe, or in the original vial followed by a syringe for storage times within the following parameters. Please note that these parameters vary based on the strength of the vial:

106 (1 million) PFU/mL vial: 
When exposed to temperatures between 2°C to 8°C, the product is stable for a maximum cumulative time of 24 hours.
When exposed to temperatures between 8°C and 25°C, the product is stable for a maximum cumulative time of 12 hours.

108 (100 million) PFU/mL vial:
When exposed to temperatures between 2°C to 8°C, the product is stable for a maximum cumulative time of 7 days.
When exposed to temperatures between 8°C and 25°C, the product is stable for a maximum cumulative time of 24 hours.

Imlygic must not be refrozen once it has thawed. Discard any thawed Imlygic in the vial or syringe stored longer than the specified times above.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
Contact Amgen Ltd in cases where additional stability data is required. Refer to the current BNF for company contact details.

19 March 2021
London MI Service