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417734003

Refrigerated Storage

ByettaAstraZeneca

AstraZeneca
Byetta
Solution for injection, pre-filled pen

In the event of an inadvertent temperature excursion the following data may be used:
If the product is exposed to temperatures above 8°C but below 25°C, its shelf-life must be reduced to 30 days (regardless of whether the product is put back into the fridge or not).

There is no additional stability for the product when exposed to temperatures below 2°C and above 25°C and so in these cases, it is recommended that the product be discarded.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

30 days
Yes
25 March 2021
London MI Service

BydureonAstraZeneca

AstraZeneca
Bydureon
2mg powder and solvent for prolonged-release suspension for injection in pre-filled pen

In the event of an inadvertent temperature excursion the following data may be used:
If the product is exposed to temperatures above 8°C but lower than 30°C, its shelf-life must be reduced to 30 days (regardless of whether the product is put back into the fridge or not).

There is no additional stability data for the product when exposed to temperatures below 2°C and above 30°C; and so in these cases, it is recommended that the product be discarded.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

30 days
Yes
25 March 2021
London MI Service

Lactation Safety Information

Yes
Likely to be degraded in infant's GI tract
Low levels anticipated in milk due to the drug's properties
No published evidence of safety
16 September 2020