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Refrigerated Storage

SimponiMerck Sharp & Dohme Limited

Merck Sharp & Dohme Limited
Simponi
Solution for injection in pre-filled syringe and pre-filled pen

In the event of an inadvertent temperature excursion the following data may be used:

Simponi may be stored at temperatures up to a maximum of 25°C for a single period of up to 30 days, but not exceeding the original expiry date printed on the carton.

Contact MSD in cases where additional stability data is required.

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

Reduce to 30 days if exposed to the conditions above
Store the product outside of the fridge if exposed to the conditions above
21 February 2022
London MI Service

Lactation Safety Information

For rheumatoid arthritis

For rheumatoid arthritis
See summary
Very limited published evidence of safety indicates negligible amounts in breast milk which are likely to be degraded in the infant’s GI tract
Very long half-life increases risk of accumulation in breastfed infants
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
15 September 2019

For inflammatory bowel disease

For inflammatory bowel disease
See summary
Very limited published evidence of safety indicates negligible amounts in breast milk which are likely to be degraded in the infant’s GI tract
Very long half-life increases risk of accumulation in breastfed infants
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
15 September 2019