dm+d

108675009

Refrigerated Storage

RemicadeMerck Sharp & Dohme Limited

Merck Sharp & Dohme Limited
Remicade
Powder for concentrate for solution for infusion, 100mg

In the event of an inadvertent temperature excursion the following data may be used:
Remicade may be stored at temperatures up to a maximum of 25 °C for a single period of up to 6 months, but not exceeding the original expiry date.

Contact MSD in cases where additional stability information is required.

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

Reduce to 6 months from the date of excursion if exposed to the conditions above
Store the product outside of the fridge if exposed to the conditions above
22 February 2022
London MI Service

RemsimaCelltrion Pharmaceuticals

Celltrion Pharmaceuticals
Remsima
Concentrate for solution for infusion, solution for injection in pre-filled syringe or pen

In the event of an inadvertent temperature excursion the following data may be used:
Pre-filled syringe and pen
In-house stability data shows the product was stable when exposed to 3 cycles of -20±5°C to 20±5°C for a total duration of 12 days.
The product may be stored at temperatures up to a maximum of 25°C for a duration of up to 28 days but not exceeding the original expiry date. Following an excursion, keep the product outside of the fridge.
Vial
In-house stability data shows the product was stable when exposed to -25±5°C for 30 days.
The vials may be stored at temperatures up to a maximum of 25°C for a single period of up to 6 months but not exceeding the original expiry date.  In this case, the product should be stored outside of the fridge.
The vials may be kept up to 40°C ± 2°C for 3 months. Following an excursion, keep the product outside of the fridge.
In-house stability data from the manufacturer have shown that unopened vials have demonstrated stability for up to 60 months when exposed to temperature cycling at conditions of -20°C ±5°C to 40°C±2°C for a total period of 12 days.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

26 January 2022
London MI Service

InflectraHospira UK Ltd (part of Pfizer)

Hospira UK Ltd (part of Pfizer)
Inflectra
100mg powder for concentrate for solution for infusion

In the event of an inadvertent temperature excursion the following data may be used:
Inflectra may be stored at temperatures up to a maximum of 25°C for a single period of up to 6 months, but not exceeding the original expiry date. Keep the product outside of the fridge.

Reduce expiry to 6 months. The new expiry date should not exceed the labelled shelf life of the product.
No
12 October 2021
London MI Service

FlixabiBiogen Biosimilars

Biogen Biosimilars
Flixabi
100 mg powder for concentrate for solution for infusion

In the event of an inadvertent temperature excursion the following data may be used:
Flixabi is stable for a single period of 6 months when exposed to temperatures of up to 25°C. Flixabi must not be returned to refrigerated storage and the new expiry date must be written on the carton.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Contact Biogen directly for any additional information in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

6 Months
No
19 March 2021
London MI Service

Lactation Safety Information

For rheumatoid arthritis

For rheumatoid arthritis
See summary
Moderate amount of 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 psoriasis

For psoriasis
Topical psoriasis preparation / corticosteroid if appropriate
Moderate amount of 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
16 September 2019

For inflammatory bowel disease

For inflammatory bowel disease
See summary
Moderate amount of 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