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444649004

Refrigerated Storage

RoActemraRoche Products Ltd

Roche Products Ltd
RoActemra
20mg/mL concentrate for solution for infusion

Contact Roche in all cases where a deviation from the recommended storage conditions has occurred. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details.

12 October 2022
London MI Service

RoActemraRoche Products Limited

Roche Products Limited
RoActemra
Solution for injection in pre-filled pen/ pre-filled syringe, 162mg

In the event of an inadvertent temperature excursion the following data may be used: Once removed from the refrigerator, the pre-filled syringe can be stored up to 2 weeks at or below 30°C.

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

12 October 2022
London MI Service

Lactation Safety Information

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
Theoretically, absorption may be increased slightly in the neonatal period due to increased gastrointestinal permeability
Negligible infant serum levels and no adverse effects reported to date in infants exposed
Can be used during breastfeeding for patients with COVID-19
Live vaccination does not need to be withheld, unless exposure also occurred during pregnancy
As a precaution, monitor the infant for adequate feeding, fever, frequent infections, diarrhoea, or unusual behaviour
30 November 2021