Rituximab products: information for supporting intrathecal risk assessment
MabTheraRoche Products Ltd
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.
In the event of an inadvertent temperature excursion the following data may be used:
In-house stability data from the manufacturers have shown that the unopened vials (100mg and 500mg) may be kept up to 25°C for 1 month.
Additionally, 500mg vials were stable when exposed to -20 ± 5 °C for 1 month.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
Rixathon may be stored at temperatures up to a maximum of 30°C for a single period of up to 7 days, but not exceeding the original expiry date. The new expiry date must be written on the carton. Upon removal from the refrigerated storage, Rixathon must not be returned to refrigerated storage.