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Trastuzumab products: information for supporting intrathecal risk assessment
Refrigerated Storage
HerceptinRoche Products Ltd
In the event of an inadvertent temperature excursion the following data may be used:
Once removed from the refrigerator Herceptin subcutaneous formulation must be administered within 6 hours and should not be kept above 30°C.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
Herceptin Roche Products Ltd
Contact Roche Products Limited 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.
Herzuma Napp Pharmaceuticals
In the event of an inadvertent temperature excursion the following data may be used:
In-house stability data shows Herzuma 150mg was stable for 36 months and Herzuma 420mg was stable for 12 months at storage conditions (2°C to 8°C) when exposed to stress/cycling stability conditions (a total of 12 days at temperatures cycling between -20 ± 5°C and 40 ± 2°C).
In-house stability data from the manufacturers have shown that the unopened vials may be kept up to 25°C for 6 months, or up to 40°C for 3 months.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk