Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Special precautions for disposal and other handling: Preparation of solution: Tremelimumab (IMJUDO) is supplied as a single-dose vial and does not contain any preservatives, aseptic technique must be observed.
Visually inspect medicinal product for particulate matter and discolouration. Tremelimumab (IMJUDO) is clear to slightly opalescent, colourless to slightly yellow solution. Discard the vial if the solution is cloudy, discoloured or visible particles are observed. Do not shake the vial.
Withdraw the required volume from the vial(s) of Tremelimumab (IMJUDO) and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) solution for injection, or glucose 50 mg/mL (5%) solution for injection. Mix diluted solution by gentle inversion. The final concentration of the diluted solution should be between 0.1 mg/mL and 10 mg/mL. Do not freeze or shake the solution.
Care must be taken to ensure the sterility of the prepared solution.
Do not re-enter the vial after withdrawal of the medicinal product.
Discard any unused portion left in the vial.
Administration: Administer the infusion solution intravenously over 60 minutes through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
Do not co-administer other medicinal products through the same infusion line.
Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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