Store at temperature not exceeding 30°C.
Zomod 3.5: Keep the vial in the outer carton in order to protect from light.
For storage conditions after reconstitution of the medicinal product, refer to Reconstituted solution as follows.
Shelf life: Zomod 1: Unopened vial: 2 Years.
Intravenous administration: The chemical and physical in-use stability of the reconstituted solution at a concentration of 1 mg/mL has been demonstrated for 3 days at 20°C-25°C stored in the original vial and/or a syringe. From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the reconstituted solution should be used immediately after preparation. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Zomod 3.5: Unopened vial: 24 months.
Reconstituted solution: The reconstituted solution should be used immediately after preparation. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. However, the chemical and physical in-use stability of the reconstituted solution has been demonstrated for 8 hours at 25°C stored in the original vial and/or a syringe. The total storage time for the reconstituted medicinal product should not exceed 8 hours prior to administration.
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