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Prior to use, the unopened vial may be kept at room temperature (up to 30°C) for up to 48 hours, if stored in the original package in order to protect from light. The solution should not be exposed to light for more than 6 hours (in unopened vial and/or in-use).
Shelf-life: After opening the vial, chemical and physical in-use stability of idarucizumab has been demonstrated for 6 hours at room temperature.
From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product shall be used immediately after opening. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
