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Store in a refrigerator (2°C-8°C).
Do not freeze.
Store in the original package in order to protect from light.
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, or up to 6 hours when exposed to light.
For storage conditions after opening of the medicinal product, see following text.
Shelf life: 4 years.
After opening the vial, chemical and physical in-use stability of idarucizumab has been demonstrated for 6 hours at room temperature (up to 30°C). The solution should not be exposed to light for more than 6 hours.
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.
