Shelf-life after dilution: Chemical and physical in use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2°C to 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Special precautions for storage: Store at temperatures between 2° C and 8°C.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Within its shelf-life and for the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25 °C) for one single period of up to 72 hours. At the end of this period, the product should not be put back in the refrigerator and should be disposed of.
For storage conditions after dilution of the medicinal product, see Shelf-life after dilution as previously mentioned.