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Omvoh ® ▼ (mirikizumab)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
How to store Omvoh® (mirikizumab) vials and diluted solution
Store unopened vials at 2 - 8°C in the outer carton to protect them from light. Do not freeze. The diluted solution should be administered immediately.
How to store unopened vials
- Store in a refrigerator (2 ºC – 8 ºC).
- Do not freeze.
- Keep the vial in the outer carton to protect it from light.1
What is the shelf-life?
How to store opened/ in-use vials and diluted solution
The product does not contain a preservative therefore,2 from a microbiological point of view, the product should be used immediately.1
- 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 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.1
Keep the diluted solution away from direct heat or light. 1
Do not freeze the diluted solution.1
The vial is considered to be in-use starting at the time the vial stopper is first punctured. Once the vial is “in-use” the Omvoh solution must be used to prepare the diluted dosing solution.2
Storage conditions after dilution under aseptic conditions
It is recommended to start the infusion immediately after dilution. If not immediately used, the diluted solution prepared with sodium chloride 9 mg/mL (0.9 %) solution for injection may be stored
- refrigerated (2 ºC – 8 ºC) for not more than 96 hours or
- at room temperature not exceeding 25 ºC for not more than 10 hours (total time must not exceed 96 hours) starting from the time of vial puncture.3
The diluted infusion solution prepared with 5 % glucose must be used within 48 hours, of which not more than 5 hours are permitted at nonrefrigerated temperature not to exceed 25 °C, starting at the time of vial puncture.3
References
1Omvoh [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Omvoh [package leaflet]. Eli Lilly Nederland B.V., The Netherlands.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Date of Last Review: 12 June 2023