Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Sodium chloride
Sodium citrate dihydrate
Polysorbate 80
Citric acid, anhydrous
Water for injections


6.2   Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Omvoh should not be administered concomitantly in the same intravenous line with other medicinal products.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
After dilution
Chemical and physical in-use stability has been demonstrated for diluted infusion solution prepared with sodium chloride 9 mg/mL (0.9 %) solution for 96 hours at 2 °C to 8 °C of which not more than 10 hours are permitted at non-refrigerated temperatures not to exceed 25 ºC, starting from the time of vial puncture.
Chemical and physical in-use stability has been demonstrated for diluted infusion solution prepared with 5 % glucose for 48 hours at 2 °C to 8 °C of which not more than 5 hours are permitted at non- refrigerated temperatures not to exceed 25 °C, starting from the time of vial puncture.
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 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

Keep the diluted solution away from direct heat or light.
Do not freeze the diluted solution.

6.4   Special precautions for storage
Unopened vial

Store in a refrigerator (2 ºC – 8 ºC).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.

For storage conditions after dilution of the medicinal product, see section 6.3.
6.5   Nature and contents of container

15 mL concentrate in a type I clear glass vial with a chlorobutyl rubber stopper, an aluminium seal and polypropylene flip top.

Pack size of 1 vial.

6.6   Special precautions for disposal and other handling
Do not use Omvoh that has been frozen.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


 Dilution prior to intravenous infusion

1.    Each vial is for single use only.
2.    Prepare the infusion solution using aseptic technique to ensure the sterility of the prepared solution.
3.    Inspect the content of the vial. The concentrate should be clear, colourless to slightly yellow and free of visible particles. Otherwise, it should be discarded.
4.    Withdraw 15 mL of the mirikizumab vial (300 mg) using an appropriately sized needle (18 to
21 gauge is recommended) and transfer to the infusion bag. The concentrate should be diluted only in infusion bags (bag size ranging from 50 - 250 mL) containing either sodium chloride 9 mg/mL (0.9 %) solution for injection or 5 % glucose solution for injection. The final concentration after dilution is approximately 1.2 mg/mL to approximately 6 mg/mL.
5.    Gently invert the infusion bag to mix. Do not shake the prepared bag.


7.    License Holder
Eli Lilly Israel Limited
4 HaSheizaf St., POB 4246 Ra’anana 4366411, Israel