Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

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

6.2   Incompatibilities
Not applicable.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
6.4   Special precautions for storage

Store in a refrigerator (2 ºC – 8 ºC).
Do not freeze.
Store in the original package in order to protect from light.

Omvoh may be stored unrefrigerated for up to 2 weeks at a temperature not above 30 ºC.
If these conditions are exceeded, Omvoh must be discarded.
6.5   Nature and contents of container

Omvoh 100 mg solution for injection in pre-filled syringe

1 mL solution in a type I clear glass syringe.
The syringe is encased in a disposable, single-dose syringe with bromobutyl rubber plunger.
Pack size of 2 pre-filled syringes.
Omvoh 100 mg solution for injection in pre-filled pen

1 mL solution in a type I clear glass syringe.
The syringe is encased in a disposable, single-dose pen with bromobutyl rubber plunger.
Pack size of 2 pre-filled pens.

6.6   Special precautions for disposal and other handling
For single use only. Omvoh should not be used if particles appear or if the solution is cloudy and/or distinctly brown.
Do not use Omvoh that has been frozen.

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


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