Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sodium chloride

Dibasic Sodium Phosphate Heptahydrate
Hydrochloric Acid Solution, 10% (for pH adjustment)
Sodium Hydroxide Solution, 10% (for pH adjustment)
Water for injection
6.2    Incompatibilities

In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products.

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 original package in order to protect from light.
Mounjaro may be stored unrefrigerated for up to 21 cumulative days at a temperature not above 30 ºC and then the pre- filled pen must be discarded.

6.5 Nature and contents of container
Glass syringe encased in a disposable pre-filled pen.
The pre-filled pen has a hidden needle, which will automatically insert into the skin when the injection button is pressed.
Each pre-filled pen contains 0.5 ml of solution.
Pack size of 4 pre-filled pens.

6.6   Special precautions for disposal and other handling
Instructions for use

Inspect Mounjaro visually before use and discard for particulate matter or discolouration.
Mounjaro that has been frozen must not be used.

The pre-filled pen is for single-use only.
The instructions for using the pen, included with the package leaflet, must be followed carefully.

Disposal

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