Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Benzyl alcohol
Glycerin
Phenol
Sodium chloride
Dibasic sodium phosphate heptahydrate hydrochloric acid solution, 10%
Sodium hydroxide solution, 10%
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

Before use
The expiry date of the product is indicated on the packaging materials.
If stored outside of the refrigerator in a temperature up to 30 ºC, discard after 30 days whether used or unused.

After first use
After first use, can be used for up to 30 days and can be stored in the refrigerator or outside of the refrigerator in a temperature up to 30 ºC. Then the pen should be discarded.

6.4   Special precautions for storage

Store in a refrigerator (2 ºC – 8 ºC).
Do not freeze.
Protect from light.
For storage conditions after first use of the medicinal product, see section 6.3.
6.5   Nature and contents of container

Clear glass cartridge encased in a multi-dose pre-filled pen.

Each pre-filled KwikPen contains 2.4 ml of solution for injection (4 doses of 0.6 ml). Each pen has excess volume for priming. However, attempting to inject any leftover medicinal product will result in an incomplete dose even though the pen still has medicinal product left in it. Needles are not included.

Pack sizes of 1 and 3 pre-filled KwikPens. Not all pack sizes may be marketed.

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 KwikPen is for multiple doses. Each KwikPen contains 4 doses. Dispose of the pen after 4 weekly doses.


The instructions for using the KwikPen, 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