Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sucrose
L-Histidine
Glacial acetic acid
Polysorbate 20
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°C - 8°C).

Do not freeze.
Store in the original package in order to protect from light.

After removal from the refrigerator, Ebglyss must be used within 7 days (at a temperature up to 30°C) or discarded. Once stored out of refrigeration, do not place back in the refrigerator.


6.5   Nature and contents of container
2 mL solution in a 2.25 mL Type-1 clear glass syringe in a pre-filled pen with extra-small round flange, with a 27 gauge special thin wall x 8 mm stacked stainless steel needle, and closed with a laminated bromobutyl elastomeric plunger and a rigid needle shield.

Pack size:1 pre-filled pen

6.6   Special precautions for disposal and other handling

Detailed instructions for administration of Ebglyss in a pre-filled pen are given at the end of the package leaflet.

The solution should be clear to opalescent, colourless to slightly yellow to slightly brown solution and free from visible particulates. If the solution is cloudy, discoloured or contains visible particulate matter, the solution should not be used.

After removing the 250 mg pre-filled pen from the refrigerator, it should be allowed to reach room temperature by waiting for 45 min before injecting Ebglyss.

The pre-filled pen should not be exposed to heat or direct sunlight and should not be shaken.

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


7.   LICENSE HOLDER
Eli Lilly Israel Ltd.
4 HaSheizaf St., POB 4246 Ra’anana 4366411, Israel