Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Macrogol (E1521)
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

This medicinal product does not require any special temperature storage conditions. Store in the original outer carton in order to protect from light. Once the solution has been drawn into the syringes, 
the injections should be used immediately, from a microbiological point of view. Chemical and physical in-use stability has been demonstrated for 4 hours at 25 °C outside of the package.

If not used immediately, in-use storage times and conditions are the responsibility of the user.

6.5     Nature and contents of container
Sunlenca injection is packaged in a dosing kit containing:
•     2 clear glass vials, each containing 1.5 mL solution for injection. Vials are sealed with an elastomeric butyl rubber closure and aluminum overseal with flip off cap;
•     2 vial access devices, 2 disposable syringes, and 2 injection safety needles for subcutaneous injection (22-gauge, 12.7 mm).

6.6     Special precautions for disposal and other handling

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

Use aseptic technique. Visually inspect the solution in the vials for particulate matter and discoloration prior to administration. Sunlenca injection is a yellow to brown solution. Do not use Sunlenca injection if the solution is discoloured or if it contains particulate matter. Once the solution is withdrawn from the vials, the subcutaneous injections should be administered as soon as possible.
The injection kit components are for single use only. Use of the vial access device is required. Two 1.5 mL injections are required for a complete dose.

Full instructions for use and handling of Sunlenca injection are provided in the package leaflet (see Instructions for Use).