Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sucrose
L-Hisitdine monohydrochloride monohydrate
L-Histidine
Polysorbate 80
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 
Individual pre-filled syringes may be stored at room temperature up to 30°C for a maximum single period of up to 30 days in the original carton in order to protect from light. Record the date when the pre-filled syringe is first removed from the refrigerator in the spaces provided on the outer carton. The discard date must not exceed the original expiry date printed on the carton. Once a syringe has been stored at room temperature (up to 30°C), it should not be returned to the refrigerator. Discard the syringe if not used within 30 days at room temperature storage or by the original expiry date, whichever is earlier.


6.4   Special precautions for storage
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light. If needed, individual pre-filled syringes may be stored at room temperature up to 30°C (see section 6.3).


6.5   Nature and contents of container


Ustekinumab Kamada 45 mg solution for injection in a prefilled syringe 0.5 mL solution for injection in a pre-filled type I glass 1 mL syringe with a fixed 29-gauge, extended finger flanges and passive safety needle device, and a plunger stopper (bromobutyl rubber), plunger rod and rigid needle shield (RNS).
Ustekinumab Kamada 90 mg solution for injection in a prefilled syringe 
1 mL solution for injection in a pre-filled syringe type I glass 1 mL syringe with a fixed 29-gauge needle, extended finger flanges and passive needle, safety device and a plunger stopper (bromobutyl rubber), plunger rod and rigid needle shield (RNS).

Ustekinumab Kamada is available in a pack of 1 pre-filled syringe.


6.6   Special precautions for disposal and other handling

The solution in the Ustekinumab Kamada pre-filled syringe should not be shaken. The solution should be visually inspected for particulate matter or discolouration prior to subcutaneous administration. The solution is clear and colourless to slightly yellow and practically free from visible particles. The medicinal product should not be used if the solution is frozen, discoloured or cloudy, or has large particles. Before administration, Ustekinumab Kamada should be allowed to reach room temperature (approximately half an hour). Detailed instructions for use are provided in the package leaflet.

Any unused medicinal product remaining in the syringe should not be used. Ustekinumab Kamada is supplied as a sterile, single-use pre-filled syringe.

The syringe and needle must never be re-used. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.