Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Sucrose
L-histidine
Polysorbate 80
Water for injections

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 pens 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 pen is first removed from the refrigerator in the space provided on the outer carton. The discard date must not exceed the original expiry date printed on the carton. Once a pre-filled pen has been stored at room temperature (up to 30°C), it should not be returned to the refrigerator. Discard the pre- filled pen 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 pen in the outer carton in order to protect from light.
If needed, individual pre-filled pens may be stored at room temperature up to 30°C (see section 6.3).
6.5    Nature and contents of container

STELARA 45 mg solution for injection in pre-filled pen
0.5 mL solution in a type I glass 1 mL syringe with a fixed stainless steel needle assembled in a pre-filled pen with a passive needle guard. The needle cover inside the bottom cap of the pre-filled pen contains dry natural rubber (a derivative of latex).

STELARA 90 mg solution for injection in pre-filled pen
1 mL solution in a type I glass 1 mL syringe with a fixed stainless steel needle assembled in a pre-filled pen with a passive needle guard. The needle cover inside the bottom cap of the pre-filled pen contains dry natural rubber (a derivative of latex).

STELARA is available in a pack of 1 pre-filled pen.

6.6    Special precautions for disposal and other handling
The solution in the STELARA pre-filled pen should not be shaken. The solution should be visually inspected for particulate matter or discolouration prior to subcutaneous administration. The solution is clear to slightly opalescent, colourless to light yellow and may contain a few small translucent or white particles of protein. This appearance is not unusual for proteinaceous solutions. The medicinal product should not be used if the solution is discoloured or cloudy, or if foreign particulate matter is present. Before administration, STELARA should be allowed to reach room temperature (approximately half an hour). Detailed instructions for use are provided in the package leaflet.

STELARA does not contain preservatives; therefore any unused medicinal product remaining in the pre-filled pen should not be used. STELARA is supplied as a sterile, single-use pre-filled pen. The pre-filled pen must never be re-used. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.