Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1     List of excipients
L-Arginine hydrochloride
L-Methionine
L-Histidine hydrochloride monohydrate
L-Histidine
Polysorbate 80
Water for injections


6.2   Incompatibilities
In the absence of compatability 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.
Keep the pre-filled syringe in the outer carton in order to protect from light and moisture.
Once removed from the refrigerator, the pre-filled syringe can be stored up to 2 weeks (14 days) at or below 30°C. The pre-filled syringe must always be kept in the carton.


6.5   Nature and contents of container
0.9 mL solution in a pre-filled syringe (type I glass) with a staked-in needle. The syringe is closed by a rigid needle shield (elastomer seal with a polypropylene shell) and a plunger stopper (butyl rubber with a fluororesin coating).

Pack sizes of 1 or 4* pre-filled syringes.
*It is possible that not all packs sizes will be marketed

6.6   Special precautions for disposal and other handling
Actemra is supplied in a single use pre-filled syringe fitted into a needle safety device. After removing the pre-filled syringe from the refrigerator the pre-filled syringe should be allowed to reach room temperature (18°C to 28°C) by waiting for 25 to 30 minutes, before injecting Actemra . The syringe should not be shaken. After removing the cap the injection must be started within 5 minutes, to prevent the medicine from drying out and blocking the needle. If the pre-filled syringe is not used within 5 minutes of removing the cap, you must dispose of it in a puncture resistant container and use a new pre-filled syringe.

If following insertion of the needle you cannot depress the plunger, you must dispose of the pre-filled syringe in a puncture resistant container and use a new pre-filled syringe.

Do not use if the medicine is cloudy or contains particles, is any colour besides colourless to slightly yellowish, or any part of the pre-filled syringe appears to be damaged.

Comprehensive instructions for the administration of Actemra in a pre-filled syringe are given in the package leaflet.

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

7.    MARKETING AUTHORISATION HOLDER
Roche Pharmaceuticals (Israel) Ltd., P.O.Box 6391 Hod Hasharon 4524079, www.roche.co.il 
8.    MARKETING AUTHORISATION NUMBER(S)

153-15-34111-00