Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients
 mPEG-2000-DSPE
Mannitol
Benzyl alcohol
Carmellose sodium
Phenol
Disodium edetate
Hydrochloric acid
Sodium hydroxide
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.
After first use
28 days or until the expiry date (whichever is earlier).
IMCIVREE-SPC-0124-V1
Do not store above 30°C.

Chemical and physical in use stability has been demonstrated for 28 days at 2-30 °C.

From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 2°C to 30°C. Other in-use storage times and conditions are the responsibility of the user.

6.4   Special precautions for storage

Store in a refrigerator (2°C to 8°C). Do not freeze. Store in the original carton in order to protect from light.

Unopened vials may be kept at room temperature, not to exceed 30°C, for up to 30 days.
or until the expiry date, whichever is sooner.
For storage conditions after first opening of the medicinal product, see section 6.3.

6.5   Nature and contents of container
2R clear glass type I multidose vial with bromobutyl grey stopper and aluminium cap.

Pack size: 1 multidose vial.

6.6   Special precautions for disposal and other handling
IMCIVREE should be removed from the refrigerator approximately 15 minutes prior to administration.
Alternatively, patients may warm the product prior to administration by rolling the vial gently between the palms of their hands for 60 seconds.

IMCIVREE should be inspected prior to each injection, and the solution should not be used if it is cloudy or contains particles.

If IMCIVREE is exposed to temperatures >30°C, it should be discarded and not used.

Always use a new syringe for each injection to prevent contamination.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.