Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
1N Sodium hydroxide solution
Disodium edetate
Acetic acid (99%)
Water for injections
Nitrogen (as inert gas)

6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except for those mentioned in section 6.6.

6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.

Shelf life after first opening:
After first opening the medicinal product should be used immediately.
Shelf life after dilution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4 Special precautions for storage
Store below 25°C.

6.5 Nature and contents of container
Carton boxes with 5 or 10 ampoules (glass Type I) containing 5 ml solution for injection.
Carton boxes with 5 or 10 ampoules (glass Type I) containing 10 ml solution for injection.
Not all pack sizes may be marketed.


6.6 Special precautions for disposal and other handling
This medicinal product is for single use only and any unused solution should be discarded.
Please inspect the medicinal product visually. It should only be used if the solution is clear and practically free from particles.

When flumazenil is to be used in infusion, it must be diluted prior to infusion. Flumazenil should only be diluted with sodium chloride 9 mg/ml (0.9 %) solution, dextrose 50 mg/ml (5 %) solution or sodium chloride 4.5 mg/ml (0.45 %) + dextrose 25 mg/ml (2.5 %) solution (10, 20, 50 ml Flumazenil 0.1 mg/ml in 500 ml solution). Compatibility between flumazenil and other solutions for injection has not been established.

Intravenous infusion solutions should be discarded after 24 hours.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.