Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS
6.1   List of excipients
Sodium chloride
Hydrochloric acid
Sodium hydroxide
Water for Injection

6.2   Incompatibilities

Midazolam Kalceks must not be diluted with dextran 6% solution in glucose.
Midazolam Kalceks must not be mixed with alkaline solutions for injection.
Midazolam precipitates in solutions containing hydrogen carbonate.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
After opening ampoule
Once opened the product should be used immediately.

Shelf life after dilution
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C and 3 days at 2-8 °C with the following infusion solutions: sodium chloride 0.9%, glucose 5% and 10%,
Ringer's solution and Hartman's solution.
From a microbiological point of view, the dilutions 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 2-8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

Store below 25°C. Keep the ampoules in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.

6.5   Nature and contents of container

Type I colourless glass ampoules with one point cut containing 1 ml, 3 ml or 10 ml solution (for 5 mg/ml) and 5 ml solution (for 1 mg/ml).

Pack size: 5 or 10 ampoules.

Not all pack sizes may be marketed.
6.6   Special precautions for disposal

Compatible with the following solution for infusion:
-   sodium chloride 0.9% solution
-   glucose 5% solution
-   glucose 10% solution
-   Ringer's solution
-   Hartmann's solution

For intravenous infusion, the content of Midazolam Kalceks ampoules may be diluted with one of the solutions mentioned above in a ratio of 15 mg midazolam per 100-1000 ml of infusion solution.

Midazolam Kalceks solution for injection/infusion is for single use only.

The solution should be examined visually before administration. Only clear solution without visible particles should be used.

Any unused medicinal product or waste material should be disposed of in accordancewith local requirements.


7     MARKETING AUTHORISATION HOLDER
A.L.Medi-Market Ltd., 3 Hakatif street, Emek Hefer Industrial Park, 3877701