Pharmaceutical particulars : מידע רוקחי

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride, hydrochloric acid 10% (W/V), water for injections.
6.2 Incompatibilities
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 first opening the container
This medicinal product should be used immediately after opening.

After dilution
Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature and for 3 days at 5 °C.
From a microbiological point of view, dilutions should be used immediately after preparation. 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
Do not store above 25°C. Protect from light.
This medicinal product should be used immediately after opening.

Midazolam B. Braun after dilution, should be used immediately after preparation. 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.

6.5 Nature and contents of container

Midazolam B. Braun 1 mg/ml
10 Polyethylene Bottle of 100mg/100ml
10 Polyethylene Bottle of 50mg/50ml
20 Polyethylene Ampoules of 5mg/5ml
Midazolam B. Braun 5 mg/ml
10 Glass Ampoules of 5mg/ml
10 Glass Ampoules of 15mg/3ml
20 Polyethylene Ampoules of 50mg/10ml

Not all pack sizes may be marketed.

6.6 Special precautions for disposal
The product is supplied in single-dose containers. Unused contents of opened ampoules must be discarded immediately.
Midazolam B. Braun may be diluted with
●       9 mg/ml (0.9 %) sodium chloride solution,
●       50 mg/ml (5 %) glucose solution,
●       Ringer’s solution,
●       Hartmann’s solution,
to a resulting concentration of 15 mg midazolam per 100 - 1000 ml of infusion solution.
The compatibility with other solutions should be checked prior to mixing.
Only to be used if solution is clear and colourless and the container and its closure are undam- aged.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.