Pharmaceutical particulars : מידע רוקחי

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Disodium edetate
Water for injections
Carbon Dioxide

6.2    Incompatibilities

Due to their alkaline pH, sodium bicarbonate solutions are incompatible with most medicinal products. In particular, they must not be administered simultaneously with solutions containing calcium, magnesium or phosphate because of the possibility of precipitation.


6.3    Shelf life
- unopened:
The expiry date of the product is indicated on the packaging materials.
6.4   Special precautions for storage
Do not store above 25°C.
To avoid formation of crystals, do not refrigerate or freeze.

6.5   Nature and contents of container

Bottles of glass type I (Ph. Eur.), sealed with rubber stoppers, contents: 100 ml supplied in packs of
20 × 100 ml


6.6   Special precautions for disposal and other handling

The containers are for single use only. Discard container and any unused content after use.

Only to be used if the solution is clear and colourless and if the bottle and its closure are undamaged.

This medicinal product is an almost saturated solution. Crystals which may possibly have developed during storage can be dissolved by simply warming the bottle.
As an additional safety measure against crystals that might be inadvertently infused with the solution, it is recommended to use an infusion set fitted with an integral fluid filter.

From a microbiological point of view, the solution should be administered immediately after connecting the container to the giving set. 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°.

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