Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients
Sodium chloride,
Disodium phosphate dodecahydrate,
Citric acid monohydrate,
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

Unopened
The expiry date of the product is indicated on the packaging materials.

After first opening:
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 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.
Store in the outer carton in order to protect from light.

6.5   Nature and contents of container
Pack sizes :
Plastic container: 10 x 100 ml
Plastic container: 20 x 100 ml
Not all pack sizes may be marketed.


6.6   Special precautions for disposal
No special requirements
Other handling instructions:
For single use only. Discard container and any unused contents after use.
Only to be used if solution is clear and colourless or faintly straw-coloured and the container and its closure do not show visible signs of damage.