Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Ethanol 96%
Sodium chloride
Disodium edetate
Sodium hydroxide solution 1M
Sodium hydroxide or hydrochloric acid (1M solutions for pH adjustment) Water for injections


6.2   Incompatibilities

It is not recommended the mixing in a small volume (e.g., in a syringe) with morphine sulfate, pethidine hydrochloride, promethazine hydrochloride, hydroxyzine hydrochloride, as precipitation of ketorolac trometamol will occur.
It is compatible with normal saline, dextrose 5%, Ringer’s solution, lactated Ringer's solution.
The compatibility of ketorolac with other drugs is not known.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
Chemical and physical in-use stability has been demonstrated for 48 hours at 25°C with the diluents detailed in section 6.2.
From a microbiological point of view, unless the method of opening and dilution precludes the risk of microbial contamination, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the user.

6.4   Special precautions for storage

Store below 25°C. Do not refrigerate or freeze.
Store in the outer carton, in order to protect from light.
6.5   Nature and contents of container

Box with 5 ampoules of amber, type 1 glass, with break-ring; each ampoule contains 1 ml solution for injection.
Box with 10 ampoules of amber, type 1 glass, with break-ring; each ampoule contains 1 ml solution for injection.
Not all pack sizes may be marketed.

6.6   Special precautions for disposal

No special requirements.