Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Not applicable.

6.2 Incompatibilities

Solutions containing ceftriaxone should not be mixed or added to other agents except those mentioned in section 6.6. In particular diluents containing calcium, (e.g. Ringer's solution, Hartmann's solution) should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form.
Ceftriaxone must not be mixed or administered simultaneously with calcium containing solutions including total parenteral nutrition (see section 4.2, 4.3, 4.4 and 4.8).
Based on literature reports, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole and aminoglycosides.


6.3 Shelf Life
The expiry date of the product is indicated on the packaging materials.

6.4 Special precautions for storage
Do not store above 25ºC. Store in the original pack to protect from light and moisture.
The drug product Ceftriaxone-Trima 1 g should be reconstituted with 10 ml of water for injection for I.V administration or with 3.5 ml of 1% w/v lidocaine hydrochloride solution for I.M administration.

For I.V. infusion: the reconstituted solution should be diluted with 20 ml of one of the following calcium-free infusion solutions: sodium chloride 0.9%, sodium chloride 0.45% and glucose 2.5%, glucose 5%, glucose 10%.

After reconstitution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2ºC to 8ºC.
From a microbiological point of view, the product must be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at temperature ranging from +2ºC and +8ºC, otherwise any unused portion must be discarded.

6.5 Nature and contents of container
10 ml glass type III vial with rubber stopper crimped with aluminum cap.
Pack sizes: 1, 5, 10 and 55 vials.
Not all pack sizes may be marketed.