Pharmaceutical particulars : מידע רוקחי

6. Pharmaceutical particulars

6.1 List of excipients

Not applicable.

6.2 Incompatibilities

Solutions containing ceftriaxone should not be mixed with 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 S.K. 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

Store below 30°C. Keep the vials in the original carton box in order to protect from light.


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

6.4 Reconstitution and dilution of the product

The use of freshly prepared solutions is recommended.
The reconstitution solvents are Lidocaine Hydrochloride solution 1% or water for Injections.
These maintain potency for maximum 6 hours at or below 25°C or 24 hours at 2- 8°C. Protect from light.
Ceftriaxone S.K., powder for solution for injection, should not be mixed in the same syringe with any drug other than 1% Lidocaine Hydrochloride solution (for intramuscular injection only).
Intramuscular injection: Ceftriaxone S.K. 1000 mg powder for solution for injection should be dissolved in 3.5 ml of 1% Lidocaine Hydrochloride solution. The solution should be administered by deep intramuscular injection. Dosages greater than 1000 mg should be divided and injected at more than one site.
Solutions in Lidocaine should not be administered intravenously.
Intravenous injection: Ceftriaxone S.K. 1000 mg powder for solution for injection in 10 ml of Water for Injections. The injection should be administered over 5 minutes, directly into the vein or via the tubing of an intravenous infusion.
Concentrations for the intravenous injection: 100mg/ml

Concentrations for the intravenous infusion: 50 mg/ml

Please refer to section 4.2 for further information.
After reconstitution:
Chemical and physical in-use stability has been demonstrated for 6 hours at  25°C and for 24 hours at 2-8°C, when reconstituted either with water for inj. or with Lidocaine HCI 1% solution. From a microbiological point of view, the product 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 the times stated above.

6.5 Nature and contents of container

10 mL clear glass type III vial with a rubber stopper (bromobutyl) and aluminium cap/plastic flip-off seal. boxes of 1 vial.