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

Store in a dry place below 25º C. Protected from light and store in the original pack.
The expiry date of the product is indicated on the packaging materials.

6.4 Reconstitution and dilution of the product

The drug product Ceftriaxone 1 g reconstituted with 10 ml of water for injection for I.V. or with 3.5 ml of 1% lidocaine solution for I.M. can be used within 12 hours when stored at not more than 25ºC.

For I.V. infusion: reconstituted in 20 ml of one of the following calcium-free infusion solutions: sodium chloride 0.9%, sodium chloride 0.45%-dextrose 2.5%, dextrose 5%, dextrose 10%, dextran 6% in dextrose 5%, hydroxyethyl starch 6-10% infusions, sterile water for injections

Can be used within 12 hours when stored at no more than 25 ºC.

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 only responsibility of the user and would not be longer than 24 hours at temperature ranging from +2 ºC and +8 ºC.

7. Manufacturer: Panpharma, France
Z.I. Du Clairay, 35133 Luitre.