Pharmaceutical particulars : מידע רוקחי

6. Pharmaceutical particulars

6.1 List of excipients
None


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.
Reconstituted solution:
The reconstituted solution is preferably to be used immediately.
Chemical and physical in-use stability has been demonstrated for 6 hours at 25°C and for 24 hours at 2°C – 8 °C.

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 only responsibility of the user and would normally not be longer than 24 hours at temperature ranging from +2 ºC and +8 ºC, unless reconstitution has taken place in controlled and validated aseptic conditions.
     6.4. Special precautions for storage

Store below 25°C. Store in the original package in order to protect from light.
For storage conditions after reconstitution of the medicinal product, see section 6.3 
6.5. Nature and contents of container

CEFTRIAXONE MEDO 1 GR is supplied in clear type I glass vials, nominal capacity 10 ml, sealed with a 20 mm diameter rubber stopper and an aluminium overcap, in a carton of 10 vials with a leaflet.

6.6. Special precautions for disposal and other handling
Concentrations for the intramuscular injection: 285,7 mg/ml
Concentrations for the intravenous injection: 100mg/ml
Concentrations for the intravenous infusion: 50 mg/ml

Reconstitution for injection:
Reconstitution should be carried out under suitable conditions and with appropriate precautions to prevent microbial contamination. It is recommended that freshly prepared solutions be used; the solutions retain satisfactory potency for six hours at a temperature not exceeding 25oC, and up to twenty four hours at 2 to 8oC. Following reconstitution, a pale yellow to amber solution is produced.


Intramuscular injection: Reconstitution uses Lidocaine 1.0% injection; 1 g ceftriaxone should be reconstituted using 3.5 ml of Lidocaine 1.0% injection. Administration is by deep intramuscular injection. If the dosage exceeds 1 g, the dose should be divided equally and administered at more than one injection site. Solutions reconstituted in Lidocaine should not be administered intravenously.


Intravenous injection: Reconstitution uses Water for Injection; 1 g Ceftriaxone should be dissolved in 10 ml of water. The injection should be administered over 5 minutes, directly into the vein.


Intravenous infusion: 1g of ceftriaxone should be dissolved in 20ml of one of the following calcium- free solutions; Dextrose Injection BP 5%, Sodium Chloride Injection BP, Sodium Chloride and Dextrose Injection BP (0.45% sodium chloride and 2.5% Dextrose), Dextran 6% in Dextrose Injection BP 5%, Hydroxyethyl Starch 6% infusions. The infusion should be administered over at least 30 minutes.


Diluents containing calcium (e.g. Ringer’s solution or Hartmann’s solution), should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same IV administration line. Therefore, ceftriaxone and calcium-containing solutions must not be mixed or administered simultaneously (see sections 4.3, 4.4 and 6.2).


Reconstitution should be carried out under suitable aseptic precautions. Following reconstitution the solution should be visually examined for any foreign particulate matter and discarded if any is observed. It is recommended that reconstituted solution is used immediately following preparation.
The solutions retain satisfactory potency for six hours at a temperature not exceeding 25oC, and up to twenty four hours at 2 to 8oC. CEFTRIAXONE MEDO 1 GR vials are for single use only, any remaining suspension/solution should be discarded.

7.     Manufacturer : MEDOCHEMIE LTD (FACTORY C), CYPRUS
2, Michael Erakleous, Agios Athanassios Industrial Area, 4101 Agios Athanassios, Limassol.