Incompatibility and Stability: Solutions containing Ceftriaxone sodium, Sulbactam sodium, and Disodium edetate should not be mixed with or added to solutions containing other agents. In particular, diluents containing calcium, (e.g. Ringer's solution, Hartmann's solution) should not be used to reconstitute Ceftriaxone sodium, Sulbactam sodium, and Disodium edetate vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Ceftriaxone sodium, Sulbactam sodium, and Disodium edetate must not be mixed or administered simultaneously with calcium-containing solutions. Based on literature reports, Ceftriaxone/disodium edetate/sulbactam is not compatible with amsacrine, fluconazole, and labetalol. When any of these drugs are to be administered concomitantly with ceftriaxone by intermittent intravenous infusion, it is recommended that they must be given sequentially, with thorough flushing of the intravenous lines (with one of the compatible fluids) between the administrations.
Compatible Reconstitution Diluents: ELORES has been shown to be compatible with following infusion solutions at given concentrations, however, reducing drug concentrations increase the stability. (See Table 3.)
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The use of freshly prepared solutions is recommended. Protect from direct sun light.
Reconstitution: Reconstitute ELORES (Ceftriaxone/Sulbactam 1.5 g/Vial Powder for Solution for Injection/Infusion) with the 10 ml WFI or any of the solvents defined above and agitate the vial gently until the powder dissolves completely and administer immediately. Though the reconstituted solution is stable up to >16 hrs at 25°C ( except 10% Dextrose) and up to >24 hrs under 2°C-8°C, however it is advisable to use the solution immediately after reconstitution.
The color of solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used.
Instructions for use: The procedures below are provided as general guidelines for the reconstitution and administration of ELORES.
Always work on a clean surface and wash the hands before performing the following procedures.
Reconstitution, product administration and handling of the administration set must be done with caution.
Reconstitution procedure: Reconstitute ELORES (Ceftriaxone/Sulbactam 1.5 g/Vial Powder for Solution for Injection/Infusion) with the 10 ml WFI or any of the solvents mentioned above.
1. Bring the ELORES (powder) and diluent (sterile Water for Injection, etc) to room temperature if refrigerated.
2. Remove caps from the ELORES and diluent vials to expose the center part of the rubber stopper.
3. Use an alcohol swab to cleanse the metal ring and rubber stopper, allow it to dry before use. Place each vial on a flat surface.
4. Remove outer wrapping from one syringe.
5. Uncover & do not touch the needle.
6. Pull the syringe plunger back until its tip is at the proper mark.
7. Place the diluent vial on a clean, flat surface and push the needle through the center of the rubber stopper on the bottle. Push the plunger all the way in to inject air into the bottle.
8. Keep the needle in the bottle containing diluent. Lift the bottle and tum it straight upside down. Check to see that the needle tip is in the liquid.
9. With the needle tip in the liquid, slowly pull back the plunger until syringe fills to the proper mark. If any bubbles appear in the syringe, remove them by pushing the plunger up slowly.
10. Transfer the diluent (10 ml WFI for 1.5 g vial or 20 ml for 3 g vial) from the needle to the vial containing ELORES powder.
11. Agitate the vial gently until the powder dissolves completely.
12. Withdraw all of the dissolved solution from the powder vial into the syringe and then inject in an infusion bag. Mix the solution, DO NOT USE if it has particles in it.
13. Administer the solution via intravenous route. Cleanse the injection site with a new alcohol swab prior to administration.
Handling Disposal: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration when ever the solution and container permit. Any unused product or waste material should be disposed of in accordance with local requirements.