Instructions and Special Precautions for Handling and Disposal: For single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Preparation of solutions for injection and infusion: The use of freshly prepared solutions is recommended.
Chemical and physical in-use stability of the reconstituted product has been demonstrated for at least 6 hours at or below 25°C or 24 hours at 2-8°C.
Ceftriaxone is completely reconstituted in its respective solvent within 150 seconds. The reconstituted solution is a clear solution with a yellow to brownish-yellow colour.
Ceftriaxone should not be mixed in the same syringe with any drug other than 1% Lidocaine Hydrochloride solution (for intramuscular injection only).
The infusion line should be flushed after each administration.
Intravenous administration (injection or infusion): Use in adults and children over 12 years of age (≥50 kg): 1 g of Ceftriaxone is dissolved in 10 mL of water for injections. The vial should be gently rolled between the palms, and visually inspected to ensure that reconstitution is complete and no particulate material is present.
For intravenous injection, administer over 5 minutes, directly into the vein or via the tubing of an intravenous infusion.
Alternatively, for intravenous infusion, the reconstituted solution should be transferred to 10 mL of one of the following calcium-free infusion fluids: sodium chloride 0.9%, sodium chloride 0.45% + dextrose 2.5%, dextrose 5%, dextrose 10%, dextran 6% in dextrose 5%, water for injections. The infusion should be administered over at least 30 minutes.
Use in the paediatric population: Neonates, infants and children 15 days to 12 years of age (<50 kg): In neonates, intravenous doses should be given over 60 minutes to reduce the potential risk of bilirubin encephalopathy.
The displacement volume of 1 g of Ceftriaxone is 0.71 mL in water for injections and 1% lidocaine hydrochloride solution. This requires the offset of solvent volume to facilitate weight-dependent dosing (primarily in children up to 12 years), if only part of the total solution is measured and administered. To prepare a final solution concentration of 100 mg/mL, reconstitute 1 g of Ceftriaxone in 9.4 mL of water for injections.
Intramuscular injection: Use in adults and children over 12 years of age (≥50 kg): 1 g of Ceftriaxone is dissolved in 3.5 mL of 1% Lidocaine Hydrochloride solution. The vial should be gently rolled between the palms, and visually inspected to ensure that reconstitution is complete and no particulate material is present. The solution should be administered by deep intramuscular injection. Dosages greater than 1 g should be divided and injected at more than one site.
Use in the paediatric population: Neonates, infants and children 15 days to 12 years of age (<50 kg): The displacement volume of 1 g of Ceftriaxone is 0.71 mL in 1% lidocaine hydrochloride solution. This requires the offset of solvent volume to facilitate weight-dependent dosing (primarily in children up to 12 years), if only part of the total solution is measured and administered. To prepare a final solution concentration of 285 mg/mL, reconstitute 1 g of Ceftriaxone in 2.9 mL of 1% lidocaine hydrochloride solution.
Any unused product or waste material should be disposed of in accordance with local requirements.
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