Each vial Ceftriaxone contains 1.196 g of ceftriaxone sodium, equivalent to 1g of ceftriaxone.
Excipient with known effect: Sodium
1g vial contains 3.6 mmol (or 83 mg) of sodium per vial.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection/infusion.
White to pale yellow powder.
4. Clinical particulars
4.1 Therapeutic indications
Ceftriaxone is indicated for the treatment of the following infections in adults and children including term neonates (from birth):
- Bacterial Meningitis
- Community acquired pneumonia
- Hospital acquired pneumonia
- Acute otitis media
- Intra-abdominal infections
- Complicated urinary tract infections (including pyelonephritis)
- Infections of bones and joints
- Complicated skin and soft tissue infections
- Bacterial endocarditis
Ceftriaxone may be used:
- For treatment of acute exacerbations of chronic obstructive pulmonary disease in adults
- For treatment of disseminated Lyme borreliosis (early (stage II) and late (stage III)) in adults and children including neonates from 15 days of age
- For Pre-operative prophylaxis of surgical site infections
- In the management of neutropenic patients with fever that is suspected to be due to a bacterial infection
- In the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above
Ceftriaxone should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum (see section 4.4).
Consideration should be given to official guidelines on the appropriate use of antibacterial agents.