Cetafor 500 mg IV

Active substance:  ceftriaxone (injectable 3rd generation cephalosporin)

Form: 500 mg powder and solvent for solution for injection (IV injection -perfusion)

1000mg powder and solvent for solution for injection (IV injection – perfusion – IM injection)

Dosage: 500 mg / 1000 mg of ceftriaxone per vial

Packaging:

• Box with one powder vial and one solvent ampoule
• 5 ml for 500 mg IV / 10 ml for 1000 mg IV
• The solvent of the IM form (4ml) contains lidocaine and can only be administered IM

Target: adults and children (including in term neonates)

Cetafor 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
• Gonorrhoea
• Syphilis
• Bacterial endocarditis

Cetafor 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

Cetafor should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum.

The dose depends on the severity, susceptibility, site and type of infection and on the age and hepato-renal function of the patient. The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of ceftriaxone should be continued for 48 – 72 hours after the patient has become afebrile or evidence of bacterial eradication has been achieved.

IV Form

IV bolus injection :

Cetafor® IV (500mg and 1000mg) should be administered by intravenous injection. The solution is prepared with the 5ml/10ml ampoule supplied in the same box. The solution should be administered directly after reconstitution by the IV route over a period of 2 to 4 minutes.

IV perfusion

Concentrations between 10 mg/ml and 40 mg/ml are recommended.

Cetafor 1000 IV and 500 mg IV should be dissolved in one of the following solutions: 0.9% sodium chloride – 5% glucose or 10% – 5% glucose + 0.9% sodium chloride – 5% glucose + 0.45% sodium chloride.

All these solutions must be administered immediately after reconstitution.Les solutions contenant de la ceftriaxone ne doivent pas être mélangées ou ajoutées à d’autres agents. En particulier, ceftriaxone n’est pas compatible avec des solutions contenant du calcium. La ceftriaxone ne doit pas être mélangée ou administrée simultanément avec des solutions contenant du calcium.

IM Form:

Cetafor 1000 mg IM should be dissolved in 4 ml of sterile lidocaine hydrochloride 1% supplied in one ampoule in the same box.  The solution should be administered by deep intragluteal injection and used immediately after reconstitution.

Doses: Please refer to the CPR

Standard dose adults: 1 to 2 g / once daily. Maximum adult dose 4 g per day. Twice daily administration (every 12 hours) may be considered when doses above 2 g per day are administered.

Standard dose children: 50 to 100 mg/kg once daily (max 4 g)