Ceftriaxone Normon 1000 mg powder for solution for injection (IM use) + 3.5 ml solvent

Composition:

The active substance is ceftriaxone (as ceftriaxone sodium).
Each vial contains 1,000 mg of ceftriaxone (as ceftriaxone sodium).
The ampoule with solvent contains 35 mg of lidocaine hydrochloride monohydrate.
After dissolving the powder in 3.5 ml of lidocaine hydrochloride monohydrate, the resulting solution has a concentration of 285.71 mg of ceftriaxone per 1 ml.

Other ingredients (excipients):

• Solvent ampoule: Water for injection

Indications:

Ceftriaxone is indicated for the treatment of the following bacterial infections:

• Bacterial meningitis

• Intra-abdominal infections (e.g., peritonitis, biliary tract infections)

• Complicated infections of bones and joints, skin, and soft tissues

• Complicated urinary tract infections, including pyelonephritis

• Respiratory tract infections

• Genital infections (including gonococcal infections)

• Lyme disease (stages II and III)
  Ceftriaxone is also indicated forsurgical prophylaxisof infections (pre- and post-operative).

Dosage:

• Adults and children ≥12 years old or ≥50 kg:1–2 g once daily (every 24 hours); in severe cases, up to 4 g/day may be used.
  

• Uncomplicated gonococcal infections:
  Single intramuscular dose of 250 mg.

• Lyme disease (stage II/III):
  50 mg/kg once daily (max. 2 g/day) for 14 days.

• Surgical prophylaxis:
  1–2 g administered 30 to 90 minutes prior to surgery.

• Renal or hepatic impairment:
  No dosage adjustment is necessary in renal impairment if liver function is normal.
  If creatinine clearance <10 ml/min, the dose should not exceed 2 g/day.

• Patients on dialysis:
  No additional dose required after dialysis. However, serum levels should be monitored to determine if dosage adjustment is needed.

• Elderly:
  No adjustment of the adult dosage is necessary.

Children under 12 years of age:

• Newborns (up to 14 days old):
  20–50 mg/kg body weight once daily. Do not exceed 50 mg/kg.

• Neonates (15–28 days), infants (1–23 months), and children (2–12 years):
  20–80 mg/kg once daily.

• Bacterial meningitis in neonates, infants, and children:
  Start with 100 mg/kg/day (maximum 4 g/day) once daily. Adjust according to pathogen and sensitivity.

Method of administration:

Ceftriaxone is administered via intramuscular injection (IM).
To prepare the injection, the vial contents should be dissolved in 3.5 ml of the supplied solvent (ampoule with lidocaine solution).

The dosage and duration of treatment should be determined by the doctor based on the disease, age, weight, and treatment response.

Treatment should be continued for at least 2–3 days after recovery or for a few days post-surgery to prevent infection.

Always follow the instructions in the leaflet or your doctor/pharmacist’s prescription.
If in doubt, consult a healthcare professional.

Storage:

• Keep out of reach of children.

• Store below 25°C.

• Keep in the original packaging to protect from light.