CEFTRIAXONE ALVOGEN POWDER FOR SOLUTION FOR INJECTION/ INFUSION 1G/VIAL [SIN14676P]

Product Info

CEFTRIAXONE ALVOGEN POWDER FOR SOLUTION FOR INJECTION/ INFUSION 1G/VIAL

[SIN14676P]

4.1 Therapeutic indications

Ceftriaxone is indicated for the treatment of the following infections when known or likely to be due to one or more susceptible micro-organisms (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) and when parenteral therapy is required:

• Pneumonia.

• Sepsis.

• Meningitis.

• Bone, skin and soft tissue infections.

• Infections in neutropenic patients.

• Gonorrhoea.

• Peri-operative prophylaxis of infections.

Treatment may be started before the results of susceptibility tests are known.

Consideration should be given to official guidance on the appropriate use of antibacterials.

4.2 Posology and method of administration

Posology
CEFTRIAXONE ALVOGEN may be administered by intramuscular injection, intravenous injection, or as intravenous infusion, after reconstitution of the solution according to the directions given below.

Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same IV administration line. Ceftriaxone must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid.

Dose and mode of administration should be determined by the severity of the infection, susceptibility of the causative organism and the patient's condition.

Combination therapy

Synergy between ceftriaxone and aminoglycosides has been demonstrated with many gram-negative bacteria under experimental conditions. Although enhanced activity of such combinations is not always predictable, it should be considered in severe, life-threatening infections due to micro-organisms such as Pseudomonas aeruginosa. Because of physical incompatibility the two drugs must be administered separately at the recommended dosages.

Standard dosage

Adults and children over 12 years

The usual dosage is 1–2 g of CEFTRIAXONE ALVOGEN once daily (every 24 hours). In severe cases or in infections caused by moderately sensitive organisms, the dosage may be raised to 4 g, once daily.

The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of CEFTRIAXONE ALVOGEN should be continued for a minimum of 48 to 72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained.

Gonorrhoea (penicillinase-producing and nonpenicillinase-producing strains)
A single dose of 250 mg intramuscularly should be administered.

Peri-operative prophylaxis
A single dose of 1–2 g depending on the risk of infection of 30–90 minutes prior to surgery. In colorectal surgery, administration of CEFTRIAXONE ALVOGEN with or without a 5-nitroimidazole, e.g. ornidazole (separate administration, see 2.2 Dosage and Administration – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) has been proven effective.

Elderly patients
These doses do not require modification in elderly patients provided that renal and hepatic function are satisfactory (see below).

Neonates, infants and children up to 12 years
The following dosage schedules are recommended for once daily administration:

Neonates (up to 14 days): 20–50 mg/kg bodyweight once daily. The daily dose should not exceed 50 mg/kg. It is not necessary to differentiate between premature and term infants.

For infants and children (15 days to twelve years): 20–80 mg/kg once daily.

For children with bodyweights of 50 kg or more, the usual adult dosage should be used.

Intravenous doses of 50 mg or more per kg should be given by infusion over at least 30 minutes.

Patients with renal and hepatic impairment
In patients with impaired renal function, there is no need to reduce the dose of CEFTRIAXONE ALVOGEN provided liver function is intact. Only in cases of pre-terminal renal failure (creatinine clearance < 10 ml per minute) should the daily dose not exceed 2 g daily.

In patients with liver damage, there is no need for the dose to be reduced provided renal function is intact.

In severe renal impairment accompanied by hepatic insufficiency, the plasma concentration of CEFTRIAXONE ALVOGEN should be determined at regular intervals and dose adjusted.

In patients undergoing dialysis, no additional supplementary dosing is required following the dialysis. Serum concentrations should be monitored, however, to determine whether dose adjustments are necessary, since the elimination rate in these patients may be reduced.

Meningitis
In bacterial meningitis in infants and children, treatment begins with doses of 100 mg/kg (up to a maximum of 4 g) once daily. As soon as the causative organism has been identified and its sensitivity determined, the dosage can be reduced accordingly. The following duration of therapy has shown to be effective:

Neisseria meningitides 4 days
Haemophilus influenzae 6 days
Streptococcus pneumoniae 7 days

Method of administration
CEFTRIAXONE ALVOGEN is intended for intravenous or intramuscular use.

For instructions on reconstitution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

Hypersensitivity to the active substance or to beta-lactam antibiotics.

In patients hypersensitive to penicillin, the possibility of allergic cross-reactions should be borne in mind.

Hyperbilirubinaemic newborns and preterm newborns should not be treated with ceftriaxone. In vitro studies have shown that ceftriaxone can displace bilirubin from its binding to serum albumin and bilirubin encephalopathy can possibly develop in these patients.

Premature newborns up to a corrected age of 41 weeks (weeks of gestation + weeks of life).

Ceftriaxone is contraindicated in neonates (≤28 days) if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium (see Dosage and administration and Interactions with Calcium-Containing Products – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving ceftriaxone and calcium-containing fluids. In some of these cases, the same intravenous infusion line was used for both ceftriaxone and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. At least one fatality has been reported in a neonate in whom ceftriaxone and calcium-containing fluids were administered at different time points via different intravenous lines; no crystalline material was observed at autopsy in this neonate. There have been no similar reports in patients other than neonates.