Posology : מינונים

4.2 Posology and method of administration
Clavenir 1G must only be administered intravenously.
Dosage
Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component.
The dose of Clavenir that is selected to treat an individual infection should take into account:
• The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4)
• The severity and the site of the infection
• The age, weight and renal function of the patient as shown below.
This Clavenir powder for solution for injection/infusion provides a total daily dose of 3000 mg amoxicillin and 600 mg clavulanic acid when administered as recommended below. If it is considered that a higher daily dose of amoxicillin is required it is recommended that an alternative intravenous formulation is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid.
The duration of therapy should be determined by the response of the patient. Some infections (e.g. osteomyelitis) require longer periods of treatment. Treatment should not be extended beyond 14 days without review (see section 4.4 regarding prolonged therapy).

Consideration should be given to local guidelines on appropriate dosing frequencies for amoxicillin/clavulanic acid.

Adults and children ≥ 40 kg
For treatment of infections as              1000 mg/200 mg every 8 hours indicated in section 4.1
For surgical prophylaxis                    For procedures less than 1 hour in duration, the recommended dose is
1000 mg/200 mg to 2000 mg/200 mg given at induction of anaesthesia
(Doses of 2000 mg/200 mg can be achieved by using an alternative intravenous formulation).
For procedures greater than 1 hour in duration, the recommended dose is
1000 mg/200 mg to 2000 mg/200 mg given at induction of anaesthesia, with up to 3 doses of 1000 mg/200 mg in 24 hours.
Clear clinical signs of infection at operation will require a normal course of intravenous or oral therapy post- operatively.

Children < 40 kg
Recommended doses:
•Children aged 3 months and over: 25 mg/5 mg per kg every 8 hours •Children aged less than 3 months or weighing less than 4 kg: 25 mg/5 mg per kg every 12 hours.
• For very young children (including preterm newborns) in the first week of life the interval of administration should not exceed twice daily administration due to immaturity of the renal pathway of elimination.

Elderly
No dose adjustment is considered necessary.

Renal impairment
Dose adjustments are based on the maximum recommended level of amoxicillin.
No dose adjustment is required in patients with creatinine clearance (CrCl) greater than 30 ml/min.

Adults and children ≥ 40 kg

CrCl: 10-30 ml/min                          Initial dose of 1000 mg/200 mg and then 500 mg/100 mg given twice daily
CrCl < 10 ml/min                              Initial dose of 1000 mg/200 mg and then 500 mg/100 mg given every 24 hours
Haemodialysis                                 Initial dose of 1000 mg/200 mg and then followed by
500 mg/100 mg every 24 hours, plus a dose of 500 mg/100 mg at the end of dialysis (as serum concentrations of both amoxicillin and clavulanic acid are decreased)

Children < 40 kg
CrCl: 10 to                                   25 mg/5 mg per kg given every 12 hours 30 ml/min
CrCl < 10                                     25 mg/5 mg per kg given every 24 hours ml/min
Haemodialysis                                 25 mg/5 mg per kg given every 24 hours, plus a dose of 12.5 mg/2.5 mg per kg at the end of dialysis (as serum concentrations of both amoxicillin and clavulanic acid are decreased).

Hepatic impairment
Dose with caution and monitor hepatic function at regular intervals (see sections 4.3 and 4.4).

Method of administration
Clavenir is for intravenous use.
Clavenir may be administered either by slow intravenous injection over a period of 3 to 4 min directly into a vein or via a drip tube or by infusion over 30 to 40 min. Clavenir is not suitable for intramuscular administration.
Children aged less than 3 months should be administered Clavenir by infusion only.
Treatment with Clavenir may be initiated by the use of an intravenous preparation and completed with an appropriate oral presentation as considered appropriate for the individual patient.