Posology : מינונים

4.2 Posology and method of administration
Levofloxacin Fresenius 5mg/ml solution for infusion is administered by slow intravenous infusion once or twice daily. The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen.
Treatment with Levofloxacin Fresenius 5mg/ml after initial use of the intravenous preparation may be completed with an appropriate oral presentation as considered appropriate for the individual patient. Given the bioequivalence of the parenteral and oral forms, the same dosage can be used.

Posology

The following dose recommendations can be given for Levofloxacin Fresenius 5mg/ml:

Dosage in patients with normal renal function (creatinine clearance > 50 ml/min) 
Indication                          Daily dose regimen                                          1 Total duration of treatment
(according to severity)    (according to severity)
Community-acquired                  500 mg once or twice       7 - 14 days pneumonia                           daily
Acute Pyelonephritis                500 mg once daily          7 - 10 days Complicated urinary tract           500 mg once daily          7 - 14 days infections
Chronic bacterial prostatitis       500 mg once daily          28 days 
Complicated skin and soft           500 mg once or twice       7 - 14 days tissue infections                   daily
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Treatment duration includes intravenous plus oral treatment. The time to switch from intravenous to oral treatment depends on the clinical situation but is normally 2 to 4 days.

Special populations

Impaired renal function (creatinine clearance ≤50 ml/min)
Dosage Regimen

250 mg/24h            500 mg/24 h            500 mg/ 12 h

Creatinine clearance           first dose: 250 mg    first dose: 500 mg     first dose: 500 mg 50 - 20 ml/min                 then: 125 mg/24 h     then: 250 mg/24 h      then: 250 mg/12 h 19-10 ml/min                   then: 125 mg/48 h     then: 125 mg/24 h      then: 125 mg/12 h <10 ml/min                     then: 125 mg/48 h     then: 125 mg/24 h      then: 125 mg/24 h (including haemodialysis and CAPD) 1

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No additional doses are required after haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

Impaired liver function

No adjustment of dose is required since levofloxacin is not metabolised to any relevant extent by the liver and is mainly excreted by the kidneys.

Older People

No adjustment of dose is required in the elderly, other than that imposed by consideration of renal function (see section 4.4 “Tendinitis and tendon rupture” and “QT interval prolongation”).

Paediatric population

Levofloxacin Fresenius 5mg/ml is contraindicated in children and growing adolescents (see section 4.3).

Method of administration

Levofloxacin Fresenius 5mg/ml solution for infusion is only intended for slow intravenous infusion; it is administered once or twice daily. The infusion time must be at least 30 minutes for 250 mg or 60 minutes for 500 mg Levofloxacin Fresenius 5mg/ml solution for infusion (see section 4.4).

For incompatibilities see section 6.2 and compatibility with other infusion solutions see section 6.6.