Posology : מינונים

4.2 Posology and method of administration
Tavanic 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 Tavanic after initial use of the intravenous preparation may be completed with an appropriate oral presentation according to the SPC for the film-coated tablets and 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 Tavanic:


Dosage in patients with normal renal function (creatinine clearance > 50 ml/min) Indication                              Daily dose regimen               Total duration of treatment1
(according to severity)
(according to severity)
Community-acquired pneumonia            500 mg once or twice daily       7 - 14 days Pyelonephritis                          500 mg once daily                7 - 10 days Complicated urinary tract infections    500 mg once daily                7 - 14 days 
Skin and soft tissue infections         500 mg once or twice daily       7 - 14 days 1
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)
Dose regimen
250 mg/24h             500 mg/24h               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 (including haemodialysis and            then: 125 mg/48 h      then: 125 mg/24 h        then: 125 mg/24 h 1
CAPD)


1
No additional doses are required after haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

Impaired liver function
No adjustment of dosage is required since levofloxacin is not metabolised to any relevant extent by the liver and is mainly excreted by the kidneys.
Elderly population
No adjustment of dosage 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
Tavanic is contraindicated in children and growing adolescents (see section 4.3).


Method of administration
Tavanic 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 Tavanic solution for infusion (see section 4.4).
For incompatibilities see section 6.2 and compatibility with other infusion solutions see section 6.6.