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לבופלוקס 5 מ"ג/מ"ל LEVOFLOX 5 MG/ML (LEVOFLOXACIN AS HEMIHYDRATE)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

תוך-ורידי : I.V

צורת מינון:

תמיסה לאינפוזיה : SOLUTION FOR INFUSION

Posology : מינונים

4.2 Posology and method of administration
Levoflox 5mg/ml 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. After initial use of the intravenous preparation the treatment may be completed with an oral presentation of levofloxacin 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 Levoflox 5mg/ml:
Dosage in patients with normal renal function (creatinine clearance >50 ml/min) 
Indication                  Daily dose regimen               Total duration of (according to severity)              treatment1
(according to severity)

Community-acquired            500 mg once or twice daily              7-14 days pneumonia
Acute Pyelonephritis               500 mg once daily                  7-10 days 
Chronic bacterial prostatitis          500 mg once daily                   28 days Complicated urinary tract             500 mg once daily                  7-14 days infections
Complicated skin and soft        500 mg once or twice daily              7-14 days tissue infections
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/24 h                  500 mg/24 h                  500 mg/12 h Creatinine                   first dose: 250 mg           first dose: 500 mg           first dose: 500 mg clearance
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
1
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 metabolized 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
Levoflox 5mg/ml is contraindicated in children and growing adolescents (see section 4.3).
Method of administration
Levoflox 5mg/ml 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 Levoflox 5mg/ml (see section 4.4).
For incompatibilities see section 6.2.
שימוש לפי פנקס קופ''ח כללית 1994 לא צוין
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בעל רישום

TEC-O-PHARM-LIBRA LTD

רישום

161 39 35215 00

מחיר

0 ₪

מידע נוסף

עלון מידע לרופא

29.08.22 - עלון לרופא 14.09.23 - עלון לרופא 20.12.23 - עלון לרופא

עלון מידע לצרכן

לתרופה במאגר משרד הבריאות

לבופלוקס 5 מ"ג/מ"ל

קישורים נוספים

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