LEVOFLOXACIN FRESENIUS 5 MGML

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

LEVOFLOXACIN AS HEMIHYDRATE

Tilgjengelig fra:

NEOPHARM (ISRAEL) 1996 LTD

ATC-kode:

S01AX19

Legemiddelform:

SOLUTION FOR INFUSION

Sammensetning:

LEVOFLOXACIN AS HEMIHYDRATE 5 MG/ML

Administreringsrute:

I.V

Resept typen:

Required

Produsert av:

FRESENIUS KABI NORGE AS, NORWAY

Terapeutisk område:

LEVOFLOXACIN

Indikasjoner:

Levofloxacin solution for infusion is indicated in adults for the treatment of the following infections: - Acute pyelonephritis and complicated urinary tract infections - Chronic bacterial prostatitisIn the below-mentioned infections levofloxacin should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections:- Community-acquired pneumonia- Complicated skin and soft tissue infectionsConsideration should be given to official guidance on the appropriate use of antibacterial agents.

Autorisasjon dato:

2021-07-31

Preparatomtale

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levofloxacin Fresenius 5mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
50 ML FILLED IN 100 ML BAGS:
Each ml of solution for infusion contains 5 mg levofloxacin (as
levofloxacin
hemihydrate).
50 ml of solution for infusion contains 250 mg of levofloxacin as
active substance.
100 ML FILLED IN 100 ML BAGS:
Each ml of solution for infusion contains 5 mg levofloxacin (as
levofloxacin
hemihydrate).
100 ml of solution for infusion contains 500 mg of levofloxacin as
active substance.
Excipient(s) with known effect: The medicinal product contains 3.54 mg
of sodium per
ml.
_ _
_For the full list of excipients, see section 6.1. _
3.
PHARMACEUTICAL FORM
Solution for infusion.
Yellow to greenish yellow solution.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Levofloxacin solution for infusion is indicated in adults for the
treatment of the
following infections:

Acute pyelonephritis and complicated urinary tract infections

Chronic bacterial prostatitis
In the below-mentioned infections levofloxacin should be used only
when it is
considered inappropriate to use other antibacterial agents that are
commonly
recommended for the treatment of these infections:

Community-acquired pneumonia

Complicated skin and soft tissue infections
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
2
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 rec