Levofloxacin Kabi 5mgmL Solution for Infusion

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

LEVOFLOXACIN HEMIHYDRATE

Available from:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (International Name):

LEVOFLOXACIN HEMIHYDRATE

Units in package:

10*50ml mL; 1*50ml mL; 25*50ml mL; 1*100ml mL; 10*100ml mL; 25*100ml mL

Manufactured by:

Fresenius Kabi Poland Sp. z.o.o

Patient Information leaflet

Not Applicable

Summary of Product characteristics

PACKAGE INSERT - INSTRUCTIONS FOR USE - READ CAREFULLY!
LEVOFLOXACIN KABI 5MG/ML SOLUTION FOR INFUSION.
COMPOSITION
50 ML FILLED IN 100 ML BOTTLE:
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 BOTTLE:
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.
Excipients:
The medicinal product contains 3.5 mg of sodium per ml
Sodium chloride
Sodium hydroxide
Hydrochloric acid
Water for injection
This medicinal product contains 177 mg sodium per 50 ml, equivalent to
8.85 % of the WHO
recommended maximum daily intake of 2 g sodium for an adult.
PHARMACEUTICAL FORM
Solution for infusion
Yellow to greenish yellow solution
Levofloxacin Kabi 5mg/ml Solution for Infusion is a ready to use
product with no prior dilution
required. It can also be added to compatible solution (see section
Pharmaceutical Precautions)
After dilution or reconstitution with compatible solution, the
solution should be clear.
PHARMACODYNAMICS
Pharmacotherapeutic group: quinolone antibacterials, fluoroquinolones
ATC-code: J01MA12
Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone
class and is the S (-)
enantiomer of the racemic active substance ofloxacin.
_Mechanism of action_
As a fluoroquinolone antibacterial agent, levofloxacin acts on the
DNA-gyrase complex and
topoisomerase IV.
_PK/PD relationship_
The degree of the bactericidal activity of levofloxacin depends on the
ratio of the maximum
concentration in serum (Cmax) or the area under the curve (AUC) and
the minimal inhibitory
concentration (MJC).
_Mechanism of resistance_
Resistance to levofloxacin is acquired through a stepwise process by
target site mutations in
both type II topoisomerases, DNA gyrase and topoisomerase IV. Other
resistance mechanisms
such as permeation barriers (common in _ Pseudomonas ae