View drug registration information details.


ItemsRegistration information
ID539
No539
Brand NameLEVOFLOXACIN KABI
IngredientsLEVOFLOXACIN HEMIHYDRATE EQ.TO LEVOFLOXACIN 500 MG/100 ML
Dosage FormSOLUTION FOR INFUSION
Primary PackagingBOTTLE
StorageDO NOT STORE ABOVE 30C, PROTECT FROM LIGHT
Shelf Life3 YEARS
Pack SizeBOX OF 100 ML/BOTTLE
Dispensing CategoryPRESCRIPTION
ATC ClassificationJ01MA12
Pharmaceutical ClassANTIBACTERIA
IndicationsCOMMUNITY-ACQUIRED PNEUMONIA, COMPLICATED SKIN AND SOFT TISSUE INFECTION, ACUTE BACTERIAL SINUSITIS, ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS, CHRONIC BACTERIAL PROSTATITIS, PYELONEPHRITISAND COMPLICATED URINARY TRACT INFECTION, INHALATION ANTHRAX
ContraindicationsHYPERSENSITIVITY, PATIENT WITH EPILEPSY, HISTORY OF TENDON DISORDER RELATED TO FLUOROQUINOLONE ADMINISTRATION, UNDER 18 YEARS OLD, DURING PREGNANCY, IN BREAST-FEEDING WOMEN
Side EffectsINSOMNIA, HEADACHE, DIZZINESS, DIARRHEA, VOMITING, NAUSEA, HEPATIC ENZYME INCREASED
Unit Price
EDL Yes
DescriptionTRANSPARENT SOLUTION WITH PALE YELLOWISH, CONTAINED IN 100 ML SEALED TRANSPARENT NEUTRAL GLASS BOTTLE
Note
License OwnerDKSH LAOS COMPANY LIMITED
ManufacturerFRESENIUS KABI VIETNAM JOINT STOCK COMPANY
CountryVIETNAM
Import Registration NoVD-29316-18
Import Registration Date2018-02-22
ActivityCERTIFICATE RELEASED
Applied Date2021-12-03
FDD Registration No04 I 5467/23
FDD Registration Date2023-04-11
Expiry Date2026-04-10

Back to drug list