View drug registration information details.
Items | Registration information |
ID | 539 |
No | 539 |
Brand Name | LEVOFLOXACIN KABI |
Ingredients | LEVOFLOXACIN HEMIHYDRATE EQ.TO LEVOFLOXACIN 500 MG/100 ML |
Dosage Form | SOLUTION FOR INFUSION |
Primary Packaging | BOTTLE |
Storage | DO NOT STORE ABOVE 30C, PROTECT FROM LIGHT |
Shelf Life | 3 YEARS |
Pack Size | BOX OF 100 ML/BOTTLE |
Dispensing Category | PRESCRIPTION |
ATC Classification | J01MA12 |
Pharmaceutical Class | ANTIBACTERIA |
Indications | COMMUNITY-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 |
Contraindications | HYPERSENSITIVITY, PATIENT WITH EPILEPSY, HISTORY OF TENDON DISORDER RELATED TO FLUOROQUINOLONE ADMINISTRATION, UNDER 18 YEARS OLD, DURING PREGNANCY, IN BREAST-FEEDING WOMEN |
Side Effects | INSOMNIA, HEADACHE, DIZZINESS, DIARRHEA, VOMITING, NAUSEA, HEPATIC ENZYME INCREASED |
Unit Price | |
EDL |
Yes |
Description | TRANSPARENT SOLUTION WITH PALE YELLOWISH, CONTAINED IN 100 ML SEALED TRANSPARENT NEUTRAL GLASS BOTTLE |
Note | |
License Owner | DKSH LAOS COMPANY LIMITED |
Manufacturer | FRESENIUS KABI VIETNAM JOINT STOCK COMPANY |
Country | VIETNAM |
Import Registration No | VD-29316-18 |
Import Registration Date | 2018-02-22 |
Activity | CERTIFICATE RELEASED |
Applied Date | 2021-12-03 |
FDD Registration No | 04 I 5467/23 |
FDD Registration Date | 2023-04-11 |
Expiry Date | 2026-04-10 |
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