Land: Kanada
Sprache: Englisch
Quelle: Health Canada
LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE)
JAMP PHARMA CORPORATION
J01MA12
LEVOFLOXACIN
500MG
TABLET
LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) 500MG
ORAL
100
Prescription
QUINOLONES
Active ingredient group (AIG) number: 0131663004; AHFS:
APPROVED
2020-11-24
_JAMP Levofloxacin_ _Page 1 of 68_ PRODUCT MONOGRAPH PR JAMP LEVOFLOXACIN Levofloxacin Tablets, USP 250 mg, 500 mg and 750 mg Levofloxacin as Levofloxacin Hemihydrate Antibacterial Agent JAMP Pharma Corporation Date of Approval: November 23, 2020 1310, rue Nobel Boucherville, Québec J4B 5H3 Submission Control No: 232133 _JAMP Levofloxacin_ _Page 2 of 68_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .................................................................3 SUMMARY PRODUCT INFORMATION ..................................................................................3 INDICATIONS AND CLINICAL USE ........................................................................................3 CONTRAINDICATIONS ..........................................................................................................5 WARNINGS AND PRECAUTIONS ..........................................................................................5 ADVERSE REACTIONS ........................................................................................................ 12 DRUG INTERACTIONS ........................................................................................................ 16 DOSAGE AND ADMINISTRATION ........................................................................................ 18 OVERDOSAGE ..................................................................................................................... 20 ACTION AND CLINICAL PHARMACOLOGY ......................................................................... 21 STORAGE AND STABILITY .................................................................................................. 25 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................................ 25 PART II: SCIENTIFIC INFORMATION...................................................................................... 27 PHARMACEUTICAL INFORMATION .................................................................................... 27 CLINICAL TRIALS ... Lesen Sie das vollständige Dokument