Ország: Kanada
Nyelv: angol
Forrás: Health Canada
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
GENERIC MEDICAL PARTNERS INC
J01MA14
MOXIFLOXACIN
400MG
TABLET
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
ORAL
30
Prescription
QUINOLONES
Active ingredient group (AIG) number: 0142242001; AHFS:
APPROVED
2016-12-12
_Page 1 of 72_ PRODUCT MONOGRAPH PR MED-MOXIFLOXACIN Moxifloxacin tablets 400 mg (as moxifloxacin hydrochloride) Manufacturer’s Standard Antibacterial Agent Generic Medical Partners Inc. 1500 Don Mills Road, Suite 711 Toronto, Ontario M3B 3K4 Date of Revision: March 23, 2022 Submission Control No: 255995 _Page 2 of 72_ 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 ...................................................................................................15 DRUG INTERACTIONS ....................................................................................................19 DOSAGE AND ADMINISTRATION .................................................................................22 OVERDOSAGE .................................................................................................................24 ACTION AND CLINICAL PHARMACOLOGY ................................................................24 STORAGE AND STABILITY ............................................................................................31 SPECIAL HANDLING INSTRUCTIONS...........................................................................31 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................31 PART II : SCIENTIFIC INFORMATION ........................................................................ 33 PHARMACEUTICAL INFORMATION .............................................................................33 CLINICAL TRIALS .................................... Olvassa el a teljes dokumentumot