País: Canadá
Língua: inglês
Origem: Health Canada
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
TEVA CANADA LIMITED
J01MA14
MOXIFLOXACIN
400MG
TABLET
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
ORAL
30/100
Prescription
QUINOLONES
Active ingredient group (AIG) number: 0142242001; AHFS:
APPROVED
2015-11-04
1 PRODUCT MONOGRAPH PR TEVA-MOXIFLOXACIN Moxifloxacin tablets 400 mg moxifloxacin (as moxifloxacin hydrochloride) Antibacterial Agent Teva Canada Limited Date of Revision: 30 Novopharm Court Dec 02, 2020 Toronto, Ontario M1B 2K9 Submission Control No: 241009 2 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 ......................................................................................................... 14 DRUG INTERACTIONS ......................................................................................................... 18 DOSAGE AND ADMINISTRATION ..................................................................................... 20 OVERDOSAGE ....................................................................................................................... 22 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 23 STORAGE AND STABILITY ................................................................................................. 29 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 29 PART II: SCIENTIFIC INFORMATION ............................................................................... 31 PHARMACEUTICAL INFORMATION ................................................................................. 31 CLINICAL TRIALS ................................................................................................................. 32 DETAILED PHA Leia o documento completo