국가: 캐나다
언어: 영어
출처: Health Canada
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
BAYER INC
J01MA14
MOXIFLOXACIN
400MG
SOLUTION
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
INTRAVENOUS
250 ML
Prescription
QUINOLONES
Active ingredient group (AIG) number: 0142242002; AHFS:
CANCELLED POST MARKET
2020-06-29
_ _ _AVELOX Product Monograph Page 1 of 73 _ PRODUCT MONOGRAPH PR AVELOX Moxifloxacin tablets 400 mg (as moxifloxacin hydrochloride) PR AVELOX I.V. Moxifloxacin injection 400 mg/250 mL (1.6 mg/mL) (as moxifloxacin hydrochloride) Antibacterial Agent Manufactured by: Bayer Inc. 2920 Matheson Boulevard East Mississauga, Ontario L4W 5R6 www.bayer.ca Date of Revision: February 18, 2020 Submission Control No: 233350 2020, Bayer Inc. ® TM see www.bayer.ca/tm-mc _ _ _AVELOX Product Monograph Page 2 of 73 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................6 WARNINGS AND PRECAUTIONS ..................................................................................6 ADVERSE REACTIONS ..................................................................................................14 DRUG INTERACTIONS ..................................................................................................19 DOSAGE AND ADMINISTRATION ..............................................................................21 OVERDOSAGE ................................................................................................................24 ACTION AND CLINICAL PHARMACOLOGY ............................................................24 STORAGE AND STABILITY ..........................................................................................32 SPECIAL HANDLING INSTRUCTIONS .......................................................................32 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................33 PART II : SCIENTIFIC INFORMATION ................................................................... 전체 문서 읽기