MOXIFLOXACIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
19-02-2021
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Active ingredient:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
Available from:
PRO DOC LIMITEE
ATC code:
J01MA14
INN (International Name):
MOXIFLOXACIN
Dosage:
400MG
Pharmaceutical form:
TABLET
Composition:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
QUINOLONES
Product summary:
Active ingredient group (AIG) number: 0142242001; AHFS:
Authorization status:
APPROVED
Authorization date:
2017-04-12
Summary of Product characteristics
Page 1 of 67
PRODUCT MONOGRAPH
PR
MOXIFLOXACIN
Moxifloxacin Tablets
400 mg Moxifloxacin (as moxifloxacin hydrochloride)
House Standard
Antibacterial Agent
PRO DOC LTÉE
2925 boul. Industriel
Laval, Québec
H7L 3W9
Date of Revision:
February 19, 2021.
SUBMISSION CONTROL NO:
248826
Page 2 of 67
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
6
ADVERSE REACTIONS
.................................................................................................
14
DRUG INTERACTIONS
.................................................................................................
18
DOSAGE AND ADMINISTRATION
.............................................................................
20
OVERDOSAGE
...............................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 22
STORAGE AND STABILITY
.........................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
......................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 30
PART II: SCIENTIFIC INFORMATION
...............................................................................
31
PHARMACEUTICAL INFORMATION
.........................................................................
31
CLINICAL TRIALS
........................................................................................
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