MOXIFLOXACIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
21-09-2021
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
Available from:
SANIS HEALTH INC
ATC code:
J01MA14
INN (International Name):
MOXIFLOXACIN
Dosage:
400MG
Pharmaceutical form:
TABLET
Composition:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
QUINOLONES
Product summary:
Active ingredient group (AIG) number: 0142242001; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-09-23
Summary of Product characteristics
Page 1 of 66
PRODUCT MONOGRAPH
PR
MOXIFLOXACIN
Moxifloxacin Tablets
400 mg Moxifloxacin
(as moxifloxacin
hydrochloride)
House Standard
Antibacterial Agent
SANIS HEALTH INC.
1 President’s Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision:
September 21, 2021
SUBMISSION CONTROL NO:
249928
Page 2 of 66
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
.........................................................................................................21
ACTION AND CLINICAL
PHARMACOLOGY.........................................................22
STORAGE AND STABILITY
....................................................................................29
SPECIAL HANDLING INSTRUCTIONS
...................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........................................29
PART II: SCIENTIFIC INFORMATION
..........................................................................
30
PHARMACEUTICAL INFORMATION
.....................................................................30
CLINICAL TRIALS
...................................................................................................31
DETAILED
PHARMACOLOGY..........................
Read the complete document
