TEVA-MOXIFLOXACIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
02-12-2020
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Active ingredient:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
Available from:
TEVA CANADA LIMITED
ATC code:
J01MA14
INN (International Name):
MOXIFLOXACIN
Dosage:
400MG
Pharmaceutical form:
TABLET
Composition:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
QUINOLONES
Product summary:
Active ingredient group (AIG) number: 0142242001; AHFS:
Authorization status:
APPROVED
Authorization date:
2015-11-04
Summary of Product characteristics
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
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