AG-MOXIFLOXACIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Available from:

ANGITA PHARMA INC.

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:

2018-06-28

Summary of Product characteristics

_AG-_
_MOXIFLOXACIN _
_Page 1 of 70 _
PRODUCT MONOGRAPH
PR
AG
-
MOXIFLOXACIN
Moxifloxacin Tablets
400 mg
(as moxifloxacin hydrochloride)
Antibacterial Agent
Date
of
Revision:
August 03, 2022
Manufactured
by:
Angita
Pharma
Inc.
1310 rue Nobel
Boucherville,Québec
J4B
5H3
Canada
SUBMISSION
CONTROL
NO:
265857
_AG-_
_MOXIFLOXACIN _
_Page 2 of 70 _
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
.........................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 31
PART II: SCIENTIFIC INFORMATION
.................................................................................
32
PHARMACEUTICAL
INFORMATION
............................................................................
32
CLINICAL TRIALS
...