APO-GATIFLOXACIN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

GATIFLOXACIN (GATIFLOXACIN HEMIHYDRATE)

Available from:

APOTEX INC

ATC code:

S01AE06

INN (International Name):

GATIFLOXACIN

Dosage:

0.3%

Pharmaceutical form:

SOLUTION

Composition:

GATIFLOXACIN (GATIFLOXACIN HEMIHYDRATE) 0.3%

Administration route:

OPHTHALMIC

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

ANTIBACTERIALS

Product summary:

Active ingredient group (AIG) number: 0142621005; AHFS:

Authorization status:

APPROVED

Authorization date:

2016-03-23

Summary of Product characteristics

_APO-GATIFLOXACIN (Gatifloxacin Ophthalmic Solution) _
_ _
_Page 1 of 41_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-GATIFLOXACIN
Gatifloxacin Ophthalmic Solution
Solution, 0.3% gatifloxacin (as hemihydrate), for ophthalmic use
Antibacterial Agent (ATC Code: S01AE06)
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
MAR 23, 2016
Date of Revision:
AUG 04, 2023
Submission Control Number: 272580.
_APO-GATIFLOXACIN (Gatifloxacin Ophthalmic Solution) _
_ _
_Page 2 of 41_
RECENT MAJOR LABEL CHANGES
None at the time of the most recent authorization.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
.....................................................................................................................
4
1.2
Geriatrics
.....................................................................................................................
4
2
CONTRAINDICATIONS
....................................................................................................
4
4
DOSAGE AND ADMINISTRATION
....................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................... 5
4.4
Administration
............................................................................................................
5
4.5
Missed Dose
.................................................................................