OCUFLOX SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OFLOXACIN

Available from:

ABBVIE CORPORATION

ATC code:

S01AE01

INN (International Name):

OFLOXACIN

Dosage:

0.3%

Pharmaceutical form:

SOLUTION

Composition:

OFLOXACIN 0.3%

Administration route:

OPHTHALMIC

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTIBACTERIALS

Product summary:

Active ingredient group (AIG) number: 0122759007; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-08-16

Summary of Product characteristics

_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
OCUFLOX®
Ofloxacin ophthalmic solution
Solution, 0.3% w/v, for ophthalmic use
USP
Antibacterial Agent (ATC code: S01AE01)
Submission Control Number: 266079
Date of Initial Authorization:
NOV
25,
1994
Date of Revision:
AUG 15, 2022
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, Quebec
H4S 1Z1
_OCUFLOX_
_(ofloxacin) Page 1 of 20_
_ _ 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
................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
.........................................................................................................
5
4.5
Missed Dose
.....................................................................................................