APO-OFLOXACIN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OFLOXACIN

Available from:

APOTEX INC

ATC code:

S01AE01

INN (International Name):

OFLOXACIN

Dosage:

0.3%

Pharmaceutical form:

SOLUTION

Composition:

OFLOXACIN 0.3%

Administration route:

OPHTHALMIC

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

ANTIBACTERIALS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2003-11-14

Summary of Product characteristics

Page 1 of 29
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-OFLOXACIN
OFLOXACIN OPHTHALMIC SOLUTION USP
0.3% W/V
ANTIBACTERIAL AGENT
APOTEX INC
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
DATE OF REVISION:
FEBRUARY 6, 2020
CONTROL NO: 233435
Page 2 of 29
RECENT MAJOR LABEL CHANGES
WARNINGS AND PRECAUTIONS, General, February 2020
WARNINGS AND PRECAUTIONS, Hypersensitivity, February 2020
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 3
1
INDICATIONS
..................................................................................................................
3
1.1
Pediatrics
..............................................................................................................
3
1.2
Geriatrics
..............................................................................................................
3
2
CONTRAINDICATIONS
...................................................................................................
3
4 DOSAGE AND ADMINISTRATION
.................................................................................
3
4.1 Recommended Dose and Dosage Adjustment
........................................................... 3
4.2 Dosing Considerations
...............................................................................................
4
4.3 Administration
............................................................................................................
4
4.4 Missed Dose
..............................................................................................................
4
5 OVERDOSAGE
...............................................................................................................
4
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
.......................... 4
7 WARNINGS AND PRECAUTIONS
..................................................................................
5
7.1 Special Populations
................................................................