APO-DICLOFENAC OPHTHALMIC SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DICLOFENAC SODIUM

Available from:

APOTEX INC

ATC code:

S01BC03

INN (International Name):

DICLOFENAC

Dosage:

0.1%

Pharmaceutical form:

SOLUTION

Composition:

DICLOFENAC SODIUM 0.1%

Administration route:

OPHTHALMIC

Units in package:

2.5/5/10ML FILL

Prescription type:

Prescription

Therapeutic area:

NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0114417004; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-05-12

Summary of Product characteristics

_APO-DICLOFENAC OPHTHALMIC (Diclofenac Sodium Ophthalmic Solution)_
_Page 1 of 28_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-DICLOFENAC OPHTHALMIC
Diclofenac Sodium Ophthalmic Solution
Ophthalmic solution, 0.1% w/v for Topical use
Anti-inflammatory agents, non-steroids
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
MAY 12, 2015
Date of Revision:
SEP 18, 2023
Submission Control Number: 275184
_APO-DICLOFENAC OPHTHALMIC (Diclofenac Sodium Ophthalmic Solution)_
_Page 2 of 28_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male
Potential
09/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
09/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS ...........................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS ...........................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.2
Recommended Dose and Dosage Adjustment
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4.4
Administration
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5
4.5
Missed Dose
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