FLAREX SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLUOROMETHOLONE ACETATE

Available from:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC code:

S01BA07

INN (International Name):

FLUOROMETHOLONE

Dosage:

0.1%

Pharmaceutical form:

SUSPENSION

Composition:

FLUOROMETHOLONE ACETATE 0.1%

Administration route:

OPHTHALMIC

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

CORTICOSTEROIDS

Product summary:

Active ingredient group (AIG) number: 0119742001; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-03-17

Summary of Product characteristics

_ _
_FLAREX_
_®_
_ Product Monograph _
_Page 1 of 14_
PRODUCT MONOGRAPH
Pr
FLAREX
®
Fluorometholone Acetate Ophthalmic Suspension
0.1% w/v
Corticosteroid
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
www.novartis.ca
Date of Preparation:
June 2, 1987
Date of Revision:
August 2, 2018
Submission Control No: 215934
FLAREX and DROP-TAINER are registered trademarks.
_ _
_FLAREX_
_®_
_ Product Monograph _
_Page 2 of 14_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................6
DOSAGE AND ADMINISTRATION
................................................................................6
OVERDOSAGE
..................................................................................................................6
ACTION AND CLINICAL PHARMACOLOGY
..............................................................6
STORAGE AND STABILITY
............................................................................................7
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................7
PART II: SCIENTIFIC INFORMATION
.................................................................................8
PHARMACEUTICAL INFORMATION
............................................................................8
CLINICAL TRIALS
..........................