FML SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLUOROMETHOLONE

Available from:

ABBVIE CORPORATION

ATC code:

S01BA07

INN (International Name):

FLUOROMETHOLONE

Dosage:

0.1%

Pharmaceutical form:

SUSPENSION

Composition:

FLUOROMETHOLONE 0.1%

Administration route:

OPHTHALMIC

Units in package:

5/10ML

Prescription type:

Prescription

Therapeutic area:

CORTICOSTEROIDS

Product summary:

Active ingredient group (AIG) number: 0106315001; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-08-29

Summary of Product characteristics

_FML (fluorometholone) _
_Page 1 of 18 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
FML®
fluorometholone ophthalmic suspension
Suspension, 0.1% w/v, for ophthalmic use
Manufacturer’s Standard
Corticosteroid Anti-Inflammatory
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, QC H4S 1Z1
Date of Initial Authorization:
OCT 30, 1972
Date of Revision:
DEC 7, 2023
Submission Control Number: 277095
FML (Fluorometholone)
_Page 2 of 18_
RECENT MAJOR LABEL CHANGES
Not available.
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 (<18 years of age)
...................................................................................
4
1.2
Geriatrics (>65 years of age)
...................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 4
4.4
Administration
........................................................................................................
5
4.5
Missed Dose
........................................................................................................