ILEVRO SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NEPAFENAC

Available from:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC code:

S01BC10

INN (International Name):

NEPAFENAC

Dosage:

0.3%

Pharmaceutical form:

SUSPENSION

Composition:

NEPAFENAC 0.3%

Administration route:

OPHTHALMIC

Units in package:

3ML

Prescription type:

Prescription

Therapeutic area:

NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0152459002; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-02-10

Summary of Product characteristics

_ _
_ILEVRO Product Monograph _
_Page 1 of 33 _
_ _
PRODUCT MONOGRAPH
Pr
ILEVRO
®
(Nepafenac) Ophthalmic Suspension
0.3% w/v
Nonsteroidal Anti-Inflammatory
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
www.novartis.ca
Submission Control No.: 206913
Date of Revision:
April 13, 2018
_ _
_ILEVRO Product Monograph _
_Page 2 of 33 _
_ _
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
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
.............