EYLEA HD SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AFLIBERCEPT

Available from:

BAYER INC

ATC code:

S01LA05

INN (International Name):

AFLIBERCEPT

Dosage:

8MG

Pharmaceutical form:

SOLUTION

Composition:

AFLIBERCEPT 8MG

Administration route:

INTRAVITREAL

Units in package:

100

Prescription type:

Schedule D

Product summary:

Active ingredient group (AIG) number: 0154950003; AHFS:

Authorization status:

APPROVED

Authorization date:

2024-02-02

Summary of Product characteristics

_EYLEA HD Aflibercept Injection _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
EYLEA
®
HD
Aflibercept injection
Single Use Vials for the Treatment of a Single Eye
8 mg / 0.07 mL Solution for Intravitreal Injection
Ophthalmological / Antineovascularization agent
ATC Code: S01LA05
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
http://www.bayer.ca
Date of Initial Authorization:
November 08, 2013
Date of Revision:
February 02, 2024
Submission Control Number: 272746
© 2024, Bayer Inc.
®
TM see www.bayer.ca/tm-mc
_EYLEA HD Aflibercept Injection _
_Page 2 of 32_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................................
4
1
INDICATIONS......................................................................................................................
4
1.1 Pediatrics
....................................................................................................................
4
1.2 Geriatrics
....................................................................................................................
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
....................................