EYLEA SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

AFLIBERCEPT

Tersedia dari:

BAYER INC

Kode ATC:

S01LA05

INN (Nama Internasional):

AFLIBERCEPT

Dosis:

2MG

Bentuk farmasi:

SOLUTION

Komposisi:

AFLIBERCEPT 2MG

Rute administrasi :

INTRAVITREAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

EENT DRUGS, MISCELLANEOUS

Ringkasan produk:

Active ingredient group (AIG) number: 0154950001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2020-09-25

Karakteristik produk

_EYLEA Aflibercept Injection _
_Page 1 of 70_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
EYLEA
®
Aflibercept injection
Single Use Pre-filled Syringes and Single Use Vials for the Treatment
of a Single Eye
2 mg / 0.05 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:
NOV 08, 2013
Date of Revision:
JUN 29, 2023
Submission Control Number: 266439
© 2023, Bayer Inc.
®
TM see www.bayer.ca/tm-mc
_EYLEA Aflibercept Injection _
_Page 2 of 70_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
06/2023
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
11/2022
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
.......................................................................................................................
4
1.2 Geriatrics
.......................................................................................................................
4
2 CONTRAINDICATIONS ......................................................................................................
4
4 DOSAGE AND ADMINISTRATION ......................................................................................
4
4.1 Dosing Considerations
....................................................................................................
4
4.2