EYLEA SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

AFLIBERCEPT

Disponibil de la:

BAYER INC

Codul ATC:

S01LA05

INN (nume internaţional):

AFLIBERCEPT

Dozare:

2MG

Forma farmaceutică:

SOLUTION

Compoziție:

AFLIBERCEPT 2MG

Calea de administrare:

INTRAVITREAL

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

EENT DRUGS, MISCELLANEOUS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2020-09-25

Caracteristicilor produsului

_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