País: Canadà
Idioma: anglès
Font: Health Canada
AFLIBERCEPT
BAYER INC
S01LA05
AFLIBERCEPT
2MG
SOLUTION
AFLIBERCEPT 2MG
INTRAVITREAL
15G/50G
Prescription
EENT DRUGS, MISCELLANEOUS
Active ingredient group (AIG) number: 0154950001; AHFS:
APPROVED
2020-09-25
_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 Llegiu el document complet