Country: Canada
Language: English
Source: Health Canada
PEGINTERFERON BETA-1A; PEGINTERFERON BETA-1A
BIOGEN CANADA INC
L03AB13
PEGINTERFERON BETA-1A
63MCG; 94MCG
KIT
PEGINTERFERON BETA-1A 63MCG; PEGINTERFERON BETA-1A 94MCG
SUBCUTANEOUS
0.5ML SYRINGE OR PEN AND 0.5 ML SYRINGE OR PEN
Prescription
INTERFERONS
Active ingredient group (AIG) number: 0257231001; AHFS:
APPROVED
2015-08-10
_PLEGRIDY_ _TM_ _ (peginterferon beta-1a) _ _Page 1 of 47 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PLEGRIDY TM peginterferon beta-1a Liquid for injection Immunomodulator Biogen Canada Inc. 3250 Bloor Street West, East Tower, Suite 1200 Toronto, ON M8X 2X9 Date of Initial Authorization: August 10, 2015 Date of Revision: June 26, 2023 Submission Control Number: 271667 © Biogen [2015]. All rights reserved. _ _ _ _ _PLEGRIDY_ _TM_ _ (peginterferon beta-1a) _ _Page 2 of 47_ RECENT MAJOR LABEL CHANGES 7.1.1 Pregnant Women 05/2020 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 Recommended Dose and Dosage Adjustment..................................................... 5 4.4 Administration................................................................................................... 6 4.5 Missed Dose .............................................................. Read the complete document