PLEGRIDY KIT

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PEGINTERFERON BETA-1A; PEGINTERFERON BETA-1A

Tersedia dari:

BIOGEN CANADA INC

Kode ATC:

L03AB13

INN (Nama Internasional):

PEGINTERFERON BETA-1A

Dosis:

63MCG; 94MCG

Bentuk farmasi:

KIT

Komposisi:

PEGINTERFERON BETA-1A 63MCG; PEGINTERFERON BETA-1A 94MCG

Rute administrasi :

SUBCUTANEOUS

Unit dalam paket:

0.5ML SYRINGE OR PEN AND 0.5 ML SYRINGE OR PEN

Jenis Resep:

Prescription

Area terapi:

INTERFERONS

Ringkasan produk:

Active ingredient group (AIG) number: 0257231001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2015-08-10

Karakteristik produk

_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
..............................................................