PLEGRIDY LIQUID

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

PEGINTERFERON BETA-1A

Sẵn có từ:

BIOGEN CANADA INC

Mã ATC:

L03AB13

INN (Tên quốc tế):

PEGINTERFERON BETA-1A

Liều dùng:

63MCG

Dạng dược phẩm:

LIQUID

Thành phần:

PEGINTERFERON BETA-1A 63MCG

Tuyến hành chính:

SUBCUTANEOUS

Các đơn vị trong gói:

0.5ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

INTERFERONS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0157230001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2015-08-10

Đặc tính sản phẩm

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