BENLYSTA POWDER FOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

BELIMUMAB

Sẵn có từ:

GLAXOSMITHKLINE INC

Mã ATC:

L04AG04

INN (Tên quốc tế):

BELIMUMAB

Liều dùng:

400MG

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

BELIMUMAB 400MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

20ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

IMMUNOSUPPRESSIVE AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0152941001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2011-07-06

Đặc tính sản phẩm

_ _
_ _
_BENLYSTA, Belimumab _
_Page 1 of 66_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
BENLYSTA
Belimumab for injection
120 mg in 5 mL vial lyophilized powder for intravenous infusion
400 mg in 20 mL vial lyophilized powder for intravenous infusion
Belimumab injection
200 mg in 1 mL for subcutaneous injection
Selective Immunosuppressant
GlaxoSmithKline Inc.
100 Milverton Drive
Suite 800
Mississauga, Ontario
L5R 4H1
Date of Initial Authorization:
July 06, 2011
Date of Revision:
March 6, 2024
Submission Control Number: 279901
_©_
_2024 GSK group of companies or its licensor _
_Trademarks are owned by or licensed to the GSK group of companies _
_ _
_ _
_BENLYSTA, Belimumab _
_Page 2 of 66_
RECENT MAJOR LABEL CHANGES
SECTION
DATE
7 WARNINGS AND PRECAUTIONS
10/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
05/2023
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
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics
...................................................................................
4
1.2
Geriatrics
...................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................. 4
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
Dosing Considerations
............................................................... 5
4.2
Recommended Dose and Dosage Adjustment .......................... 5