MVASI SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

BEVACIZUMAB

Sẵn có từ:

AMGEN CANADA INC

Mã ATC:

L01FG01

INN (Tên quốc tế):

BEVACIZUMAB

Liều dùng:

25MG

Dạng dược phẩm:

SOLUTION

Thành phần:

BEVACIZUMAB 25MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANTINEOPLASTIC AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0151381001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2018-04-30

Đặc tính sản phẩm

MVASI (bevacizumab) Product Monograph
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_Page 1 of 98_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MVASI
®
bevacizumab for injection
100 mg and 400 mg vials (25 mg/mL solution for injection)
In-house Standard
Anti-neoplastic
Amgen Canada Inc.
6775 Financial Drive, Suite 300
Mississauga, ON L5N 0A4
Date of Initial Approval:
April 30, 2018
Date of Revision:
March 28, 2023
Submission Control No: 269155
©
2018-2022 Amgen Canada Inc., All Rights Reserved.
MVASI (bevacizumab) Product Monograph
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_Page 2 of 98_
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 4
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
.................................................................................................................
5
2
CONTRAINDICATIONS
....................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
......................................................... 5
4
DOSAGE AND ADMINISTRATION
..................................................................................
6
4.1
Dosing Considerations
.............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
........................................................ 7
4.3
Administration
..........................................................................................................
7
5
OVERDOSAGE
.................................................................................................................
8
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
.......................... 8
7
DESCRIPTION
..................................................................................................................
8
8
WARNINGS AND PRECAUTIONS
.................