DOCETAXEL INJECTION SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

DOCETAXEL

Sẵn có từ:

SANDOZ CANADA INCORPORATED

Mã ATC:

L01CD02

INN (Tên quốc tế):

DOCETAXEL

Liều dùng:

10MG

Dạng dược phẩm:

SOLUTION

Thành phần:

DOCETAXEL 10MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

2/8/16ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANTINEOPLASTIC AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0127884002; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2015-03-30

Đặc tính sản phẩm

_ _
_DOCETAXEL INJECTION _
_Page 1 of 74_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr DOCETAXEL INJECTION
Docetaxel
Sterile Solution, 10 mg/ mL, for Intravenous Infusion
Must be diluted directly in infusion solution
Manufacturer’s Standard
Antineoplastic Agent
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC
J4B 1E6
Date of Initial Authorization:
March 31, 2015
Date of Revision:
December 11, 2023
Submission Control Number: 278247
_ _
_DOCETAXEL INJECTION _
_Page 2 of 74_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential
12/2023
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding
12/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics
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5
1.2
Geriatrics
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5
2
CONTRAINDICATIONS
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5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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7
4.1
Dosing Considerations
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7
4.2
Recommended Dose and Dosage Adjustment
....