TARO-DOCETAXEL SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

DOCETAXEL

Sẵn có từ:

TARO PHARMACEUTICALS INC

Mã ATC:

L01CD02

INN (Tên quốc tế):

DOCETAXEL

Liều dùng:

20MG

Dạng dược phẩm:

SOLUTION

Thành phần:

DOCETAXEL 20MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

5ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANTINEOPLASTIC AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0127884004; AHFS:

Tình trạng ủy quyền:

CANCELLED PRE MARKET

Ngày ủy quyền:

2022-07-11

Đặc tính sản phẩm

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_Taro-Docetaxel - Product Monograph _
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_Page 1 of 57 _
PRODUCT MONOGRAPH
PR
TARO-DOCETAXEL
(Docetaxel for Injection)
Single Vial Formulation
CONCENTRATED SOLUTION
20 MG / ML
80 MG / 4 ML
160 MG / 8 ML
USP Standard
FOR INTRAVENOUS INFUSION, MUST BE DILUTED BEFORE USE
ANTINEOPLASTIC AGENT
Taro Pharmaceuticals Inc.
Date of Revision:
130 East Drive, Brampton August 10, 2021
Ontario L6T 1C1
Submission Control No: 253784
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_Taro-Docetaxel - Product Monograph _
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_Page 2 of 57 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
..................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................27
DOSAGE AND ADMINISTRATION
..............................................................................28
OVERDOSAGE
................................................................................................................31
ACTION AND CLINICAL PHARMACOLOGY
............................................................32
STORAGE AND STABILITY
..........................................................................................33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................34
PART II: SCIENTIFIC INFORMATION
....................................................................35
PHARMACEUTICAL INFORMATION
..........................................................................35
CLINICAL TRIALS
.............................................................