DOCETAXEL INJECTION SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

DOCETAXEL

Доступна з:

SANDOZ CANADA INCORPORATED

Код атс:

L01CD02

ІПН (Міжнародна Ім'я):

DOCETAXEL

Дозування:

10MG

Фармацевтична форма:

SOLUTION

Склад:

DOCETAXEL 10MG

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

2/8/16ML

Тип рецепту:

Prescription

Терапевтична области:

ANTINEOPLASTIC AGENTS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2015-03-30

Характеристики продукта

_ _
_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
.............................................................................................
2
TABLE OF CONTENTS
................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics
.................................................................................................................
5
1.2
Geriatrics
.................................................................................................................
5
2
CONTRAINDICATIONS
...................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.............................................................. 6
4
DOSAGE AND ADMINISTRATION
..................................................................................
7
4.1
Dosing Considerations
.............................................................................................
7
4.2
Recommended Dose and Dosage Adjustment
....