DOCETAXEL INJECTION SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

DOCETAXEL

Disponible des:

SANDOZ CANADA INCORPORATED

Codi ATC:

L01CD02

Designació comuna internacional (DCI):

DOCETAXEL

Dosis:

10MG

formulario farmacéutico:

SOLUTION

Composición:

DOCETAXEL 10MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

2/8/16ML

tipo de receta:

Prescription

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2015-03-30

Fitxa tècnica

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_DOCETAXEL INJECTION _
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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
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_DOCETAXEL INJECTION _
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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
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4
1
INDICATIONS
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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
....