OXALIPLATIN SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

OXALIPLATIN

Disponible des:

PFIZER CANADA ULC

Codi ATC:

L01XA03

Designació comuna internacional (DCI):

OXALIPLATIN

Dosis:

5MG

formulario farmacéutico:

SOLUTION

Composición:

OXALIPLATIN 5MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

10/20/40ML

tipo de receta:

Prescription

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0152220003; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2017-06-01

Fitxa tècnica

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_Oxaliplatin – Product Monograph_
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_Page 1 of 64_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
OXALIPLATIN
Oxaliplatin Injection, 5 mg/mL
Sterile concentrate 50 mg / 10 mL, 100 mg / 20 mL, 200 mg / 40 mL for
intravenous infusion
Antineoplastic Agent
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Initial Authorization:
DEC 16, 2015
Date of Revision:
MAY 10, 2023
Submission Control Number: 270750
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_Oxaliplatin – Product Monograph_
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_Page 2 of 64_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female
and Male Potential
05/2023
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding
05/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
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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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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Ad