OXALIPLATIN INJECTION, USP SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

OXALIPLATIN

Disponible des:

DR REDDY'S LABORATORIES LTD

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:

2016-10-17

Fitxa tècnica

_Oxaliplatin Injection, USP – Product Monograph _
_Page 1 of 57 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
OXALIPLATIN INJECTION, USP
Oxaliplatin Injection
Sterile Solution, 5 mg / mL, for Intravenous Infusion
(Available as 50 mg / 10 mL, 100 mg / 20 mL, 200 mg / 40 mL)
CONCENTRATE - MUST BE DILUTED BEFORE ADMINISTRATION
USP
Antineoplastic Agent
Manufactured by:
Dr. Reddy’s Laboratories Ltd.,
Bachupally– 500 090
India
Imported and Distributed by:
DR. REDDY’S LABORATORIES CANADA INC.,
Mississauga, ON L4W 4Y1
Canada
Date of Initial Authorization:
October 17, 2016
Date of Revision:
December 21 ,2023
Submission Control Number: 277339
_Oxaliplatin Injection, USP – Product Monograph _
_Page 2 of 57 _
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
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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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