OXALIPLATIN INJECTION, USP SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

OXALIPLATIN

Dostopno od:

FRESENIUS KABI CANADA LTD

Koda artikla:

L01XA03

INN (mednarodno ime):

OXALIPLATIN

Odmerek:

5MG

Farmacevtska oblika:

SOLUTION

Sestava:

OXALIPLATIN 5MG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

10/20/40ML

Tip zastaranja:

Prescription

Terapevtsko območje:

ANTINEOPLASTIC AGENTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2016-09-02

Lastnosti izdelka

_OXALIPLATIN INJECTION, USP (oxaliplatin injection) _
_Page 1 of 69 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
OXALIPLATIN INJECTION, USP
Oxaliplatin injection
Sterile concentrate, 5 mg/mL (50 mg/10 mL, 100 mg/20 mL, and 200 mg/40
mL), Intravenous Infusion
USP
Antineoplastic Agent
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Initial Authorization:
SEP 02, 2016
Date of Revision:
NOV 21, 2023
Submission Control No: 277422
_OXALIPLATIN INJECTION, USP (oxaliplatin injection) _
_Page 2 of 69 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male
Potential
11/2023
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding
11/2023
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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5
1
INDICATIONS
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5
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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6
4.1
Dosing Considerations
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6