DOCETAXEL INJECTION USP SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

DOCETAXEL

Mevcut itibaren:

PFIZER CANADA ULC

ATC kodu:

L01CD02

INN (International Adı):

DOCETAXEL

Doz:

10MG

Farmasötik formu:

SOLUTION

Kompozisyon:

DOCETAXEL 10MG

Uygulama yolu:

INTRAVENOUS

Paketteki üniteler:

2/8/16ML

Reçete türü:

Prescription

Terapötik alanı:

ANTINEOPLASTIC AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2016-08-08

Ürün özellikleri

_Pr_
_Docetaxel Injection USP – Product Monograph _
_Page 1 of 74_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DOCETAXEL INJECTION USP
Docetaxel
Sterile Solution, 10 mg/mL, for Intravenous Infusion
Must be diluted directly in infusion solution
Antineoplastic Agent
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Initial Authorization:
MAR 01, 2011
Date of Revision:
JUN 20, 2023
Submission Control Number: 272292
_ _
_Pr_
_Docetaxel Injection USP – Product Monograph _
_Page 2 of 74_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential
06/2023
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding
06/2023
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
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4
1
INDICATIONS
..............................................................................................................
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
............................................................ 6
4
DOSAGE AND ADMINISTRATION
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6
4.1
Dosing Considerations
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6
4.2
Recommended Dos