ZINECARD POWDER FOR SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

DEXRAZOXANE

から入手可能:

PFIZER CANADA ULC

ATCコード:

V03AF02

INN（国際名）:

DEXRAZOXANE

投薬量:

500MG

医薬品形態:

POWDER FOR SOLUTION

構図:

DEXRAZOXANE 500MG

投与経路:

INTRAVENOUS

パッケージ内のユニット:

500MG/50ML VIAL

処方タイプ:

Prescription

治療領域:

MISCELLANEOUS THERAPEUTIC AGENTS

製品概要:

Active ingredient group (AIG) number: 0152586002; AHFS:

認証ステータス:

APPROVED

承認日:

2003-10-07

製品の特徴

_Product Monograph _
_ _
_ZINECARD (dexrazoxane for injection) _
_Page 1 of 23_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ZINECARD®
Dexrazoxane for injection
Sterile lyophilized Powder for Solution, 250 mg / vial & 500 mg /
vial, Intravenous Infusion
Cardioprotective Agent
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Initial Authorization:
OCT 08, 2003
Date of Revision:
APR 11, 2023
Submission Control Number: 267046
® Pharmacia Inc.
Pfizer Canada ULC, Licensee
©
Pfizer Canada ULC 2023
_ _
_Product Monograph _
_ _
_ZINECARD (dexrazoxane for injection) _
_Page 2 of 23_
RECENT MAJOR LABEL CHANGES
Not applicable
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
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...........