ZINECARD POWDER FOR SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

DEXRAZOXANE

Verfügbar ab:

PFIZER CANADA ULC

ATC-Code:

V03AF02

INN (Internationale Bezeichnung):

DEXRAZOXANE

Dosierung:

500MG

Darreichungsform:

POWDER FOR SOLUTION

Zusammensetzung:

DEXRAZOXANE 500MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

500MG/50ML VIAL

Verschreibungstyp:

Prescription

Therapiebereich:

MISCELLANEOUS THERAPEUTIC AGENTS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2003-10-07

Fachinformation

_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
...........