ZINECARD POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DEXRAZOXANE

Tersedia dari:

PFIZER CANADA ULC

Kode ATC:

V03AF02

INN (Nama Internasional):

DEXRAZOXANE

Dosis:

500MG

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

DEXRAZOXANE 500MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

500MG/50ML VIAL

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS THERAPEUTIC AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2003-10-07

Karakteristik produk

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