ZINECARD POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DEXRAZOXANE

Διαθέσιμο από:

PFIZER CANADA ULC

Φαρμακολογική κατηγορία (ATC):

V03AF02

INN (Διεθνής Όνομα):

DEXRAZOXANE

Δοσολογία:

250MG

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

DEXRAZOXANE 250MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

250MG/25ML VIAL

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

MISCELLANEOUS THERAPEUTIC AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0152586001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2003-10-07

Αρχείο Π.Χ.Π.

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