Ország: Kanada
Nyelv: angol
Forrás: Health Canada
DEXRAZOXANE
PFIZER CANADA ULC
V03AF02
DEXRAZOXANE
250MG
POWDER FOR SOLUTION
DEXRAZOXANE 250MG
INTRAVENOUS
250MG/25ML VIAL
Prescription
MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0152586001; AHFS:
APPROVED
2003-10-07
_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 ........... Olvassa el a teljes dokumentumot