Country: Canada
Language: English
Source: Health Canada
IRON (SUCROFERRIC OXYHYDROXIDE)
VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD
V03AE05
SUCROFERRIC OXYHYDROXIDE
500MG
TABLET (CHEWABLE)
IRON (SUCROFERRIC OXYHYDROXIDE) 500MG
ORAL
30/90
Prescription
PHOSPHATE-REMOVING AGENTS
Active ingredient group (AIG) number: 0108536040; AHFS:
APPROVED
2018-01-05
_ _ _Page 1 of 29_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr VELPHORO ® Sucroferric Oxyhydroxide Chewable Tablet 500 mg iron (equivalent to 2500 mg sucroferric oxyhydroxide) Phosphate Binder Manufactured by: Vifor Fresenius Medical Care Renal Pharma Ltd. Rechenstrasse 37, 9014 St. Gallen Switzerland Imported by: Otsuka Canada Pharmaceutical Inc. Saint-Laurent, Quebec, H4S 2C9 Date of Initial Approval: January 5, 2018 Date of Revision: August 30, 2021 Submission Control No: 244717 _ _ _ _ _Page 2 of 29_ TABLE OF CONTENTS 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 DOSAGE AND ADMINISTRATION ......................................................................... 4 3.1 Dosing Considerations..................................................................................... 4 3.2 Recommended Dose and Dosage Adjustment .............................................. 4 3.3 Administration................................................................................................... 5 3.4 Missed Dose..................................................................................................... 5 4 OVERDOSAGE ......................................................................................................... 5 5 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............. 5 6 WARNINGS AND PRECAUTIONS............................. Read the complete document