VELPHORO TABLET (CHEWABLE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

IRON (SUCROFERRIC OXYHYDROXIDE)

Tersedia dari:

VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD

Kode ATC:

V03AE05

INN (Nama Internasional):

SUCROFERRIC OXYHYDROXIDE

Dosis:

500MG

Bentuk farmasi:

TABLET (CHEWABLE)

Komposisi:

IRON (SUCROFERRIC OXYHYDROXIDE) 500MG

Rute administrasi :

ORAL

Unit dalam paket:

30/90

Jenis Resep:

Prescription

Area terapi:

PHOSPHATE-REMOVING AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0108536040; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2018-01-05

Karakteristik produk

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