VELPHORO TABLET (CHEWABLE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

IRON (SUCROFERRIC OXYHYDROXIDE)

Διαθέσιμο από:

VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD

Φαρμακολογική κατηγορία (ATC):

V03AE05

INN (Διεθνής Όνομα):

SUCROFERRIC OXYHYDROXIDE

Δοσολογία:

500MG

Φαρμακοτεχνική μορφή:

TABLET (CHEWABLE)

Σύνθεση:

IRON (SUCROFERRIC OXYHYDROXIDE) 500MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30/90

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

PHOSPHATE-REMOVING AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2018-01-05

Αρχείο Π.Χ.Π.

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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.............................