TRIFERIC AVNU SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

IRON (FERRIC PYROPHOSPHATE CITRATE)

Διαθέσιμο από:

ROCKWELL MEDICAL INC

Φαρμακολογική κατηγορία (ATC):

B03AC

INN (Διεθνής Όνομα):

IRON, PARENTERAL PREPARATIONS

Δοσολογία:

1.5MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

IRON (FERRIC PYROPHOSPHATE CITRATE) 1.5MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

IRON PREPARATIONS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0108536041; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2022-10-26

Αρχείο Π.Χ.Π.

_TRIFERIC_
_®_
_ AVNU Product Monograph _
_ _
_Page 1 of 25_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TRIFERIC
®
AVNU
ferric pyrophosphate citrate injection
Intravenous Infusion
1.5 mg elemental iron/mL (as ferric pyrophosphate citrate) Solution
Preservative-free
Hematinic
Rockwell Medical, Inc.
30142 Wixom Road
Wixom, MI 48393
Imported/Distributed by:
RMC Healthcare Inc.
Parksville, BC
V9P 2B1
Date of Initial Approval:
April 21, 2021
Submission Control No: 239850
_ _
_TRIFERIC_
_®_
_ AVNU Product Monograph _
_Page 2 of 25_
RECENT MAJOR LABEL CHANGES
Not Applicable
TABLE OF CONTENTS
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
.................................................... 5
4.3
Administration.....................................................................................................
5
4.4
Reconstitution..................................