TRIFERIC AVNU SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

IRON (FERRIC PYROPHOSPHATE CITRATE)

متاح من:

ROCKWELL MEDICAL INC

ATC رمز:

B03AC

INN (الاسم الدولي):

IRON, PARENTERAL PREPARATIONS

جرعة:

1.5MG

الشكل الصيدلاني:

SOLUTION

تركيب:

IRON (FERRIC PYROPHOSPHATE CITRATE) 1.5MG

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

IRON PREPARATIONS

ملخص المنتج:

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

الوضع إذن:

CANCELLED PRE MARKET

تاريخ الترخيص:

2022-10-26

خصائص المنتج

_TRIFERIC_
_®_
_ AVNU Product Monograph _
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_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..................................