VENOFER SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

IRON (IRON SUCROSE)

Inapatikana kutoka:

AMERICAN REGENT, INC

ATC kanuni:

B03AC

INN (Jina la Kimataifa):

IRON, PARENTERAL PREPARATIONS

Kipimo:

20MG

Dawa fomu:

SOLUTION

Tungo:

IRON (IRON SUCROSE) 20MG

Njia ya uendeshaji:

INTRAVENOUS

Vitengo katika mfuko:

5ML

Dawa ya aina:

Prescription

Eneo la matibabu:

IRON PREPARATIONS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0108536014; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2001-04-17

Tabia za bidhaa

_Pr_
_VENOFER_
_®_
_ Iron Sucrose Injection _
_Page 1 of 31_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
VENOFER®
Iron Sucrose Injection
Solution, 20 mg elemental Iron/mL (as iron sucrose),
Intravenous Use
USP
Iron, parenteral preparations
AMERICAN REGENT, INC.
5 Ramsey Road
Shirley, New York USA 11967
www.americanregent.com
Date of Initial Authorization:
April 5, 2001
Date of Revision:
February 14, 2023
Imported by:
Fresenius Medical Care Canada Inc.
Richmond Hill, Ontario, L4B 4W6
Submission Control Number: 263718
_ _
_Pr_
_VENOFER_
_® _
_Iron Sucrose Injection _
_Page 2 of 31_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.1 Pregnant Women
02/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
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
.