VENOFER SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

IRON (IRON SUCROSE)

Dostupné s:

AMERICAN REGENT, INC

ATC kód:

B03AC

INN (Mezinárodní Name):

IRON, PARENTERAL PREPARATIONS

Dávkování:

20MG

Léková forma:

SOLUTION

Složení:

IRON (IRON SUCROSE) 20MG

Podání:

INTRAVENOUS

Jednotky v balení:

5ML

Druh předpisu:

Prescription

Terapeutické oblasti:

IRON PREPARATIONS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2001-04-17

Charakteristika produktu

_Pr_
_VENOFER_
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_ 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
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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
.