VENOFER SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

IRON (IRON SUCROSE)

제공처:

AMERICAN REGENT, INC

ATC 코드:

B03AC

INN (국제 이름):

IRON, PARENTERAL PREPARATIONS

복용량:

20MG

약제 형태:

SOLUTION

구성:

IRON (IRON SUCROSE) 20MG

관리 경로:

INTRAVENOUS

패키지 단위:

5ML

처방전 유형:

Prescription

치료 영역:

IRON PREPARATIONS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2001-04-17

제품 특성 요약

_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
.