PMS-IRON SUCROSE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IRON (IRON SUCROSE)

Available from:

PHARMASCIENCE INC

ATC code:

B03AC

INN (International Name):

IRON, PARENTERAL PREPARATIONS

Dosage:

20MG

Pharmaceutical form:

SOLUTION

Composition:

IRON (IRON SUCROSE) 20MG

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

IRON PREPARATIONS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2020-07-30

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-IRON SUCROSE
Iron Sucrose Injection
Solution, 20 mg elemental Iron/mL (as iron sucrose), Intravenous Use
House Standard
Iron, parenteral preparations
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Date of Initial Authorization:
JUL 30, 2020
Date of Revision:
SEP 12, 2023
Submission Control Number: 274654
RECENT MAJOR LABEL CHANGES
4.5 Missed Dose
09/2023
7 Warnings and Precautions, 7.1.1 Pregnant Women
09/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................................
4
1
INDICATIONS
.....................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................... 5
4
DOSAGE AND ADMINISTRATION
........................................................................................
5
4.1
Dosing Considerations
...........................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
............................................................