PMS-IRON SUCROSE SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

IRON (IRON SUCROSE)

Beschikbaar vanaf:

PHARMASCIENCE INC

ATC-code:

B03AC

INN (Algemene Internationale Benaming):

IRON, PARENTERAL PREPARATIONS

Dosering:

20MG

farmaceutische vorm:

SOLUTION

Samenstelling:

IRON (IRON SUCROSE) 20MG

Toedieningsweg:

INTRAVENOUS

Eenheden in pakket:

15G/50G

Prescription-type:

Prescription

Therapeutisch gebied:

IRON PREPARATIONS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2020-07-30

Productkenmerken

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
....................................................................................................................
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
................................................................... 5
4
DOSAGE AND ADMINISTRATION
........................................................................................
5
4.1
Dosing Considerations
...........................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
............................................................