MONOFERRIC SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IRON (FERRIC DERISOMALTOSE)

Available from:

PHARMACOSMOS A/S

ATC code:

B03AC

INN (International Name):

IRON, PARENTERAL PREPARATIONS

Dosage:

100MG

Pharmaceutical form:

SOLUTION

Composition:

IRON (FERRIC DERISOMALTOSE) 100MG

Administration route:

INTRAVENOUS

Units in package:

1/5/10ML

Prescription type:

Prescription

Therapeutic area:

IRON PREPARATIONS

Product summary:

Active ingredient group (AIG) number: 0108536004; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-09-17

Summary of Product characteristics

_MONOFERRIC_
_®_
_ (Ferric Derisomaltose for Injection) Product Monograph _
_Page 1 of 40_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MONOFERRIC
®
Ferric Derisomaltose for Injection
Solution, 100 mg elemental iron/mL (as ferric derisomaltose [also
known as iron isomaltoside 1000]),
Intravenous use
Iron, parenteral preparations
Manufactured by:
Pharmacosmos A/S
Roervangsvej 30
DK-4300 Holbaek
Denmark
Imported/Distributed by:
Pfizer Canada ULC
Kirkland (Québec) H9J 2M5
Canada
Date of Initial Authorization:
JUN 22, 2018
Date of Revision:
NOV 03, 2022
Submission Control Number: 263715
_ _
_MONOFERRIC_
_®_
_ (Ferric Derisomaltose for Injection) Product Monograph _
_Page 2 of 40 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
09/2021
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
09/2021
7 WARNINGS AND PRECAUTIONS, Cardiovascular
09/2021
7 WARNINGS AND PRECAUTIONS, Immune
09/2021
7 WARNINGS AND PRECAUTIONS, Skin
09/2021
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
_ _
11/2022
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding
09/2021
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
09/2021
4 DOSAGE AND ADMINISTRATION,
4.2 Recommended Dose and
Dosage Adjustment
09/2021
4 DOSAGE AND ADMINISTRATION,
4.4 Administration
09/2021
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
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4
1
INDICATIONS
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4
1.1
Pediatrics:
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4
1.2
Geriatrics:
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