MONOFERRIC SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

IRON (FERRIC DERISOMALTOSE)

MAH:

PHARMACOSMOS A/S

ATC_code:

B03AC

INN:

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

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2021-09-17

SPC

_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
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics:
................................................................................................................
4
1.2
Geriatrics:
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