DOTAREM SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

GADOTERATE MEGLUMINE

MAH:

GUERBET

ATC_code:

V08CA02

INN:

GADOTERIC ACID

dosage:

376.9MG

pharmaceutical_form:

SOLUTION

composition:

GADOTERATE MEGLUMINE 376.9MG

administration_route:

INTRAVENOUS

units_in_package:

VIALS:5/10/15/20/60100ML

prescription_type:

Ethical

therapeutic_area:

OTHER DIAGNOSTIC AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0158590001; AHFS:

authorization_status:

APPROVED

authorization_date:

2016-11-25

SPC

_Product Monograph _
_DOTAREM Gadoterate meglumine injection _
_Page 1 of 42 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
DOTAREM
Gadoterate Meglumine Injection
Solution, 376.9 mg/mL, equivalent to 0.5 mmol/mL, Intravenous
Contrast Enhancement Agent for Magnetic Resonance Imaging (MRI)
Manufacturer:
Guerbet
BP 57400
95943 Roissy CdG Cedex
FRANCE
Importer:
Methapharm Inc.
81 Sinclair Blvd
Brantford, Ontario
Canada N3S 7X6
Date of Initial Authorization:
NOV 25, 2016
Date of Revision:
July 5, 2023
Submission Control Number: 269429
_ _
_Product Monograph _
_DOTAREM Gadoterate meglumine injection _
_Page 2 of 42 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.1 Pregnant Women
07/2023
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 an