MULTIHANCE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

GADOBENATE DIMEGLUMINE

Available from:

BRACCO IMAGING CANADA

ATC code:

V08CA08

INN (International Name):

GADOBENIC ACID

Dosage:

529MG

Pharmaceutical form:

SOLUTION

Composition:

GADOBENATE DIMEGLUMINE 529MG

Administration route:

INTRAVENOUS

Units in package:

5ML/10ML/15ML/20ML/50ML

Prescription type:

Ethical

Therapeutic area:

OTHER DIAGNOSTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0149628001; AHFS:

Authorization status:

APPROVED

Authorization date:

2004-03-31

Summary of Product characteristics

_ _
_Product Monograph _
_ _
_MultiHance_
_®_
_ (gadobenate dimeglumine injection) _
_Page 1 of 49_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
MULTIHANCE®
gadobenate dimeglumine injection
Solution, 0.5M (529 mg/mL), Intravenous
Contrast enhancement agent for magnetic resonance imaging (MRI)
ATC: V08CA08
Bracco Imaging Canada
11065 boul. Louis-H.-Lafontaine
Montreal, Quebec
Canada H1J 2Z4
Date of Initial Authorization:
MAR 31, 2004
Date of Revision:
OCT 18, 2023
Submission Control Number: 272850
_ _
_Product Monograph _
_ _
_MultiHance_
_®_
_ (gadobenate dimeglumine injection) _
_Page 2 of 49_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2
Recommended Dose and
Dosage Adjustment
11/2019
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
10/2023
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
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
6
4.1
Dosing Considerations
.......................................