GADOVIST 1.0 SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

GADOBUTROL

Available from:

BAYER INC

ATC code:

V08CA09

INN (International Name):

GADOBUTROL

Dosage:

604.72MG

Pharmaceutical form:

SOLUTION

Composition:

GADOBUTROL 604.72MG

Administration route:

INTRAVENOUS

Units in package:

15ML

Prescription type:

Ethical

Therapeutic area:

OTHER DIAGNOSTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0138761002; AHFS:

Authorization status:

APPROVED

Authorization date:

1999-11-08

Summary of Product characteristics

_ _
_GADOVIST Product Monograph _
_Page 1 of 45_
PRODUCT MONOGRAPH
GADOVIST
®
1.0
gadobutrol injection
604 mg/mL (1.0 mmol/mL)
For Intravenous Use
Contrast Enhancement Agent
for Magnetic Resonance Imaging (MRI)
For Professional Use Only
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
Canada
http://www.bayer.ca
Submission Control No: 212848
Date of Revision:
March 5, 2018
© 2018, Bayer Inc.
® TM see www.bayer.ca/tm-mc. All other trademarks are the property of
their respective
owners.
_ _
_GADOVIST Product Monograph _
_Page 2 of 45_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND STABILITY
..........................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................20
PART II: SCIENTIFIC INFORMATION
................................................................................22
PHARMACEUTICAL INFORMATION
.................