PRIMOVIST SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

GADOXETATE DISODIUM

Available from:

BAYER INC

ATC code:

V08CA10

INN (International Name):

GADOXETIC ACID

Dosage:

181.43MG

Pharmaceutical form:

SOLUTION

Composition:

GADOXETATE DISODIUM 181.43MG

Administration route:

INTRAVENOUS

Units in package:

5ML/7.5ML/10ML

Prescription type:

Ethical

Therapeutic area:

OTHER DIAGNOSTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0152685001; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-01-14

Summary of Product characteristics

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_PRIMOVIST Product Monograph _
_Page 1 of 29 _
PRODUCT MONOGRAPH
PRIMOVIST
®
gadoxetate disodium injection
181.43 mg/mL (0.25 mmol/mL)
Intravenous contrast enhancement agent
for magnetic resonance imaging (MRI)
For Professional Use Only
Distributed and Imported by:
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
http://www.bayer.ca
Date of Revision:
May 12, 2017
Submission Control No: 202821
© 2017, Bayer Inc.
®
TM see www.bayer.ca/tm-mc. All other trademarks are the property of
their respective
owners.
_ _
_PRIMOVIST Product Monograph _
_Page 2 of 29 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND STABILITY
..........................................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
................................................................................16
PHARMACEUTICAL IN