VASOVIST SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

GADOFOSVESET TRISODIUM

Saatavilla:

BAYER INC

ATC-koodi:

V08CA11

INN (Kansainvälinen yleisnimi):

GADOFOSVESET

Annos:

244MG

Lääkemuoto:

SOLUTION

Koostumus:

GADOFOSVESET TRISODIUM 244MG

Antoreitti:

INTRAVENOUS

Kpl paketissa:

10ML

Prescription tyyppi:

Ethical

Terapeuttinen alue:

OTHER DIAGNOSTIC AGENTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0151671001; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2009-08-06

Valmisteyhteenveto

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PRODUCT MONOGRAPH
VASOVIST
®
gadofosveset trisodium injection
244 mg/mL (0.25mmol/mL)
For intravenous use
Intravenous contrast enhancement agent
for magnetic resonance imaging (MRI)
Bayer Inc.
77 Belfield Road
Toronto, ON
M9W 1G6
Canada
www.bayer.ca
Submission Control Number: 121901
©2008, Bayer Inc.
Date of Revision:
July 16, 2008
®Vasovist is a registered trademark, used under license by Bayer Inc.
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Page 2 of 46
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....................................................................................................9
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND
ADMINISTRATION..............................................................................18
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND
STABILITY..........................................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
................................................................................24
PHARMACEUTICAL
INFORMATION..........................................................................24
CLINICAL
TRIALS............................................