Land: Canada
Taal: Engels
Bron: Health Canada
GADOFOSVESET TRISODIUM
BAYER INC
V08CA11
GADOFOSVESET
244MG
SOLUTION
GADOFOSVESET TRISODIUM 244MG
INTRAVENOUS
10ML
Ethical
OTHER DIAGNOSTIC AGENTS
Active ingredient group (AIG) number: 0151671001; AHFS:
CANCELLED POST MARKET
2009-08-06
_ _ _ _ Page 1 of 46 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. _ _ _ _ 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............................................ Lees het volledige document