Country: Canada
Language: English
Source: Health Canada
IOPAMIDOL
BRACCO IMAGING CANADA
V08AB04
IOPAMIDOL
61%
LIQUID
IOPAMIDOL 61%
INTRAVASCULAR
15/50/100/150 ML
Ethical
ROENTGENOGRAPHY
Active ingredient group (AIG) number: 0116899003; AHFS:
MARKETED
1998-01-08
_Product Monograph _ _ _ _ISOVUE_ _®_ _ _ _Page 1 of 45_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION ISOVUE® Iopamidol ISOVUE-200 (injection, 41% w/v, 200 mg I/mL) ISOVUE 300 (injection, 61% w/v, 300 mg I/mL) ISOVUE MULTIPACK 300 (injection, 61% w/v, 300 mg I/mL) ISOVUE-370 (injection, 76% w/v, 370 mg I/mL) ISOVUE MULTIPACK-370 (injection, 76% w/v, 370 mg I/mL) USP NON-IONIC RADIOGRAPHIC CONTRAST AGENT (ATC: V08AB04) Bracco Imaging Canada 11065 boul. Louis-H.-Lafontaine Montreal, Quebec Canada H1J 2Z4 Date of Initial Authorization: July 15, 2002 Date of Revision: December 17, 2021 Submission Control Number: 254894 _ _ _Product Monograph _ _ _ _ISOVUE_ _®_ _ (iopamidol) _ _Page 2 of 45_ RECENT MAJOR LABEL CHANGES Not applicable 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 ..................................................................... 5 1 INDICATIONS .............................................................................................................. 5 1.1 Pediatrics ................................................................................................................... 5 1.2 Geriatrics ................................................................................................................... 5 2 CONTRAINDICATIONS ................................................................................................. 6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 6 4.1 Dosing Considerations ................................................................. Read the complete document