Land: Kanada
Språk: engelska
Källa: Health Canada
IOPAMIDOL
BRACCO IMAGING CANADA
V08AB04
IOPAMIDOL
76%
LIQUID
IOPAMIDOL 76%
INTRAVASCULAR
200/500 ML
Ethical
ROENTGENOGRAPHY
Active ingredient group (AIG) number: 0116899001; AHFS:
APPROVED
2000-04-19
_Product Monograph _ _ _ _ISOVUE_ _®_ _ _ _Page 1 of 45_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION ISOVUE® Iopamidol Injection ISOVUE-200 Solution, 41% w/v, 200 mg I/mL, Subarachnoid/Intravascular ISOVUE-300 Solution, 61% w/v, 300 mg I/mL, Intravascular ISOVUE MULTIPACK-300 Solution, 61% w/v, 300 mg I/mL, Intravascular ISOVUE-370 Solution, 76% w/v, 370 mg I/mL, Intravascular ISOVUE MULTIPACK-370 Solution, 76% w/v, 370 mg I/mL, Intravascular 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 21, 2022 Submission Control Number: 264222 _ _ _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 Dosi Läs hela dokumentet