País: Canadà
Idioma: anglès
Font: Health Canada
IOTHALAMATE MEGLUMINE
LIEBEL-FLARSHEIM COMPANY LLC
V08AA04
IOTALAMIC ACID
172MG
SOLUTION
IOTHALAMATE MEGLUMINE 172MG
URETHRAL
250/500ML
Ethical
ROENTGENOGRAPHY
Active ingredient group (AIG) number: 0102763004; AHFS:
APPROVED
2021-12-02
_ _ _Page 1 of 14_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION CYSTO-CONRAY ® II Iothalamate Meglumine Injection USP 17.2 % w/v Solution IONIC IODINATED RADIOGRAPHIC CONTRAST MEDIUM FOR INSTILLATION OF THE URINARY TRACT. Liebel-Flarsheim Company LLC Date of Revision: 8800 Durant Road November 26, 2021 Raleigh, North Carolina 27616 USA Importer: Liebel-Flarsheim Canada Inc. 7500 Trans-Canada Highway Pointe-Claire, Quebec H9R 5H8 Submission Control No.: 255550 _ _ _ _ _Page 2 of 14_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS ..................................................................................3 ADVERSE REACTIONS ....................................................................................................5 DOSAGE AND ADMINISTRATION ................................................................................8 OVERDOSAGE ..................................................................................................................8 ACTION AND CLINICAL PHARMACOLOGY ..............................................................8 STORAGE AND STABILITY ............................................................................................9 DOSAGE FORMS, COMPOSITION AND PACKAGING ...............................................9 PART II: SCIENTIFIC INFORMATION ...............................................................................10 PHARMACEUTICAL INFORMATION ..........................................................................10 DETAILED PHARMACOLOGY .....................................................................................10 REFER Llegiu el document complet