מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
IOTHALAMATE MEGLUMINE
LIEBEL-FLARSHEIM CANADA INC
V08AA04
IOTALAMIC ACID
300MG
SOLUTION
IOTHALAMATE MEGLUMINE 300MG
INTRAVASCULAR
100/150/250ML
Ethical
ROENTGENOGRAPHY
Active ingredient group (AIG) number: 0102763002; AHFS:
CANCELLED POST MARKET
2018-03-14
_ _ _Page 1 of 40_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION CONRAY ® 30 (Iothalamate meglumine injection USP 30% w/v) CONRAY ® 43 (Iothalamate meglumine injection USP 43% w/v) CONRAY ® 60 (Iothalamate meglumine injection USP 60% w/v) IONIC IODINATED RADIOGRAPHIC CONTRAST MEDIUM FOR INTRAVASCULAR USE Liebel-Flarsheim Canada Inc. 7500 Trans-Canada Highway Pointe-Claire, QC, H9R 5H8 CANADA Date of Revision: December 27, 2017 Submission Control No: 205718 _ _ _ _ _Page 2 of 40_ 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 ....................................................................................................8 DOSAGE AND ADMINISTRATION ..............................................................................12 OVERDOSAGE ................................................................................................................25 ACTION AND CLINICAL PHARMACOLOGY ............................................................25 STORAGE AND STABILITY ..........................................................................................27 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................27 PART II: SCIENTIFIC INFORMATION ...............................................................................29 PHARMACEUTICAL INFORMATION ..........................................................................29 DETAILED PHARMACOLOGY .....................................................................................30 TOXICOLOGY . קרא את המסמך השלם