Riik: Kanada
keel: inglise
Allikas: Health Canada
IOVERSOL
LIEBEL-FLARSHEIM COMPANY LLC
V08AB07
IOVERSOL
68%
SOLUTION
IOVERSOL 68%
INTRAVASCULAR
50ML/75ML/100ML/125ML
Ethical
ROENTGENOGRAPHY
Active ingredient group (AIG) number: 0131317003; AHFS:
APPROVED
2012-11-06
_ _ _Page 1 of 55_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION OPTIRAY ® Ioversol Injection Solution OPTIRAY ® 240 Ioversol Injection 51% w/v, 240 mgI/mL OPTIRAY ® 300 Ioversol Injection 64% w/v, 300 mgI/mL OPTIRAY ® 320 Ioversol Injection 68% w/v, 320 mgI/mL OPTIRAY ® 350 Ioversol Injection 74% w/v, 350 mgI/mL Nonionic Iodinated Radiographic Contrast Medium Intravascular, Subarachnoidal Liebel-Flarsheim Company LLC 8800 Durant Road Raleigh, North Carolina 27616 USA Importer: Liebel-Flarsheim Canada Inc. 7500 Trans-Canada Highway Pointe-Claire, Quebec, H9R 5H8 Canada Date of Revision: November 26, 2021 Submission Control No: 255548 _ _ _ _ _Page 2 of 55_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ..................................................................................................13 DRUG INTERACTIONS ..................................................................................................19 DOSAGE AND ADMINISTRATION ..............................................................................19 OVERDOSAGE ................................................................................................................33 ACTION AND CLINICAL PHARMACOLOGY ............................................................33 STORAGE AND STABILITY ..........................................................................................36 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................36 PART II: SCIENTIFIC INFORMATION ....... Lugege kogu dokumenti