Страна: Канада
мова: англійська
Джерело: Health Canada
GADOVERSETAMIDE
LIEBEL-FLARSHEIM CANADA INC
V08CA06
GADOVERSETAMIDE
330.9MG
SOLUTION
GADOVERSETAMIDE 330.9MG
INTRAVENOUS
15ML
Ethical
OTHER DIAGNOSTIC AGENTS
Active ingredient group (AIG) number: 0142281001; AHFS:
CANCELLED PRE MARKET
2018-03-23
_ _ _Page 1 of 37 _ PRODUCT MONOGRAPH OPTIMARK ® Gadoversetamide Injection 5, 10, 15, 20 mL in glass vials for injection and pharmacy bulk package: 50 mL vial for injection 330.9 mg/mL of Gadoversetamide Paramagnetic, intravascular, contrast agent for magnetic resonance imaging (MRI) Liebel-Flarsheim Canada Inc. Pointe-Claire, QC, H9R 5H8 CANADA Date of Revision: June 15, 2017 Control No.: 204201 _ _ _Page 2 of 37_ 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 ..................................................................................................11 DRUG INTERACTIONS ..................................................................................................16 DOSAGE AND ADMINISTRATION ..............................................................................17 OVERDOSAGE ................................................................................................................18 ACTION AND CLINICAL PHARMACOLOGY ............................................................19 STORAGE AND STABILITY ..........................................................................................22 SPECIAL HANDLING INSTRUCTIONS .......................................................................22 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................22 PART II: SCIENTIFIC INFORMATION ...............................................................................24 PHARMACEUTICAL INFORMATION ......................................................... Прочитайте повний документ