ULTRAVIST SUMMARY
ULTRAVIST Injection 240 mg I/mL Pharmacy Bulk Package
ULTRAVIST Injection 300 mg I/mL Pharmacy Bulk Package
ULTRAVIST Injection 370 mg I/mL Pharmacy Bulk Package
ULTRAVIST® (iopromide) is indicated for the following:
INTRA-ARTERIAL:
ULTRAVIST Injection (300 mg I/mL) is indicated for cerebral arteriography and peripheral arteriography.
ULTRAVIST Injection (370 mg I/mL)* is indicated for coronary arteriography and left ventriculography, visceral angiography, and aortography.
INTRAVENOUS:
ULTRAVIST Injection (240 mg I/ mL) is indicated for peripheral venography.
ULTRAVIST Injection (300 mg I/mL)* is indicated for contrast enhanced computed tomographic (CECT) imaging of the head and body, and excretory urography.
*For information on the concentrations and doses for the Pediatric Population see the PRECAUTIONS, PEDIATRIC USE and the DOSAGE AND ADMINISTRATION sections.
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NEWS HIGHLIGHTS
Published Studies Related to Ultravist (Iopromide)
Nephrotoxic effects of iodixanol and iopromide in patients with abnormal renal function receiving N-acetylcysteine and hydration before coronary angiography and intervention: a randomized trial. [2009.01]
BACKGROUND: The use of contrast agents during coronary intervention can result in nephropathy, particularly in patients with renal dysfunction. We aimed to determine whether the use of iso-osmolar iodixanol is less nephrotoxic than that of low-osmolar iopromide when patients are adequately prehydrated and have received N-acetylcysteine... CONCLUSION: There remains a high incidence of CIN despite prehydration and routine use of N-acetylcysteine in patients with pre-existing renal dysfunction undergoing coronary interventional procedures. Although our study is underpowered, iodixanol was not associated with a statistically significant lower incidence of CIN when compared with iopromide.
A prospective, double-blind, randomized, controlled trial on the efficacy and cardiorenal safety of iodixanol vs. iopromide in patients with chronic kidney disease undergoing coronary angiography with or without percutaneous coronary intervention. [2008.12.01]
OBJECTIVES: This study was undertaken to compare the renal safety as well as cardiovascular (CV) effects and diagnostic image quality of iso-osmolar iodixanol vs. low-osmolar iopromide in patients with chronic kidney disease (CKD) undergoing coronary interventions. BACKGROUND: With the growing number of contrast-enhanced procedures being performed for coronary artery disease management, the safety and efficacy of iodinated contrast media (CM) have come under increased scrutiny... CONCLUSIONS:: Consistent with several previous trials comparing iso-osmolar iodixanol and low-osmolar comparator CM, iodixanol was associated with a lower incidence of CIN and fewer CV events than iopromide. Copyright 2008 Wiley-Liss, Inc.
High iodine concentration contrast material for noninvasive multislice computed tomography coronary angiography: iopromide 370 versus iomeprol 400. [2006.03]
CONCLUSION: The intravenous administration of iomeprol 400 provides higher attenuation of the coronary arteries and of the great arteries of the thorax as compared with iopromide 370 using the same injection parameters.
Comparison between the efficacy of dimeric and monomeric non-ionic contrast media (iodixanol vs iopromide) in urography in patients with macroscopic haematuria. [2003.04]
Non-ionic dimers induce less diuresis than non-ionic monomers, resulting in increased opacification of the urinary tract in intravenous urography. This trial compared the diagnostic efficacy of iodixanol and iopromide in patients with macroscopic haematuria... The higher opacification provided by iodixanol allowed better results and a higher diagnostic confidence in the upper excretory pathway.
Is contrast-related vasodilatation after intra-coronary iodixanol and iopromide in vivo endothelium-dependent? [2001.12]
CONCLUSION: If iodixanol or iopromide are used as contrast agents, contrast-related vessel area increase in vivo seems to be endothelium-dependent.
Clinical Trials Related to Ultravist (Iopromide)
Ultravist 370 mgI/ml: Safety and Efficacy in Computed Tomography of Head and Body [Recruiting]
This is a research study involving the use of a contrast agent called Ultravist® Injection.
Ultravist®, the study drug, is used to improve the pictures obtained using computed
tomography (CT). Ultravist acts like a dye to make CT pictures brighter and easier to read.
In the case of this study, it will be injected into a vein in the patient's arm; from there,
it travels through the blood stream and to the areas to be examined. CT scans will then be
taken of the patient's head and/or body as ordered by his/her physician.
PMS Study Ultravist-IMAGE, IoproMide (UltrAvist) to Gain Further Information on Tolerability and Safety in X-ray Examination [Recruiting]
The purpose of this study is to obtain data on the safety and efficacy of Ultravist
application in usual daily use. The radiologist will administer the contrast medium to the
patient as he/she would have done without the study. No other examinations will be performed
than would have been done routinely.
A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients [Recruiting]
The investigators intend to find out which contrast agent has less kidney toxicity in renal
impaired patients undergoing cardiac angiography or percutaneous coronary intervention
(PCI).
Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI) [Recruiting]
The purpose of this study is to determine the incidence of contrast induced nephropathy and
myocardial tissue reperfusion following iso-osmolar iodixanol or ipo-osmolar iopromide
administration in patients with acute myocardial infarction undergoing primary PCI.
Contrast-Medium Induced Nephrotoxicity in Patients Undergoing Coronary Angiography - Iodixanol Versus Iopromide [Recruiting]
In the treatment of coronary heart disease which is the major cause of heart attack, direct
mechanical treatment with catheters such as the coronary angiography, coronary balloon
intervention and stenting intervention are the mainstay of therapy in recent years. In that
procedures, the investigators should use the contrast media, and it may cause kidney
toxicity especially in the patients with underlying kidney disease and decreased kidney
function. The investigators intended to find out which contrast agent has less kidney
toxicity in the catheter based treatment of coronary arterial diseases in patients with
underlying decreased kidney function
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