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Federal Trial Court Rebuffs Bracco's Claim for Billions of Dollars in Damages Against GE Healthcare for Advertising of X-Ray Contrast Agent. Court finds published clinical studies sponsored by GEHC were sound
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Product Highlights
- The only isosmolar contrast medium (IOCM) available in the United
States1
- Patient-procedure friendly, particularly when risk is high3
- Formulated with sodium and calcium at biologic levels4
- Provides excellent diagnostic efficacy2,5
- Helps improve efficiency, and maximize contrast for high-quality
images and diagnostic outcomes6
Product Description
Launched in 1996, VISIPAQUE is the only isosmolar contrast medium (IOCM™) available in the U.S. With an osmolality equal to that of blood, VISIPAQUE was designed for patient safety and comfort. VISIPAQUE is also the only contrast medium formulated with sodium and calcium in a ratio equivalent to blood. In 1997, VISIPAQUE received FDA approval for use in children over one year of age. With an excellent safety profile, VISIPAQUE is approved for a broad range of diagnostic procedures requiring intravascular contrast, such as coronary angiography, CT, IVP, and venography.
References: 1. Data on file, GE Healthcare. 2. Klow NE, Levorstad K, Berg Kj,
et al. lodixanol in cardioangiography in patients with coronary artery
disease. Tolerability, cardiac and renal effects. Acta Radiol. 1993;34:72-77. 3.
Davidson Cj, Laskey WK, Hermiller jB, et al. Randomized trial of contrast
media utilization in high risk PTCA:The COURT Trial. Circulation. 2000;101:2172-2177.
4. VI51PAQUE Prescribing Information. 5. Hill jA, Cohen MB, Kou WH, et
al. lodixanol, a new isosmotic non ionic contrast agent compared to iohexol
in cardiac angiography. Am J Cardiol. 1994;74:57-63. 6. Spencer CM, Goa
KL. lodixanol: a review of its pharmacodynamic and pharmacokinetic properties
and diagnostic use as an X-ray contrast medium. Drugs. 1996;52:899-927.
NOT FOR INTRATHECAL USE. All nonionic, iodinated contrast media currently available inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media. Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media.
Caution must be exercised in patients with severely impaired renal function, combined renal and hepatic disease, combined renal and cardiac disease, severe thyrotoxicosis, myelomatosis, or anuria, particularly when large doses are administered.
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