Indications and Usage:
Isovue-200, 250, 300*, 370*
Isovue is indicated for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, coronary arteriography and ventriculography, pediatric angiocardiography, selective visceral arteriography and aortography, peripheral venography (phlebography), and adult and pediatric intravenous excretory urography and intravenous adult and pediatric contrast enhancement of computed tomographic (CECT) head and body imaging. Please consult full prescribing information for detailed product usage.
IMPORTANT SAFETY INFORMATION:
Isovue IS NOT FOR INTRATHECAL USE.
Nonionic iodinated contrast media 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. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events.
As with all injectable contrast agents, the possibility of severe reactions should be borne in mind, regardless of the patient’s pre-existing medical history. As with any other iodinated 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.
*The Isovue Imaging Bulk Package is for use with an automated contrast injector or a contrast management system approved or cleared for use with it.
Please see full Prescribing Information for individual product indications and usage.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.
Isovue is currently manufactured for Bracco Diagnostics Inc. at two locations: BIPSO GmbH, Singen (Germany) and Patheon Italia S.p.A., Ferentino (Italy).
Isovue is a registered trademark of Bracco Diagnostics Inc.
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