Indications and Usage:
ISOVUE®-200, 250, 300*, 370*
ISOVUE® (Iopamidol Injection) 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.
ISOVUE® (Iopamidol Injection) Imaging Bulk Package (IBP) is indicated for angiography throughout the cardiovascular system in adults, including cerebral and peripheral arteriography, coronary arteriography and ventriculography, selective visceral arteriography and aortography, peripheral venography (phlebography), and in pediatric patients for angiocardiography; or for intravenous contrast enhancement of computed tomographic (CECT) imaging of the head and body in adult and pediatric patients.
*The ISOVUE (Iopamidol Injection) Imaging Bulk Package is for use with an automated contrast injector or a contrast management system approved or cleared for use with it.
IMPORTANT SAFETY INFORMATION:
ISOVUE (Iopamidol Injection) IS NOT FOR INTRATHECAL USE. Iopamidol Injection is available as ISOVUE-M® 200 (Iopamidol Injection 41%), and ISOVUE-M® 300 (Iopamidol Injection 61%) for intrathecal administration.
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. Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration.
Please see full Prescribing Information for ISOVUE (Iopamidol Injection) by clicking here.
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 and ISOVUE-M are currently manufactured for Bracco Diagnostics Inc. at three locations: BIPSO GmbH, Singen (Germany), Patheon Italia S.p.A., Ferentino (Italy) and S. M. Farmeceutici SRL, Tito (Italy).
ISOVUE and ISOVUE-M are registered trademarks of Bracco Diagnostics Inc.
Indications and Usage for ISOVUE®-300 (Iopamidol Injection 61%) Imaging Bulk Package and
ISOVUE®-370 (Iopamidol Injection 76%) Imaging Bulk Package
ISOVUE® (Iopamidol Injection) Imaging Bulk Package (IBP) is indicated for angiography throughout the cardiovascular system in adults, including cerebral and peripheral arteriography, coronary arteriography and ventriculography, selective visceral arteriography and aortography, peripheral venography (phlebography), and in pediatric patients for angiocardiography; or for intravenous contrast enhancement of computed tomographic (CECT) imaging of the head and body in adult and pediatric patients.
The ISOVUE (Iopamidol Injection) Imaging Bulk Package is for use with an automated contrast injector or a contrast management system approved or cleared for use with it.
IMPORTANT SAFETY INFORMATION:
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. Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration.
Please see full Prescribing Information for ISOVUE Imaging Bulk Package by clicking here.
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 and ISOVUE-M are currently manufactured for Bracco Diagnostics Inc. at at three locations: BIPSO GmbH, Singen (Germany), Patheon Italia S.p.A., Ferentino (Italy) and S. M. Farmeceutici SRL, Tito (Italy).
ISOVUE and ISOVUE-M are registered trademarks of Bracco Diagnostics Inc.
