CT Exprès^® 3D Contrast Media Delivery System

CT Exprès^® 3D Contrast Media Delivery System
INDICATIONS:
The CT Exprès^® 3D Contrast Media Delivery System is indicated for controlled automatic administration, on the venous side, of contrast media and saline, to human subjects while undergoing examination by means of a computed tomography (CT) scanner.

The CT Exprès 3D Contrast Media Delivery System is specifically indicated for use in CT procedures for the delivery of ISOVUE (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of 20 bottles of contrast media or a maximum of ten (10) hours, whichever comes first, per Day Set III HP disposable. The Bottle Spike disposable is for single-bottle use only and must be discarded with the contrast media bottle. The Patient Set must be discarded after each patient procedure.

The CT Exprès 3D is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.

CONTRAINDICATIONS:
This device is not intended for injection of contrast media for coronary arteriography, or for any other use for which the device is not indicated.

Bracco Injeneering S.A. reserves the right at any time and without notice, to change the specifications and features described herein, or to change the production or adjust the product described.

Not all products are available in all global markets.

CT Exprès is distributed by Bracco Diagnostics Inc., 259 Prospect Plains Road, Bldg. H, Monroe Township, NJ 08831 USA; Phone: (800) 631-5245; Fax: (609) 514-2424; Customer Service: 1-877-BRACCO 9 (1-877-272-2269)); CT Exprès Email: empowerinfo@diag.bracco.com.

CT Exprès is manufactured for Bracco Injeneering S.A., Avenue de Sévelin 46, CH-1004 Lausanne, Switzerland. https://imaging.bracco.com

About Bracco Injeneering S.A.
Bracco Injeneering S.A., located in Lausanne, Switzerland, is the most recently added Business Unit of Bracco Imaging. Bracco Injeneering is committed to develop the best-in-class integrated injection solutions with a strong heritage in research and innovation. It provides quality solutions for state-of-the-art radiology centers, offering proven injection technology, built on Bracco Imaging’s expertise.

Thanks to this strengthened product portfolio, including the CT Exprès 3D Contrast Media Delivery System, EmpowerCTA^®+ Injector System, EmpowerMR^® Injector System, NEXO^® Contrast Management System and NEXO [DOSE]^® Multi-Modality Radiation Informatics, Bracco Imaging will be able to focus on constant innovation, not only for devices, but also for software development and data management.

CT Exprès, EmpowerCTA, EmpowerMR, NEXO and NEXO [DOSE]^® are registered trademarks of Bracco Injeneering S.A.

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.

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.

Caution must be exercised in patients with severely impaired renal function, those with combined renal and hepatic disease, or anuria, particularly when larger and repeat doses are administered. Radiopaque diagnostic contrast agents are potentially hazardous in patients with multiple myeloma or other paraproteinemia, particularly in those with therapeutically resistant anuria. Caution should be exercised in hydrating patients with underlying conditions that may be worsened by fluid overload, such as congestive heart failure. Diabetic nephropathy may predispose to acute renal impairment following intravascular contrast media administration. Acute renal impairment following contrast media administration may precipitate lactic acidosis in patients who are taking biguanides. Preparatory dehydration is dangerous and may contribute to acute renal failure in patients with advanced vascular disease, diabetic patients, and in susceptible nondiabetic patients (often elderly with preexisting renal disease). Patients should be well hydrated prior to and following iopamidol administration.

The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid or cardiovascular reactions, should always be considered. Patients at increased risk include those with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine per se, and patients with a known clinical hypersensitivity (bronchial asthma, hay fever, and food allergies).

*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 ISOVUE Imaging Bulk Package by clicking here.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.

ISOVUE and ISOVUE-M are currently manufactured for Bracco Diagnostics Inc. at two locations: BIPSO GmbH, Singen (Germany) and Patheon Italia S.p.A., Ferentino (Italy).

ISOVUE and ISOVUE-M are registered trademarks of Bracco Diagnostics Inc.