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Título: Bracco Diagnostics Inc. Creates First and Only U.S. FDA-Approved Multi-Dose Compliant Contrast Medium as Breakthrough Solution for Point-of-Care Use in the CT Suite
Fecha: 24-11-2014
MONROE TOWNSHIP, N.J.--(BUSINESS WIRE)--Bracco Diagnostics Inc. (BDI), the U.S. subsidiary of Bracco Imaging S.p.A. - a global leading company in the diagnostic imaging business - today announced the availability of its innovative ISOVUE® (iopamidol injection) Imaging Bulk Package* (IBP), the first and only, specific combination multi-patient, multi-dose compliant contrast medium approved by the U.S. Food and Drug Administration (FDA), for point-of-care use in the computed tomography (CT) suite.1
The ISOVUE IBP was designed to increase safety and improve workflow, while minimizing risk and maintaining compliance regarding the use of multi-dose contrast media for radiological procedures in the CT suite.
Pharmacy Bulk Packages (PBPs) for multi-dose contrast media were originally approved in the 1990s with prescribing information for use in a “suitable work area, such as laminar flow hood, using an aseptic (sterile) technique”, typically found in the hospital pharmacy setting. Over time, The Joint Commission, which accredits and certifies healthcare organizations nationwide, began issuing citations to medical centers for using PBPs to transfer contrast media outside of the pharmacy in conditions that were not fully compliant with prescribing information. In 2012, the Institute for Safe Medication Practices called for hospital pharmacy oversight on the purchase, distribution, storage and use of intravenous contrast media, the use of single dose vials or pre-filled syringes for radiological use, and the proper use of PBPs.2
“To overcome the challenges facing many of our customers, Bracco worked diligently with the FDA to develop a completely new multi-dose/multi-patient contrast management system that would meet the FDA’s rigorous standards and would be CT-suite compliant,” said Alberto Spinazzi, MD, Senior Vice President, Global Medical and Regulatory Affairs, Bracco Group. “The ISOVUE IBP is a breakthrough solution, in that it facilitates appropriate, custom-tailored contrast media dosing, because every patient is different rather than a ‘one-size-fits-all’ dosing.”
The ISOVUE IBP allows for easy and cost-effective intravenous contrast enhancement of CT imaging of the head and body in adult and pediatric patients. The ISOVUE IBP provides 10-hour on-demand dosing from the same container without the risk of incurring multi-dosing citations associated with transferring contrast media outside the hospital pharmacy setting.
“Point-of-Care administration of contrast media in multi-patient, multi-dosing situations has become a major ‘hot-button’ issue impacting most CT suites nationwide,” said Dr. Spinazzi. “Bracco’s new ISOVUE IBP meets these challenges head on. Compared with single-use containers, this product has the potential to enhance hospital efficiencies, yield greater cost-effectiveness, increase throughput, and reduce contrast waste.”
“The evolving health care landscape is creating greater pressures on our customers to find ways to optimize workflow, improve compliance and enhance patient satisfaction,” said Vittorio Puppo, President and CEO, Bracco Diagnostics Inc. “Bracco continues to remain at the forefront of Imaging by investing in the development of solutions that enable our customers to tackle these challenges head on. Only Bracco’s ISOVUE IBP enables customers to tailor contrast delivery based on the individual patient profile, leading to more streamlined, cost effective and compliant imaging procedures.”
For more information about the ISOVUE IBP, call Professional Services (1-800-257-5181) or visit www.imaging.bracco.com/us-en/isovue.
Please See Important Safety Information Below.
INDICATIONS FOR USE:
ISOVUE (Iopamidol Injection) Imaging Bulk Package (IBP) is indicated for intravenous contrast enhancement of computed tomographic (CECT) imaging of the head and body in adult and pediatric patients.
IMPORTANT SAFETY INFORMATION:
Isovue IS NOT FOR INTRATHECAL USE. Iopamidol Injection is available as Isovue-M® 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 at www.imaging.bracco.com/us-en/isovue
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.
About Bracco Imaging
Bracco Imaging S.p.A., part of the Bracco Group, is one of the world’s leading companies in the diagnostic imaging business. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions that meet medical needs.
Bracco Imaging offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray Imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), Nuclear Medicine through radioactive tracers, and Gastrointestinal Endoscopy. The diagnostic imaging offer is completed by several medical devices and advanced administration systems for contrast imaging products in the fields of radiology.
The Company operates in more than 100 markets worldwide, either directly or indirectly, through subsidiaries, joint ventures, licenses and distribution partnership agreements. With an on-going research covering all key modalities, Bracco Imaging has a strong presence in key geographies: North America, Europe and Japan operating through the Joint Venture Bracco-Eisai Co. Ltd. The Company also operates in Brazil, South Korea, and China through the Joint Venture Bracco Sine Pharmaceutical Corp. Ltd.
Operational investments have been made in order to achieve top quality and compliances with a sustainable eco-friendly production. Manufacturing activities are located in Italy, Switzerland, Japan, China, and Germany.
Bracco Imaging is an innovative Research and Development (R&D) player with an efficient process oriented approach and a track record of innovation in the diagnostic imaging industry. R&D activities are managed in the three Research Centres located in Italy, Switzerland, and USA.
To learn more about Bracco Imaging, visit www.braccoimaging.com.
1Isovue® (iopamidol injection) Imaging Bulk Package full Prescribing Information.
2“Inappropriate Use of PBP of IV Contrast Increases Risk of Infections.” ISMP Medication Safety Alert! September 20, 2012.http://www.ismp.org/Newsletters/acutecare/showarticle.aspx?id=31
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Contacts
Bracco Diagnostics Inc.
Lakshmi Sundar, 609-514-2236
Lakshmi.Sundar@diag.bracco.com
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