Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, announced today that the United States Pharmacopeia (USP) has added the definition of the Imaging Bulk Package (IBP) to the USP 40NF 35 Chapter 659 Packaging and Storage Requirements.1
The IBP was approved by the U.S. Food and Drug Administration (FDA) for the nonionic iodinated contrast medium ISOVUE in 2014. The USP now recognizes the IBP as the only contrast medium container suitable for multi-dose, multi-patient use directly in radiology rooms. The new definition of the IBP is now available online; the revised chapter will become official May 1, 2017.
The IBP is a container that is designed to be part of a system that allows withdrawal of successive portions of a medication for parenteral administration to multiple patients without changing the safety, strength, quality, or purity of the remaining portion. Therefore, the ISOVUE IBP can be safely used in Radiology or CT rooms either (1) in conjunction with a specific transfer set to fill syringes for any syringe-based contrast injection system approved for use in the U.S., or (2) in conjunction with a contrast injector system designed and approved to make direct use of it, such as the CT Exprès™ injector sold by Bracco Diagnostics. This differs greatly from the container defined by the USP as the Pharmacy Bulk Package (PBP), which requires preparation of individual patient doses in aseptic clean-air compounding areas, which are not typically available in radiology departments.
"Bracco is proud to stand apart as the only company to offer a compliant imaging bulk packaging option," said Vittorio Puppo, President and CEO, Bracco Diagnostics Inc. "We are pleased to offer our customers additional flexibility and convenience in their Radiology or Computed Tomography (CT) suite."
In light of the important limitations of PBP use in radiology, Bracco worked closely with the FDA to define the regulatory pathway and validation requirements for the development of a new multi-dose, multi-patient ISOVUE presentation that is safe and compliant for use in standard Radiology or CT rooms in conjunction with any marketed syringe-based injector system, or with the syringe-less CT Exprès injector.
"The FDA approval of the ISOVUE IBP was based on the review of an innovative and extensive battery of testing that Bracco designed, with FDA concurrence, to prove the safety and integrity of the ISOVUE IBP in resisting microbial contamination and maintaining its chemical stability," said Alberto Spinazzi, MD, Head of Global Medical and Regulatory Affairs, Bracco Group. "Following FDA approval, the USP has now added the definition of the IBP as an injection packaging system specifically intended for use in the Radiology or CT room, to safely deliver multiple single doses of contrast to multiple patients."
Please see Important Safety Information below.
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 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 http://www.braccoimaging.com/us-en/products-and-solutions/x-ray-computed-tomography/isovue/prescribing-information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch 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.
CT Exprès 3D Contrast Media Delivery System
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 health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.
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.
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 is manufactured for Bracco Injeneering S.A., Avenue de Sévelin 46, CH-1004 Lausanne, Switzerland; http://imaging.bracco.com
CT Exprès is a trademark of Bracco Injeneering S.A.
Not all products are available in all countries.
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.