Bracco Diagnostics Inc. introduces new CardioGen-82 (Rubidium Rb 82 Generator) infusion system

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Bracco Diagnostics Inc. introduces new CardioGen-82 (Rubidium Rb 82 Generator) infusion system

Press releases may be edited for formatting or style | October 19, 2020 Cardiology Infusion Pumps Molecular Imaging

IMPORTANT SAFETY INFORMATION:

WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT AND FAILURE TO FOLLOW THE ELUATE TESTING PROTOCOL

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Please see full prescribing information for complete boxed warning


High Level Radiation Exposure with Use of Incorrect Eluent

Using the incorrect eluent can cause high Strontium (Sr) 82 and Sr 85 breakthrough levels (5.1)



Use only additive-free 0.9%Sodium Chloride Injection USP to elute the generator (2.5)



Immediately stop the patient infusion and permanently discontinue the use of the affected CARDIOGEN-82 generator if the incorrect solution is used to elute the generator (4)



Evaluate the patient's radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow (2.10)


Excess Radiation Exposure with Failure to Follow the Eluate Testing Protocol

Excess radiation exposure occurs when the levels of Sr 82 or Sr 85 in the rubidium Rb 82 chloride injection exceed limits. (5.2)



Record eluate volume, including waste and test volumes. (2.5)



Strictly adhere to the generator eluate testing protocol (2.6, 2.7)



Stop using the generator if it reaches any of its Expiration Limits (2.8)

Please see full Prescribing Information for CARDIOGEN-82 (Rubidium Rb 82 Generator) including boxed WARNING at https://imaging.bracco.com/us-en/products/nuclear-medicine-radiopharmaceuticals/cardiogen-82.

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.

CARDIOGEN-82 is manufactured for Bracco Diagnostics Inc., Monroe Township, NJ 08831, by GE Healthcare, Medi-Physics, Inc., South Plainfield, NJ 07080.

CARDIOGEN-82 is a registered trademark of Bracco Diagnostics Inc.


About Bracco Imaging S.p.A.
Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider, headquartered in Milan, Italy.

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), and Nuclear Medicine through radioactive tracers and novel PET imaging agents. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. The Company operates in over 100 markets worldwide, either directly or indirectly, through subsidiaries, joint ventures, licenses and distribution partnership agreements. Bracco Imaging has a strong presence in key geographies: North America, China, Europe, Japan, Brazil, Mexico and South Korea.

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