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Indications and Usage:
CARDIOGEN-82® (Rubidium Rb 82 Generator) is a closed system used to produce rubidium Rb 82 chloride injection for intravenous administration. Rubidium Rb 82 chloride injection is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.
IMPORTANT SAFETY INFORMATION:
WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT
AND FAILURE TO FOLLOWTHE ELUATE TESTING PROTOCOL
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)
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.
Please see full Prescribing Information for CARDIOGEN-82® (Rubidium Rb 82 Generator) including boxed WARNING here.
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.
WE ARE CARDIAC PET is a trademark of Bracco Diagnostics Inc.
HEARTSEE is a trademark of The University of Texas Health Science Center at Houston on behalf of the Board of Regents of The University of Texas System, and used under a
license by Bracco Diagnostics Inc.