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The RUBY-FILL® Rubidium Rb 82 Generator contains accelerator produced Strontium-82, which decays to Rubidium-82. When the generator is eluted with saline it produces a sterile, non-pyrogenic solution of Rb-82 Chloride used for Cardiac Positron Emission Tomography (PET), a non-invasive imaging procedure of the myocardium, to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.
Due to the short half-life (75 s) of Rb-82, the use of an elution system is required for delivery of the Rb-82 Chloride into a patient for the purposes of performing Myocardial Perfusion Imaging with PET. The Rubidium Elution System has been exclusively designed for use with the RUBY-FILL® Rubidium 82 Generator and to deliver accurate doses of Rb-82 Chloride to patients.
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RUBY-FILL is a closed system used to produce rubidium Rb 82 chloride injection for intravenous use. 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
Please note changes in Boxed Warning, Dosage and Administration, Directions for Eluting Rubidium Rb 82 Chloride Injection (2.5), Contraindications (4), Warnings and Precautions, High Level Radiation Exposure with Use of Incorrect Eluent (5.1).
WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT AND FAILURE TO FOLLOW QUALITY CONTROL TESTING PROCEDURE
Please see full prescribing information for complete boxed warning
High Level Radiation Exposure with Use of Incorrect Eluent
Using incorrect eluent can cause high Sr 82 and Sr 85 breakthrough levels (5.1)
Excess Radiation Exposure with Failure to Follow Quality Control Testing Procedure
Excess radiation exposure occurs when the levels of Sr 82 or Sr 85 in the rubidium Rb 82 chloride injection exceed specified limits (5.2)
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This information is not intended as medical advice. Responsibility for patient care resides with the healthcare professional on the basis of his or her professional license, experience and knowledge of the patient. For full Prescribing Information including indications, contraindications, warnings, precautions and adverse events, please see the appropriate product labeling.