RUBY-FILL® (Rubidium Rb82 Generator)

The RUBY-FILL® Rubidium82 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.

Prescribing Information 

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Indication:

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

WARNING: UNINTENDED STRONTIUM 82 (Sr 82) AND STRONTIUM 85 (Sr 85) RADIATION EXPOSURE

Please see full prescribing information for complete boxed warning

  • Unintended radiation exposure occurs when the levels of Sr 82 or Sr 85 in the rubidium Rb 82 chloride injection exceed specific limits.
  • Perform generator eluate tests:

1) Determine Rb 82, Sr 82, Sr 85 levels in the eluate:

  •  Once daily, prior to any drug administration, and
  •  With additional daily tests after detection of an Alert Limit.

2) Stop use of the generator at its Expiration Limit.

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Safety Data Sheets

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DISCLAIMER:

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.