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RUBY-FILL® (Rubidium Rb82 Generator)

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Important Safety Information

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The RUBY-FILL® Rubidium 82 Generator contains an 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.

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. PET imaging with Rb-82 Chloride may be performed under rest and/or stress conditions.

The Rubidium Elution System has been exclusively designed to be used with the RUBY-FILL® generator and to deliver accurate doses of Rb-82 Chloride to patients.

Indication

RUBY-FILL® (Rubidium Rb 82 Generator) produces a parenteral solution of 82RbCl (Rubidium Chloride Rb 82 Injection) for intravenous infusion. Rubidium Chloride Rb 82 Injection is indicated as an accessory to positron emission tomography (PET) for imaging of the myocardium, to evaluate regional myocardial perfusion in adult patients, as an aid in the diagnosis or assessment of suspected or known coronary artery disease.

RUBY-FILL® (Rubidium Rb 82 Generator) must be used with an infusion system specifically labeled for use with the generator and capable of accurate measurement and delivery of adequate doses of Rubidium Chloride Rb 82 Injection.

SERIOUS WARNINGS AND PRECAUTIONS

Radiopharmaceuticals should be used only by those health professionals who are appropriately qualified in the use of radioactive prescribed substances in humans. Rubidium Rb-82 chloride should not be administered to pregnant women unless it is considered that the benefits to be gained by the patient outweigh the potential hazards to the fetus.

The product should be administered under the supervision of a health professional who is experienced in the use of radiopharmaceuticals. Appropriate management of therapy and complications is only possible when adequate diagnostic and treatment facilities are readily available.

Safety Data Sheets

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Fiche de données de sécurité

 

Operation Automation

Safety

  • Automated safety alerts and how they minimize risk of strontium breakthrough
  • System lockout denies access to patient infusion controls if quality control is not completed or if strontium levels are elevated
  • No need to record dose calibrator readings or manually calculate strontium breakthrough detection

Efficiency

  • Automated quality control and reports
  • Enhanced maneuverability
  • Stick-on printed patient infusion labels
  • 30 L generator volume

Engineered for User Confidence & Efficiency

  • 30L generator volume for flexible capacity
  • Long 60-day shelf life
  • Enhanced maneuverability

Accurate Patient-Specific Infusion Options

  • Weight-Based Dosing
  • Constant-Activity Options
  • Reduces test-retest Variability

Click here to view Full Prescribing Information

 

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