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Prescribing Information

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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.

Indication for Use

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

Safety and Efficiency

Safety

• Automated safety alerts that help 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

Precision Driven

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*

RUBY-FILL: Reach Even Greater Heights

Safety Data Sheet

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It’s Easy to Get Started with RUBY-FILL

To learn more about the latest advancements in Cardiac PET imaging contact customer service at customerservice@jdi.jubl.com or enter your contact information here:

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This FDA approval provides clearance to use the Rubidium Elution system and RUBY-FILL® (Rubidium Rb82 generator) in mobile settings.

RUBY-FILL is used for cardiac PET imaging under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in patients with suspected or existing coronary artery disease.

Since the FDA approval of RUBY-FILL in 2016, Jubilant Radiopharma has partnered with health care providers across the U.S. to establish and grow cardiac PET programs. Typically, cardiac PET is performed in larger hospitals, outpatient programs and physician offices whose patient volumes can support a full time cardiac PET program. This new offering will enable the use of cardiac PET in smaller community hospitals, in rural settings, and in areas where a full time cardiac PET program may not be warranted.

Jubilant Radiopharma is committed to offering this imaging modality in smaller settings, thereby increasing patient access to the benefits of cardiac PET imaging.

RUBY Mobile Solutions allows you, our customer, the ability to:

• Start a cardiac PET program on a part-time basis
• Experience first-hand the value a RUBY-FILL® (Rubidium Rb 82 Generator) and Elution System can bring to your practice
• Determine how it will fit into a broader program for your patients in the future

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For more information about RUBY Mobile Solutions, please fill out the form below, and we will be in touch with you.

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