Are you getting the most out of your Rb-82 Generator?
The RUBY-FILL® Rubidium 82 Generator is clinically proven to deliver industry-leading efficiency
with reliable consistency and dosing flexibility.1-3
RUBY-FILL® has been proven to:
Consistently deliver expected yield with nearly
100% accuracy
In a recent study comparing currently available generators,
RUBY-FILL® showed industry-leading efficiency3
Deliver highly accurate patient doses
Over the life of the generator, the deviation of delivered dose vs. requested dose approached 0%3
Provide clinical flexibility
RUBY-FILL® provides a long shelf life and flexible,
patient-specific dosing1
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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.
New Important Safety Information April 2019
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).
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WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT AND FAILURE TO FOLLOW QUALITY CONTROL TESTING PROCEDURE
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Please see full prescribing information for complete boxed warning
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High Level Radiation Exposure with Use of Incorrect Eluent
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Using the incorrect eluent can cause high Strontium (Sr 82) and (Sr 85) breakthrough levels (5.1)
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Use only additive-free 0.9% Sodium Chloride Injection USP to elute the generator (2.5)
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Immediately stop the patient infusion and discontinue the use of the affected RUBY-FILL generator if the incorrect solution is used to elute the generator (4)
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Evaluate the patient’s radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow (2.9)
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Excess Radiation Exposure with Failure to Follow Quality Control Testing Procedure
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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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Strictly adhere to the generator quality control testing procedure (2.6)
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Stop use of a generator at any of its Expiration Limits (2.7)
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The risk information provided here is not comprehensive.
Please visit RUBY-FILL.com for full Prescribing Information including BOXED WARNING.
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.
References: 1. RUBY-FILL® [package insert]. Kirkland, Quebec, Canada: Jubilant DraxImage Inc; April 2019. 2.
Renaud JM, Wiles M, Garrard L, Beanlands RSB, deKemp A. New rubidium-82 generator efficiency improves over time. J Nucl Med. 2018;59
(suppl 1):1045. 3. Lewin HC, Millard A. Dose accuracy of 82Rb generator systems. Paper presented at: SNMMI Mid-Winter Meeting;
January 17–19, 2019; Palm Springs, CA.
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