June 11, 2019 -- Are you getting the most out of your cardiac Rb-82 generator?

Web version

banner
 

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
 
button
  rubyfill
 
split line
 

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).

 
 
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 the incorrect eluent can cause high Strontium (Sr 82) and (Sr 85) breakthrough levels (5.1)
  Use only additive-free 0.9% Sodium Chloride Injection USP to elute the generator (2.5)
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)
Evaluate the patient’s radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow (2.9)
 
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)
  Strictly adhere to the generator quality control testing procedure (2.6)
Stop use of a generator at any of its Expiration Limits (2.7)
 
 
 

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.

 
footer
 
 Do not reply to this email as it was sent from an unmonitored account.
  
Unsubscribe from the Breaking News.
  
Reset your password.
  
Contact AuntMinnie.com support.
  
AuntMinnie.com Privacy Policy
  
Email sent to: .
 

AuntMinnie.com, 1350 North Kolb Road, Suite 215, Tucson, AZ 85715 USA - (520) 298-1000

Copyright © 2019 AuntMinnie.com
 

To read this and get access to all of the exclusive content on AuntMinnie.com create a free account or sign-in now.

Member Sign In:
MemberID or Email Address:  
Do you have a AuntMinnie.com password?
No, I want a free membership.
Yes, I have a password:  
Forgot your password?
Sign in using your social networking account:
Sign in using your social networking
account: