Application Information

This drug has been submitted to the FDA under the reference 019414/001.

Names and composition

"CARDIOGEN-82" is the commercial name of a drug composed of RUBIDIUM CHLORIDE RB-82.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
019414/001 CARDIOGEN-82 RUBIDIUM CHLORIDE RB-82 INJECTABLE/INJECTION N per A

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
019414/001 CARDIOGEN-82 RUBIDIUM CHLORIDE RB-82 INJECTABLE/INJECTION N per A
202153/001 RUBY-FILL RUBIDIUM CHLORIDE RB-82 SOLUTION/INTRAVENOUS N per A

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Answered questions

Any Nuclear Medicine Tech using Rb-82 (CardioGen-82)?
Just wondering if there are a lot of these in use. I know there is a notice to stop using them immediately and return them to Bracco. Asked by Shandra Dewit 1 year ago.

The FDA is now telling physicians to stop using CardioGen-82 for cardiac positron-emission tomography (PET) scans after issuing an earlier alert about a risk of increased radiation exposure due to an isotope "breakthrough" problem [1]. The device manufacturer, Bracco Diagnostics, has voluntarily recalled the device. CardioGen-82 is a generator that is used at clinical sites to produce rubidium (Rb)-82 chloride injection used for nuclear medicine scans, the FDA alert notes. As previously reported by heartwire, the FDA issued a July 15, 2011 alert noting that it had received two reports of patients who received more than the expected radiation dose while undergoing cardiac PET scans with Rb-82 chloride injection. According to that communication, the excess radiation exposure occurred as a result of a "strontium breakthrough" problem with the CardioGen-82, and the FDA was investigating the cause. In the alert issued today, the FDA notes that after further investigation, the agency "has determined that the current CardioGen-82 manufacturing procedures are not sufficient to ensure reliable performance of the generator used to produce the Rb-82 chloride injection. Reliable generator performance is essential to help prevent strontium breakthrough from CardioGen-82 and to prevent patients from being exposed to excess radiation." Today's alert does not say that additional cases have been identified, although it does say that the FDA is investigating whether the tests used at sites that used the CardioGen-82 are "sufficient" to have accurately detected strontium breakthrough from the scanner. The agency is advising physicians who use CardioGen-82 for cardiac nuclear scans to use alternative imaging tests while the problem is being investigated, and that patients who have questions or concerns should contact their physicians. SINCERELY YOURS ALWAYS ... Answered by Esmeralda Richeson 1 year ago.


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