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CardioGen-82 is a closed system used to produce rubidium Rb 82 chloride injection for intravenous administration. Rubidium Rb 82 chloride injection is 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 of existing coronary artery disease.

 

 

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www.cardiogen.com

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Indications and Usage:
CardioGen-82 is a closed system used to produce rubidium Rb 82 chloride injection for intravenous administration.  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.

IMPORTANT SAFETY INFORMATION

WARNING: UNINTENDED STRONTIUM-82 (Sr-82) AND STRONTIUM-85 (Sr-85) RADIATION EXPOSURE

Unintended radiation exposure occurs when the levels of Sr-82 or Sr-85 in the rubidium Rb 82 chloride injection exceed specified limits [see Warnings and Precautions (5.1)].


Perform generator eluate tests:

1. Record each generator eluate volume, including waste and test volumes, and keep a record of the cumulative eluate volume [see Dosage and Administration (2.4)].


2. Determine Rb-82, Sr-82, Sr-85 levels in the eluate:

  • Once daily, prior to any drug administrations, and
  • At additional daily tests after detection of an Alert Limit. Alert Limits are:
    • 14 L for the generator's cumulative eluate volume, or
    • An eluate Sr-82 level of 0.002 μCi/mCi Rb-82, or
    • An eluate Sr-85 level of 0.02 μCi/mCi Rb-82.
    • Perform the additional daily tests at time points determined by the day's elution volume; tests are performed every 750 mL [see Dosage and Administration (2.5)].

3. Stop use of a generator at an Expiration Limit of:

  • 17 L for the generator's cumulative eluate volume, or
  • 42 days post generator calibration date, or
  • An eluate Sr-82 level of 0.01 μCi/mCi Rb-82, or
  • An eluate Sr-85 level of 0.1 μCi/mCi Rb-82 [see Dosage and Administration (2.6)].

 

Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular events. Perform pharmacologic stress testing in accordance with the pharmacologic stress agent's prescribing information and only in the setting where cardiac resuscitation equipment and trained staff are readily available.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call 1-800-FDA-1088.

For more information about CardioGen-82 go to www.cardiogen.com

CardioGen-82 is manufactured for Bracco Diagnostics Inc.