CARDIOGEN-82

WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT and FAILURE TO FOLLOW THE ELUATE TESTING PROTOCOL High Level Radiation Exposure with Use of Incorrect Eluent Patients are exposed to high radiation levels when the CardioGen-82 generator is eluted with the incorrect eluent due to high strontium (Sr) 82 and Sr 85 breakthrough levels. Use only additive-free 0.9% Sodium Chloride Injection to elute the generator. If an incorrect solution is used to elute the CardioGen-82 generator: Immediately stop the patient infusion; Evaluate the patient’s radiation absorbed dose, and monitor for the effects of radiation to critical organs such as bone marrow; Permanently discontinue the use of the affected generator [see Dosage and Administration (2.5) and Warnings and Precautions (5.1) ]. Excess Radiation Exposure with Failure to Follow the Eluate Testing Protocol Excess radiation exposure occurs when the levels of Sr 82 or Sr 85 in the Rubidium Chloride Rb 82 Injection exceed specified limits. Record each generator eluate volume, including waste and test volumes, and keep a record of the cumulative eluate volume. Strictly adhere to the generator eluate testing protocol, to minimize the risk of excess radiation exposure, including daily testing and additional testing at Alert Limits. Stop using the generator if it reaches any of its Expiration Limits: 17 L for the generator’s cumulative eluate volume 42 days post generator calibration date An eluate Sr 82 level of 0.01 microCi /mCi Rb 82 An eluate Sr 85 level of 0.1 microCi /mCi Rb 82 [see Dosage and Administration ( 2.5 , 2.6 , 2.7 , 2.8 ) and Warnings and Precautions ( 5.2 )] WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT and FAILURE TO FOLLOW THE ELUATE TESTING PROTOCOL 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. Use only addit