Rubidium chloride rb-82

Dose Delivery Limit of CardioGen-82 The maximum available Rb 82 activity per elution (dose delivery limit) will decrease as the generator ages. Certain doses, including the maximum recommended dose of 2,220 MBq (60 mCi), may not be achievable for the entire shelf-life of the generator. Table 1 provides an estimate of the maximum available activity of Rb 82 as a function of generator age for a generator with an initial 100 mCi of Sr 82. [See table below.] <60 mCi at ≥ 14 days and ≥ 33 days, respectively.

Dosing and Administration of Rubidium Chloride Rb 82 Injection Dosing The recommended dose of Rubidium Chloride Rb 82 Injection per rest or stress component of a PET MPI procedure in adults is 10 MBq/kg to 30 MBq/kg actual body weight (0.27 mCi/kg to 0.81 mCi/kg) administered by intravenous infusion at 50 mL/minute or 20 mL/minute through a catheter inserted into a large peripheral vein.

Do not exceed a maximum dose of 2,220 MBq (60 mCi) or a maximum volume of 100 mL per rest or stress component of a procedure. Administration Instructions Observe aseptic techniques in all drug handling and administration. Use CardioGen-82 with the CardioGen-82 Model 1700 Infusion System to elute and administer Rubidium Chloride Rb 82 Injection.

Use the lowest dose necessary, consistent with the goal of as low as reasonably achievable (ALARA), to obtain adequate cardiac visualization based on patient body weight and the imaging equipment and acquisition methodology used to perform the procedure. For example, 3D image acquisition may require doses at the lower end of the recommended range, compared to 2D imaging.

Administer two single doses to complete rest and stress myocardial perfusion imaging (MPI) [see Dosage and Administration] . The minimum interval between the rest and stress doses is 10 minutes to allow sufficient Rb 82 decay. Instruct patients to void as soon as a study is completed and as often as possible thereafter for at least one hour [see Warnings and Precautions] .

Infusion System Use CardioGen-82 only with the CardioGen-82 Infusion System Model 1700, which is specifically designed for use with the generator and capable of accurate measurement and delivery of doses of Rubidium Chloride Rb 82 Injection. The accuracy of the CardioGen-82 Infusion System Model 1700 for measuring Rubidium Rb 82 Chloride Injection is as follows: For doses of 1,110 MBq to 2,220 MBq (30 mCi to 60 mCi), the system provides an accuracy of ± 10%.

For doses of 370 MBq to 1,110 MBq (10 mCi to 30 mCi), the system provides an accuracy of ± 15%. Follow instructions in the CardioGen-82 Infusion System Model 1700 Operator’s Manual for the setup and administration of Rubidium Chloride Rb 82 Injection.

Eluate Testing Protocol for Infusion System Model 1700 General Precautions Use only additive-free 0.9% Sodium Chloride Injection for all elutions [see Warnings and Precautions] . Observe aseptic technique throughout. Follow all instructions in the CardioGen-82 Infusion System Model 1700 Operator’s Manual for performing all eluate testing as described.

Mandatory Eluate Testing Perform Mandatory Eluate Testing to determine Rb 82, Sr 82, and Sr 85 levels (see Daily Quality Control Procedure) : Daily – Before administering Rubidium Chloride Rb 82 Injection to the first patient each day. Repeat as indicated after an Alert Limit has been detected. Alert Limits and System Response : The CardioGen-82 Infusion System Model 1700 will automatically indicate when any of the following Alert Limits have been reached: 14 L total elution volume has passed through the generator column, or Sr 82 level reaches 0.002 microCi per mCi Rb 82, or Sr 85 level reaches 0.02 microCi per mCi Rb 82.

Once an Alert Limit has been reached, the system will require additional eluate testing at intervals determined by the day’s elution volume and enforced by the system software. Specifically, the infusion system will require the user to perform additional eluate testing after each 750 mL of elution volume when any Alert Limit parameter has been reached.

Infusion System Calibration Before administering Rubidium Chloride Rb 82 Injection to the first patient, perform the Rubidium Chloride Rb 82 Injection Dose Calibration using an external dose calibrator at the following times (see Calibration Procedure) : After installation of a new generator After installation of a new CardioGen-82 Accessory Package, Item # 001710 Every 14 days Calibration Procedure Set a dose calibrator for Rb 82 as recommended by the manufacturer.

Obtain the reading from the instrument in millicuries. Following the prompts in the Graphical User Interface (GUI) for the CardioGen-82 Infusion System Model 1700, elute the generator with additive-free 0.9% Sodium Chloride Injection at a rate of 50 mL/min and collect the eluate in the stoppered vial specifically provided for use with the CardioGen-82 Infusion System Model 1700 (alternative vials, glass or plastic are not suitable).

Note the exact time of end of elution (EOE). Using the external dose calibrator, assay the eluate at exactly 2:30, 3:45, or 5:00 minutes after EOE. Following the prompts in the GUI for the CardioGen-82 Infusion System Model 1700, enter the Rb 82 reading from the dose calibrator and the time since EOE. The infusion system software will automatically calculate the Calibration Ratio.

If the ratio is within +/- 2% (0.98 to 1.02), the infusion system will allow acceptance of the calibration factor that was used for the elution. If the ratio is not within +/- 2% (0.98 to 1.02), the system requires another calibration elution (steps 1 through 4). Repeat steps 1 through 4 for a flow rate of 20 mL/min. Daily Quality Control Procedure Each day, before administering Rubidium Chloride Rb 82 Injection, perform the following testing: Place the stoppered vial into the Sr detector well.

Use only the stoppered vial provided for use with the CardioGen-82 Infusion System Model 1700. Following the GUI prompts, initiate the Daily Quality Control workflow. The infusion system will automatically perform the Sr Detector Background Reading. The infusion system will automatically perform the Generator Column Wash.

Strontium Level Test and Dose Constancy: The infusion system will elute the generator with 50 mL of additive-free 0.9% Sodium Chloride Injection at a rate of 50 mL/min into the stoppered vial. The Sr detector measures the Rb 82 and strontium in the 50 mL elution. The infusion system software will automatically calculate the Sr 82 and Sr 85 levels on the day (post calibration) of the measurement using the ratio of Sr 85/Sr 82 on the day of calibration provided on the generator label, and using the full exponential decay calculation for each, accounting for the generator’s age.

Using the Rb 82 and strontium measurements, the infusion system software will automatically calculate microCi Sr 82/mCi Rb 82 and microCi Sr 85/mCi Rb 82. The GUI will automatically indicate if the results exceed Alert or Expiration Limits. The infusion system software will automatically calculate Dose Constancy. Constancy Check of the Sr detector: The GUI will prompt the user to perform the constancy check of the Sr detector.

Place the external constancy source in the detector well of the infusion system. The infusion system software will automatically calculate the constancy of the Sr detector versus the external constancy source when instructed.

Expiration Limits of CardioGen-82 The CardioGen-82 Infusion System Model 1700 software will automatically indicate and will stop use of CardioGen-82 once any one of the following Expiration Limits is reached. A total elution volume of 17 L has passed through the generator column 60 days post 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