CARDIOGEN-82 Solution for injection (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Bracco Diagnostics Inc
Λέξεις κλειδιά
0270-0091
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BOXED WARNING SECTION
<b>WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT AND FAILURE TO FOLLOW THE ELUATE TESTING PROTOCOL</b> <b><u>High Level Radiation Exposure with Use of Incorrect Eluent</u> <b>Patients ...
1. 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 indicated for Positron Emission Tomography (PET) imaging ...
2. Dosage and Administration
2.1 Radiation Safety Drug Handling Rubidium Rb 82 is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration <em>[See Warnings and ...
3. Dosage Forms and Strengths
CardioGen-82 is a closed system used to produce rubidium Rb 82 chloride injection for intravenous use. CardioGen-82 consists of strontium Sr 82 adsorbed on a hydrous stannic oxide column with an activity ...
4. Contraindications
CardioGen-82 is contraindicated if a solution other than additive free 0.9% Sodium Chloride Injection USP has been used to elute the generator at any time. Immediately stop the patient infusion and permanently ...
5. Warnings and Precautions
5.1 High Level Radiation Exposure with Use of Incorrect Eluent <b>Use only additive free 0.9% Sodium Chloride Injection USP to elute the generator.</b> Apply the provided saline tag to the additive free ...
6.1. Clinical Trials Experience
The following serious adverse reactions have been identified during postapproval use of CardioGen-82. Because these reactions are reported voluntarily from a population of uncertain size, it is not always ...
8.1. Pregnancy
Risk Summary There are no data available on the use of rubidium Rb 82 chloride in pregnant women. Animal reproductive studies have not been conducted with rubidium Rb 82 chloride injection. However, all ...
8.2. Lactation
Risk Summary There is no information regarding the presence of Rb 82 chloride in human milk, the effects on the breastfed infant or the effects on milk production. Due to the short half-life of rubidium ...
8.4. Pediatric Use
Rubidium Rb 82 chloride injection safety and effectiveness in pediatric patients have not been established.
8.5. Geriatric Use
In elderly patients with a clinically important decrease in cardiac function, lengthen the delay between infusion and image acquisition <em>[see Dosage and Administration (2.3)]</em>. Observe for the possibility ...
8.6. Renal Impairment
Reductions in renal function are not anticipated to alter clearance of rubidium Rb 82 chloride injection because Rb 82 decays to stable Kr-82 with a half-life of 75 seconds and Kr-82 is exhaled through ...
8.7. Hepatic Impairment
Reductions in hepatic function are not anticipated to alter clearance of rubidium Rb 82 chloride injection.
11. Description
11.1 Chemical Characteristics CardioGen-82 contains accelerator-produced Sr 82 adsorbed on stannic oxide in a lead-shielded column and provides a means for obtaining sterile nonpyrogenic solutions of rubidium ...
12.1. Mechanism of Action
Rb 82 is analogous to potassium ion (K+) in its biochemical behavior and is rapidly extracted by the myocardium proportional to the blood flow. Rb+ participates in the sodium-potassium (Na+/K+) ion exchange ...
12.2. Pharmacodynamics
In human studies, myocardial activity was noted within the first minute after peripheral intravenous injection of Rb 82. When areas of infarction or ischemia are present in the myocardium, they are visualized ...
12.3. Pharmacokinetics
With a physical half-life of 75 seconds, Rb 82 is very rapidly converted by radioactive decay into a trace amount of stable Kr-82 gas, which is passively expired by the lungs.
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term studies have been performed to evaluate carcinogenic potential, mutagenicity potential, or to determine whether rubidium Rb 82 chloride injection may affect fertility in males or females. ...
14. Clinical Studies
In a descriptive, prospective, blinded image interpretation study<sup>6</sup> of adult patients with known or suspected coronary artery disease, myocardial perfusion deficits in stress and rest PET images ...
15. References
1. Senthamizhchelvan S. et al. Human biodistribution and radiation dosimetry of <sup>82</sup>Rb. J Nucl Med, 2010; 15:1592-99. 2. Senthamizhchelvan S. et al. Radiation dosimetry of <sup>82</sup>Rb in humans ...
16.1. How Supplied
CardioGen-82 (rubidium Rb 82 generator), used to produce rubidium Rb 82 chloride injection, consists of Sr 82 adsorbed on a hydrous stannic oxide column with an activity of 3,330 MBq to 5,550 MBq (90 millicuries ...
16.2. Storage and Handling
Store the generator at 20° to 25°C (68° to 77°F) [See USP]. Receipt, transfer, possession, storage, disposal or use of this product is subject to the radioactive material regulations and licensing requirements ...
17. Patient Counseling Information
Pregnancy Advise a pregnant woman of the potential risk to a fetus <em>[see Use in Specific Populations (8.1)]</em>. Lactation Advise lactating women that exposure to Rb-82 chloride through breast milk ...