CardioGen-82 150 mCi/1
Rubidium Chloride RB-82 · INJECTION, SOLUTION · Bracco Diagnostics Inc
CardioGen-82 is a injection, solution containing rubidium chloride rb-82 at 150 mCi/1, taken intravenous. Manufactured by Bracco Diagnostics Inc.
Key Facts
- Brand Name
- CardioGen-82
- Generic Name
- Rubidium Chloride RB-82
- NDC Code (Product)
0270-0091- Manufacturer
- Bracco Diagnostics Inc
- Strength
- 150 mCi/1
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA019414
- Marketing Start
- 12/30/1989
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE CardioGen-82, used to produce Rubidium Chloride Rb 82 Injection, is indicated for positron emission tomography (PET) of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease. CardioGen-82, used to produce Rubidium Chloride Rb 82 Injection, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Dosing when using the Model 510 Infusion System: 1,480 MBq (40 mCi), with a range of 1,110 MBq to 2,220 MBq (30 mCi to 60 mCi) per rest or stress component of a procedure via intravenous infusion at 50 mL/min. ( 2.2 ) Dosing when using the Model 1700 Infusion System: 10 MBq/kg to 30 MBq/kg actual body weight (0.27 mCi/kg to 0.81 mCi/kg) per rest or stress component of a procedure via intravenous infusion at 50 mL/minute or 20 mL/minute. ( 2.2 ) 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. ( 2.2 ) The minimum interval between the rest and stress doses is 10 minutes to allow sufficient Rb 82 decay. ( 2.2 ) Start image acquisition 60 seconds to 90 seconds after completion of the infusion; if a longer circulation time is anticipated, wait for 120 seconds. Image acquisition is 5 minutes long. ( 2.3 ) For radiation safety, infusion systems, elution instruction, eluate testing, dose delivery, and expiration limits of CardioGen-82, and radiation dosimetry see full prescribing information. ( 2.1 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9 , 2.10 ) 2.1 Radiation Safety - Drug Handling CardioGen-82,…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: High Level Radiation Exposure with Use of Incorrect Eluent [see Warnings and Precautions ( 5.1 )] Excess Radiation Exposure with Failure to Follow Eluate Testing Protocol [see Warnings and Precautions ( 5.2 )] The following serious adverse reactions have been identified during post-approval use of CardioGen-82. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Radiation Exposure High level radiation exposure to the bone marrow from using an incorrect eluent. Excess radiation exposure due to insufficient eluate testing. To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc. at 1-800-257-8151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Frequently Asked Questions
What is CardioGen-82 used for?
CardioGen-82 contains Rubidium Chloride RB-82. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is CardioGen-82 a controlled substance?
CardioGen-82 is not classified as a controlled substance by the DEA.
What is the generic name for CardioGen-82?
The generic name for CardioGen-82 is Rubidium Chloride RB-82. There are no other listed brand versions of Rubidium Chloride RB-82.
What is the NDC code for CardioGen-82 150 mCi/1?
The NDC (National Drug Code) for CardioGen-82 150 mCi/1 is 0270-0091, listed by Bracco Diagnostics Inc.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)