• IOWA DEPARTMENT OF PUBLIC HEALTH

    the requirements for licensing Bracco CardioGen-82 Strontium/Rubidium generators. Description of Circumstances: Due to the worldwide shortage of molybdenum and therefore Technecium-99m for diagnostic nuclear medicine studies, many licensees are attempting to purchase Bracco CardioGen-82 Strontium/Rubidium generators for cardiology studies.

  • An Analysis of 3 Common CardioGen-82 82Rb Infusion System ...

    All 3 methods for augmenting the 82 Rb CardioGen-82 Infusion System produced different outcomes for patient dose, image counts, and generator volume use. The standard 50-mL method ensured the maximum amount of counts available for imaging throughout the life of the generator.

  • FDA reminds imaging facilities to follow safety procedures ...

    Apr 29, 2019· FDA reminds imaging facilities to follow safety procedures for rubidium 82 generators used in Positron Emission Tomography (PET) myocardial perfusion imaging

  • Cardiogen-82 - FDA prescribing information, side effects ...

    CardioGen-82 is a radionuclide generator that produces Rb-82 chloride injection; the Rb-82 emits the radiation detected in a PET scan. Rb-82 is a medical isotope with a short half-life (75 seconds ...

  • Cardiogen-82 Generator Advanced Patient Information ...

    Nov 18, 2018· Uses for Cardiogen-82 Generator Rubidium Rb 82 injection is used in adults to help diagnose heart disease. It is used in a procedure called a positron emission tomography (PET) scan to help your doctor see an image of your heart. This medicine shows how much blood is getting to your heart muscle when you are resting or exercising (stressed).

  • CardioGen-82 (by Bracco Diagnostics Inc)

    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 Rb 82 chloride injection. The chemical form of Rb-82 is 82 RbCl. The amount (millicuries) of Rb-82 obtained in each elution will depend on the potency of the generator.

  • An Analysis of 3 Common CardioGen-82 Rb Infusion System ...

    An Analysis of 3 Common CardioGen-82 82Rb Infusion System Injection Methods and Their Impact on Clinical Volume and Image Counts Amanda E. Roby, PET, CNMT, ARRT, Nils P. …

  • Radiation events prompt FDA notice on Rb-82 generators

    Additional long-term risks could include radiation-induced cancers." The revised FDA safety labels include instructions on the proper use of rubidium generators and warnings about the serious consequences of improper procedures. The agency also mandates training for all imaging facilities that use the CardioGen-82 and Ruby-Fill systems.

  • CardioGen-82 Study and Testing Disappears

    Jun 12, 2012· Las Vegas, NV Katie had a CardioGen-82 PET Scan in March 2011 for a heart issue—results came back negative. But in July her doctor called: …

  • t REGU 4UNITED 4 NUCLEAR REGULATORY COMMISSION

    radioactive Strontium-82 used in the Rubidium-82 elution process was, in fact, approved by the Food and Drug Administration, in 2001, as a "Drug" under existing regulation. To further sugport this request, I am including recently updated technical information regarding the CardioGen-82 along with documentation of its FDA approvals.

  • Common Side Effects of Cardiogen-82 (rubidium Rb 82 ...

    May 13, 2019· Cardiogen-82 (rubidium Rb 82 generator) is a diagnostic aid used 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.Common side effects of Cardiogen-82 include: unintended radiation exposure.

  • Bracco`s Rb-82 Generator | manualzz.com

    CardioGen-82® (Rubidium Rb 82 Generator) Infusion System User's Guide. CardioGen-82 Infusion System QC 1st Elution: Generator Column Wash (W) - This prepares the column for use - Performed with a 50 mL elution - Performed daily 2. CardioGen-82® (Rubidium Rb 82 Generator) Infusion System User's Guide. 1st Elution: The Generator Column Wash 1.

  • cardiogen 82 include - googom.be

    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 of 90-150 millicuries Sr-82 at calibration time.

  • Press Room | Bracco Imaging

    Bracco Diagnostics Inc. Launches the New CardioGen-82 ® (Rubidium Rb 82 Generator) Website with Superior Resources. Bracco Imaging partners with PHS Technologies Group, LLC to bring Dose Monitoring Solutions to its customers. Researchers Awarded 2013 Bracco Diagnostics Inc./RSNA Research Grants

  • CardioGen-82 is to return to the US market, with revised ...

    CardioGen-82 is to return to the US market, with revised labelling to include a Boxed Warning,

  • ADMINISTRATION 2-4 safety Medication seconds in

    FDA’s ongoing investigation of the procedures used to test for strontium breakthrough at the clinical sites that use CardioGen-82. Healthcare professionals should consider alternatives to the CardioGen-82 generator when planning nuclear medicine cardiac scans. Chantix (varenicline) drug label now contains updated efficacy and safety information

  • 2014 Meeting of Mid-Atlantic States Radiation Control …

    usage of CardioGen-82 at certain clinical sites is responsible for the exposure of some patients to more radiation than is typically associated with a CardioGen-82 scan. This increased radiation exposure was due to the administration of CardioGen-82 generator eluates that contained excessive

  • CardioGen-82® (Rubidium Rb 82 Generator) | Bracco Imaging

    CardioGen-82 ® (Rubidium Rb 82 Generator) 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 or existing …

  • These highlights do not include all the information needed ...

    CardioGen-82 consists of strontium Sr 82 adsorbed on a hydrous stannic oxide column with an activity of 90-150 millicuries Sr 82 at calibration time. 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.

  • Daniel Chapa - Clinical Application Specialist - Bracco ...

    Include this LinkedIn profile on other websites. Daniel Chapa. Cardiogen-82 Clinical Application Specialist at Bracco Diagnostics Inc. company placeholder image.

  • Cardiogen-82 (rubidium chloride rb-82) Safety Alerts ...

    The following FDA safety notices may be specifically about Cardiogen-82 or relate to a group or class of drugs which include Cardiogen-82 (rubidium chloride rb-82). These notices may include a list of possible medication recalls, market withdrawals, alerts and warnings.

  • rb 82 82rubidium - buy-environmental.co.za

    CardioGen-82 PI to FDA July-27-2010 CLEAN. CardioGen-82 PI to FDA_July-27-2010_CLEAN.doc . HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CARDIOGEN-82 safely and effectively. See full prescribing information for CARDIOGEN-82. CARDIOGEN-82 ® (rubidium Rb 82 Generator) To produce rubidium ...

  • BRACCO DIAGNOSTICS, INC. TO MEET WITH NRC AND …

    of the CardioGen-82® rubidium generators from the market. Discussion: The U.S. Nuclear Regulatory Commission (NRC) plans to conduct a public meeting on February 16, 2012, in Rockville, Maryland, to meet with representatives from Bracco Diagnostics, Inc., manufacturers of the CardioGen-82® rubidium generator. Please see the

  • Nuclear Medicine Clinical Applications Specialist ...

    Apr 25, 2019· ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: Provide full support for the prospective and current CardioGen-82 customers to include Cardiac PET introduction presentations, radiation safety, training and ongoing continuing education. Train all customer personnel on the CardioGen-82® generators, infusion system

  • Rubidium Rb 82 (By injection) - PubMed Health

    Jan 01, 2017· Rubidium Rb 82 injection is used in adults to help diagnose heart disease. It is used in a procedure called a positron emission tomography (PET) scan to help your doctor see an image of your heart. This medicine shows how much blood is getting to …

  • 3D PET Imaging System & Rubidium 82 - Cardiac Imaging

    CardioGen-82 | Cardiac PET Imaging. The Rubidium-82 generator, CardioGen-82, is a closed system that produces the radiotracer for intravenous administration. CardioGen-82 includes a self-contained cart that houses a shield for the generator, on-board support for electronics, and a waste container.

  • Cardiogen-82 Information, Side Effects, Warnings and Recalls

    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 Rb 82 chloride injection. The chemical form of Rb-82 is 82 RbCl. The amount (millicuries) of Rb-82 obtained in each elution will depend on the potency of the generator.

  • The Basics of Cardiac Rb PET/CT

    Introduction • Patients with suspected or known CAD benefit from the information provided by a noninvasive cardiac imaging test, regarding the presence, extent, and severity of CAD. • An important goal of imaging is to provide a high quality appropriate test for the right patient at the

  • 82 generator cardiogen - giardinoristorante.it

    Rubidium82 (82 Rb) is a radioactive isotope of rubidium. 82 Rb is widely used in myocardial perfusion isotope undergoes rapid uptake by myocardiocytes, which makes it a valuable tool for identifying myocardial ischemia in Positron Emission Tomography (PET) imaging. 82 Rb is used in the pharmaceutical industry and is marketed as Rubidium82 chloride under the trade names RUBYFILL ...

  • Bracco Diagnostics Inc. Launches Web Site on CardioGen-82 ...

    CardioGen-82 is the only FDA approved generator-based PET perfusion agent reimbursed for the evaluation of coronary artery disease. As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper patient management and to ensure minimum radiation exposure to occupational workers.

  • Alerts - Index - Medscape

    Alert CardioGen-82 Returns to Market For its return, the FDA-approved revised labeling for CardioGen-82 includes a new boxed warning. The label warns of unintended radiation exposure when levels ...