DailyMed - CARDIOGEN-82- rubidium chloride rb-82 injection ...

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.

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MAUDE Adverse Event Report: BRACCO DIAGNOSTICS INC ...

The saline bag was replaced after the testing was performed as a matter of routine occurrence. The 500 ml ns bag was inadvertently replaced with a 500 ml bag of lactated ringers. Lactated ringer's solution should not be used with the rb-82 generator because it will result in the release of significantly more sr-82/85 in the elution.

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NDC 0270-0091 Cardiogen-82 Rubidium Chloride Rb-82

Cardiogen-82 with NDC 0270-0091 is a a human prescription drug product labeled by Bracco Diagnostics Inc. The generic name of Cardiogen-82 is rubidium chloride rb-82.

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Cardiogen-82 (rubidium Rb 82 generator) Patient ...

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.

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CardioGen Gets Boxed Warning | Medpage Today

CardioGen Gets Boxed Warning CardioGen-82, a generator that produces the PET imaging agent rubidium-82, can return to market, says the FDA, but it must carry a new boxed warning.

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CardioGen-82 (Bracco Diagnostics Inc): FDA Package Insert ...

Sep 15, 2018· CardioGen-82 ® (rubidium Rb 82 generator) consists of Sr-82 adsorbed on a hydrous stannic oxide column with an activity of 90-150 millicuries Sr-82 at calibration time. A lead shield surrounded by a labeled plastic container encases the generator.

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FSME-11-076, July, Other, Cardiogen-82 Rubidium-82 …

(PET) scans. The manufacturer, Bracco Diagnostics, Inc. has decided to voluntarily recall CardioGen-82. CardioGen-82 consists of a generator that is used at clinical sites to produce rubidium (Rb)-82 chloride injection. A CardioGen-S2 PET scan is one of a variety of nuclear medicine scans that use radioactive drugs to evaluate the heart.

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MAUDE Adverse Event Report: MDS NORDION CARDIOGEN - 82 ...

Model Number SR-85/SR-82 RATIO: Event Date 01/14/2011: Event Type Malfunction Event Description Liquid spill, noticed by staff, to be in generator shield. Staff mopped up spill and scanned for radiation. Radiation not detected. Mopped-up material scanned at a later time and determined to be radioactive.

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

May 13, 2019· 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. Storage And Handling

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CardioGen-82®

Module Three: Introduction to Medical Imaging and Non-Nuclear Cardiac Imaging Module Three Module Three Self-Assessment Module Four: Nuclear Medicine, Nuclear Cardiology and Hybrid Medical Imaging Module Four Module Four Self-Assessment Module Five: Introduction to CardioGen-82 ® (Rubidium Rb 82 Generator) Module Five

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FDA Drug Safety Communication: Planned return of CardioGen ...

Jan 12, 2012· [2-15-2012] The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals; in particular, the medical imaging community, about the planned return of CardioGen-82 …

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wearecardiacpet.com

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 coronary ...

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Cardiogen-82 Generator - Rubidium Rb 82 (Intravenous Route ...

Side Effects of Cardiogen-82 Generator – Rubidium Rb 82 (Intravenous Route) Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Some side effects may occur that usually do not need medical attention.

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CardioGen-82 (Bracco Diagnostics Inc): FDA Package Insert ...

Apr 01, 2019· Store and/or dispose of the generator in accordance with the conditions of NRC radioactive materials license pursuant to 10 CFR, Part 20, or equivalent conditions pursuant to Agreement State Regulation. For questions about the disposal of the CardioGen-82 generator, contact Bracco Diagnostics Inc. at 1-800-447-6883, option 3. 16.3 Storage

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CardioGen-82 (Bracco Diagnostics Inc): FDA Package Insert

Sep 15, 2018· 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 of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected ...

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DailyMed - CARDIOGEN-82- rubidium chloride rb-82 injection ...

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. Close

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Story of Rubidium-82 and Advantages for Myocardial ...

Sep 11, 2015· Rubidium-82 has a long story, starting in 1954. After preclinical studies in dogs showing that myocardial uptake of this radionuclide was directly proportional to myocardial blood flow (MBF), clinical studies were performed in the 80s leading to an approval in the USA in 1989.

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Cardiogen 82 and the Hazards of Radiation Exposure - YouTube

Mar 28, 2012· CardioGen-82 (Bracco Diagnostic, Inc) is literally the combination of a machine that manufactures a low half-life radioactive tracer, Rubidium-82 (half-life of 76 seconds) from its parent ...

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Stop Using the Cardiogen-82; Scanner Recalled - Medscape

July 26, 2011 (Rockville, Maryland)— The FDA is now telling physicians to stop using the CardioGen-82 cardiac positron-emission tomography (PET) scanner after issuing an earlier alert about a ...

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

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Rubidium Rb 82 (Intravenous Route) Description and Brand ...

Cardiogen-82 Generator; Descriptions. 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).

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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.

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CardioGen-82 Information - Food and Drug Administration

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 ...

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How does the CardioGen-82 work? - Searcy Law

Nov 01, 2011· CardioGen-82 is the combination of a machine that manufactures Rubidium-82 from its parent Strontium-82 and Rubidium-82 itself. Read on to find how it works. CardioGen-82 is the combination of a machine that manufactures Rubidium-82 from its parent Strontium-82 and Rubidium-82 itself. Read on to find how it works

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Bracco Diagnostics Inc. Launches the New CardioGen-82 ...

CardioGen-82 is a closed system used to produce rubidium Rb 82 chloride injection for intravenous use. Rubidium Rb 82 chloride injection is a radioactive diagnostic agent indicated ... imaging offer is completed by several medical devices and advanced administration systems for contrast imaging products in the fields of radiology.

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FDA Releases Preliminary Findings From Ongoing CardioGen ...

Jan 13, 2012· FDA Releases Preliminary Findings From Ongoing CardioGen-82 Investigations CardioGen-82 consists of a generator that is used at clinical sites to produce rubidium (Rb)-82 chloride injection. A CardioGen-82 positron emission tomography (PET) scan is one of a variety of nuclear medicine scans that use radioactive drugs to evaluate myocardial ...

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Bracco, Lantheus Partner to Promote CardioGen 82 for PET ...

September 24, 2008 - Bracco Diagnostics Inc. and Lantheus Medical Imaging Inc. said yesterday they entered into an agreement for Lantheus to co-promote Bracco’s CardioGen-82 (Rubidium Rb 82 Generator), a myocardial perfusion positron emission tomography (PET) imaging agent.

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CardioGen-82 (Bracco Diagnostics Inc): FDA Package Insert

Sep 15, 2018· 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 of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with …

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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 ...

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Cardiogen-82 Generator Advanced Patient Information ...

Nov 18, 2018· Other Medical Problems. The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Congestive heart failure—Use with caution. May cause side effects to become worse. Proper Use of Cardiogen-82 Generator

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3D PET Imaging System & Rubidium 82 | Cardiac Imaging, Inc.

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.

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FSME-11-068, July, Other, Cardiogen-82, Rubidium-82 …

(FSME-11-068, July, Other, Cardiogen-82, Rubidium-82 Generator) July 15, 2011 . ALL AGREEMENT STATES, MICHIGAN . NOTIFICATION OF ISSUANCE OF IMPORTANT SAFETY INFORMATION CONCERNING THE CARDIOGEN-82 RUBIDIUM-82 GENERATOR” (FSME-11-068) Purpose: To provide the Agreement States with a copy of the information safety notice issued on

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FDA issues warning on cardiac PET scans - Expert Briefings

FDA issues warning on cardiac PET scans. July 18th, 2011 // 1:18 pm @ jmpickett The FDA has notified the public and the medical imaging community about the potential for inadvertent, increased radiation exposure in patients who underwent or will be undergoing cardiac PET scans with rubidium (Rb)-82 chloride injection from CardioGen-82 (Bracco Diagnostics).

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FDA Halts CardioGen-82, Bracco Starts Recall | Diagnostic ...

Jul 27, 2011· Health care professionals should stop using CardioGen-82 for cardiac positron emission tomography (PET) scans, the FDA said. The manufacturer, Bracco Diagnostics Inc. is voluntarily recalling CardioGen-82, according to an FDA statement released Tuesday afternoon. CardioGen-82 consists of …

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