Cardiogen 82 Generator

MAUDE Adverse Event Report: BRACCO DIAGNOSTICS INC ...

The test was repeated with equivalent results. This test indicated lower than expected volume to produce the same activity. Shortly thereafter, it was noticed that the bag hanging on the generator to complete the qc tests did not contain the saline solution and was lactated ringer's solution.

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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 Generator (Intravenous) - Drugs.com

Nov 18, 2018· Before Using Cardiogen-82 Generator. In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies

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Cardiogen-82 (rubidium Rb 82 generator) dose, indications ...

PDR Drug Summaries are concise point-of-care prescribing, dosing and administering information to help phsyicans more efficiently and accurately prescribe in their practice PDR's drug summaries are available free of charge and serve as a great resource for US based MDs, DOs, NPs and PAs in patient practice

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

1) Record each generator eluate volume, including waste and test volumes, and keep a record of the cumulative eluate volume [see DOSAGE AND ADMINISTRATION]. CardioGen-82 contains accelerator-produced Sr-82 adsorbed on stannic oxide in a lead-shielded column and provides a …

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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 - FDA prescribing information, side effects ...

Jan 12, 2012· FDA Drug Safety Communication: Planned return of CardioGen-82 to market with new Boxed Warning. ... CardioGen-82 consists of a generator that …

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

Before Using Cardiogen-82 Generator – Rubidium Rb 82 (Intravenous Route) In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies

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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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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 Rb 82 chloride injection for intravenous use

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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. The container label provides complete assay data for each generator.

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Bracco Updates Status of CardioGen-82 Recall, Third ...

Dec 13, 2011· Bracco Updates Status of CardioGen-82 Recall, Third Patient Being Tested. December 13, 2011 – During RSNA 2011, Bracco explained it is working with the U.S. Food and Drug Administration (FDA) to re-introduce CardioGen-82 (Rubidium Rb 82 Generator) since its recall this past summer. ... (MPI) scans with CardioGen-82, crossing U.S. borders who ...

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

Bracco Diagnostics Inc. Launches Web Site on CardioGen-82 ® (Rubidium Rb 82 Generator) Princeton, NJ , 05/28/2005 " www.CardioGen.com" to Feature Updated Information on Cardiac PET Bracco Diagnostics Inc. announced today the launch of a new Web site with content focused on the myocardial perfusion agent CardioGen-82. ...

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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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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 a generator ...

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Drug Notes - Rubidium rb 82 (By injection) - ssl.adam.com

Jul 04, 2018· Cardiogen-82 Generator There may be other brand names for this medicine. When This Medicine Should Not Be Used: You should not receive this medicine if you have had an allergic reaction to rubidium Rb 82. How to Use This Medicine: Injectable. A doctor or other trained health professional will give you this medicine.

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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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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

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

(FSME-11-076, July, Other, Cardiogen-82 Rubidium-82 Generator) July 28, 2011 . ALL AGREEMENT STATES, MICHIGAN . NOTIFICATION OF ISSUANCE OF IMPORTANT VOLUNTARY RECALL INFORMATION CONCERNING THE CARDIOGEN-82 RUBIDIUM-82 GENERATOR (FSME-11-076) Purpose: To provide the Agreement States with a copy of the U.S. Food and Drug

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CardioGen-82®Rubidium Rb 82 Generator - Drug label and ...

Cardiogen-82 (Rubidium Rb 82 Generator) is intended for use only with an appropriate, properly calibrated infusion system labeled for use with the generator. Receipt, transfer, handling, possession or use of this product is subject to the radioactive material ...

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Cardiogen-82 (rubidium Rb 82 generator): 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 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.

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

Sep 15, 2018· 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 of 90-150 millicuries Sr-82 …

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FDA Releases Preliminary Findings From Ongoing CardioGen ...

Jan 13, 2012· 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 perfusion.

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

Sep 15, 2018· Use CardioGen-82 only with an infusion system specifically designed for use with the generator and capable of accurate measurement and delivery of doses of rubidium Rb 82 chloride injection. Follow instructions in the Infusion System User’s Guide for the set up and intravenous infusion of rubidium Rb 82 chloride injection dose(s).

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

Bracco Diagnostics Inc. Launches the New CardioGen-82® (Rubidium Rb 82 Generator) Website with Enhanced Resources Monroe Township, April 1, 2014 - Bracco Diagnostics Inc. - the U.S subsidiary of Bracco Imaging S.p.A., a global leading company in the diagnostic imaging business, announced today

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CardioGen-82®

Module Five: Introduction to CardioGen-82 ® (Rubidium Rb 82 Generator) Module Five Module Five Self-Assessment Glossary References Refresh Page ...

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