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Cyndex Pharmacy

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ph. +233 21553370
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MANARA HEALTHCARE

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3-11 Primrose Avenue Rosebery
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ph. +61 296624144
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ph. +91 9819725471
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Tao Corporate Centre 2291
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ph. (632) 836-5838
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Healthcare Distribution Centre
24 Penjuru Road (off Penjuru Close)
#03-04 CWT Commodity Hub
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ph. +65 65097629
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SUPER FORTUNE ENTERPRISE CO LTD

5 F-1 - 42 Sec.1 Ming
Sheng E. Road Jehovah Building
101 Taipei
(Taiwan)

ph. +886 225673456
Fax +886 225319231
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Interpharmacare Co., Ltd.

90 Moo 13 Soi Mahacha
Bangpleeyai
Bangplee
Samutprakarn 10540
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ph. + 66 2 675 9140-2
Fax + 66 2 325 0265
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HOANG GIA INVESCO, JSC

No 74-76 Hoa Bang Str
Cau Giay
Dist Ha Noi Hanoi
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ph. +43 7846952
 

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REGIONAL HEALTH CARE GROUP

3-11 Primrose Avenue Rosebery
NSW 2018 - Sydney
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ph. +61 296624144
Fax +61 296626040
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India

Imaging Products (India ) Ltd

Mumbai
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ph. +91 9819725471
Fax +91 2228320208
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PT DIPA PHARMALAB INTERSAINS

Jl. Panjang No. 10
Kebon Jeruk
Jakarta 11530
(Indonesia)

ph.  +62 215348644
Fax +62 2153676066
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REGIONAL HEALTH LIMITED

19C Orbit Drive
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ph. +64 94140040
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S. EJAZUDDIN & CO LTD

PO Box 5629 - Zia Plaza
Altaf Hussain Road
74000 Karachi
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ph. +92 21212032
Fax +92 212629716
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NEW MARKETLINK INTERNATIONAL CORP

Tao Corporate Centre 2291
Don Chino Roches Ave
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ph. (632) 836-5838
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LF ASIA PHARMACEUTICAL DIVISION

Healthcare Distribution Centre
24 Penjuru Road (off Penjuru Close)
#03-04 CWT Commodity Hub
(Singapore 609128)

ph. +65 65097629
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SUPER FORTUNE ENTERPRISE CO LTD

5 F-1 - 42 Sec.1 Ming
Sheng E. Road Jehovah Building
101 Taipei
(Taiwan)

ph. +886 225673456
Fax +886 225319231
Thailand

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Interpharmacare Co., Ltd.

90 Moo 13 Soi Mahacha
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Samutprakarn 10540
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ph. + 66 2 675 9140-2
Fax + 66 2 325 0265
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HOANG GIA INVESCO, JSC

No 74-76 Hoa Bang Str
Cau Giay
Dist Ha Noi Hanoi
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ph. +43 7846952

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JUSTESA IMAGEN ARGENTINA, S.A.

Viamonte 1328, 9º piso
1053 Buenos Aires
(Capital Federal)

ph. +5411 4373-0629
Colombia

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Colombia

Sistemas Medicos, LTDA.

Apartado Aereo 24456
Calle 58 No. 35A61
Bogota
(Colombia)

ph. +571-221-9837
Fax +571-222-5310
Perù

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Perù

REIMED, SCRL

Pasaje Villaran 192-194 U-12
Urb. Los Sauces Surquillo
Lima 15076
(Peru)

ph. 511-448-1087
Fax 511-448-3447
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Lifenir S.A.

Justicia 2069
C 11800 Montevideo
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ph. +5982-400-3020
Fax +5982-4007320
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SUFOMECA

Torre Polar Oeste
Plaza Venezuela
Floor 7, Room 7C
Caracas
PO Box 1050
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ph. +582-12-793-3222
Fax +582-12-781-1923

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App. 27 - Floor 8
1164 Sofia
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ph. +359 29624478
Fax +359 28683968
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LERIVA IMAGING S.A.

33 Pigis Avenue &
6 Anapiron Polemou Street
151 27 Melissia
Athens (Greece)

ph. +30 210-6199886
Fax +30 210 61 78 733
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EWOPHARMA A.G. ROMANIA

B-dul Primaverii 19 -21
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011972 - Bucharest
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ph. +40 212601344
Fax +40 212029327
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EWOPHARMA REPRESENTATION OFFICE

Budakeszi ut 73/F
H-1021 Budapest
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ph. +36 12004650
Fax +36 13980316

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Local distributor

Ethiopia

Caroga Pharma PVT. Ltd

P.O.Box 12627
Addis Abeba
(Ethiopia)

ph. +251 11 4654944 / 11 4161090
Fax +251 11 4654595
Ghana

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Ghana

Cyndex Pharmacy

P.O.Box DS 1165 Dansoman
Accra
(Ghana)

ph. +233 21553370
Fax +233-244366622 / 21850072
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Israel

DEXCEL

Or-Akiva 30600
30600000 Israel
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ph. +972-4-6364015
Fax +972-4-6364004
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THE ARAB DRUG STORE

Khaleel Al Salem street
Amman
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ph. +962 6 5502995
Fax +962 6 5502984
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Nairobi X-Rays Supplies Ltd.

P.O. Box 41669
Nairobi
(Kenya)

ph. +254 20446265-6-7-8
Fax +254 20 4448515/17
Lebanon

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Lebanon

Unione Pharmaceutic. d'Orient

Rue du Musée Imm. Stephan QtrBadaro
Beyrouth
(Lebanon)

ph. +961 1 396085-6
Fax +961 1 396047
Mauritius

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Mauritius

The Mauritius Pharmacy

4, Louis Pasteur Str Forest Side
(Mauritius)

ph. +230 6762435
Fax +230 675 1387
Saudi Arabia

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Saudi Arabia

SARABEEL COMMERCIAL EST.

Medical Division
P.O. BOX 14795
21434 Jeddah
(Saudi Arabia)

ph. +966 12657 2246
South Africa

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South Africa

AXIM - Head Office Midrand

121 Gazelle Avenue
Corporate Park South
Midrand Johannesburg 2000
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ph. +27 113140140
Fax +27 113140141
Uganda

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Uganda

Kampala X-Rays Suppliers

Plot 181 Bombo Rd (KuBbiri)
P.O. Box 9519
Kampala
(Uganda)

ph. +256 41 534313
Fax +256 41 349919
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DELTA MEDlCAL

Delta Medical Promotions AG Representative Office
43 Chernovola Street
08132 Vyshneve, Kyiv region
Ukraine

ph. +38 445933355

RESP product logo

CardioGen-82 (Rubidium Rb 82 Generator): Image quality and efficiency in cardiac Positron Emission Tomography (PET) for more than two decades.

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RESP product logo

SDS

For more information about the safety of the CardioGen-82 system Download the Safety Data Sheet (PDF)

CardioGen-82® (Rubidium Rb 82 Generator)

accordion

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 artery disease.

CardioGen-82 system's high sensitivity and specificity can improve diagnostic accuracy.1-4

  • Diagnostic accuracy: 92% sensitivity, 81% specificity4

More counts with PET can mean improved image quality1,5,6:

  • PET's higher spatial and contrast resolution can provide higher sensitivity1,7,8
  • PET's dedicated attenuation correction can lead to fewer artifacts and increased specificity1,7
  • Shorter image acquisition times can mean less patient movement during scanning, resulting in better images. A typical PET MPI rest/stress protocol can take as little as 1/6th the time of a typical SPECT study (excluding patient preparation and documentation)1,2

PET MPI provides benefits for a diverse patient population:

  • Limited mobility patients can experience greater comfort with shorter image acquisition times.
  • Pharmacologic stress option for those unable to perform a treadmill test.
  • Women - PET MPI's lesser soft-tissue attenuation can result in better image quality, regardless of breast size1,7,10
  • High-BMI patients - Less soft-tissue attenuation with PET can lead to better image quality.1,9,10 According to the Mayo Clinic, PET is "recommended for men over 120 kg and women over 100 kg, in whom SPECT images are frequently of poor quality" 11

Consider PET MPI for your thriving practice.
Cardiac PET offers not only excellent performance but also efficiencies:

  • CONVENIENCE - A typical PET MPI rest/stress protocol can take as little as 1/6th the time of a typical SPECT study (excluding patient preparation and documentation)1,2
  • EFFICIENCY - On-demand, fixed-cost CardioGen-82 system reduces logistic hassles associated with unit dose agents
  • CERTAINTY - Greater diagnostic certainty can reduce costly serial testing1,2
  • NON-INVASIVE - PET procedure can help reduce overall radiation exposure to occupational staff and patients from serial testing.12-14

The Bracco Nuclear Medicine team strongly emphasizes education and provides on-site training for all CardioGen-82 system users to safeguard you and your patients.

Occupational Safety

  • Occupational "radiation doses for all tasks during routine Rb-82 stress-rest PET are lower than measured Tc-99m MIBI values."14

Bracco demonstrates its commitment to the safe use of the CardioGen-82 system for years to come through unparalleled safety protocols and customer training.

Patient safety
Recent data set the record straight on radiation dosimetry with the CardioGen-82 system.
(Also, see CardioGen-82 (Rubidium Rb 82 Generator) boxed WARNING)

  • "A clinical 82Rb injection of 2 ⚫ 1,480 MBq (80 mCi) would result in...only slightly above the average annual natural background exposure in the United States (3.1 mSv)"12
  • "...reasonably low radiation exposure"12
    Only 3.7 mSv average radiation exposure to the patient6,12

1.Bateman TM, Heller GV, McGhie AI, et al. Diagnostic accuracy of rest/stress ECG-gated Rb-82 myocardial perfusion PET: comparison with ECG-gated Tc-99m sestamibi SPECT. J Nucl Cardiol. 2006;13(1):24-33. 2.Merhige ME, Breen WJ, Shelton V, Houston T, D'Arcy BJ, Perna AF. Impact of myocardial perfusion imaging with PET and 82Rb on downstream invasive procedure utilization, costs, and outcomes in coronary disease management. J Nucl Med. 2007;48(7):1069-1076. 3.Patterson RE, Eisner RL, Horowitz SF. Comparison of cost-effectiveness and utility of exercise ECG, single photon emission computed tomography, positron emission tomography, and coronary angiography for diagnosis of coronary artery disease. Circulation. 1995;91(1):54-65. 4.CardioGen-82 (Rubidium Rb 82 Generator) full Prescribing Information. Monroe Township, NJ: Bracco Diagnostics Inc., April 2013. 5.Rahmim A, Zaidi H. PET versus SPECT: strengths, limitations and challenges. Nucl Med Commun. 2008;29(3):193-207. 6.DiCarli, M. et al (2007). Cardiac PET and PET/CT Imaging. New York. Springer. 7.Yoshinaga K, Chow BW, Williams K, et al. What is the Prognostic Value of Myocardial Perfusion Imaging Using Rubidium-82 Positron Emission Tomography? J. Am. Coll. 2006;48:1029-1039. 8.Go RT, Marwick TH, MacIntyre WJ, et al. A Prospective Comparison of Rubidium-82 PET and Thallium-201 SPECT Myocardial Perfusion Imaging Utilizing a Single Dipyridamole Stress in the Diagnosis of Coronary Artery Disease. J Nucl Med. 1990;31(12):1899-1905. 9.Schwaiger M, Ziegler S, Nekolla SG. PET/CT: challenge for nuclear cardiology. J Nucl Med. 2005;46(10):1664-1678. 10.Sampson UK, Dorbala S, Limaye A, et al. Diagnostic Accuracy of Rubidium-82 Myocardial Perfusion Imaging With Hybrid Positron Emission Tomography/Computed Tomography in the Detection of Coronary Artery Disease. J. Am. Coll. Cardiol. 2007;49:1052-1058. 11.Gibbons RJ, Chareonthaitawee P. Establishing the prognostic value of Rb-82 PET myocardial perfusion imaging: a step in the right direction. JACC Cardiovasc Imaging. 2009;2(7):855-857. 12.Senthamizhchelvan S, Bravo PE, Esaias C, et al. Human biodistribution and radiation dosimetry of 82Rb. J Nucl Med. 2010;51(10):1592-1599. 13.Senthamizhchelvan S, Bravo PE, Lodge MA, Merrill J, Bengel FM, Sgouros G. Radiation dosimetry of 82Rb in humans under pharmacologic stress. J Nucl Med. 2011;52(3):485-491. 14.Schleipman AR, Castronovo FP Jr, Di Carli MF, Dorbala S. Occupational radiation dose associated with Rb-82 myocardial perfusion positron emission tomography imaging. J Nucl Cardiol. 2006;13(3):378-384.

Product Order # Product Description (unit size)  
CardioGen-82®   CardioGen-82 Accessory Package

001510

CardioGen-82 Accessory Pack (1 complete set of tubing for Infusion System)

CardioGen-82 Accessory Package
001520 CardioGen-82 Waste Bottle (2 bottles / box) CardioGen-82 Waste Bottles
001530 CardioGen-82 Elution Test Vials (25 – 50mL vials / box) CardioGen-82 Elution Test Vial
001550 CardioGen-82 Elution Vial Shield (1 shield / box) CardioGen-82 Elution Test Vial Shield
001511 CardioGen-82 Waste Bottle Caps (12 vented caps / box) CardioGen-82 Waste Bottle Caps
001506 CardioGen-82 42” Patient Administration Set (25 sets / box) CardioGen-82 Patient Administration
001565 CardioGen-82 Thermal Printer Paper (12 rolls / box) CardioGen-82 Thermal Printer Paper

Note: These items may not be returned for credit

Questions?

  • Call Customer Service at 1-877-BRACCO-9 (1-877-272-2269), Option 2.

For more information on prescribing the CardioGen-82 system including the boxed WARNING,

For more information about the safety of the CardioGen-82 system

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"Handbook of Nuclear Cardiology: Cardiac SPECT and Cardiac PET"

Gary Heller & Rober C. Hendel Editors, published by Springer-Verlag London 2013, Chapter 2 Cardiac Positron Emission Tomography, by Justin Lundbye, MD

Useful Nuclear Medicine and Radiology Links
For more information regarding Nuclear Medicine and Radiology, Healthcare Administration, Cardiology, Accreditation and Certification, and more, see the links below.

This Internet site may provide links or references to other sites but the owners of this site have no responsibility for the content of such other sites and shall not be liable for any damages or injury arising from that content. Any links to other sites are provided as merely a convenience to the users of this Internet site.

American Society of Nuclear Cardiology
www.asnc.org 

American College of Cardiology
www.acc.org

Molecular Imaging Technology Alliance
www.medicalimaging.org

American Heart Association
www.heart.org

MedAxiom
www.medaxiom.com 

Society of Nuclear Medicine and Molecular Imaging
www.snmmi.org 

Bracco offers A Patient Guide to Cardiac PET Imaging (PDF) with helpful information about cardiac PET imaging from the patient perspective.

Your patients may have many questions about their cardiac PET exam, including:

  • What is a cardiac PET exam?
  • How should I prepare?
  • Who will read the results?

We’ve developed this Patient Guide to Cardiac Imaging that you can download and print out for your patients, to help answer many of those questions.

To review these articles in their entirety, please contact your Local Account Manager.

Influence of Sex on Risk Stratification with Stress Myocardial Perfusion Rb-82 Positron Emission Tomography
Jenna Kay, Sharmila Dorbala, Abhinav Goyal, Reza Fazel, Marcelo DiCarli, Andrew Einstein, Robert Beanlands, Michael Merhige, Brent Williams, Emir Valedar, Benjamin Chow, James Min, Daniel Berman, Sana Shah, Naveen Bellam, Javed Butler, Leslee Shaw
Download Abstract 

Diagnostic Performance of Positron Emission Tomography in the Detection of Coronary Artery Disease: a Meta-Analysis
Kiran R. Nandalur, MD, Ben A. Dwamena, MD, Asim F.Choudhri, MD, Sirisha R. Nandalur, MD, Priya Reddy, and Ruth C. Carlos, MD
Download Abstract 

Impact of Myocardial Perfusion Imaging with PET and 82Rb on Downstream Invasive Procedure Utilization, Costs, and Outcomes in Coronary Disease Management
Michael E. Merhige, William J. Breeny, Victoria Shelton, Teresa Houston, Brian J. D'Arcy, and Anthony F. Perna
Download Abstract 

Diagnostic Accuracy of Rest/Stress ECG-Gated Rb-82 Myocardial Perfusion PET: Comparison with ECG-Gated Tc-99m Sestamibi SPECT
Timothy M. Bateman, MD, Gary V. Heller, MD, PhD, A. Iain McGhie, MD, John D. Friedman, MD, James A. Case, PhD, Jan R. Bryngelson, BN, Ginger K. Hertenstein, CNMT, Kelly L. Moutray, ME, Kimberly Reid, MS, and S. James Cullom, PhD
Download Abstract 

Clinical Myocardial Perfusion PET/CT*
Marcelo F. Di Carli, Sharmila Dorbala, Jolene Meserve, Georges El Fakhri, Arkadiusz Sitek, and Stephen C. Moore
Download Abstract 

Radiation Dosimetry of 82Rb in Humans Under Pharmacologic Stress
Srinivasan Senthamizhchelvan, Paco E. Bravo, Martin A. Lodge, Jennifer Merrill, Frank M. Bengel, and George Sgouros
Download Abstract 

Human Biodistribution and Radiation Dosimetry of 82Rb
Srinivasan Senthamizhchelvan, Paco E. Bravo, Caroline Esaias, Martin A. Lodge, Jennifer Merrill, Robert F. Hobbs, George Sgouros, and Frank M. Bengel
Download Abstract 

Occupational Radiation Dose Associated with Rb-82 Myocardial Perfusion Positron Emission Tomography Imaging
A. Robert Schleipman, CNMT, RT, MA, Frank P. Castronovo, Jr, PhD, FACR, Marcelo F. Di Carli, MD, FACC, and Sharmila Dorbala, MBBS, FACC
Download Abstract 

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1-800-257-5181, Option 1

Professional Services

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Indications and Usage

Indications and Usage:
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 artery disease.

IMPORTANT SAFETY INFORMATION:

WARNING: UNINTENDED STRONTIUM-82 (Sr-82) AND STRONTIUM-85 (Sr-85) RADIATION EXPOSURE

Unintended radiation exposure occurs when the levels of Sr-82 or Sr-85 in the rubidium Rb 82 chloride injection exceed specified limits
[see Warnings and Precautions (5.1)].

Perform generator eluate tests:
1) Record each generator eluate volume, including waste and test volumes, and keep a record of the cumulative eluate volume
[see Dosage and Administration (2.4)].

2) Determine Rb-82, Sr-82, Sr-85 levels in the eluate:

  • Once daily, prior to any drug administrations, and
  • At additional daily tests after detection of an Alert Limit. Alert Limits are:
    • 14 L for the generator's cumulative eluate volume, or
    • An eluate Sr-82 level of 0.002 μCi/mCi Rb-82, or
    • An eluate Sr-85 level of 0.02 μCi/mCi Rb-82.
    • Perform the additional daily tests at time points determined by the day's elution volume; tests are performed every 750 mL
      [see Dosage and Administration (2.5)].

3) Stop use of a generator at an Expiration Limit of:

    • 17 L for the generator's cumulative eluate volume, or
    • 42 days post generator calibration date, or
    • An eluate Sr-82 level of 0.01 μCi/mCi Rb-82, or
    • An eluate Sr-85 level of 0.1 μCi/mCi Rb-82 [see Dosage and Administration (2.6)].

Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular events. Perform pharmacologic stress testing in accordance with the pharmacologic stress agent's prescribing information and only in the setting where cardiac resuscitation equipment and trained staff are readily available.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information for CardioGen-82 (Rubidium Rb 82 Generator) including boxed WARNING by clicking here.

CardioGen-82 is manufactured for Bracco Diagnostics Inc., Monroe Township, NJ 08831, by GE Healthcare, Medi-Physics, Inc., South Plainfield, NJ 07080

CardioGen-82 is a registered trademark of Bracco Diagnostics Inc.