Bracco Diagnostics Inc. Launches the New CardioGen-82Ã‚Â® (Rubidium Rb82 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 the launch of a new website for CardioGen-82 (http://www.cardiogen.com) with additional resources for healthcare providers to improve their use of cardiac positron emission tomography (PET) myocardial perfusion imaging (MPI).
Bracco Diagnostics is re-launching this enhanced version of the site as a part of their continued effort to support the nuclear medicine community with valuable and up-to-date information. The site's added features are all designed to support CardioGen-82 users' businesses and help them better serve their patients. The site now as a single point of reference for CardioGen-82 users to enhance their cardiac PET experience.
The revised CardioGen-82 website features product and infusion system details, references for patients and other supplemental resources to support and improve cardiac PET MPI. In addition, it now includes relevant information about the latest clinical research, reimbursement details and appropriate use criteria.
- Complete reimbursement information: a portal for customers containing all of the most recent details necessary for submitting reimbursement queries, this section also includes general information about the reimbursement process helpful for both new and existing customers.
- Clinical studies: updated regularly to provide the nuclear medicine community with the latest research and clinical studies in the field and compiled in a single repository, this catalog is an excellent resource to keep up-to-date.
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 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:
- 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)].
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 or 0.002 µCi/mCi Rb-82, or
- An eluate Sr-85 level or 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)].
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)].
Please see full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
CardioGen-82 is manufactured for Bracco Diagnostics Inc., Monroe Township, NJ 08831, by GE Healthcare, Medi-Physicis, Inc., South Plainfield, NJ 07080.
About Bracco Imaging
Bracco Imaging S.p.A., part of the Bracco Group, is one of the world's leading companies in the diagnostic imaging business. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures, and markets diagnostic imaging agents and solutions that meet medical needs. Bracco Imaging offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray Imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), Nuclear Medicine through radioactive tracers, and Gastrointestinal Endoscopy. The diagnostic imaging offer is completed by several medical devices and advanced administration systems for contrast imaging products in the fields of radiology.
The Company operates in over 90 markets worldwide, either directly or indirectly, through subsidiaries, joint ventures, licenses and distribution partnership agreements. With an on-going research covering all key modalities, Bracco Imaging has a strong presence in key geographies: North America, Europe, and Japan operating through the Joint Venture Bracco-Eisai Co. Ltd. The Company also operates in Brazil, South Korea, and China through the Joint Venture Bracco Sine Pharmaceutical Corp. Ltd. Operational investments have been made in order to achieve top quality and compliance with a sustainable eco-friendly production. Manufacturing activities are located in Italy, Switzerland, Japan, China, and Germany.
Bracco Imaging is an innovative Research and Development (R&D) player with an efficient process oriented approach and a track record of innovation in the diagnostic imaging industry. R&D activities are managed in the three Research Centers located in Italy, Switzerland, and USA.
To learn more about Bracco Imaging, visit www.braccoimaging.com.
To learn more about CardioGen-82, visit www.cardiogen.com.