NorthStar Medical Radioisotopes will host a ribbon-cutting, groundbreaking and speakers event, “Molybdenum-99: Domestic Radioisotope Production Now, Expansion for the Future,” at NorthStar corporate headquarters in Beloit, Wis
| WHAT: | NorthStar Medical Radioisotopes will host a ribbon-cutting, groundbreaking and speakers event, “Molybdenum-99: Domestic Radioisotope Production Now, Expansion for the Future,” at NorthStar corporate headquarters in Beloit, Wis. The event will mark nearly a year of continuous domestic Mo-99 supply for U.S. healthcare providers, demonstrate progress on NorthStar’s expansion plans and discuss current and future U.S. supply of important medical radioisotopes. | |
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| Media are invited to attend and photography/videography is permitted. | |
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| WHO: | Confirmed speakers: | |
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| WHERE: | NorthStar Medical Radioisotopes Corporate Headquarters | |
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| 1800 Gateway Boulevard, Beloit, Wisconsin 53511 | |
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| WHEN: | Thursday, September 19, 2019. Reporters are invited to attend from 10:15 – 11:30 a.m. for the groundbreaking ceremony and speaker discussions. Media tours are available; please inquire at registration. | |
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| Please plan to arrive at 10 a.m. to check in. | |
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| WHY: | NorthStar’s RadioGenix® System (technetium 99m generator) is an innovative, high technology platform that is approved and commercially available to produce technetium-99m (Tc-99m), a widely used medical radioisotope important for over 40,000 patients on a daily basis in the United States who require diagnostic imaging tests. Tc-99m is obtained from another radioisotope, molybdenum 99 (Mo-99). The proprietary RadioGenix System uses U.S.-produced, non-uranium based material and an environmentally friendly production process to produce Tc-99m rather than overseas, uranium-based production. Before RadioGenix technology became available, the supply of Mo-99 in the United States has experienced frequent and sometimes severe interruptions which negatively impact patient healthcare. The RadioGenix System is the first and only automated isotope separation system of its kind for use with non-uranium based Mo-99, and is designed to help alleviate shortage situations and expand domestic radioisotope supply for patients needing important diagnostic imaging tests. | |
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| CONTACT: | For more information or if you are a reporter interested in attending, please contact Priscilla Harlan on behalf of NorthStar Medical Radioisotopes, telephone (781) 799-7917, or pharlan@shiningrockllc.com. |
Indication and Important Risk Information about the RadioGenix® System and Sodium Pertechnetate Tc 99m Injection USP
INDICATION
The RadioGenix® System is a technetium Tc-99m generator used to produce Sodium Pertechnetate Tc 99m Injection, USP. Sodium Pertechnetate Tc 99m Injection is a radioactive diagnostic agent and can be used in the preparation of FDA-approved diagnostic radiopharmaceuticals.
Sodium Pertechnetate Tc 99m Injection is also indicated in
- Adults for Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy).
- Adults and pediatric patients for Thyroid Imaging and Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.
IMPORTANT RISK INFORMATION
- Allergic reactions (skin rash, hives, or itching) including anaphylaxis have been reported following the administration of Sodium Pertechnetate Tc 99m Injection. Monitor all patients for hypersensitivity reactions.
- Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.
- Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 12 to 24 hours after Sodium Pertechnetate Tc 99m Injection administration.
- Sodium Pertechnetate Tc 99m Injection should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.
- Only use potassium molybdate Mo-99, processing reagents, saline and other supplies, including kits, provided by NorthStar Medical Radioisotopes. Do not administer Sodium Pertechnetate Tc 99m Injection after the 0.15 microCi of Mo-99/mCi of Tc-99m limit has been reached or when the 12 hour expiration time from elution is reached, whichever occurs earlier.
To report SUSPECTED ADVERSE REACTIONS, contact NorthStar Medical Radioisotopes, LLC at 1-844-438-6659; or FDA at 1-800-332-1088 or http://www.fda.gov/medwatch.
For Full RadioGenix® System Prescribing Information, click here or visit https://www.northstarnm.com/wp-content/uploads/2019/08/radiogenix-system-pi-july2019.pdf.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190913005349/en/
Contacts
NorthStar Medical Radioisotopes
Priscilla Harlan, (781) 799-7917
pharlan@shiningrockllc.com
Source: NorthStar Medical Radioisotopes
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http://www.businesswire.com/news/home/20190913005349/en
