Effective from June 1st 2014 and following approval by the US
Food and Drug Administration (FDA), GE Healthcare today announced the
intent to supply generators for the production of sodium pertechnetate;
technetium (Tc99m) injection to its radiopharmacies in the US.
Globally more than 70 percent of all diagnostic SPECT (single photon
emission computed tomography) procedures using gamma cameras rely on the
use of Tc99m as the radioactive component. It is commonly
used as an imaging agent and in preparation of FDA-approved diagnostic
radiopharmaceutical kits to help diagnose many different types of
diseases including those in cardiology, oncology, and neurology.
GE Healthcare is responsible for more than 30 percent of the world’s
supply of radioactive tracers and has 31 radiopharmacies in the US.
“Radioactive tracers are difficult to manufacture because of their short
half-life. By supplying our generators, GE Healthcare has better control
over its supply chain. It could also help to increase the availability
of Tc99m for our customers in the longer term,“ said Jan
Makela, GM, Core Imaging. “Currently we supply Tc99m
generators (branded Drytec™ outside the US) to many countries around the
world and the inclusion of the US is a big step to increasing our
leadership in this market. It represents a significant growth
opportunity for our SPECT business.”
Technetium-99m, when used as a radioactive
tracer, can be detected in the body by
medical equipment such as gamma
cameras. The short physical half-life,
or time it remains radioactive, of the isotope and its biological
half-life of 1 day (in terms of human activity and metabolism)
allows for scanning procedures which collect data rapidly but keep total
patient radiation exposure low.
Important Risk and Safety Information for Sodium Pertechnetate Tc99m
Injection
Long term cumulative radiation exposure is associated with increased
risk of cancer. Radiation risks associated with the use of sodium
pertechnetate Tc99m injection are greater in children than in adults. 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.
As in the use of any radioactive material, care should be taken to
minimize radiation exposure to the patient consistent with proper
patient management and to insure minimum radiation exposure to
occupational workers. Radiopharmaceuticals should be used only by
physicians who are qualified by training and experience in the safe use
and handling of radionuclides, and whose experience and training have
been approved by the appropriate government agency authorized to license
the use of radionuclides.
Allergic reactions including anaphylaxis have been reported infrequently
following the administration of sodium pertechnetate Tc99m. Technetium
Tc99m is excreted in human milk during lactation so formula feedings
should be substituted for breast feedings.
About GE Healthcare
GE Healthcare provides transformational medical technologies and
services to meet the demand for increased access, enhanced quality and
more affordable healthcare around the world. GE (NYSE: GE) works on
things that matter - great people and technologies taking on tough
challenges. From medical imaging, software & IT, patient monitoring and
diagnostics to drug discovery, biopharmaceutical manufacturing
technologies and performance improvement solutions, GE Healthcare helps
medical professionals deliver great healthcare to their patients.
For our latest news, please visit http://newsroom.gehealthcare.com
Copyright Business Wire 2014