About Neuraceq (florbetaben F18 injection)
Indication
This medicinal product is for diagnostic use only.
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NeuraCeq is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment. NeuraCeq should be used in conjunction with a clinical evaluation. A negative scan indicates sparse or no neuritic plaques, which is not consistent with a diagnosis of AD. For the limitations in the interpretation of a positive scan, please refer to the full product monograph.
Important Safety Information
NeuraCeq cannot be used to diagnose Alzheimer's disease and it cannot predict a patient's predisposition for beta-amyloid neuritic plaques development in the future. NeuraCeq images should only be interpreted by readers trained in the interpretation of PET images with florbetaben F18 injection. Following training, image-reading errors (including false positive or false negative interpretation of NeuraCeq images) may still occur. Additional interpretation errors may occur due to image noise, brain atrophy with a thinned cortical ribbon, or image blurs.
Administration of NeuraCeq, as with other radiopharmaceuticals, results in a low amount of ionizing radiation exposure. Safety precautions should be taken to ensure healthcare providers and patients do not receive unintentional radiation exposure from NeuraCeq.
Most Common Adverse Events
The most common side effects observed in clinical trials were injection site reaction and injection site pain.
About Piramal Imaging SA
Piramal Imaging SA, a division of Piramal Enterprises Ltd., was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. By developing novel PET tracers for molecular imaging, Piramal Imaging is focusing on a key field of modern medicine. Piramal Imaging strives to be a leader in the Molecular Imaging field by developing innovative products that improve early detection and characterization of chronic and life threatening diseases, leading to better therapeutic outcomes and improved quality of life. For more information please go to www.piramal.com/imaging.
About ISOLOGIC Innovative Radiopharmaceuticals
ISOLOGIC Innovative Radiopharmaceuticals (ISOLOGIC) is a Canadian radiopharmaceutical company dedicated to nuclear medicine and the science of radiopharmaceutical production. ISOLOGIC's commitment to these fields includes cyclotron centers, SPECT and PET radiopharmaceutical manufacturing facilities throughout Canada. Utilizing significant experience, expertise to provide its customers and patients with reliable, safe and high quality radiopharmaceutical products and services. ISOLOGIC's open formulary of radiopharmaceutical drugs and medical devices provides the flexibility of choice, providing its customers with access to all radiopharmaceuticals, having Health Canada market authorization.
SOURCE Isologic
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