GE Healthcare’s Pharmaceutical Diagnostics unit develops and supplies imaging agents used to support around 100 million procedures per year globally, equivalent to three patients every second. Clariscan, approved by U.S. FDA in November 2019, is the latest in a growing range of imaging agents available in the U.S. which are used across MRI, X-ray/CT and ultrasound to enhance the image and support diagnosis.
Clariscan is manufactured in Norway using a proprietary manufacturing process. As with all GE Healthcare contrast media products, all stages of manufacturing, from development of the active pharmaceutical ingredient (API) to finished product, are managed entirely by GE. Clariscan is available in single dose vials of 10, 15 and 20 mL and now 100 mL Pharmacy Bulk Package in an innovative +PLUSPAK polymer bottle.
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About GE Healthcare:
GE Healthcare is the $16.7 billion healthcare business of GE (NYSE: GE). As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping to drive productivity and improve outcomes for patients, providers, health systems and researchers around the world. Follow us on Facebook, LinkedIn, Twitter and Insights , or visit our website www.gehealthcare.com for more information.
CLARISCAN™ (gadoterate meglumine) injection for intravenous use
PRODUCT INDICATIONS AND USE:
CLARISCAN™ (gadoterate meglumine) is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine, and associated tissues in adult and pediatric patients to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
Additional pediatric use information is approved for Guerbet LLC’s Dotarem (gadoterate meglumine injection). However, due to Guerbet LLC’s marketing exclusivity, this drug product is not labeled with that pediatric information.
IMPORTANT SAFETY INFORMATION ABOUT CLARISCAN™
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
See full Prescribing Information for complete Boxed Warning.
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs.
