ProHance^® (gadoteridol) injection, 279.3 mg/mL

Bracco launched its first gadolinium-based Magnetic Resonance Imaging (MRI) contrast agent, ProHance, in the US market in 1992 with over eight million doses used worldwide.  ProHance is the only nonionic MRI contrast agent for CNS with a high dose indication in adults (0.1 plus 0.2 mmol/kg cumulative dose) that does not interfere with other laboratory tests.  It has the highest thermodynamic conditional stability constant and lowest osmolality of all contrast agents in its class.

ProHance is indicated for use in MRI in adults and children over two years of age to visualize lesions with abnormal vascularity in the brain, spine and associated tissues.  ProHance is also indicated for use in MRI in adults to visualize lesions in the head and neck.

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with:

• Acute or chronic severe renal insufficiency (glomerular filtration rate < 30mL/min/1.73m²), or
• Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.

In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration.

As with all paramagnetic agents, caution should be exercised in patients with deoxygenated sickle erythrocytes and renal insufficiency with or without hepatic impairment. The possibility of a reaction, including serious, life threatening, or fatal, anaphylactic or cardiovascular reactions, or other idiosyncratic reactions, should always be considered, especially in those patients with a history of a known clinical hypersensitivity or a history of asthma or other allergic respiratory disorders.

For more information, please visit www.prohance.com.

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ProHance
ProHance Multipack