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Prohance (Gadoteridol) - Summary

 


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A comprihensive source of nutritional information

Manufactured for
Bracco Diagnostics Inc.
Princeton, NJ 08543
by ALTANA Pharma AG
78224 Singen (Germany)


Revised May 2007
F1/3.5524.44

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 < 30 mL/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 (See WARNINGS).

 

PROHANCE SUMMARY

ProHance®
(Gadoteridol Injection)

ProHance (Gadoteridol Injection) is a nonionic contrast medium for magnetic resonance imaging (MRI), available as a 0.5M sterile clear colorless to slightly yellow aqueous solution in vials and syringes for intravenous injection.

Central Nervous System

ProHance (Gadoteridol Injection) is indicated for use in MRI in adults and children over 2 years of age to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues.

Extracranial/Extraspinal Tissues

ProHance is indicated for use in MRI in adults to visualize lesions in the head and neck.


See all Prohance indications & dosage >>

PROHANCE NEWS HIGHLIGHTS

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Published Studies Related to Prohance (Gadoteridol)

Risk for nephrogenic systemic fibrosis with gadoteridol (ProHance) in patients who are on long-term hemodialysis. [2008.05]

more >>

Clinical Trials Related to Prohance (Gadoteridol)

SH L 562BB Phase II/III Dose Justification and Gadoteridol-Controlled Comparative Study [Recruiting]

Safety and Efficacy of Gadobutrol 1.0 Molar (Gadovist®) in Patients for Central Nervous System (CNS) Imaging [Recruiting]

Evaluation of the Risk of NSF Following ProHance Injection in Patients With Chronic Kidney Disease [Recruiting]

more >>

Page last updated: 2008-11-29

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