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Result : Searchterm 'Distribution Information' found in 0 term [] and 22 definitions []
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(Mn-DPDP) This agent, mangafodipir trisodium, is a hepatocyte specific MRI contrast agent. Manganese is very toxic, so it has to be chelated and put in the form of a vitamin B6 analog, which is taken up by normal hepatocytes to some extent.
Teslascan® was developed in the early 1980's, went through clinical trials in the early 1990's, and was approved in 1997. One problem with assessing the efficacy of this agent is the fact that the phase III trials finished in the early 1990's, and the techniques used for MR today are very different from the techniques used almost a decade ago.
This contrast agent shortens the T1 relaxation time. On T1 weighted pictures it makes a normal liver look brighter. Since metastases, for example, do not generally take up this agent, the contrast between the enhancing liver and the non-enhancing lesions will increase on T1 weighted pictures. It does not have much effect on T2 weighted images.
Drug Information and Specification T1, Predominantly positive enhancement PHARMACOKINETIC Hepatobiliary, pancreatic, adrenal DOSAGE 5 µmol/kg, 0.5 ml/kg PREPARATION Finished product DEVELOPMENT STAGE Approved PRESENTATION Vials of 100 ml DO NOT RELY ON THE INFORMATION PROVIDED HERE, THEY ARE NOT A SUBSTITUTE FOR THE ACCOMPANYING PACKAGE INSERT!
Distribution Information TERRITORY TRADE NAME DEVELOPMENT STAGE DISTRIBUTOR | | | | | Further Reading: | | Basics:
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Vasovistâ„¢ is an albumin-targeted intravascular contrast agent. It is indicated for contrast enhanced MR angiography (CE-MRA) for the visualization of abdominal or limb vessels in patients with suspected or known vascular disease. After IV injection, Vasovistâ„¢ binds reversibly to human albumin in plasma, which results in long-lasting increased relaxivity. Imaging from 5 to 50 min is possible. A small unbound portion is, by glomerular filtration, eliminated by the kidneys.
AngioMARK® was the formerly trade name and MS-325 the research name. Currently the phase III clinical trials are completed to determine its efficacy for peripheral vascular disease and coronary artery disease.
In the U.S., EPIX received an approvable letter from the U.S. Food and Drug Administration (FDA) for Vasovistâ„¢ in January 2005. In 2009, Epix Pharmaceuticals has sold the U.S., Canadian and Australian rights for its blood pool agent (now named ABLAVARâ„¢), to Lantheus Medical Imaging, Inc..
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 less than 30 mL/min/1.73m 2), or acute renal insufficiency of any severity due to the hepato-renal syndrome or the liver transplantation period.
See also MRI Safety.
Drug Information and Specification NAME OF COMPOUND Diphenylcyclohexyl phosphodiester-Gd-DTPA, gadofosveset trisodium, MS-325 T1, predominantly positive enhancement 20-45 mmol-1sec-1, Bo=0,47T PHARMACOKINETIC Intravascular, short elimination half life CONCENTRATION 244 mg/mL, 0.25mmol/mL DOSAGE 0.12 mL/kg, 0.03 mmol/kg DEVELOPMENT STAGE approved DO NOT RELY ON THE INFORMATION PROVIDED HERE, THEY ARE NOT A SUBSTITUTE FOR THE ACCOMPANYING PACKAGE INSERT!
Distribution Information TERRITORY TRADE NAME DEVELOPMENT STAGE DISTRIBUTOR North America, Australia for sale | | | | • View the DATABASE results for 'Vasovist™' (7).
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