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Adenoscan

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Adenoscan®
Cardiology A sterile formulation of adenosine used as an adjunct to thallium in cardiac imaging to evaluate CAD in Pts unable to adequately exercise and take the treadmill component of related tests. See Treadmill test.


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The EIR also noted the FDAers obtained a documentary sample of Adenoscan (adenosine for injection) "for consideration of an open-ended seizure," but that the firm's recall, undertaken on the last day of the inspection, eliminated the need for the seizure.
1999 issue of "The Journal of Nuclear Medicine" found that the firm failed to disclose that Adenoscan was "indicated only for patients who were not able to exercise adequately.
APP's production of Adenoscan (adenosine for injection) was cited for a number of deviations, including aseptic fills with high particle counts, and the letter referred to a recall of "all lots of Adenoscan" initiated on an unspecified date.
 
 
 
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