Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: GE Healthcare Buchler GmbH & Co KG, Gieselweg 1, 38110 Braunschweig, Germany
Pharmacotherapeutic group: diagnostic radiopharmaceuticals, hepatic and reticuloendothelial system, selenium (75Se)tauroselcholic acid
ATC Code: V09DX01
Tauroselcholic acid is a bile acid analogue which shows identical physiological behaviour with naturally occurring bile acid conjugates.
At the chemical concentrations and activities used for diagnostic procedures [75Se]tauroselcholic acid does not appear to exert any pharmacodynamic effects.
No data are available.
The distribution of activity is almost entirely confined to the lumen of the biliary ducts, gut and liver.
Following oral administration in normal subjects, approximately 95% of the labelled bile acid is absorbed, mainly by the terminal ileum during each enterohepatic cycle.
Whole body retention data from normal subjects showed 97 to 100% of [75Se]tauroselcholic was excreted with a biological half-life of 2.6 days and that, in most cases, a small component of about 3% was eliminated with a mean half time of 62 days.
No data are available.
A single dose study in rats has indicated a safety margin of greater than 10,000 times the maximum human oral dosage. This agent is not intended for regular or continuous administration. Repeat dose toxicity studies, mutagenicity and long-term carcinogenicity studies have not been performed.
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