Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: GE Healthcare Buchler GmbH & Co KG, Gieselweg 1, 38110 Braunschweig, Germany
SeHCAT 370kBq capsules.
| Pharmaceutical Form |
|---|
|
Capsule, hard. Size 3, hard gelatin capsule with an orange body and ivory cap, containing a white powder. |
[^756Se] tauroselcholic acid is supplied as capsules of 370 kBq at the activity reference date.
Each capsule contains less than 0.1 mg of tauroselcholic acid.
Selenium-75 has a physical half-life of approximately 118 days and decays by gamma emission with principal energies at 0.136 MeV and 0.265 MeV.
Excipient(s) with known effect:
This medicinal product contains:
Sodium: 71.04mg per capsule.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Selenium ⁷⁵Se tauroselcholic acid |
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. It is used for the investigation of bile acid malabsorption and measurement of bile acid pool loss. |
| List of Excipients |
|---|
|
Disodium phosphate dihydrate The gelatin capsule contains the following ingredients: Titanium dioxide |
SeHCAT is available in a polystrene container with polythene caps. The capsules are held in place with polythene foam pads.
Pack size: single capsule packs.
GE Healthcare Buchler GmbH & Co KG, Gieselweg 1, 38110 Braunschweig, Germany
PA22661/001/001
Date of first authorisation: 15 November 1989
Date of last renewal: 15 November 2009
| Drug | Countries | |
|---|---|---|
| SEHCAT | Spain, Ireland, United Kingdom |
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