SEHCAT Capsule, hard Ref.[27589] Active ingredients: Selenium ⁷⁵Se tauroselcholic acid

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: GE Healthcare Buchler GmbH & Co KG, Gieselweg 1, 38110 Braunschweig, Germany

Product name and form

SeHCAT 370kBq capsules.

Pharmaceutical Form

Capsule, hard.

Size 3, hard gelatin capsule with an orange body and ivory cap, containing a white powder.

Qualitative and quantitative composition

[^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
Gelatin capsule

The gelatin capsule contains the following ingredients:

Titanium dioxide
Quinoline yellow
Erythrosine
Gelatin

Pack sizes and marketing

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.

Marketing authorization holder

GE Healthcare Buchler GmbH & Co KG, Gieselweg 1, 38110 Braunschweig, Germany

Marketing authorization dates and numbers

PA22661/001/001

Date of first authorisation: 15 November 1989
Date of last renewal: 15 November 2009

Drugs

Drug Countries
SEHCAT Spain, Ireland, United Kingdom

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