SeHCAT TM 370 kBq

Land: Norge

Språk: norsk

Kilde: Statens legemiddelverk

Aktiv ingrediens:

Tauroselkolsyre

Tilgjengelig fra:

GE Healthcare Buchler GmbH & Co. KG

ATC-kode:

V09DX01

INN (International Name):

Tauroselkolsyre

Dosering :

370 kBq

Legemiddelform:

Kapsel, hard

Enheter i pakken:

Boks av plast 1 stk

Resept typen:

C

Autorisasjon status:

Markedsført

Autorisasjon dato:

1999-09-20

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
FOR
SEHCAT, CAPSULE
1.
NAME OF THE MEDICINAL PRODUCT
SeHCAT
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tauroselcholic (
75
Se) acid is supplied as capsules of 370 kBq at the activity reference
date.
Each capsule contains less than 0.1mg 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
Sodium: 71.04 mg/capsule
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Tauroselcholic (
75
Se) acid is used for the investigation of bile acid malabsorption and
measurement of bile acid pool loss. It may be used in the assessment
of ileal function,
in the investigation of inflammatory bowel disease and chronic
diarrhoea and in the
study of entero-hepatic circulation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and elderly patients
The normal dose for adults and the elderly is one capsule,
administered orally.
Paediatric population
If the product is to be administered to children the same dosage as in
adults is used
(see section 4.4 and 11).
There is no paediatric dosage form or clinical experience of the use
of this product in
children. A careful assessment of the risk/benefit ratio should be
undertaken before
use of this product in children, particularly since the use of a fixed
dose result in an
increased effective dose equivalent in children (see section 11).
Hepatic impairment
Careful consideration of the activity to be administered is required
since an
increased radiation exposure is possible in these patients.
Method of administration
To ensure smooth passage of the capsule into the stomach, it is
recommended that 15
ml drinks of water are taken by the patient before, during and after
swallowing the
capsule. The patient should be in a sitting or standing position
during administration.
The instru