SeHCAT 370kBq capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tauroselcholic acid

Available from:

GE Healthcare Buchler GmbH & Co KG

ATC code:

V09DX; V09DX01

INN (International Name):

Tauroselcholic acid

Dosage:

370 K.bequerel

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to Restricted Prescription (C)

Therapeutic area:

Other hepatic and reticulo endothelial system diagnostic radiopharmaceuticals; selenium (75Se) tauroselcholic acid

Authorization status:

Marketed

Authorization date:

1989-11-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SEHCAT 370 KBQ CAPSULES
[
75
Se]tauroselcholic acid
(called SeHCAT in this leaflet)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your nuclear medicine doctor
who will supervise the
procedure.

If you get any side effects, talk to your nuclear medicine doctor.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What SeHCAT is and what it is used for
2.
What you need to know before SeHCAT is used
3.
How SeHCAT is used
4.
Possible side effects
5.
How SeHCAT is stored
6.
Contents of the pack and other information
1.
WHAT SEHCAT IS AND WHAT IT IS USED FOR
This medicine is a radiopharmaceutical product for diagnostic use
only. It is used only to help
identify illness of certain sections of the digestive system.
SeHCAT is given before a scan and helps a special camera see inside a
part of your body.
•
It contains an active ingredient called ‘tauroselcholic acid’.
•
Once swallowed it can be seen from outside your body by a special
camera used in the scan.
•
The scan can help your doctor see how well your digestive system is
working.
Your doctor or nurse will explain which part of your body will be
scanned.
The use of SeHCAT does involve exposure to small amounts of
radioactivity. Your doctor and the
nuclear medicine doctor have considered that the clinical benefit that
you will obtain from the
procedure with the radiopharmaceutical outweighs the risk due to
radiation.
2.
WHAT YOU NEED TO KNOW BEFORE SEHCAT IS USED
SeHCAT must not be used:
•
If you are allergic (hypersensitive) to the active ingredient or any
other ingredients (listed in
Section 6).
WARNINGS AND PRECAUTIONS
Please talk to your nuclear medicine doctor who is conducting the
investigation before you are given
SeHCAT.
TAKE SPECIAL CARE WITH SEHCAT
Talk to your doctor or nurse

Summary of Product characteristics

Health Products Regulatory Authority
25 November 2021
CRN00CF99
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SeHCAT 370kBq capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
[
75
Se] 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.
3 PHARMACEUTICAL FORM
Capsule, hard.
Size 3, hard gelatin capsule with an orange body and ivory cap,
containing a white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
[
75
Se]taurosel cholic 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 _
The normal dose for adults is one capsule, administered orally.
_Elderly Population _
The adult dose may be used.
_Paediatric population _
There is no paediatric dosage form or clinical experience of the use
of this product in children. If the product is to be
administered to children the same dosage as in adults is used.
A careful assessment of the risk/benefit ratio should be undertaken
before use of the product in children, particularly since use
of a fixed dose results in an increased effective dose equivalent in
children (seesection 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
Health Products Regulatory Authority
25 November 2021
CRN00CF99
Page 2