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SEHCAT

Active substance(s): TAUROSELCHOLIC ACID (75SE)

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sap1183207_ch12926247_gehealthcare_PP15322.qxp_SeHCAT 22.10.15 12:53 Seite 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

SeHCAT 370 kBq capsules
[75Se]tauroselcholic acid

(called SeHCAT in this leaflet)

Read all of this leaflet carefully before you are
given SeHCAT.

• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or nurse.
In this leaflet:
1. What SeHCAT is and what it is used for
2. Before you are given SeHCAT
3. How SeHCAT is given
4. Possible side effects
5. How to store SeHCAT
6. Further information

1. What SeHCAT is and what it is used for

This medicine is for diagnostic use only. It is used
only to help identify illness.

SeHCAT is a ‘radiopharmaceutical’ medicine. It 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.
2. Before you are given SeHCAT

You should not be given SeHCAT:
• If you are allergic (hypersensitive) to the active
ingredient or any other ingredient. (Listed in
Section 6).
Do not have SeHCAT if the above applies to you. If
you are not sure talk to your doctor or nurse.
Take special care with SeHCAT
Check with your doctor or nurse before having
SeHCAT:
• If you have been told by a doctor that your
liver is not working properly or that there is a
blockage in your bile ducts.
• If you are pregnant or think you might be
pregnant.
• If you are on a low sodium diet.

Taking other medicines
Please tell your doctor or nurse if you are taking
or have recently taken any other medicines,
including medicines obtained without a
prescription. This includes herbal medicines. This
is because some medicines can affect the way
SeHCAT works.

No medicines have been reported that affect the
way SeHCAT works. But it is still best to tell your
doctor or nurse if you are taking other medicines.

Having SeHCAT with food and drink
• You may be asked to take drinks of water
before, during and after swallowing the
capsule.

Pregnancy and breast-feeding
You must tell your doctor if you are pregnant or
think you may be pregnant. Your doctor will only
use this product if it is considered that the benefit
outweighs the risk.
Do not breast-feed if you are given SeHCAT. This
is because small amounts of ‘radioactivity’ may
pass into the mother’s milk. If you are breastfeeding, your doctor may wait until you have
finished breast-feeding before using SeHCAT. If it
is not possible to wait your doctor will ask you to:
• stop breast-feeding for 3 to 4 hours, and
• use formula feed for your child, and
• express (remove) breast milk and throw away
the milk.
Your doctor will let you know when you can start
breast-feeding again.
Driving and using machines
Ask your doctor if you can drive or use machines
after you have been given SeHCAT.

Important information about SeHCAT
When SeHCAT is used you are exposed to
radioactivity.
• Your doctor will always consider the possible
risks and benefits before you are given the medicine.
Ask your doctor if you have any questions.

3. How SeHCAT is given

SeHCAT will be given to you by a specially trained
and qualified person.
• SeHCAT will always be used in a hospital or
clinic.
• They will tell you anything you need to know
for its safe use.
Your doctor will decide on the dose that is best for
you.
The usual dose is:
• One single capsule.
You should be sitting or standing when you take
the capsule.
4. Possible side effects

Like all medicines, SeHCAT can cause side effects,
although not everybody gets them.

Allergic reactions
If you have an allergic reaction when you are in
hospital or a clinic having the scan, tell the doctor
or nurse straight away. The signs may include:
• skin rash or itching or flushing
• swelling of the face
• difficulty in breathing
If any of these side effects above happen after
you leave the hospital or clinic, go straight to the
casualty department of your nearest hospital.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or nurse.

turn over ➤

SeHCAT is kept out of the reach and sight of
children.

The product label includes the correct storage
conditions and the expiry date for the batch. Hospital staff will ensure that the product is stored
and disposed of correctly and not used after the
expiry date stated on the label.
6. Further information

What SeHCAT contains
• The active ingredient is [75Se]tauroselcholic
acid. Each capsule of SeHCAT contains 370 kBq
(Kilobecquerel – the unit in which radioactivity
is measured) of [75Se]tauroselcholic acid.
• The other ingredients are disodium phosphate
dihydrate and a capsule (containing titanium
dioxide, quinoline yellow, erythrosine and
gelatin).
What SeHCAT looks like and contents of the
pack
SeHCAT is a hard capsule supplied in a
polystyrene container.
Marketing Authorisation Holder
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom
Manufacturer:

GE Healthcare Buchler GmbH & Co. KG
Gieselweg 1
D-38110 Braunschweig
Germany

This leaflet was last revised: 02 June 2015.
Marketing Authorisations
UK: PL 00221/0105
Ireland: PA 240/3/2

SeHCAT is a trademark of GE Healthcare.

GE and the GE Monogram are trademarks of
General Electric Company.

GE Healthcare

PATIENT
INFORMATION

SeHCAT™
370 kBq capsules

12926247

5. How to store SeHCAT

SC510P-GB1015-PIL

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[75Se]tauroselcholic
acid
SC510P

1183207-101/1015 / Oe1000

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PACK LEAFLET: INFORMATION FOR THE HEALTHCARE PROFESSIONAL
1 NAME OF THE MEDICINAL PRODUCT
SeHCAT 370 kBq capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
[75Se]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.
This medicinal product contains:

Sodium: 71.04 mg in each capsule.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM
Capsule, hard.
Hard, gelatin capsule.

4

CLINICAL PARTICULARS

4.1 Indications
[75Se]tauroselcholic 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
The normal dose for adults and the elderly is one capsule, administered
orally.

If the product is to be administered to children the same dosage as in adults
is used. 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 the product in children, particularly
since use of a fixed dose results in an increased Effective Dose Equivalent in
children (see section 11).
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 instructions for preparation of radiopharmaceuticals are given in
section 12

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients

4.4 Special warnings and precautions for use
The possibility of hypersensitivity should always be considered. Advanced
life support facilities should be readily available.

Caution is advised in the administration of [75Se]tauroselcholic acid to
patients with severe hepatic dysfunction or biliary tract obstruction as in
these conditions radiation dose to the liver will be significantly increased.
For each patient, exposure to ionising radiation must be justifiable on the
basis of likely benefit. The activity administered must be such that the
resulting radiation dose is as low as reasonably achievable bearing in mind
the need to obtain the intended diagnostic or therapeutic result.
This medicinal product contains 71.04 mg sodium in each capsule. This
needs to be taken into consideration for patients on a controlled sodium
diet.

4.5 Interactions with other medicinal products and other forms of
interaction
No interaction studies have been performed and no interactions have been
reported to date.

4.6 Fertility, pregnancy and lactation Pregnancy:
Pregnancy:
No data are available on the use of this product in human pregnancy.
Animal reproduction studies have not been performed.

When it is necessary to administer radioactive medicinal products to
women of childbearing potential, information should always be sought
about pregnancy. Any woman who has missed a period should be assumed
to be pregnant until proven otherwise. Where uncertainty exists it is
important that radiation exposure should be the minimum consistent with
achieving the desired clinical information. Alternative techniques which do
not involve ionising radiation should be considered. Radionuclide procedures
carried out on pregnant women also involve radiation doses to the foetus.
Only imperative investigations should be carried out during pregnancy,
when the likely benefit exceeds the risk incurred by the mother and the foetus.

Breast-feeding:
Before administering a radioactive medicinal product to a mother who is
breast feeding consideration should be given as to whether the investigation
could be reasonably delayed until after the mother has ceased breast feeding and as to whether the most appropriate choice of radiopharmaceutical
has been made, bearing in mind the secretion of activity in breast milk. If the
administration is considered necessary, breast feeding should be interrupted. Breast milk should be expressed and discarded about three to four
hours after [75Se]tauroselcholic acid administration, after which breast feeding can be resumed.

4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been
performed.

4.8 Undesirable effects
The frequencies of undesirable effects are defined as follows:
Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to
<1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known
(cannot be estimated from the available data)

Immune system disorders
Not known: Hypersensitivity

4.9 Overdose
It is considered that overdosage is unlikely as the product is presented as a
capsule which is administered orally in a controlled clinical setting. Should
overdosage occur there are no known procedures which could be used to
increase the clearance of activity from the body.
5

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: diagnostic radiopharmaceuticals, hepatic and
reticulo endothelial system, selenium (75Se) tauroselcholic acid, ATC Code:
V09DX01
At the chemical concentrations and activities used for diagnostic
procedures [75Se]tauroselcholic acid does not appear to exert any
pharmacodynamic effects.

5.2 Pharmacokinetic properties
Tauroselcholic acid is a bile acid analogue which shows identical
physiological behaviour with naturally occurring bile acid conjugates.
Following oral administration in normal subjects, approximately 95% of the
labelled bile acid is absorbed, mainly by the terminal ileum during each
enterohepatic cycle. The distribution of activity is almost entirely confined to
the lumen of the biliary ducts, gut and liver. 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.
5.3 Preclinical safety data
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.
6

PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Disodium phosphate dihydrate
Gelatin capsule

The gelatin capsule contains the following ingredients:
Titanium dioxide
Quinoline yellow
Erythrosine
Gelatin

6.2 Incompatibilities
Not applicable.

6.3 Shelf life
18 weeks from the date of manufacture. The activity reference date is 12
weeks before expiry.
6.4 Special precautions for storage
Store below 25°C. Do not freeze. Protect from light.
Store in accordance with national regulations for radioactive materials.

6.5 Nature and contents of container
SeHCAT is available in polystyrene containers with polythene caps. The
capsules are held in place with polythene foam pads.
Pack size: single capsule packs.

6.6 Special precautions for disposal and other handling
Normal safety precautions for handling radioactive materials should be
observed. After use, all materials associated with the preparation and
administration of radiopharmaceuticals, including any unused product and
its container, should be decontaminated or treated as radioactive waste and
disposed of in accordance with the conditions specified by the local competent authority. Contaminated material must be disposed of in accordance
with the conditions specified by the local competent authority. Contaminated material must be disposed of as radioactive waste via an authorised
route.
7 MARKETING AUTHORISATION HOLDER
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom

8 MARKETING AUTHORISATION NUMBER
UK: PL 00221/0105
Ireland: PA 240/3/2
Denmark: DK R. 1137
Finland: 11211
Hungary: OGYI T-8600/01-02
Norway: MTnr. 8321
Sweden: 80002
Belgium: 997 IS 89 F12
9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

UK
Ireland

Date of first authorisation
07 January 2002
15 November 1989

10 DATE OF REVISION OF THE TEXT
02 June 2015

Date of last renewal
20 April 2006
15 November 2004

Organ

Absorbed dose
per unit activity administered (mGy/MBq)
Adult
15 year
10 year
5 year
1 year

Adrenals
Bladder
Bone surfaces
Brain
Breast
Gall bladder
GI-tract
Stomach
SI
Colon
(ULI
(LLI

3.2E-01
3.3E-01
2.3E-01
4.8E-02
7.7E-02
6.4E+00

4.1E-01
4.2E-01
3.0E-01
5.6E-02
9.6E-02
7.1E+00

6.2E-01
6.7E-01
4.3E-01
7.9E-02
1.8E-01
9.0E+00

9.4E-01
1.0E+00
6.4E-01
1.2E-01
2.8E-01
1.5E+01

1.5E+00
1.7E+00
1.2E+00
2.0E-01
5.2E-01
4.8E+01

4.2E-01
1.9E+00
2.0E+00
1.9E+00
2.1E+00

5.5E-01
2.4E+00
2.4E+00
2.3E+00
2.6E+00

9.3E-01
3.8E+00
3.8E+00
3.5E+00
4.2E+00

1.5E+00
5.9E+00
5.8E+00
5.3E+00
6.5E+00

2.5E+00
1.0E+01
1.0E+01
9.1E+00)
1.2E+01)

Heart
Kidneys
Liver
Lungs
Muscles
Oesophagus
Ovaries
Pancreas

3.3E-01
5.0E-01
6.9E-01
2.4E-01
2.0E-01
1.1E-01
1.0E+00
4.5E-01

4.3E-01
6.1E-01
8.7E-01
3.3E-01
2.5E-01
1.4E-01
1.3E+00
5.8E-01

6.4E-01
8.9E-01
1.3E+00
4.7E-01
3.7E-01
1.9E-01
2.0E+00
1.1E+00

9.6E-01
1.3E+00
1.8E+00
7.2E-01
5.5E-01
2.9E-01
2.9E+00
1.7E+00

1.6E+00
2.0E+00
3.2E+00
1.3E+00
9.8E-01
4.8E-01
4.9E+00
2.6E+00

Red marrow
Skin
Spleen
Testes
Thymus
Thyroid
Uterus

2.9E-01
7.5E-02
3.0E-01
9.2E-02
1.1E-01
6.9E-02
7.5E-01

3.4E-01
9.1E-02
4.1E-01
1.3E-01
1.4E-01
9.6E-02
9.4E-01

4.6E-01
1.4E-01
6.6E-01
2.2E-01
1.9E-01
1.5E-01
1.5E+00

6.0E-01
2.2E-01
1.0E+00
3.7E-01
2.9E-01
2.7E-01
2.3E+00

8.3E-01
4.2E-01
1.7E+00
7.0E-01
4.8E-01
5.2E-01
3.8E+00

Remaining Organs

2.6E-01

3.4E-01

5.3E-01

8.3E-01

1.3E+00

Effective Dose
(mSv/MBq)

6.9E-01

8.6E-01

1.3E+00

2.0E+00

3.9E+00

For this product the Effective Dose to a healthy adult resulting from the
administration of a 370 kBq capsule is typically 0.26 mSv.

In most clinical investigations for which this substance is used (e.g. Crohn’s
disease) the effects of impaired ileal absorption and shorter gastrointestinal
transit time tend to reduce the dose commitment compared with the normal
case. However, in patients with severe cholestatic jaundice, the liver dose
has been estimated to be about 100 times the normal value.

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
This radiopharmaceutical may be received, used and administered only by
authorised persons in designated clinical settings. Their receipt, storage,
use, transfer and disposal are subject to the regulations and/or appropriate
licences of the local competent official organisations (see section 6.6).
The administration of radiopharmaceuticals creates risks for other persons
from external radiation or contamination from spills of urine, vomiting, etc.
Radiation protection precautions in accordance with national regulations
must therefore be taken.

PROCEDURE FOR USE
Measurement of bile pool loss
Measurement of the rate of bile loss from the endogenous pool using
SeHCAT may be achieved either by determining the retention of activity in
the body over a period of days or by determining the excretion of activity in
faeces. The results may be expressed as a rate of loss if several
measurements are taken, or more simply as a retained percentage after a
fixed period (7 days is convenient). A whole body counter or other counter or
other counting techniques may be used.
For some investigations scintigraphic studies may be appropriate.

Measurement of retained activity
Whole body counter
A 370 kBq (10 μCi) capsule is administered to the patient together with a
drink of water. Using conventional whole body counting techniques an initial
count of the patient provides, after background subtraction, a zero-time or
100% value.
After 7 days the patient is counted again, and the retained activity
expressed as a percentage of the original value.

Alternative techniques
If a whole body counter is not available, other counting techniques may be
used successfully. Since the activity is confined to the abdominal region, a
counter with a field of view encompassing the abdomen can be employed. A
gamma camera with its collimator removed has proved successful and
single crystal probes have also been used.
It is important to keep the positioning of the patient and counter constant at
each measurement. To minimise the effect of geometric variations, the
counting head should be arranged at the maximum height above the
patient couch.

A standard axial positioning of the patient along the centreline of the
counter should be maintained. The centre of the crystal should be
positioned midway between the umbilicus and the base of the sternum.
To avoid excessive background interference from sources of technetium99m, it is recommended that the camera window be set at the 289 keV
photon peak of selenium-75 (20% window).
If an uncollimated gamma camera is being used, normal gamma camera
procedures for spectrum stabilisation and uniformity checking with flood
sources should be observed. If the patient is the subject of other
simultaneous radionuclide studies, check that the interference from other
photon peaks is eliminated or make allowances in the procedure to
compensate for the excessive count rate.

Procedure
1 The patient should be given at least 15 ml of water to drink prior to
taking the capsule. A similar drink of water should be taken with the
capsule and again afterwards to encourage rapid transit of the capsule
to the stomach and subsequent dispersion of the contents.
2
3
4
5
6
7
8
9

Allow 3 hours for physiological equilibration.

Measure the background twice, setting the camera window as
described above. A preset count or time may be used.
Place the patient on the couch as described above. Count for preset
time (300 seconds suggested and record the counts).

Repeat steps 3-7 after 7 days.

Correct the day 7 value for radioactive decay by multiplying by 1.04.

10 Express day 7 value as percentage of day 0 value.

Measurement of excreted activity
The alternative method of estimating bile acid loss is by scintillation
counting of total faecal samples collected over a period (e.g. 7 days). A
dosage of 370 kBq (10 μCi) (orange and yellow capsule) is recommended. It
is important to ensure that standard geometry is monitored and that total
collection of faeces is achieved. Samples from patients undergoing two
simultaneous radionuclide investigations should not be counted unless
faecal excretion of the other radionuclide is known to be insignificant, or
unless the counting equipment can be selectively set to accumulate only
selenium-75 photon emissions.

Counting of the faecal γ activity using a sodium iodide crystal detector in a
well counter or other suitable instrument is the counting method of choice.
The procedure for the administration of the capsule of SeHCAT is the same
as when measuring retained activity.

13 OTHER INFORMATION
Manufacturer:
GE Healthcare Buchler GmbH & Co. KG
Gieselweg 1
D-38110 Braunschweig
Germany

SeHCAT is a trademark of GE Healthcare.

GE and the GE Monogram are trademarks of General Electric Company.

HEALTHCARE PROFESSIONAL
INFORMATION

370 kBq capsules

Measure the background again.

After background subtraction, calculate the geometric mean of the two
patient counts √(PA x AP).

GE Healthcare

SeHCAT™

Turn the patient and repeat the count from the other view.

12926250

11 DOSIMETRY
The table below shows the dosimetry as calculated according to the
Publication 80 of the ICRP (International Commission on Radiological
Protection, Radiation Dose to Patients from Radiopharmaceuticals,
Pergamon Press 1998).

SC510P-GB1015-SPC

sap1183211_ch12926250_gehealthcare_PP15322.qxp_SeHCAT 22.10.15 12:58 Seite 1

[75Se]tauroselcholic
acid
SC510P

1183211-102/1015 / Oe1000

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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