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SEHCAT

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

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sap1183207_ch13645326_variante_gehealthcare_SeHCAT_PP20231.qxp_SeHCAT 20.02.17 09:27 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 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
2. 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 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 believe you might be
pregnant.
• If you are breast-feeding.
• This medicinal product contains 3.01 mmol (or
71.04 mg) sodium per capsule. To be taken into
consideration by patients on a controlled
sodium diet.
Children and adolescents
Talk to your nuclear medicine doctor if you are
under 18 years old.

Other medicines and SeHCAT
Please tell your nuclear medicine doctor if you
are taking, have recently taken or might take any
other medicines, since they might interfere with
the interpretation of the images.
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, breast-feeding, and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your nuclear medicine doctor for advice before
you are given this medicine.
You must inform the nuclear medicine doctor
before the administration of SeHCAT if there is a
possibility you might be pregnant, if you have
missed your period or if you are breast-feeding.
When in doubt, it is important to consult your
nuclear medicine doctor who will supervise the
procedure.
If you are pregnant
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.
If you are breast-feeding
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.
3. How SeHCAT is used

There are strict laws on the use, handling and
disposal of radiopharmaceutical products.
SeHCAT will only be used in special controlled
areas. This product will only be handled and given
to you by people who are trained and qualified to
use it safely. These persons will take special care
for the safe use of this product and will keep you
informed of their actions.
The nuclear medicine doctor supervising the
procedure will decide on the quantity of SeHCAT
to be used in your case. It will be the smallest
quantity necessary to get the desired information.
The quantity to be administered usually recommended for an adult is one capsule and the
maximal recommended activity is 370 kBq (kilobecquerel, the unit used to express radioactivity).
Administration of SeHCAT and conduct of the
procedure
SeHCAT is administered by oral administration.
One capsule is sufficient to conduct the test that
your doctor needs.
You should be sitting or standing when you take
the capsule.
turn over ➤

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Like all medicines, SeHCAT can cause side effects,
although not everybody gets them. The following
side effects may happen with this medicine:
Allergic reactions (frequency not known)
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.
This radiopharmaceutical will deliver low
amounts of ionising radiation associated with the

5. How SeHCAT is stored

4. Possible side effects

Reporting of side effects
If you get any side effects, or if you notice any
side effects not listed in this leaflet, please tell
your doctor or nurse. You can also report side
effects directly via the national reporting system:
UK
The Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
By reporting side effects, you can help provide
more information on the safety of this medicine.
You will not have to store this medicine. This
medicine is stored under the responsibility of the
specialist in appropriate premises. Storage of
radiopharmaceuticals will be in accordance with
national regulations on radioactive materials.
The following information is intended for the
specialist only.
SeHCAT is kept out of the sight and reach of
children.
Do not use this medicine after the expiry date
and time, which are stated on the label after ‘EXP’.

6. Contents of the pack and other 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.
One capsule contains 370 kBq (kilobecquerels, the
unit used to express radioactivity).
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

GE Healthcare

PATIENT
INFORMATION

SeHCAT™
370 kBq capsules
[75Se]tauroselcholic
acid
SC510P

1183207-101/0317/ Oe6000

SC510P-GB0217-PIL

least risk of cancer and hereditary abnormalities
(passing on faulty genes).

This leaflet was last revised in February 2017.
Marketing Authorisations
UK: PL 00221/0105
Ireland: PA 0240/003/002

SeHCAT is a trademark of GE Healthcare.
GE and the GE Monogram are trademarks of
General Electric Company.

13645326

Duration of the procedure
Your nuclear medicine doctor will inform you
about the usual duration of the procedure.
The nuclear medicine doctor will inform you if
you need to take any special precautions after
receiving this medicine. Contact your nuclear
medicine doctor if you have any questions.
Use in children and adolescents
If the product is to be administered to children the
same dosage as in adults is used.
If you have been given more SeHCAT than you
should
An overdose is unlikely because you will only
receive a single dose of SeHCAT precisely controlled
by the nuclear medicine doctor supervising the
procedure. However, in the case of overdose, you
will receive the appropriate treatment.
Should you have any further questions on the use
of SeHCAT, please ask the nuclear medicine
doctor who supervises the procedure.

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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
[ 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: 71.04 mg in each capsule.
For a full list of excipients, see section 6.1.
75

3 PHARMACEUTICAL FORM
Capsule, hard.
Hard, gelatin capsule.
4

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).
Exposure to ionising radiation is linked with cancer induction and a
potential for development of hereditary defects. As the effective dose is
0.26 mSv when the maximal recommended activity of 370 kBq is
administered these adverse reactions are expected to occur with a low
probability.

Immune system disorders
Not known: Hypersensitivity
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk
balance of the medicinal product. Healthcare professionals are asked to
report any suspected adverse reactions via the national reporting system:
UK
The Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

CLINICAL PARTICULARS

4.1 Indications
This medicinal product is for diagnostic use only.
[ Se]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.
75

4.2 Posology and method of administration
Posology
Adult 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.
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).
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 instructions for preparation of radiopharmaceuticals are given in
section 12.
For patient preparation, see section 4.4.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed
in section 6.1.

4.4 Special warnings and precautions for use
Potential for hypersensitivity or anaphylactic reactions
If hypersensitivity or anaphylactic reactions occur, the administration of
the medicinal product must be discontinued immediately and intravenous
treatment initiated, if necessary. To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.
Caution is advised in the administration of [ Se]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.
Individual benefit/risk justification
For each patient, the radiation exposure must be justifiable by the likely
benefit. The activity administered should in every case be as low as
reasonably achievable to obtain the required diagnostic information.
Hepatic impairment
Careful consideration of the benefit risk ratio in these patients is required
since an increased radiation exposure is possible.
Paediatric population
No data are available. Careful consideration of the indication is required
since the effective dose per MBq is higher than in adults (see section 11).
Specific warnings
This medicinal product contains 3.01 mmol (71.04 mg) sodium in each
capsule. This should be taken into account in patients on a low sodium
diet.
Precautions with respect to environmental hazard see section 6.6.
75

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
Women of childbearing potential
When an administration of radiopharmaceuticals to a woman of
childbearing potential is intended, it is important to determine whether or
not she is pregnant. Any woman who has missed a period should be
assumed to be pregnant until proven otherwise. If in doubt about the
potential pregnancy (if the woman has missed a period, if the period is very
irregular, etc.), alternative techniques not using ionising radiation (if there
are any) should be offered to the patient.
Pregnancy:
No data are available on the use of this product in human pregnancy.
Animal reproduction studies have not been performed.
Radionuclide procedures carried out on pregnant women also involve
radiation doses to the foetus. Only essential investigations should therefore
be carried out during pregnancy, when the likely benefit far 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 [ Se]tauroselcholic acid administration, after which breast feeding
can be resumed.
75

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.

8 MARKETING AUTHORISATION NUMBER(S)
UK:
PL 00221/0105
Ireland: PA 0240/003/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 07 January 2002
Date of last renewal: 20 April 2006

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).

Organ

Paediatric population
No data are available.

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.
Paediatric population
No data are available.
PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: diagnostic radiopharmaceuticals, hepatic
and reticulo endothelial system, selenium ( Se) tauroselcholic acid,
ATC Code: V09DX01
Mechanism of action
Tauroselcholic acid is a bile acid analogue which shows identical physiological behaviour with naturally occurring bile acid conjugates.
Pharmacodynamic effects
At the chemical concentrations and activities used for diagnostic
procedures [ Se]tauroselcholic acid does not appear to exert any
pharmacodynamic effects.
Clinical efficacy and safety
See Pharmacodynamic effects.
Paediatric population
No data are available.
75

75

5.2 Pharmacokinetic properties
Distribution
The distribution of activity is almost entirely confined to the lumen of the
biliary ducts, gut and liver.
Organ Uptake
Following oral administration in normal subjects, approximately 95% of
the labelled bile acid is absorbed, mainly by the terminal ileum during each
enterohepatic cycle.
Elimination
See Half-life.
Half-life
Whole body retention data from normal subjects showed 97 to 100% of
[ Se]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.
Paediatric population
No data are available.
75

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

7 MARKETING AUTHORISATION HOLDER
GE Healthcare Limited
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom

10 DATE OF REVISION OF THE TEXT
February 2017

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie

5

Radiation protection precautions in accordance with national regulations
must therefore be taken.
Any unused medicinal product or waste material should be disposed of in
accordance with local requirements.

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
The shelf life for this product is 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
General warning
Radiopharmaceuticals should 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
licenses of the competent official organisation.
Radiopharmaceuticals should be prepared in a manner which satisfies
both radiation safety and pharmaceutical quality requirements.
Appropriate aseptic precautions should be taken.
If at any time in the preparation of this product the integrity of this
container is compromised it should not be used.
Administration procedures should be carried out in a way to minimise risk
of contamination of the medicinal product and irradiation of the operators.
Adequate shielding is mandatory.
The administration of radiopharmaceuticals creates risks for other persons
from external radiation or contamination from spill of urine, vomiting, etc.

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

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 zerotime 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 Allow 3 hours for physiological equilibration.
3 Measure the background twice, setting the camera window as
described above. A preset count or time may be used.
4 Place the patient on the couch as described above. Count for preset
time (300 seconds suggested and record the counts).
5 Turn the patient and repeat the count from the other view.
6 Measure the background again.
7 After background subtraction, calculate the geometric mean of the
two patient counts √(PA x AP).

8 Repeat steps 3-7 after 7 days.
9 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.
SeHCAT is a trademark of GE Healthcare.
GE and the GE Monogram are trademarks of General Electric Company.

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GE Healthcare

HEALTHCARE PROFESSIONAL
INFORMATION

SeHCAT™
370 kBq capsules
[75Se]tauroselcholic
acid
SC510P

13645303

SC510P-GB0217-SPC

1183211-102/0317/ Oe6000

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Source: Medicines and Healthcare Products Regulatory Agency

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