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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

I iver 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,

' ncluding 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.

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5. How to store SeHCAT

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).

GE Healthcare BuchlerGmbH &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.

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:

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 i 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 i nvestigation 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

	Date of first authorisation	Date of last renewal
UK	07 January 2002	20 April 2006
Ireland	15 November 1989	15 November 2004

10 DATE OF REVISION OF THE TEXT

02 June 2015

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],

	Absorbed dose per unit activity administered (mGy/MBa)
Organ	Adult	15 year	10 year	5 year	1 year
Adrenals	3.2E-01	4.1E-01	6.2E-01	9.4E-01	1.5E+00
Bladder	3.3E-01	4.2E-01	6.7E-01	L0E+00	1.7E+00
Bone surfaces	2.3E-01	3.0E-01	4.3E-01	6.4E-01	1.2E+00
Brain	4.8E-02	5.6E-02	7.9E-02	1.2E-01	2.0E-01
Breast	7.7E-02	9.6E-02	1.8E-01	2.8E-01	5.2E-01
Gall bladder Gl-tract	6.4E+00	7.1E+00	9.0E+00	1.5E+01	4.8E+01
Stomach	4.2E-01	5.5E-01	9.3E-01	1.5E+00	2.5E+00
SI	1.9E+00	2.4E+00	3.8E+00	5.9E+00	1.0E+01
Colon	2.0E+00	2.4E+00	3.8E+00	5.8E+00	1.0E+01
(UU	1.9E+00	2.3E+00	3.5E+00	5.3E+00	9.1E+00)
(LLI	2.1E+00	2.6E+00	4.2E+00	6.5E+00	1.2E+01)
Heart	3.3E-01	4.3E-01	6.4E-01	9.6E-01	1.6E+00
Kidneys	5.0E-01	6.1E-01	8.9E-01	1.3E+00	2.0E+00
Liver	6.9E-01	8.7E-01	1.3E+00	1.8E+00	3.2E+00
Lungs	2.4E-01	3.3E-01	4.7E-01	7.2E-01	1.3E+00
Muscles	2.0E-01	2.5E-01	3.7E-01	5.5E-01	9.8E-01
Oesophagus	LIE-01	1.4E-01	1.9E-01	2.9E-01	4.8E-01
Ovaries	L0E+00	1.3E+00	2.0E+00	2.9E+00	4.9E+00
Pancreas	4.5E-01	5.8E-01	1.1E+00	1.7E+00	2.6E+00
Red marrow	2.9E-01	3.4E-01	4.6E-01	6.0E-01	8.3E-01
Skin	7.5E-02	9.1E-02	1.4E-01	2.2E-01	4.2E-01
Spleen	3.0E-01	4.1E-01	6.6E-01	L0E+00	1.7E+00
Testes	9.2E-02	1.3E-01	2.2E-01	3.7E-01	7.0E-01
Thymus	LIE-01	1.4E-01	1.9E-01	2.9E-01	4.8E-01
Thyroid	6.9E-02	9.6E-02	1.5E-01	2.7E-01	5.2E-01
Uterus	7.5E-01	9.4E-01	1.5E+00	2.3E+00	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 kBg 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. Flowever, 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 technigues may be used.

For some investigations scintigraphic studies may be appropriate.

Measurement of retained activity Whole body counter

A 370 kBg (10 pCi] capsule is administered to the patient together with a drink of water. Using conventional whole body counting technigues 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 technetium-99m, 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.