SEHCAT 370 KBQ Капсула

Содержание инструкции

1. SeHCAT 370 kBq hard capsule
   1. What SeHCAT is and what it is used for
   2. What you need to know before using SeHCAT
   3. How to use SeHCAT
   4. Possible side effects
   5. How to store SeHCAT
   6. Contents of the pack and other information

SeHCAT 370 kBq hard capsule

tauroselcholic acid ( Se)

Read this leaflet carefully before using this medicine as it contains important
information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask the specialist doctor in nuclear medicine who will supervise the procedure.
• If any side effects occur, including those not listed in this leaflet, ask your nuclear medicine specialist doctor. See section 4.

Contents of this leaflet:

• 1. What SeHCAT is and what it is used for
• 2. What you need to know before using SeHCAT
• 3. How to use SeHCAT
• 4. Possible side effects
• 5. How to store SeHCAT
• 6. Contents of the pack and other information

1. What SeHCAT is and what it is used for

SeHCAT is a ‘radiopharmaceutical’ medicine for diagnostic use only.
SeHCAT is used exclusively to identify a disorder in some parts of the digestive system.
SeHCAT is used before a scan and helps a special gamma camera to see inside
a part of your body using a special device (e.g. gamma camera or whole-body).

• It contains an active substance called ‘tauroselcholic acid (Se)’.
• Once ingested, it can be seen from outside your body by a special device used in the scan.
• The scan can help the doctor see how your digestive system is working.

The nuclear medicine specialist or the nurse will tell you which part of the body will be scanned.
The use of SeHCAT involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine
specialist have assessed that the clinical benefit of this examination performed with a
radiopharmaceutical is greater than the risk created by exposure to these small amounts of radiation.

2. What you need to know before using SeHCAT

Do not use SeHCAT:

• If you are allergic (hypersensitive) to the active ingredient or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or suspect you may be pregnant.
• If you are breastfeeding.

Warnings and precautions
Consult your nuclear medicine specialist before using SeHCAT:

• If a doctor has told you that your liver is not functioning properly.

Before the administration of SeHCAT you will be asked to drink water and to urinate as often as possible

Children and adolescents

• Talk to your nuclear medicine specialist if you are under 18 years of age.

Other medicines and SeHCAT
Inform your nuclear medicine specialist if you are taking or have recently taken any other
medicines, because some medicines may interfere with SeHCAT.

SeHCAT with food and drink
You will be asked to drink some water before, during and after swallowing the capsule
During the administration the patient should be seated or standing.

Pregnancy, breastfeeding and fertility
You must inform your nuclear medicine specialist before the administration of SeHCAT if there is a
possibility that you are pregnant, if you have missed a menstrual period or if you are breastfeeding. In
case of doubt it is important to consult your nuclear medicine specialist.

If you are pregnant
SeHCAT should not be administered to you if you are pregnant or think you may be pregnant.
(see section 2, Do not use SeHCAT)

If you are breastfeeding
SeHCAT should not be administered to you if you are breastfeeding
(see section 2, Do not use SeHCAT).

Driving and operating machinery
Ask your doctor if you can drive vehicles or operate machinery after you have been administered
SeHCAT.

SeHCAT contains sodium
This medicine contains 71.04 mg of sodium (3.01 mmol) per capsule. You may need to
take this into account in patients who are on a low-sodium diet.

3. How to use SeHCAT

There are strict laws regulating the use, handling and disposal of radiopharmaceuticals.
SeHCAT will only be used in dedicated controlled areas. This medicine will be handled and
administered exclusively by personnel trained and qualified to use it safely.
This personnel will provide you with all the necessary information about the procedure.
Dose
The nuclear medicine specialist responsible for performing the examination will decide the dose of SeHCAT to use
in your case. The doctor will choose the smallest amount necessary to obtain the desired information
.
Normally the recommended amount for an adult is one capsule and the maximum recommended activity is
370 kBq (kilobecquerel, the unit used to express radioactivity).

Use in children and adolescents
The amount to be administered to a child or adolescent will be the same as that for adults.
Before using this product in children, a careful assessment of the
benefit/risk ratio must be carried out, in particular because the use of a fixed dose involves an increase in the
effective dose in children.
There is no specific dosage or clinical experience for the use of this product in children.

Administration of SeHCAT and performance of the examination
SeHCAT is taken orally.
Normally, only one capsule is sufficient to perform the examination requested by the doctor.
The capsule can be taken either sitting or standing.

Duration of the examination
The nuclear medicine specialist will inform you about the duration of the procedure and will inform you about any
particular precautions to be observed after administration of the medicine. Contact the nuclear medicine
specialist for any doubts or questions.

After administration you must:
avoid close proximity to young children and pregnant women for a reasonable period of time,
taking into account the biological half-life of the radiopharmaceutical, which is 2.6 days, and the energy of
emission of the radionuclide (100-400 keV). Ask the nuclear medicine specialist for any
information.

If you have been given an excessive dose of SeHCAT:
It is unlikely that you will be given an excessive dose of medicine, as you will receive a
single capsule from the nuclear medicine specialist in an accurate and controlled manner. However, in case of
overdose, you will receive appropriate treatment.
If you have further questions about the use of this medicine, contact the nuclear medicine specialist.

4. Possible side effects

Like all medicines, SeHCAT can cause side effects, although not everybody gets them.
With this medicinal product, the following side effects may occur

Allergic reactions (Hypersensitivity) Frequency not known
If you experience an allergic reaction, inform your doctor immediately, as you may need urgent medical attention. The signs may include:

• skin rash, itching, redness
• swelling of the face
• difficulty breathing If any of the side effects described above occur after you have left the hospital or clinic, go directly to the emergency room of the nearest hospital.

This radiopharmaceutical will release low levels of ionizing radiation which are associated with a minimum
risk of developing cancer and hereditary anomalies (transmission of defective genes).

Reporting of side effects
If any side effect occurs, including those not listed in this leaflet, contact
the nuclear medicine specialist. You can also report side effects directly through
the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-
una-sospetta-reazione-avversa. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store SeHCAT

You do not need to store this medicine. This medicine is stored under the responsibility of a specialist and in appropriate premises. The storage of radiopharmaceuticals will occur in accordance with national regulations regarding radioactive products.
The following information is intended exclusively for the specialist.
SeHCAT must be kept out of the sight and reach of children.
This medicine must not be used after the date and time of expiry stated on the label after SCAD.

6. Contents of the pack and other information

What SeHCAT contains

• The active ingredient is tauroselcholic acid ( Se). Each SeHCAT capsule contains 370 kBq (kilobecquerel - the unit of measure used to measure radioactivity) of tauroselcholic acid ( Se).
• The other components are disodium hydrogen phosphate dihydrate and a gelatin capsule containing titanium dioxide, quinoline yellow, erythrosine, gelatin, sodium lauryl sulfate and acetic acid.

Appearance of SeHCAT and contents of the pack
SeHCAT is a hard capsule supplied in a polystyrene container

Marketing Authorisation Holder
GE Healthcare S.r.l.
Via Galeno 36,
20126 Milano - Italy

Manufacturer
GE Healthcare Buchler GmbH & Co. KG.
Gieselweg 1
38110 Braunschweig - Germany
or
GE Healthcare Limited
The Grove Centre White Lion Road Amersham
Buckinghamshire HP7 9LL, United Kingdom
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The following information is intended exclusively for healthcare professionals:
The complete Summary of Product Characteristics (SPC) of SeHCAT is provided as a separate document
in the product packaging. This allows for providing healthcare professionals with further
scientific and practical information relating to the administration and use of this radiopharmaceutical.
Refer to the SPC