Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: GE Healthcare Buchler GmbH & Co KG, Gieselweg 1, 38110 Braunschweig, Germany
This medicinal product is for diagnostic use only.
[75Se]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.
The normal dose for adults is one capsule, administered orally.
The adult dose may be used.
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).
Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.
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.
The table below shows the dosimetry as calculated according t o the Publication 8 0 of the ICRP.
| Absorbed dose per unit activity administered (mGy/MBq) | |||||
|---|---|---|---|---|---|
| Organ | Adult | 15 years | 10 years | 5 years | 1 year |
| Adrenals Bladder Bone surfaces Brain Breast Gallbladder GI-tract Stomach SI Colon ULI LLI Heart Kidneys Liver Lungs Muscles Oesophagus Ovaries Pancreas Red marrow Skin Spleen Testes Thymus Thyroid Uterus Remaining Organs | 3.2E-01 3.3E-01 2.3E-01 4.8E-02 7.7E-02 6.4E+00 4.2E-01 1.9E+00 2.0E+00 1.9E+00 2.1E+00 3.3E-01 5.0E-01 6.9E-01 2.4E-01 2.0E-01 1.1E-01 1.0E+00 4.5E-01 2.9E-01 7.5E-02 3.0E-01 9.2E-02 1.1E-01 6.9E-02 7.5E-01 2.6E-01 | 4.1E-01 4.2E-01 3.0E-01 5.6E-02 9.6E-02 7.1E+00 5.5E-01 2.4E+00 2.4E+00 2.3E+00 2.6E+00 4.3E-01 6.1E-01 8.7E-01 3.3E-01 2.5E-01 1.4E-01 1.3E+00 5.8E-01 3.4E-01 9.1E-02 4.1E-01 1.3E-01 1.4E-01 9.6E-02 9.4E-01 3.4E-01 | 6.2E-01 6.7E-01 4.3E-01 7.9E-02 1.8E-01 9.0E+00 9.3E-01 3.8E+00 3.8E+00 3.5E+00 4.2E+00 6.4E-01 8.9E-01 1.3E+00 4.7E-01 3.7E-01 1.9E-01 2.0E+00 1.1E+00 4.6E-01 1.4E-01 6.6E-01 2.2E-01 1.9E-01 1.5E-01 1.5E+00 5.3E-01 | 9.4E-01 1.0E+00 6.4E-01 1.2E-01 2.8E-01 1.5E+01 1.5E+00 5.9E+00 5.8E+00 5.3E+00 6.5E+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 6.0E-01 2.2E-01 1.0E+00 3.7E-01 2.9E-01 2.7E-01 2.3E+00 8.3E-01 | 1.5E+00 1.7E+00 1.2E+00 2.0E-01 5.2E-01 4.8E+01 2.5E+00 1.0E+01 1.0E+01 9.1E+00 1.2E+01 1.6E+00 2.0E+00 3.2E+00 1.3E+00 9.8E-01 4.8E-01 4.9E+00 2.6E+00 8.3E-01 4.2E-01 1.7E+00 7.0E-01 4.8E-01 5.2E-01 3.8E+00 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 kBqcapsule 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.
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.
18 weeks from the date of manufacture.
The activity reference date is 12 weeks before the expiry date.
Store below 25°C. Do not freeze. Store in the original container in order to protect from light.
Store in accordance with national regulations for radioactive materials.
SeHCAT is available in a polystrene container with polythene caps. The capsules are held in place with polythene foam pads.
Pack size: single capsule packs.
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. 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.
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