Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: GE Healthcare Buchler GmbH & Co KG, Gieselweg 1, 38110 Braunschweig, Germany
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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 [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, 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.
Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
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).
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.
No interaction studies have been performed and no interactions have been reported to date.
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.
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.
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.
No studies on the effects on the ability to drive and use machines have been performed.
The frequencies of undesirable effects are defined as follows: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,0 00 to <1/100), rare (≥1/10, 000to <1/1,0 00), 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.
Not known: Hypersensitivity
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 to HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
No data are available.
Not applicable.
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