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.
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 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
No data are available.
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