Radionuclide procedures carried out on pregnant women also involve radiation dose 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 foetus.
Before administering radiopharmaceuticals to a mother who is breastfeeding consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breastfeeding, and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk. If the administration is considered necessary, breastfeeding should be interrupted for 24 hours and the expressed feeds discarded.
When an administration of a radiopharmaceutical 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 her 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.
Effects on the ability to drive or use machines have not to be expected after use of this product.
During the evaluation of adverse reactions the following frequency data are taken as a basis: 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), not known (cannot be estimated form the available data).
Very rarely transient headache or epigastric pain may occur directly after administration of 99mTc-EDDA/HYNIC-TOC.
Exposure to ionisation radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is about 3.7mSv when the maximal recommended activity of 740MBq is administered these adverse events are expected to occur with a low probability.
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