Technetium ⁹⁹ᵐTc stannous agent labelled cells

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 foetus. Administration of 925 MBq results in an absorbed dose to the uterus of 4.3 mGy. Doses above 0.5 mGy should be regarded as a potential risk to the foetus.

Before administering radiopharmaceuticals to a mother who is breast-feeding consideration should be given to the possibility of delaying administration of radionuclide until the mother has ceased breastfeeding and to what is the most appropriate choice of radiopharmaceuticals, learing in ind the secretion of activity in breast milk If the administration is considered necessary, breast-feeding should be interrupted and the expressed feeds discarded. Breast-feeding can be restarted about 12 hours post injection or when the level in milk will not result in a radiation dose to the child greater than 1 mSv.

Women of childbearing potential

When an administration of radioapharmaceutical 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 a period is very irregular etc) alternative techniques not using ionising radiation (if there are any) should be offered to the patient.

Technetium ^99mTc stannous agent has no or negligible influence on the ability to drive and use machines.

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.

As the effective dose is 7.9 mSv when the maximal recommended activity of 925 MBq is administered these adverse reactions are expected to occur with a low probability.

Adverse reactions after the intravenous administration of both the unlabelled and the technetium-99m complexes. Are very rare <1/10,000.

The following effects have been described: flush, headache, vasodilatation, nausea, dizziness, swelling of the arm, erythema and itching at the injection site, diaphoresis and tinnitus, urticaria, generalized pruritus. Cardiac arrhythmia, facial oedema and coma have been reported.

This product contains no excipients that have a recognised action or effect, or knowledge of which is important for safe and effective use of the product.