Technetium ⁹⁹ᵐTc macrosalb

There is no experience from the use of technetium [^99mTc] macrosalb injection in pregnant women.

Radionuclide procedures carried out on pregnant women also involve radiation doses to the fetus. Only imperative investigations should therefore be carried out during pregnancy, when the likely benefit exceeds the risk incurred by the mother and the foetus.

Before administering a radioactive medicinal product to a mother who is breastfeeding consideration should be given as to whether the investigation could be reasonably delayed until 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 for 12 hours and the expressed feeds discarded. Breastfeeding can be restarted when the level in the milk will not result in a radiation dose to a child greater than 1 mSv.

Women of childbearing potential

When it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. Where uncertainty exists it is important that radiation exposure should be the minimum consistent with achieving the desired clinical information.

Alternative techniques which do not involve ionising radiation should be considered.

No studies on the effects on 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 (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Very rare: after intravenous administration of technetium [^99mTc] macrosalb aggregates, hypersensitivity reactions appear such as urticaria, shivering fits, fever, nausea, reddening of the face and sweating as well as impairments of cardiac and circulatory functions in the form of changes in respiration, pulse, blood pressure and collapse which may be related to vascular occlusion.

Serious anaphylactoid reactions including shock with possible fatal outcome have been reported, but are very rare. The appearance of these reactions may also not be immediate. Local allergic reactions at the injection site have been observed.

If symptoms such as redness, itching, sneezing, coughing, sweating or feeling cold, difficulty breathing, nausea, vomiting, oedema, urticaria or other sensitivity reactions occur during injection, administration of the medicinal product must be interrupted immediately. Emergency equipment including the medicinal products necessary for treatment must be ready at hand.

Ionized radiation can cause cancer and genetic changes. As most nuclear medicine investigations are carried out with low effective doses of radiation of less than 20 mSv, the probability of these effects occurring should be regarded as being very slight. The effective dose after administration of the maximum recommended activity of this medicinal product is 2.2 mSv.