Pregnancy & Lactation : הריון/הנקה

4.6     Fertility, pregnancy and lactation

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.

Pregnancy
Myoview is contraindicated in pregnancy (see section 4.3).. Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus. Administration of 250 MBq tetrofosmin (99mTc) at exercise, followed by 750 MBq at rest results in an absorbed dose to the uterus of 8.1 mGy. A radiation dose above 0.5 mGy (equivalent to the exposure from annual background radiation) would be regarded as a potential risk to the foetus.

Breast feeding
Before administering a radiopharmaceuticals to a mother who is breast feeding consideration should be given to the possibility of delaying the administration of a radionuclide until the mother has ceased breast feeding and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk. Tetrofosmin (99mTc) is present in human milk in small amounts (<1% of maternal dose). If the administration is considered necessary, breastfeeding should be interrupted for 3 to 6 hours and the expressed feeds discarded.

Fertility
Animal reproductive toxicity studies have not been performed with this product.