Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Women of childbearing potential
Sodium iodide I-131 is contraindicated during established or suspected pregnancy or when preg- nancy has not been excluded (the absorbed dose to the uterus for this medicinal product is likely to be in the range 11-511 mGy, and the foetal thyroid gland avidly concentrates iodine during the sec- ond and third trimesters), see section 4.3. When it is necessary to administer a radioactive medici- nal product to women of childbearing potential, information should always be sought about preg- nancy.



Pregnancy
Any woman who has missed a period should be assumed to be pregnant until proven otherwise. Al- ternative techniques which do not involve ionising radiation should be considered. Should differen- tiated thyroid carcinoma be diagnosed during pregnancy, radioactive iodine treatment must be postponed until after the pregnancy. Women receiving sodium iodide I-131 should be advised NOT to become pregnant within 6-12 months after administration.

Contraception in males and females
Women are advised to use contraception for a time period of 6 -12 months. As a precaution, men should not father a child for a time period of 6 months after radioiodine treatment to allow the re- placement of irradiated by non-irradiated spermatozoa.

Breastfeeding
Before administering a radioactive medicinal product to a mother who is breast-feeding considera- tion 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 activity in breast milk. Breast-feeding should be discon- tinued after sodium iodide I-131 administration.