Yttrium ⁹⁰Y chloride

Yttrium (⁹⁰Y)-labelled medicinal products are contraindicated in established or suspected pregnancy or when pregnancy has not been excluded.

Before administering a radioactive medicinal product to a mother who is breast-feeding, consideration should be given to whether the investigation could be reasonably delayed until the mother has ceased breast-feeding. If the administration cannot be delayed, a lactating mother should be advised to stop breast-feeding.

Further information concerning the use of a yttrium (⁹⁰Y)-labelled medicinal products in pregnancy and breast-feeding is specified in the Summary of Product Characteristics of the medicinal product to be radiolabelled.

Fertility

Further information concerning the use of a yttrium (⁹⁰Y)-labelled medicinal concerning fertility is specified in the Summary of Product Characteristics of the medicinal product to be radiolabelled.

Women of childbearing potential

Women of childbearing potential have to use effective contraception during and after treatment.

Effects on ability to drive and to use machines following treatment by yttrium (⁹⁰Y)-labelled medicinal products will be specified in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.

Possible adverse reactions following the intravenous administration of a yttrium (⁹⁰Y)-labelled medicinal product prepared by radiolabelling with yttrium (⁹⁰Y) chloride, will be dependent on the specific medicinal product being used. Such information will be supplied in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled. For each patient, exposure to ionising radiation must be justifiable on the basis of likely clinical benefit. The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to obtain the intended therapeutic result.

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

The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and mutations. In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself.