Revised SPC changes include:

Section 4.2 Posology and method of administration has had the following added:

Paediatric patients: The experience in children is limited (see sections 4.4, 4.8, 5.1 and 5.2).

Section 4.4 Special warnings and special precautions for use has had following added:

In clinical trials, second malignancies have been reported in paediatric patients with Hodgkin’s disease and acute lymphoblastic leukaemia receiving chemotherapy regimes including several cytotoxics (e.g. etoposide, doxorubicin, cyclophosphamide).

Since dexrazoxane is a cytotoxic agent, with topoisomerase II inhibition activity, combination of dexrazoxane with chemotherapy may lead to an increased risk of second malignancy.

Section 4.8 Undesirable effects has had the following paragraph added:

Secondary acute myeloid leukaemia (AML) / myelodysplastic syndrome (MDS) has been observed in paediatric patients with Hodgkin’s disease or acute lymphoblastic leukaemia receiving dexrazoxane in combination with chemotherapy.