Overdose : מינון יתר

4.9.   OVERDOSE

The principal toxic effect is profound myeloablation and pancytopenia, but the central nervous system, liver, lungs, and gastrointestinal tract may also be affected.

There is no known antidote to BUSULFAN RAZ 6 MG/ML other than haematopoietic stem cell transplantation. In the absence of haematopoietic progenitor cell transplantation, the recommended dosage of BUSULFAN RAZ 6 MG/ML would constitute an overdose of busulfan. The haematologic status should be closely monitored and vigorous supportive measures instituted as medically indicated.

There have been two reports that busulfan is dialyzable, thus dialysis should be considered in the case of an overdose. Since, busulfan is metabolized through conjugation with glutathione, administration of glutathione might be considered.

It must be considered that overdose of BUSULFAN RAZ 6 MG/ML will also increase exposure to DMA. In human the principal toxic effects were hepatotoxicity and central nervous system effects. CNS changes precede any of the more severe side effects. No specific antidote for DMA overdose is known. In case of overdose, management would include general supportive care.