Busilvex 6 mg/ml concentrate for solution for infusion - Ireland[爱尔兰药品]

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Busilvex 6 mg/ml concentrate for solution for infusion (八)

2013-10-12 15:29:21 来源: 作者: 【大中小】浏览:8038次评论:0条

l haemorrhage
Hepato-biliary disorders	Hepatomegaly Jaundice	Veno occlusive liver disease *
Skin and subcutaneous tissue disorders	Rash Pruritis Alopecia	Skin desquamation Erythema Pigmentation disorder
Musculoskeletal and connective tissue disorders	Myalgia Back pain Arthralgia
Renal and urinary disorders	Dysuria Oligurea	Haematuria Moderate renal insufficiency
Reproductive system and breast disorders			Premature menopause Ovarian failure**
General disorders and administration site conditions	Asthenia Chills Fever Chest pain Oedema Oedema general Pain Pain or inflammation at injection site Mucositis
Investigations	Transaminases increased Bilirubin increased GGT increased Alkaline phosphatases increased Weight increased Abnormal breath sounds Creatinine elevated	Bun increase Decrease ejection fraction

*veno occlusive liver disease is more frequent in paediatric population.
** reported in post marketing with IV busulfan
*** reported in post marketing with oral busulfan
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 Busilvex other than haematopoietic progenitor cell transplantation. In the absence of haematopoietic progenitor cell transplantation, the recommended dose of Busilvex 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 Busilvex will also increase exposure to DMA. In human the principal toxic effects were hepatotoxicity and central nervous system (CNS) 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.
5. Pharmacological properties
5.1 Pharmacodynamic propertie