Drug information for BUSULFEX

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
INJECTABLE; INJECTION	6MG/ML	Prescription	(Reference Drug)	BUSULFAN	Busulfan	OTSUKA PHARM	20954 2011-06-29 Label 2011-06-29 Label 2011-06-29 Letter 2011-06-29 Letter 2007-04-25 Letter 2007-04-20 Label 2004-06-04 Review 2004-03-09 Review 2004-03-09 Review 2003-07-08 Review 2003-03-06 Label 2003-01-13 Letter 2002-12-23 Letter 2002-11-13 Letter 2002-11-13 Label 2002-04-24 Letter 1999-06-14 Review 1999-02-04 Letter 1999-02-04 Label

Drug Adverse Effects information for BUSULFEX

Role code	Indications	Reaction	# Reports
PS	ACUTE MYELOID LEUKAEMIA	ACUTE PULMONARY OEDEMA	1
PS	ACUTE MYELOID LEUKAEMIA	CARDIAC ARREST	1
PS	ACUTE MYELOID LEUKAEMIA	CARDIAC FAILURE	1
PS	ACUTE MYELOID LEUKAEMIA	CLOSTRIDIUM COLITIS	2
PS	ACUTE MYELOID LEUKAEMIA	SEPSIS	2
PS	BONE MARROW CONDITIONING REGIMEN	ACUTE RESPIRATORY DISTRESS SYNDROME	1
PS	BONE MARROW CONDITIONING REGIMEN	BONE MARROW FAILURE	1
PS	BONE MARROW CONDITIONING REGIMEN	CHOLANGITIS	1
PS	BONE MARROW CONDITIONING REGIMEN	CHOLELITHIASIS	1
PS	BONE MARROW CONDITIONING REGIMEN	CONFUSIONAL STATE	1
PS	BONE MARROW CONDITIONING REGIMEN	EJECTION FRACTION DECREASED	1
PS	BONE MARROW CONDITIONING REGIMEN	HYPERBILIRUBINAEMIA	1
PS	BONE MARROW CONDITIONING REGIMEN	LEFT VENTRICULAR DYSFUNCTION	1
PS	BONE MARROW CONDITIONING REGIMEN	MIOSIS	1
PS	BONE MARROW CONDITIONING REGIMEN	MUCOSAL INFLAMMATION	1
PS	BONE MARROW CONDITIONING REGIMEN	MULTI-ORGAN DISORDER	1
PS	BONE MARROW CONDITIONING REGIMEN	MULTIPLE-DRUG RESISTANCE	1
PS	BONE MARROW CONDITIONING REGIMEN	NEUROLOGICAL DECOMPENSATION	1
PS	BONE MARROW CONDITIONING REGIMEN	OVERDOSE	1
PS	BONE MARROW CONDITIONING REGIMEN	PSEUDOMONAS INFECTION	1
PS	BONE MARROW CONDITIONING REGIMEN	REFRACTORINESS TO PLATELET TRANSFUSION	1
PS	BONE MARROW CONDITIONING REGIMEN	RENAL FAILURE	1
PS	BONE MARROW CONDITIONING REGIMEN	SEPSIS	1
PS	BONE MARROW CONDITIONING REGIMEN	SOMNOLENCE	1
PS	BONE MARROW CONDITIONING REGIMEN	STAPHYLOCOCCAL INFECTION	1
PS	BONE MARROW CONDITIONING REGIMEN	THROMBOCYTOPENIA	1
PS	BONE MARROW CONDITIONING REGIMEN	UNEVALUABLE EVENT	1
PS	BONE MARROW TRANSPLANT	ACUTE GRAFT VERSUS HOST DISEASE	1
PS	BONE MARROW TRANSPLANT	ACUTE PULMONARY OEDEMA	2
PS	BONE MARROW TRANSPLANT	CARDIAC ARREST	2
PS	BONE MARROW TRANSPLANT	CARDIAC FAILURE	2
PS	BONE MARROW TRANSPLANT	CHRONIC GRAFT VERSUS HOST DISEASE	1
PS	BONE MARROW TRANSPLANT	KERATITIS	1
PS	BONE MARROW TRANSPLANT	MATERNAL EXPOSURE BEFORE PREGNANCY	1
PS	BONE MARROW TRANSPLANT	PREGNANCY	1
PS	BONE MARROW TRANSPLANT	PREMATURE MENOPAUSE	1
PS	BONE MARROW TRANSPLANT	RASH	1
PS	BONE MARROW TRANSPLANT	TRANSPLANT	1
PS	MYELOID LEUKAEMIA	ASPERGILLOSIS	2
PS	MYELOID LEUKAEMIA	BRONCHOPULMONARY ASPERGILLOSIS	2
PS	MYELOID LEUKAEMIA	CHRONIC GRAFT VERSUS HOST DISEASE	2
PS	MYELOID LEUKAEMIA	FUNGAL INFECTION	2
PS	MYELOID LEUKAEMIA	GRAFT VERSUS HOST DISEASE	2
PS	MYELOID LEUKAEMIA	RENAL FAILURE	4
PS	STEM CELL TRANSPLANT	ACUTE PULMONARY OEDEMA	1
PS	STEM CELL TRANSPLANT	ACUTE RESPIRATORY DISTRESS SYNDROME	2
PS	STEM CELL TRANSPLANT	BRAIN NATRIURETIC PEPTIDE INCREASED	1
PS	STEM CELL TRANSPLANT	CHOLESTASIS	1
PS	STEM CELL TRANSPLANT	CYTOLYTIC HEPATITIS	3
PS	STEM CELL TRANSPLANT	ENTEROCOCCUS TEST POSITIVE	2
PS	STEM CELL TRANSPLANT	PROTHROMBIN TIME PROLONGED	2
PS	STEM CELL TRANSPLANT	PROTHROMBIN TIME SHORTENED	1
PS	STEM CELL TRANSPLANT	PULMONARY ALVEOLAR HAEMORRHAGE	1
PS	STEM CELL TRANSPLANT	SEPSIS	1
PS	STEM CELL TRANSPLANT	STEM CELL TRANSPLANT	2
PS	STEM CELL TRANSPLANT	SURGICAL PROCEDURE REPEATED	1
SS	BONE MARROW TRANSPLANT	ASCITES	8
SS	BONE MARROW TRANSPLANT	BILIRUBIN CONJUGATED INCREASED	8
SS	BONE MARROW TRANSPLANT	CYTOMEGALOVIRUS TEST POSITIVE	8
SS	BONE MARROW TRANSPLANT	HEPATIC FAILURE	8
SS	BONE MARROW TRANSPLANT	HEPATIC FUNCTION ABNORMAL	8
SS	BONE MARROW TRANSPLANT	HISTIOCYTOSIS HAEMATOPHAGIC	8
SS	BONE MARROW TRANSPLANT	JAUNDICE	8
SS	BONE MARROW TRANSPLANT	NEUTROPHIL COUNT INCREASED	8
SS	BONE MARROW TRANSPLANT	PLEURAL EFFUSION	8
SS	BONE MARROW TRANSPLANT	SYSTEMIC CANDIDA	8
SS	BONE MARROW TRANSPLANT	THROMBOTIC MICROANGIOPATHY	8
SS	BONE MARROW TRANSPLANT	VENOOCCLUSIVE LIVER DISEASE	8
SS	BONE MARROW TRANSPLANT	WEIGHT INCREASED	8
SS	VENOOCCLUSIVE LIVER DISEASE	ASCITES	2
SS	VENOOCCLUSIVE LIVER DISEASE	BILIRUBIN CONJUGATED INCREASED	2
SS	VENOOCCLUSIVE LIVER DISEASE	CYTOMEGALOVIRUS TEST POSITIVE	2
SS	VENOOCCLUSIVE LIVER DISEASE	HEPATIC FAILURE	2
SS	VENOOCCLUSIVE LIVER DISEASE	HEPATIC FUNCTION ABNORMAL	2
SS	VENOOCCLUSIVE LIVER DISEASE	HISTIOCYTOSIS HAEMATOPHAGIC	2
SS	VENOOCCLUSIVE LIVER DISEASE	JAUNDICE	2
SS	VENOOCCLUSIVE LIVER DISEASE	NEUTROPHIL COUNT INCREASED	2
SS	VENOOCCLUSIVE LIVER DISEASE	PLEURAL EFFUSION	2
SS	VENOOCCLUSIVE LIVER DISEASE	SYSTEMIC CANDIDA	2
SS	VENOOCCLUSIVE LIVER DISEASE	THROMBOTIC MICROANGIOPATHY	2
SS	VENOOCCLUSIVE LIVER DISEASE	VENOOCCLUSIVE LIVER DISEASE	2
SS	VENOOCCLUSIVE LIVER DISEASE	WEIGHT INCREASED	2
C	PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE	CYTOMEGALOVIRUS ENTEROCOLITIS	2
C	PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE	VENOOCCLUSIVE DISEASE	2

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