Drug information for ELSPAR

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
VIAL	10,000IU/VIAL	Prescription		ASPARAGINASE	Asparaginase	MERCK	101063 2007-04-20 Letter 2007-04-20 Label 2006-07-25 Letter 2006-07-21 Label 2004-07-07 Letter 2004-03-12 Letter 2004-03-12 Label

Drug Adverse Effects information for ELSPAR

Role code	Indications	Reaction	# Reports
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	ABDOMINAL RIGIDITY	4
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	4
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	ASCITES	4
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	BILIRUBIN CONJUGATED INCREASED	4
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	CONFUSIONAL STATE	4
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	DIABETIC KETOACIDOSIS	5
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	DISSEMINATED INTRAVASCULAR COAGULATION	8
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	DRUG INTERACTION	5
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	ECCHYMOSIS	4
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	EPILEPSY	1
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	GRAND MAL CONVULSION	4
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	HEPATITIS FULMINANT	8
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	HERPES ZOSTER DISSEMINATED	8
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	HYPERTENSION	4
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	INFECTION IN AN IMMUNOCOMPROMISED HOST	4
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	MULTI-ORGAN FAILURE	8
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	MYOCARDITIS	8
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	OCULAR ICTERUS	4
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	PAIN	5
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	PALLOR	4
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	PANCREATIC CYST	5
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	PANCREATIC NECROSIS	9
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	PANCREATITIS	1
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	PANCREATITIS ACUTE	4
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	PAPILLOEDEMA	4
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	PROTHROMBIN TIME PROLONGED	4
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	PYREXIA	9
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	TARDIVE DYSKINESIA	4
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	URINARY INCONTINENCE	4
PS	ACUTE LYMPHOCYTIC LEUKAEMIA	WEIGHT DECREASED	5
PS	B PRECURSOR TYPE ACUTE LEUKAEMIA	BLOOD TEST ABNORMAL	8
PS	B PRECURSOR TYPE ACUTE LEUKAEMIA	ENTEROCOLITIS INFECTIOUS	8
PS	B PRECURSOR TYPE ACUTE LEUKAEMIA	GROIN PAIN	8
PS	B PRECURSOR TYPE ACUTE LEUKAEMIA	HYPOTENSION	8
PS	B PRECURSOR TYPE ACUTE LEUKAEMIA	PRESYNCOPE	8
PS	B PRECURSOR TYPE ACUTE LEUKAEMIA	PYREXIA	8
PS	PANCREATITIS ACUTE	ABDOMINAL RIGIDITY	1
PS	PANCREATITIS ACUTE	ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	1
PS	PANCREATITIS ACUTE	ASCITES	1
PS	PANCREATITIS ACUTE	BILIRUBIN CONJUGATED INCREASED	1
PS	PANCREATITIS ACUTE	CONFUSIONAL STATE	1
PS	PANCREATITIS ACUTE	DRUG INTERACTION	2
PS	PANCREATITIS ACUTE	EPILEPSY	1
PS	PANCREATITIS ACUTE	GRAND MAL CONVULSION	1
PS	PANCREATITIS ACUTE	HYPERTENSION	1
PS	PANCREATITIS ACUTE	OCULAR ICTERUS	1
PS	PANCREATITIS ACUTE	PALLOR	1
PS	PANCREATITIS ACUTE	PANCREATIC NECROSIS	1
PS	PANCREATITIS ACUTE	PANCREATITIS	1
PS	PANCREATITIS ACUTE	PANCREATITIS ACUTE	1
PS	PANCREATITIS ACUTE	PAPILLOEDEMA	1
PS	PANCREATITIS ACUTE	PROTHROMBIN TIME PROLONGED	1
PS	PANCREATITIS ACUTE	PYREXIA	1
PS	PANCREATITIS ACUTE	TARDIVE DYSKINESIA	1
PS	PANCREATITIS ACUTE	URINARY INCONTINENCE	1
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	ACUTE HEPATIC FAILURE	4
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	BILE DUCT CANCER	15
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	BLOOD CREATININE INCREASED	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	BLOOD UREA INCREASED	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	BONE MARROW TRANSPLANT	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	BRONCHOPULMONARY ASPERGILLOSIS	12
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	CARDIAC FAILURE CONGESTIVE	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	CARDIOTOXICITY	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	CHEST PAIN	12
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	COLONIC POLYP	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	CONGESTIVE CARDIOMYOPATHY	15
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	COUGH	12
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	DIARRHOEA	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	ELECTROCARDIOGRAM QT PROLONGED	12
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	ENCEPHALOPATHY	4
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	ENTEROCOCCAL SEPSIS	4
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	GROWTH HORMONE DEFICIENCY	12
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	HEPATIC CIRRHOSIS	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	HEPATIC LESION	12
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	HYPOKALAEMIA	12
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	HYPOMAGNESAEMIA	12
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	METASTASES TO LIVER	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	METASTASES TO LUNG	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	METASTASES TO STOMACH	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	METASTASIS	6
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	NEOPLASM MALIGNANT	12
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	NEUROPATHY PERIPHERAL	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	NEUTROPHIL COUNT DECREASED	12
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	OSTEOSCLEROSIS	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	OVARIAN FAILURE	12
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	PLEURAL EFFUSION	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	PYREXIA	12
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	RASH	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	RENAL CYST	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	RENAL IMPAIRMENT	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	RENAL MASS	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	RESPIRATORY FAILURE	12
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	THROMBOCYTOPENIA	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	THYROID CANCER	12
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	TOXICITY TO VARIOUS AGENTS	9
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	VENOOCCLUSIVE LIVER DISEASE	4
SS	ACUTE LYMPHOCYTIC LEUKAEMIA	WHITE BLOOD CELL COUNT DECREASED	12
SS	CLOSTRIDIUM DIFFICILE COLITIS	ENTEROCOLITIS INFECTIOUS	1
SS	CLOSTRIDIUM DIFFICILE COLITIS	FLUID RETENTION	1
SS	CLOSTRIDIUM DIFFICILE COLITIS	HEADACHE	1
SS	CLOSTRIDIUM DIFFICILE COLITIS	HYPERTENSION	1
SS	CLOSTRIDIUM DIFFICILE COLITIS	NEUTROPHIL COUNT DECREASED	1
SS	CLOSTRIDIUM DIFFICILE COLITIS	WHITE BLOOD CELL COUNT DECREASED	1
SS	EPSTEIN-BARR VIRUS INFECTION	GUILLAIN-BARRE SYNDROME	3
SS	EPSTEIN-BARR VIRUS INFECTION	PERICARDIAL EFFUSION	3
SS	EPSTEIN-BARR VIRUS INFECTION	PYREXIA	3
SS	LYMPHOCYTIC LEUKAEMIA	ENTEROCOLITIS INFECTIOUS	14
SS	LYMPHOCYTIC LEUKAEMIA	FLUID RETENTION	14
SS	LYMPHOCYTIC LEUKAEMIA	HEADACHE	14
SS	LYMPHOCYTIC LEUKAEMIA	HYPERTENSION	14
SS	LYMPHOCYTIC LEUKAEMIA	NEUTROPHIL COUNT DECREASED	14
SS	LYMPHOCYTIC LEUKAEMIA	WHITE BLOOD CELL COUNT DECREASED	14
SS	PRODUCT USED FOR UNKNOWN INDICATION	ACUTE HEPATIC FAILURE	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	BILE DUCT CANCER	2
SS	PRODUCT USED FOR UNKNOWN INDICATION	CONGESTIVE CARDIOMYOPATHY	2
SS	PRODUCT USED FOR UNKNOWN INDICATION	ENCEPHALOPATHY	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	ENTEROCOCCAL SEPSIS	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	METASTASIS	2
SS	PRODUCT USED FOR UNKNOWN INDICATION	VENOOCCLUSIVE LIVER DISEASE	1
C	ACUTE LYMPHOCYTIC LEUKAEMIA	ANAEMIA	5
C	ACUTE LYMPHOCYTIC LEUKAEMIA	BRONCHOPULMONARY ASPERGILLOSIS	1
C	ACUTE LYMPHOCYTIC LEUKAEMIA	DIARRHOEA	5
C	ACUTE LYMPHOCYTIC LEUKAEMIA	DRUG INTERACTION	8
C	ACUTE LYMPHOCYTIC LEUKAEMIA	ELECTROCARDIOGRAM QT PROLONGED	1
C	ACUTE LYMPHOCYTIC LEUKAEMIA	GASTROINTESTINAL HAEMORRHAGE	5
C	ACUTE LYMPHOCYTIC LEUKAEMIA	HAEMATOCHEZIA	5
C	ACUTE LYMPHOCYTIC LEUKAEMIA	ILEUS PARALYTIC	8
C	ACUTE LYMPHOCYTIC LEUKAEMIA	MUSCLE HAEMORRHAGE	5
C	ACUTE LYMPHOCYTIC LEUKAEMIA	NEUTROPENIA	5
C	ACUTE LYMPHOCYTIC LEUKAEMIA	PLATELET COUNT DECREASED	5
C	ACUTE LYMPHOCYTIC LEUKAEMIA	PULMONARY HAEMORRHAGE	5
C	ACUTE LYMPHOCYTIC LEUKAEMIA	RENAL IMPAIRMENT	5
C	ACUTE LYMPHOCYTIC LEUKAEMIA	RESPIRATORY FAILURE	1
C	ACUTE LYMPHOCYTIC LEUKAEMIA	VENTRICULAR EXTRASYSTOLES	1
C	ACUTE LYMPHOCYTIC LEUKAEMIA	WHITE BLOOD CELL COUNT DECREASED	5
C	ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT	BRONCHOPULMONARY ASPERGILLOSIS	3
C	ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT	ELECTROCARDIOGRAM QT PROLONGED	3
C	ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT	RESPIRATORY FAILURE	3
C	ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT	VENTRICULAR EXTRASYSTOLES	3
C	ACUTE MYELOID LEUKAEMIA	ASPERGILLOMA	3
C	ACUTE MYELOID LEUKAEMIA	DISEASE COMPLICATION	3
C	ACUTE MYELOID LEUKAEMIA	GRAFT VERSUS HOST DISEASE	3
C	ACUTE MYELOID LEUKAEMIA	INFECTION	3
C	ACUTE MYELOID LEUKAEMIA	LEUKAEMIA RECURRENT	9
C	ACUTE MYELOID LEUKAEMIA	STEM CELL TRANSPLANT	3
C	ANTIBIOTIC PROPHYLAXIS	DRUG INTERACTION	2
C	ANTIBIOTIC PROPHYLAXIS	ILEUS PARALYTIC	2
C	BRONCHOPULMONARY ASPERGILLOSIS	BRONCHOPULMONARY ASPERGILLOSIS	1
C	BRONCHOPULMONARY ASPERGILLOSIS	ELECTROCARDIOGRAM QT PROLONGED	1
C	BRONCHOPULMONARY ASPERGILLOSIS	RESPIRATORY FAILURE	1
C	BRONCHOPULMONARY ASPERGILLOSIS	VENTRICULAR EXTRASYSTOLES	1
C	HYPERTENSION	DRUG INTERACTION	4
C	HYPERTENSION	ILEUS PARALYTIC	4
C	PRODUCT USED FOR UNKNOWN INDICATION	DRUG INTERACTION	4
C	PRODUCT USED FOR UNKNOWN INDICATION	ILEUS PARALYTIC	4
C	PROPHYLAXIS	DRUG INTERACTION	9
C	PROPHYLAXIS	ILEUS PARALYTIC	9
C	PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER	DRUG INTERACTION	2
C	PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER	ILEUS PARALYTIC	2
C	T-CELL LYMPHOMA	LEUKOENCEPHALOPATHY	9

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