Drug information for REOPRO

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
INJECTABLE; INJECTION	2MG/ML	Prescription		ABCIXIMAB	abciximab	CENTOCOR INC	103575 2004-03-29 Letter 2004-03-29 Label 2004-03-29 Review 2004-03-29 Letter 2004-03-29 Label 2004-03-29 Review 2003-12-04 Letter 2003-12-04 Letter

Drug Adverse Effects information for REOPRO

Role code	Indications	Reaction	# Reports
PS	ACUTE CORONARY SYNDROME	DRUG INEFFECTIVE	1
PS	ACUTE CORONARY SYNDROME	PULMONARY HAEMORRHAGE	1
PS	ACUTE MYOCARDIAL INFARCTION	DEATH	1
PS	ACUTE MYOCARDIAL INFARCTION	HAEMORRHAGE	6
PS	ACUTE MYOCARDIAL INFARCTION	HAEMORRHAGIC TRANSFORMATION STROKE	2
PS	ACUTE MYOCARDIAL INFARCTION	INCORRECT ROUTE OF DRUG ADMINISTRATION	6
PS	ACUTE MYOCARDIAL INFARCTION	INJECTION SITE HAEMORRHAGE	6
PS	ACUTE MYOCARDIAL INFARCTION	ISCHAEMIC STROKE	6
PS	ACUTE MYOCARDIAL INFARCTION	MYOCARDIAL INFARCTION	6
PS	ACUTE MYOCARDIAL INFARCTION	PLATELET COUNT DECREASED	6
PS	ACUTE MYOCARDIAL INFARCTION	PULMONARY OEDEMA	1
PS	ACUTE MYOCARDIAL INFARCTION	RENAL IMPAIRMENT	1
PS	ACUTE MYOCARDIAL INFARCTION	RESPIRATORY FAILURE	1
PS	ACUTE MYOCARDIAL INFARCTION	SUBDURAL HAEMATOMA	1
PS	ACUTE MYOCARDIAL INFARCTION	THROMBOSIS	6
PS	CORONARY ARTERIAL STENT INSERTION	SUBDURAL HAEMATOMA	3
PS	ILL-DEFINED DISORDER	CYTOLYTIC HEPATITIS	1
PS	ILL-DEFINED DISORDER	PULMONARY ALVEOLAR HAEMORRHAGE	1
PS	INFARCTION	CORONARY ARTERY OCCLUSION	3
PS	INFARCTION	DEATH	2
PS	MYOCARDIAL INFARCTION	CEREBRAL HAEMORRHAGE	4
PS	MYOCARDIAL INFARCTION	DEATH	1
PS	MYOCARDIAL INFARCTION	DRUG INEFFECTIVE	10
PS	MYOCARDIAL INFARCTION	MYOCARDIAL RUPTURE	4
PS	MYOCARDIAL INFARCTION	PULMONARY HAEMORRHAGE	6
PS	PERCUTANEOUS CORONARY INTERVENTION	GINGIVAL BLEEDING	1
PS	PERCUTANEOUS CORONARY INTERVENTION	ISCHAEMIA	1
PS	PERCUTANEOUS CORONARY INTERVENTION	PLATELET COUNT ABNORMAL	1
PS	PERCUTANEOUS CORONARY INTERVENTION	PRODUCT QUALITY ISSUE	1
PS	PERCUTANEOUS CORONARY INTERVENTION	THROMBOSIS IN DEVICE	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	ARTERIAL RUPTURE	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	CARDIAC ARREST	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	DEATH	4
PS	PRODUCT USED FOR UNKNOWN INDICATION	DIABETIC KETOACIDOSIS	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	DIALYSIS	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	DRUG INEFFECTIVE	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	GINGIVAL BLEEDING	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	HAEMORRHAGE	4
PS	PRODUCT USED FOR UNKNOWN INDICATION	HAEMORRHAGE INTRACRANIAL	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	HAEMORRHAGIC TRANSFORMATION STROKE	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	INCORRECT ROUTE OF DRUG ADMINISTRATION	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	INJECTION SITE HAEMORRHAGE	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	ISCHAEMIA	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	ISCHAEMIC STROKE	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	MYOCARDIAL INFARCTION	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	PLATELET COUNT ABNORMAL	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	PLATELET COUNT DECREASED	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	PNEUMONIA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	PNEUMOTHORAX	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	PULMONARY HAEMORRHAGE	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	SEPSIS	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	THROMBOSIS	3
PS	STENT PLACEMENT	HAEMORRHAGE	2
PS	STENT PLACEMENT	PNEUMONIA	2
PS	STENT PLACEMENT	PNEUMOTHORAX	2
PS	STENT PLACEMENT	SEPSIS	2
SS	ACUTE CORONARY SYNDROME	DRUG INEFFECTIVE	1
SS	ACUTE CORONARY SYNDROME	PULMONARY HAEMORRHAGE	1
SS	ACUTE MYOCARDIAL INFARCTION	DEATH	1
SS	ACUTE MYOCARDIAL INFARCTION	HAEMORRHAGE	12
SS	ACUTE MYOCARDIAL INFARCTION	HAEMORRHAGIC TRANSFORMATION STROKE	4
SS	ACUTE MYOCARDIAL INFARCTION	INCORRECT ROUTE OF DRUG ADMINISTRATION	12
SS	ACUTE MYOCARDIAL INFARCTION	INJECTION SITE HAEMORRHAGE	12
SS	ACUTE MYOCARDIAL INFARCTION	ISCHAEMIC STROKE	12
SS	ACUTE MYOCARDIAL INFARCTION	MYOCARDIAL INFARCTION	12
SS	ACUTE MYOCARDIAL INFARCTION	PLATELET COUNT DECREASED	12
SS	ACUTE MYOCARDIAL INFARCTION	PULMONARY OEDEMA	1
SS	ACUTE MYOCARDIAL INFARCTION	RENAL IMPAIRMENT	1
SS	ACUTE MYOCARDIAL INFARCTION	RESPIRATORY FAILURE	1
SS	ACUTE MYOCARDIAL INFARCTION	THROMBOSIS	12
SS	CORONARY ARTERY DISEASE	RETROPERITONEAL HAEMORRHAGE	1
SS	CORONARY ARTERY DISEASE	SHOCK HAEMORRHAGIC	1
SS	CORONARY ARTERY THROMBOSIS	RETROPERITONEAL HAEMORRHAGE	3
SS	CORONARY ARTERY THROMBOSIS	SHOCK HAEMORRHAGIC	3
SS	MYOCARDIAL INFARCTION	CEREBRAL HAEMORRHAGE	4
SS	MYOCARDIAL INFARCTION	DRUG INEFFECTIVE	7
SS	MYOCARDIAL INFARCTION	PULMONARY HAEMORRHAGE	3
SS	PERCUTANEOUS CORONARY INTERVENTION	GINGIVAL BLEEDING	1
SS	PERCUTANEOUS CORONARY INTERVENTION	ISCHAEMIA	1
SS	PERCUTANEOUS CORONARY INTERVENTION	PLATELET COUNT ABNORMAL	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	DRUG INEFFECTIVE	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	GINGIVAL BLEEDING	3
SS	PRODUCT USED FOR UNKNOWN INDICATION	HAEMORRHAGE	6
SS	PRODUCT USED FOR UNKNOWN INDICATION	HAEMORRHAGIC TRANSFORMATION STROKE	2
SS	PRODUCT USED FOR UNKNOWN INDICATION	INCORRECT ROUTE OF DRUG ADMINISTRATION	6
SS	PRODUCT USED FOR UNKNOWN INDICATION	INJECTION SITE HAEMORRHAGE	6
SS	PRODUCT USED FOR UNKNOWN INDICATION	ISCHAEMIA	3
SS	PRODUCT USED FOR UNKNOWN INDICATION	ISCHAEMIC STROKE	6
SS	PRODUCT USED FOR UNKNOWN INDICATION	MYOCARDIAL INFARCTION	6
SS	PRODUCT USED FOR UNKNOWN INDICATION	PLATELET COUNT ABNORMAL	3
SS	PRODUCT USED FOR UNKNOWN INDICATION	PLATELET COUNT DECREASED	6
SS	PRODUCT USED FOR UNKNOWN INDICATION	PULMONARY HAEMORRHAGE	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	THROMBOSIS	6
C	ACUTE CORONARY SYNDROME	GASTROINTESTINAL HAEMORRHAGE	6
C	CHEST PAIN	GASTROINTESTINAL HAEMORRHAGE	2
C	INFARCTION	THROMBOCYTOPENIA	3
C	PERCUTANEOUS CORONARY INTERVENTION	CARDIAC ARREST	1
C	PERCUTANEOUS CORONARY INTERVENTION	RETROPERITONEAL HAEMATOMA	1
C	PERCUTANEOUS CORONARY INTERVENTION	VESSEL PERFORATION	1
I	CORONARY ARTERY DISEASE	RETROPERITONEAL HAEMORRHAGE	1
I	CORONARY ARTERY DISEASE	SHOCK HAEMORRHAGIC	1
I	CORONARY ARTERY THROMBOSIS	RETROPERITONEAL HAEMORRHAGE	3
I	CORONARY ARTERY THROMBOSIS	SHOCK HAEMORRHAGIC	3

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