Drug information for OMNIPAQUE 70

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
SOLUTION; URETHRAL	15.1%	Discontinued		IOHEXOL	Iohexol	GE HEALTHCARE	18956 2007-10-04 Letter 2005-03-30 Letter 2004-12-29 Letter 2004-03-10 Letter 2003-08-05 Review 2002-12-23 Letter 2002-12-23 Letter 1998-05-11 Review

Drug Adverse Effects information for OMNIPAQUE 70

Role code	Indications	Reaction	# Reports
PS	ACUTE CORONARY SYNDROME	BRAIN SCAN ABNORMAL	1
PS	ACUTE CORONARY SYNDROME	COMA SCALE ABNORMAL	1
PS	ACUTE CORONARY SYNDROME	CONTRAST MEDIA REACTION	1
PS	ACUTE CORONARY SYNDROME	DISORIENTATION	1
PS	ACUTE CORONARY SYNDROME	DRUG LEVEL INCREASED	1
PS	ACUTE CORONARY SYNDROME	HEADACHE	1
PS	ACUTE CORONARY SYNDROME	HEMIPLEGIA	1
PS	ACUTE CORONARY SYNDROME	NAUSEA	1
PS	ACUTE CORONARY SYNDROME	STUPOR	1
PS	ACUTE CORONARY SYNDROME	VOMITING	1
PS	CAROTID ARTERY STENT INSERTION	CARDIAC HYPERTROPHY	1
PS	CAROTID ARTERY STENT INSERTION	FLUID RETENTION	1
PS	CAROTID ARTERY STENT INSERTION	PULMONARY OEDEMA	1
PS	CAROTID ARTERY STENT INSERTION	RENAL FAILURE ACUTE	1
PS	CHEST PAIN	BLOOD PRESSURE INCREASED	1
PS	CHEST PAIN	CARDIO-RESPIRATORY ARREST	1
PS	CHEST PAIN	DEATH	1
PS	CHEST PAIN	HEART RATE INCREASED	1
PS	DEEP VEIN THROMBOSIS	CAESAREAN SECTION	6
PS	DEEP VEIN THROMBOSIS	FOETAL EXPOSURE DURING DELIVERY	1
PS	DEEP VEIN THROMBOSIS	FOETAL EXPOSURE DURING PREGNANCY	1
PS	DEEP VEIN THROMBOSIS	LOW BIRTH WEIGHT BABY	2
PS	DEEP VEIN THROMBOSIS	MATERNAL DRUGS AFFECTING FOETUS	4
PS	DEEP VEIN THROMBOSIS	NEONATAL TACHYPNOEA	4
PS	DEEP VEIN THROMBOSIS	PREMATURE BABY	2
PS	DEEP VEIN THROMBOSIS	SMALL FOR DATES BABY	1
PS	DEEP VEIN THROMBOSIS	TRANSIENT TACHYPNOEA OF THE NEWBORN	2
PS	DEEP VEIN THROMBOSIS	WEIGHT DECREASE NEONATAL	1
PS	DEEP VEIN THROMBOSIS	X-RAY GASTROINTESTINAL TRACT ABNORMAL	1
PS	DYSPHONIA	ERYTHEMA MULTIFORME	1
PS	DYSPHONIA	LYMPHOCYTE STIMULATION TEST POSITIVE	1
PS	HEADACHE	ERYTHEMA MULTIFORME	1
PS	HEADACHE	LYMPHOCYTE STIMULATION TEST POSITIVE	1
PS	HEPATIC NEOPLASM	ACIDOSIS	1
PS	HEPATIC NEOPLASM	ANAPHYLACTOID SHOCK	1
PS	HEPATIC NEOPLASM	CONTINUOUS HAEMODIAFILTRATION	1
PS	HEPATIC NEOPLASM	DISSEMINATED INTRAVASCULAR COAGULATION	1
PS	HEPATIC NEOPLASM	HEPATIC ENCEPHALOPATHY	1
PS	HEPATIC NEOPLASM	HEPATIC FAILURE	1
PS	HEPATIC NEOPLASM MALIGNANT	MATERNAL DRUGS AFFECTING FOETUS	1
PS	HEPATIC NEOPLASM MALIGNANT	NEOPLASM PROGRESSION	1
PS	LUNG ABSCESS	INFUSION SITE EXTRAVASATION	1
PS	LUNG ABSCESS	PAIN IN EXTREMITY	1
PS	OEDEMA PERIPHERAL	BLOOD PRESSURE IMMEASURABLE	1
PS	OEDEMA PERIPHERAL	CHEST DISCOMFORT	1
PS	OEDEMA PERIPHERAL	CHILLS	1
PS	OEDEMA PERIPHERAL	DYSPNOEA	1
PS	PAIN MANAGEMENT	ABSCESS	1
PS	PAIN MANAGEMENT	EXTRADURAL ABSCESS	2
PS	PAIN MANAGEMENT	INJECTION SITE ABSCESS	1
PS	PAIN MANAGEMENT	INJECTION SITE PAIN	2
PS	PAIN MANAGEMENT	INJECTION SITE SWELLING	2
PS	PAIN MANAGEMENT	PAIN	1
PS	PAIN MANAGEMENT	STAPHYLOCOCCAL INFECTION	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	ANAPHYLACTOID SHOCK	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	BLOOD PRESSURE DECREASED	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	BLOOD PRESSURE INCREASED	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	BLOOD TEST ABNORMAL	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	CHILLS	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	CONVULSION	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	COUGH	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	DYSPNOEA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	FALL	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	HYPOTENSION	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	IMPAIRED DRIVING ABILITY	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	INFUSION SITE EXTRAVASATION	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	INJECTION SITE ABSCESS	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	INJECTION SITE EXTRAVASATION	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	INJECTION SITE PAIN	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	INJECTION SITE SWELLING	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	LOSS OF CONSCIOUSNESS	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	NAUSEA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	OEDEMA PERIPHERAL	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	PAIN	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	PARASPINAL ABSCESS	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	PYREXIA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	STAPHYLOCOCCAL INFECTION	4
PS	PRODUCT USED FOR UNKNOWN INDICATION	STEVENS-JOHNSON SYNDROME	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	VOMITING	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	WHITE BLOOD CELL COUNT INCREASED	1
PS	RECTAL PROLAPSE	BLOOD PRESSURE IMMEASURABLE	1
PS	RECTAL PROLAPSE	CHEST DISCOMFORT	1
PS	RECTAL PROLAPSE	CHILLS	1
PS	RECTAL PROLAPSE	DYSPNOEA	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	CHILLS	2
SS	PRODUCT USED FOR UNKNOWN INDICATION	DYSPNOEA	2

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