Drug information for ULTRAVIST 370

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
INJECTABLE; INJECTION	76.9%	Prescription	(Reference Drug)	IOPROMIDE	iopromide	BAYER HLTHCARE	20220 2012-05-07 Label 2012-05-04 Letter 2010-01-20 Letter 2010-01-08 Label 2010-01-05 Letter 2007-09-06 Letter 2007-09-04 Label 2005-08-15 Letter 2004-04-05 Label 2004-03-16 Letter 2003-05-29 Letter

Drug Adverse Effects information for ULTRAVIST 370

Role code	Indications	Reaction	# Reports
PS	ANGIOGRAM	ANAPHYLACTIC SHOCK	1
PS	ANGIOGRAM	BLOOD PRESSURE DECREASED	1
PS	ANGIOGRAM	CHEST DISCOMFORT	1
PS	ANGIOGRAM	EYELID OEDEMA	1
PS	ANGIOGRAM	FLUSHING	1
PS	ANGIOGRAM	HEART RATE DECREASED	1
PS	ANGIOGRAM	HYPOAESTHESIA ORAL	1
PS	ANGIOGRAM	RESPIRATORY DISORDER	1
PS	ANGIOGRAM	URTICARIA	1
PS	CHEST PAIN	URTICARIA	1
PS	COMPUTERISED TOMOGRAM	BLOOD PRESSURE ABNORMAL	1
PS	COMPUTERISED TOMOGRAM	BURNING SENSATION	1
PS	COMPUTERISED TOMOGRAM	CARDIAC ARREST	1
PS	COMPUTERISED TOMOGRAM	CHEST DISCOMFORT	1
PS	COMPUTERISED TOMOGRAM	DEPRESSED LEVEL OF CONSCIOUSNESS	2
PS	COMPUTERISED TOMOGRAM	DISCOMFORT	1
PS	COMPUTERISED TOMOGRAM	DIZZINESS	1
PS	COMPUTERISED TOMOGRAM	DYSARTHRIA	1
PS	COMPUTERISED TOMOGRAM	DYSPNOEA	2
PS	COMPUTERISED TOMOGRAM	ERYTHEMA	1
PS	COMPUTERISED TOMOGRAM	FALL	1
PS	COMPUTERISED TOMOGRAM	HEART RATE INCREASED	1
PS	COMPUTERISED TOMOGRAM	HYPERHIDROSIS	1
PS	COMPUTERISED TOMOGRAM	HYPOKALAEMIA	1
PS	COMPUTERISED TOMOGRAM	HYPOTENSION	1
PS	COMPUTERISED TOMOGRAM	NAUSEA	2
PS	COMPUTERISED TOMOGRAM	OXYGEN SATURATION DECREASED	1
PS	COMPUTERISED TOMOGRAM	PALPITATIONS	2
PS	COMPUTERISED TOMOGRAM	PULSE ABSENT	1
PS	COMPUTERISED TOMOGRAM	TREMOR	1
PS	COMPUTERISED TOMOGRAM	UNRESPONSIVE TO STIMULI	2
PS	COMPUTERISED TOMOGRAM	URTICARIA	1
PS	COMPUTERISED TOMOGRAM	VOMITING	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	ANAPHYLACTIC SHOCK	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	DIZZINESS	2
PS	COMPUTERISED TOMOGRAM ABDOMEN	DYSPNOEA	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	ERYTHEMA	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	FATIGUE	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	HYPOKALAEMIA	2
PS	COMPUTERISED TOMOGRAM ABDOMEN	NAUSEA	2
PS	COMPUTERISED TOMOGRAM ABDOMEN	PALPITATIONS	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	PRURITUS	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	PULSE PRESSURE DECREASED	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	URTICARIA	2
PS	COMPUTERISED TOMOGRAM ABDOMEN	VENTRICULAR FIBRILLATION	1
PS	COMPUTERISED TOMOGRAM ABDOMEN	VOMITING	1
PS	COMPUTERISED TOMOGRAM THORAX	URTICARIA	1
PS	ENDOMETRIOSIS	ERYTHEMA	1
PS	ENDOMETRIOSIS	URTICARIA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	ADVERSE DRUG REACTION	1
PS	PROSTATE CANCER	PRURITUS	1
PS	PROSTATE CANCER	URTICARIA	1
PS	RENAL NEOPLASM	ANAPHYLACTIC REACTION	1
PS	RENAL NEOPLASM	ASTHENIA	1
PS	RENAL NEOPLASM	BRAIN OEDEMA	1
PS	RENAL NEOPLASM	CEREBRAL HAEMORRHAGE	1
PS	RENAL NEOPLASM	COUGH	1
PS	RENAL NEOPLASM	MYOCARDIAL HAEMORRHAGE	1
PS	RENAL NEOPLASM	PULMONARY OEDEMA	1
PS	SCAN	ASPHYXIA	1
PS	UROGRAM	BLOOD PRESSURE DECREASED	1
PS	UROGRAM	CHOKING	1
PS	UROGRAM	FACE OEDEMA	1
PS	UROGRAM	GENERALISED ERYTHEMA	1
SS	ANGIOGRAM	URTICARIA	1
SS	CHEST PAIN	URTICARIA	1
SS	COMPUTERISED TOMOGRAM	ERYTHEMA	1
SS	COMPUTERISED TOMOGRAM	URTICARIA	1
SS	COMPUTERISED TOMOGRAM ABDOMEN	ERYTHEMA	1
SS	COMPUTERISED TOMOGRAM ABDOMEN	PRURITUS	1
SS	COMPUTERISED TOMOGRAM ABDOMEN	URTICARIA	2
SS	COMPUTERISED TOMOGRAM THORAX	URTICARIA	1
SS	ENDOMETRIOSIS	ERYTHEMA	1
SS	ENDOMETRIOSIS	URTICARIA	1
SS	PROSTATE CANCER	PRURITUS	1
SS	PROSTATE CANCER	URTICARIA	1
C	ABDOMINAL PAIN	SYNCOPE	2
C	ASCITES	SYNCOPE	1
C	DIABETES MELLITUS	SYNCOPE	1
C	DIARRHOEA	SYNCOPE	1
C	DYSPEPSIA	SYNCOPE	3
C	EYE ALLERGY	SYNCOPE	1
C	HEADACHE	SYNCOPE	1
C	HEPATIC NEOPLASM MALIGNANT	SYNCOPE	2
C	HYPERTENSION	SYNCOPE	1
C	INSOMNIA	SYNCOPE	1
C	MUSCLE SPASMS	SYNCOPE	1
C	OEDEMA PERIPHERAL	SYNCOPE	1
C	PRURITUS	SYNCOPE	1
C	RASH	SYNCOPE	2
C	SCAB	SYNCOPE	1
C	SCAN WITH CONTRAST	SYNCOPE	2
C	URINARY TRACT INFECTION	SYNCOPE	1
C	URTICARIA	SYNCOPE	2

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