Drug information for ISOVUE-300

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; INJECTION 61% Prescription AP (Reference Drug) IOPAMIDOL Iopamidol BRACCO 18735
2002-07-08 Letter
2002-06-20 Letter
INJECTABLE; INJECTION 61% Prescription AP (Reference Drug) IOPAMIDOL Iopamidol BRACCO 20327
2003-12-11 Letter
2003-07-23 Letter

Drug Adverse Effects information for ISOVUE-300

Role code Indications Reaction # Reports
PS ANGIOGRAM COMPARTMENT SYNDROME 1
PS ANGIOGRAM EXTRAVASATION 1
PS CYSTOSCOPY PRODUCT QUALITY ISSUE 1
C ATRIAL SEPTAL DEFECT REPAIR ANHEDONIA 1
C ATRIAL SEPTAL DEFECT REPAIR ANXIETY 1
C ATRIAL SEPTAL DEFECT REPAIR EMOTIONAL DISTRESS 1
C ATRIAL SEPTAL DEFECT REPAIR FEAR 1
C ATRIAL SEPTAL DEFECT REPAIR INJURY 1
C ATRIAL SEPTAL DEFECT REPAIR MULTI-ORGAN FAILURE 1
C ATRIAL SEPTAL DEFECT REPAIR PAIN 1
C ATRIAL SEPTAL DEFECT REPAIR RENAL FAILURE 1
C ATRIAL SEPTAL DEFECT REPAIR RENAL IMPAIRMENT 1
C ATRIAL SEPTAL DEFECT REPAIR RENAL INJURY 1
C ATRIAL SEPTAL DEFECT REPAIR STRESS 1
C ATRIAL SEPTAL DEFECT REPAIR UNEVALUABLE EVENT 1
C CATHETERISATION CARDIAC ANHEDONIA 1
C CATHETERISATION CARDIAC ANXIETY 1
C CATHETERISATION CARDIAC EMOTIONAL DISTRESS 1
C CATHETERISATION CARDIAC FEAR 1
C CATHETERISATION CARDIAC INJURY 1
C CATHETERISATION CARDIAC MULTI-ORGAN FAILURE 1
C CATHETERISATION CARDIAC PAIN 1
C CATHETERISATION CARDIAC RENAL FAILURE 1
C CATHETERISATION CARDIAC RENAL IMPAIRMENT 1
C CATHETERISATION CARDIAC RENAL INJURY 1
C CATHETERISATION CARDIAC STRESS 1
C CATHETERISATION CARDIAC UNEVALUABLE EVENT 1
C CORONARY ARTERY BYPASS ANHEDONIA 1
C CORONARY ARTERY BYPASS ANXIETY 1
C CORONARY ARTERY BYPASS EMOTIONAL DISTRESS 1
C CORONARY ARTERY BYPASS FEAR 1
C CORONARY ARTERY BYPASS INJURY 1
C CORONARY ARTERY BYPASS MULTI-ORGAN FAILURE 1
C CORONARY ARTERY BYPASS PAIN 1
C CORONARY ARTERY BYPASS RENAL FAILURE 1
C CORONARY ARTERY BYPASS RENAL IMPAIRMENT 1
C CORONARY ARTERY BYPASS RENAL INJURY 1
C CORONARY ARTERY BYPASS STRESS 1
C CORONARY ARTERY BYPASS UNEVALUABLE EVENT 1
C PRODUCT USED FOR UNKNOWN INDICATION ANXIETY 1
C PRODUCT USED FOR UNKNOWN INDICATION EMOTIONAL DISTRESS 1
C PRODUCT USED FOR UNKNOWN INDICATION FEAR 1
C PRODUCT USED FOR UNKNOWN INDICATION INJURY 1
C PRODUCT USED FOR UNKNOWN INDICATION PAIN 1
C PRODUCT USED FOR UNKNOWN INDICATION RENAL FAILURE 1
C PRODUCT USED FOR UNKNOWN INDICATION RENAL IMPAIRMENT 1
C PRODUCT USED FOR UNKNOWN INDICATION RENAL INJURY 1
C PRODUCT USED FOR UNKNOWN INDICATION STRESS 1
C PRODUCT USED FOR UNKNOWN INDICATION UNEVALUABLE EVENT 1
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