이오메프롤

is a radiographic contrast agent indicated for: Intra-arterial Procedures † ( 1.1 ) Cerebral arteriography, includingintra-arterial digital subtraction angiography (IA-DSA), in adults and pediatric patients Visceral and peripheral arteriography and aortography, including IA-DSA, in adults and pediatric patients Coronary arteriography and cardiac ventriculography in adults Radiographic evaluation of cardiac chambers and related arteries in pediatric patients Intravenous Procedures † ( 1.2 ) Computed tomography (CT) of the head and body in adults and pediatric patients CT angiography of intracranial, visceral, and lower extremity arteries in adults and pediatric patients Coronary CT angiography in adults and pediatric patients CT urography in adults and pediatric patients † Specific concentrations are recommended for each type of imaging procedure. ( 2.2 , 2.3 , 2.4 , 2.5 ) 1.1 Intra-arterial Procedures † IOMERVU is indicated for: Cerebral arteriography, including intra-arterial digital subtraction angiography (IA-DSA), in adults and pediatric patients Visceral and peripheral arteriography and aortography, including IA-DSA, in adults and pediatric patients Coronary arteriography and cardiac ventriculography in adults Radiographic evaluation of cardiac chambers and related arteries in pediatric patients 1.2 Intravenous Procedures † IOMERVU is indicated for: Computed tomography (CT) of the head and body in adults and pediatric patients CT angiography of intracranial, visceral, …

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Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency resuscitation equipment and trained personnel available. ( 5.2 ) Acute Kidney Injury: Acute injury including renal failure can occur. Minimize dose and maintain adequate hydration to minimize risk. ( 5.3 ) Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. ( 5.4 ) Thyroid Dysfunction in Pediatric Patients 0 Years to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity. ( 5.8 ) 5.1 Risks Associated with Inadvertent Intrathecal Administration IOMERVU is for intra-arterial or intravenous use only and must not be administered intrathecally [see Dosage and Administration ( 2.1 )]. Intrathecal administration, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. 5.2 Hypersensitivity Reactions IOMERVU can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock [see Adverse Reactions ( 6.2 )]. Most severe reactions develop shortly after the start of injection (e.g., within 1 to 3 minutes), but delayed reactions can occur. There is an increased risk in patients with a history of a previous reaction to …

8.1 Pregnancy Risk Summary Available data from literature and postmarketing reports on iomeprol use in pregnant women over decades have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, no adverse developmental outcomes were observed with intravenous administration of iomeprol to pregnant rats and rabbits at doses up to 0.45-times the maximum recommended human dose of 86,000 mg iodine. Animal studies show that iomeprol crosses the placenta ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk …