이오버솔

is indicated for: OPTIRAY is a radiographic contrast agent indicated for the following: Intra-arterial Procedures ( 1.1 ) Adults: Cerebral Arteriography (320 mg iodine/mL) Peripheral Arteriography (320, 350 mg iodine/mL ) Visceral and Renal Arteriography, Aortography (320 mg iodine/mL) Coronary Arteriography and Left Ventriculography (320, 350 mg iodine/mL) Pediatric Patients: Angiocardiography (320, 350 mg iodine/mL) Intravenous Procedures ( 1.2 ) Adults: Computed tomography (CT) Imaging of Head and Body (320, 350 mg iodine/mL) Venography (320, 350 mg iodine/mL) Intravenous Excretory Urography (320, 350 mg iodine/mL) Intravenous Digital Subtraction Angiography (350 mg iodine/mL) Pediatric Patients: CT Imaging of the Head and Body, and Intravenous Excretory Urography (320mg iodine/mL). 1.1 Intra-arterial In adults OPTIRAY 320: cerebral arteriography, peripheral arteriography, visceral and renal arteriography, aortography, coronary arteriography, and left ventriculography. OPTIRAY 350: peripheral arteriography, coronary arteriography, and left ventriculography. In pediatric patients OPTIRAY 320 and OPTIRAY 350: angiocardiography. 1.2 Intra-venous In adults OPTIRAY 320: CT imaging of the head and body, venography, and intravenous excretory urography. OPTIRAY 350: CT imaging of the head and body, venography, intravenous excretory urography, and intravenous digital subtraction angiography (IV-DSA). In pediatric patients OPTIRAY 320: CT imaging of the head and body, and …

Symptomatic hyperthyroidism. Symptomatic Hyperthyroidism ( 4 )

Hypersensitivity Reactions: life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available. ( 5.2 ) Contrast Induced 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 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 OPTIRAY is indicated for intravascular use only [see Dosage and Administration ( 2.1 )] . Inadvertent intrathecal administration can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. 5.2 Hypersensitivity Reactions OPTIRAY can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis and anaphylactic shock. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Most severe reactions develop shortly after the start of the injection (e.g. within 1 to 3 minutes), but delayed reactions may occur. There is an increased risk in patients with a history of a previous reaction to contrast agent, and known allergies (i.e., bronchial asthma, …

8.1 Pregnancy Risk Summary Postmarketing data with OPTIRAY use in pregnant women are insufficient to determine if there is a risk of drug-associated adverse developmental outcomes. Ioversol crosses the placenta and reaches fetal tissues in small amounts [see Data]. In animal reproduction studies, no adverse developmental effects were observed following daily intravenous administrations of ioversol to pregnant rats (from Gestation Day 7 to 17) and rabbits (Gestation Day 6 to 18) at doses 0.35 and 0.71 times, respectively, the maximum recommended human dose. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a …