ISOVUE 200

2 DOSAGE AND ADMINISTRATION Individualize the volume and concentration according to the specific dosing tables accounting for factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel. ( 2.2 , 2.3 , 2.4 , 2.5 ) See full prescribing information for important dosage and administration information and dilution instructions. ( 2.1 , 2.6 ) 2.1 Important Dosing and Administration Information ISOVUE is for intra-arterial, intravenous, or oral use only. Do not administer intrathecally [see Warnings and Precautions ( 5.1 )] . Specific concentrations of ISOVUE are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.5 )]. Individualize the volume, concentration, and rate of administration of ISOVUE according to the specific dosing tables [see Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.5 )] . Consider factors such as: age, body weight, blood vessel size and blood flow rate, anticipated pathology and degree and extent of opacification required, structures or area to be examined, concomitant medical conditions, imaging equipment, and technique to be employed. Hydrate patients before and after ISOVUE administration [see Warnings and Precautions ( 5.3 )] . Use aseptic technique for all handling and administration of ISOVUE for intra-arterial and intravenous procedures. ISOVUE may be administered at either body temperature (37°C, 98.6°F) or room temperature (20°C to 25°C, 68°F to 77°F). Visually inspect ISOVUE for particulate matter or discoloration before administration. Do not administer ISOVUE if particulate matter or discolorations are observed. Do not mix ISOVUE with other drugs or inject in intravenous lines containing other drugs or total nutritional admixtures. ISOVUE single-dose containers are intended for one procedure only. Discard any unused portion. 2.2 Recommended Dosage for Intra-arterial Procedures in Adults The recommended doses for intra-arterial procedures in adults are shown in Table 1. Table 1: Recommended Concentrations and Volumes of ISOVUE for Intra-arterial Procedures in Adults Imaging Procedure Concentration (mg Iodine/mL) Volume to Administer per Single Injection for Selected Injection Sites Maximum Cumulative Total Dose Cerebral Arteriography 300 8 mL to 12 mL by carotid puncture or transfemoral catheterization 90 mL Peripheral Arteriography 300 5 mL to 40 mL into the femoral artery or subclavian artery 25 mL to 50 mL into the aorta for a distal runoff 250 mL Selective Visceral Arteriography and Aortography 370 Up to 10 mL for the renal arteries Up to 50 mL into the larger vessels such as the aorta or celiac artery 225 mL Coronary Arteriography and Cardiac Ventriculography 370 2 mL to 10 mL for selective coronary artery injection 25 mL to 50 mL for cardiac ventriculography or for nonselective opacification of multiple coronary arteries following injection at the aortic root 200 mL 2.3 Recommended Dosage for Intravenous Procedures in Adults The recommended doses for intravenous procedures in adults are shown in Table 2. Table 2: Recommended Concentrations and Volumes of ISOVUE for Intravenous Procedures in Adults Imaging Procedure Concentration (mg Iodine/mL) Volume to Administer Excretory Urography 250 50 mL to 100 mL by rapid injection 300 50 mL by rapid injection 370 40 mL by rapid injection CT of the Head 250 130 mL to 240 mL 300 100 mL to 200 mL CT of the Body 250 130 mL to 240 mL by rapid infusion or bolus injection 300 100 mL to 200 mL by rapid infusion or bolus injection 370 80 mL to 160 mL by rapid infusion or bolus injection Peripheral Venography 200 25 mL to 150 mL per lower extremity; the maximum total dose is 350 mL 300 15 mL to 100 mL per lower extremity; the maximum total dose is 230 mL 2.4 Recommended Dosage for Intra-arterial and Intravenous Procedures in Pediatric Patients The recommended doses for intra-arterial and intravenous procedures in pediatric patients are shown in Table 3. Table 3: Recommended Concentrations and Volumes per Body Weight of ISOVUE for Intra- arterial and Intravenous Procedures in Pediatric Patients Imaging Procedure Concentration (mg Iodine/mL) Volume per Body Weight to Administer Maximum Dose Intra-arterial Procedures Angiocardiography 370 0.5 mL/kg to 2 mL/kg per single injection Maximum Cumulative Dose by Weight Neonates: 5 mL/kg Aged 4 weeks and older: 8 mL/kg Do not exceed maximum cumulative doses by age below. Maximum Cumulative Dose by Age <2 years 40 mL 2 years to 4 years 50 mL 5 years to 9 years 100 mL 10 years to 18 years 125 mL Intravenous Procedures Excretory Urography 250 1.2 mL/kg to 3.6 mL/kg 120 mL 300 1 mL/kg to 3 mL/kg 100 mL CT of the Head and Body 250 1.2 mL/kg to 3.6 mL/kg 120 mL 300 1 mL/kg to 3 mL/kg 100 mL 2.5 Recommended Dosage for Oral Procedures in Pediatric Patients and Adults The recommended concentration of diluted ISOVUE is either 6 mg iodine/mL or 9 mg iodine/mL administered orally as shown in Table 4. See Table 5 for dilution instructions of ISOVUE [see Dosage and Administration ( 2.6 )] Table 4: Recommended Volumes of Diluted ISOVUE for Oral Administration for CT of the Abdomen and Pelvis in Pediatric Patients and Adults ‡ Prepare diluted ISOVUE solution to a concentration of either 6 mg iodine/mL or 9 mg iodine/mL according to Table 5 [see Dosage and Administration ( 2.6 )]. Age Volume of Diluted ISOVUE ‡ to Administer Administration Instructions Pediatric patients less than 3 years of age 50 mL to 300 mL Administer the oral dose approximately 60 minutes before beginning the CT procedure. Pediatric patients 3 years to 5 years of age 300 mL to 360 mL Pediatric patients 6 years to 11 years of age 360 mL to 500 mL Pediatric patients 12 years of age and older 500 mL to 1,000 mL Adults 2.6 Directions for Dilution of ISOVUE for Oral Administration Dilute ISOVUE to 6 mg iodine/mL or 9 mg iodine/mL in water or clear liquids such as apple juice according to Table 5. Use diluted ISOVUE immediately. Discard any unused portion after the procedure. Table 5: Volumes of ISOVUE and Added Liquid to Dilute ISOVUE for Oral Administration for CT of the Abdomen and Pelvis § Use water or clear liquids such as apple juice. Final Concentration of Diluted ISOVUE (mg Iodine/mL) ISOVUE Volume of Added Liquid § (mL) Concentration (mg Iodine/mL) Volume (mL) 6 200 30 970 250 24 976 300 20 980 370 16 984 9 200 45 955 250 36 964 300 30 970 370 24 976

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1 INDICATIONS AND USAGE ISOVUE is a radiographic contrast agent indicated for: Intra-arterial Procedures † ( 1.1 ) Cerebral arteriography in adults Peripheral arteriography in adults Selective visceral arteriography and aortography in adults Coronary arteriography and cardiac ventriculography in adults Angiocardiography in pediatric patients Intravenous Procedures † ( 1.2 ) Excretory urography in adults and pediatric patients Computed tomography (CT) of head and body in adults and pediatric patients Peripheral venography in adults Oral Procedures † ( 1.3 ) CT of the abdomen and pelvis to delineate the gastrointestinal tract in adults and pediatric patients † Specific concentrations are recommended for each type of imaging procedure.