Optiray 320

2 DOSAGE AND ADMINISTRATION The Imaging Bulk Package is not for direct infusion. Adjust the volume and concentration of OPTIRAY. Modify the dose accounting for factors such as age, body weight, vessel size, blood flow rate within the vessel. Please see details in full Prescribing Information. ( 2 ) 2.1 Important Administration Instructions OPTIRAY is for intravascular use only [see Boxed Warning, Contraindications (4), Warnings and Precautions ( 5.1 )] . Use sterile technique for all handling and administration of OPTIRAY. Inspect glass container prior to use for breakage or other damage and do not use damaged containers. Warm OPTIRAY and administer at body or room temperature. Inspect OPTIRAY for particulate matter or discoloration before administration. Do not administer if OPTIRAY contains particulate matter or is discolored. Do not mix OPTIRAY with other drugs, solutions or total parenteral nutrition mixtures. Use the lowest dose necessary to obtain adequate visualization. Adjust the volume and concentration of OPTIRAY. Modify the dose accounting for factors such as age, body weight, vessel size, blood flow rate within the vessel, anticipated pathology, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed. Avoid extravasation when injecting OPTIRAY; especially in patients with severe arterial or venous disease [see Warnings and Precautions ( 5.6 )] . Hydrate patients before and after OPTIRAY administration [see Warnings and Precautions ( 5.3 )]. 2.2 Intra-arterial Procedures in Adults Cerebral Arteriography Use OPTIRAY 320. The recommended dose for visualization of cerebral arteries is shown below (may repeat as necessary): Diagnostic area Dose Maximum Cumulative Dose carotid or vertebral arteries 2 to 12 mL 200 mL aortic arch injection (four vessel study) 20 to 50 mL 200 mL Peripheral Arteriography Use OPTIRAY 320 or OPTIRAY 350. The recommended dose for visualization of peripheral arteries is shown below (may repeat as necessary): Diagnostic area Dose Maximum Cumulative Dose aorta-iliac runoff 60 mL (range 20 to 90 mL) 250 mL common iliac, femoral 40 mL (range 10 to 50 mL) 250 mL subclavian, brachial 20 mL (range 15 to 30 mL) 250 mL Visceral and Renal Arteriography and Aortography Use OPTIRAY 320. The recommended dose for visualization for the aorta and visceral arteries is shown below (may repeat as necessary): Diagnostic area Dose Maximum Cumulative Dose aorta 45 mL (range 10 to 80 mL) 250 mL celiac 45 mL (range 12 to 60 mL) 250 mL superior mesenteric 45 mL (range 15 to 60 mL) 250 mL renal or inferior mesenteric 9 mL (range 6 to 15 mL) 250 mL Coronary Arteriography and Left Ventriculography Use OPTIRAY 320 or OPTIRAY 350. The recommended dose for visualization of the coronary arteries and left ventricle is shown below (may repeat as necessary): Diagnostic area Dose Maximum Cumulative Dose left coronary 8 mL (range 2 to 10 mL) 250 mL right coronary 6 mL (range 1 to 10 mL) 250 mL left ventricle 40 mL (range 30 to 50 mL) 250 mL 2.3 Intravenous Procedures in Adults Computed Tomography Use OPTIRAY 320 or OPTIRAY 350 for head and body imaging. Head Imaging The recommended dosing is shown below: Scan immediately after completion of the intravenous administration. Infusion OPTIRAY 320 50 to 150 mL OPTIRAY 350 50 to 150 mL Body Imaging OPTIRAY may be administered by bolus injection, by rapid infusion, or by a combination of both. The recommended dosing is shown below: Scanning interval will vary with indication and target organ Bolus Injection Infusion OPTIRAY 320 25 to 75mL 50 to 150 mL OPTIRAY 350 25 to 75mL 50 to 150 mL Venography Use OPTIRAY 320 or OPTIRAY 350. The recommended dose is 50 to 100 mL per extremity; with a maximum cumulative dose of 250 mL. Intravenous Urography Use OPTIRAY 350 or OPTIRAY 320. The recommended dose is shown below: Usual Dose High Dose Urography Maximum Dose OPTIRAY 320 50 to 75mL 1.5 to 2 mL/kg 150 mL OPTIRAY 350 50 to 75mL 1.4 mL/kg 150 mL Intravenous Digital Subtraction Angiography (IV-DSA) Use OPTIRAY 350. The recommended dose range per injection is 30 to 50 mL; may repeat as necessary with a maximum cumulative dose of 250mL. Injection rates will vary depending on the site of catheter placement and vessel size. Central catheter injections are usually made at a rate of between 10 and 30 mL/second. Peripheral injections are usually made at a rate of between 12 and 20 mL/second. 2.4 Pediatric Dosing Intra-arterial Procedures Angiocardiography Use OPTIRAY 350 or OPTIRAY 320. The recommended single ventricular dose is 1.25 mL/kg (range 1 mL/kg to 1.5 mL/kg). The maximum cumulative dose is 5 mL/kg up to a maximum total volume of 250 mL. Intravenous Procedures Computed Tomography Use OPTIRAY 320. Head and Body Imaging The recommended dose in pediatric patients is 1.5 mL/kg to 2 mL/kg (range 1 mL/kg to 3 mL/kg). Intravenous Urography Use OPTIRAY 320. The recommended dose for pediatric patients is 1 mL/kg to 1.5 mL/kg (range 0.5 mL/kg to 3 mL/kg); with a maximum cumulative dose not exceeding 3 mL/kg. 2.5 OPTIRAY Imaging Bulk Package Instruction The Imaging Bulk Package is not for direct infusion. The OPTIRAY ® Imaging Bulk Package (IBP) is for use only with an automated contrast injection system, contrast management system, or contrast media transfer set cleared for use with this contrast agent in this Imaging Bulk Package. See device labeling for information on devices indicated for use with this Imaging Bulk Package and techniques to help assure safe use. The OPTIRAY ® Imaging Bulk Package is to be used in an imaging room designated to perform radiological procedures that involves administration of an intravascular contrast agent. Utilize sterile technique for penetrating the container closure of the OPTIRAY ® Imaging Bulk Package and transferring OPTIRAY ® solution. The container closure may be penetrated only one time with a suitable sterile component of the automated contrast injection system, contrast management system, or contrast media transfer set cleared for use with this Imaging Bulk Package. Do not use if tamper-evident ring is broken or missing. The OPTIRAY ® Imaging Bulk Package container closure can only be penetrated one time. Once penetrated, suspend and maintain the Imaging Bulk Package container in an inverted position for the specified duration of its use. During the entire period of use, ensure that the contents of the OPTIRAY ® Imaging Bulk Package container are in continuous contact with the contrast media transfer set, automated contrast injector system or contrast management system. Do not remove the dispensing set from the OPTIRAY ® Imaging Bulk Package container closure to ensure the protection of the contrast media against any possible contamination. The OPTIRAY ® Imaging Bulk Package can be used for a maximum of 12-hours once the container closure has been penetrated. Discard any unused contrast media and associated consumables 12-hours after the initial penetration of the OPTIRAY ® Imaging Bulk Package. OPTIRAY ® in this Imaging Bulk Package should be stored at 25°C (77°F), excursion is permitted from 15°C to 30°C (59°F to 86°F).

See official label

1 INDICATIONS AND USAGE OPTIRAY 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).