Optiray 350

OPTIRAY 350- ioversol injection
OPTIRAY 320- ioversol injection
OPTIRAY 300- ioversol injection
Liebel-Flarsheim Company LLC

1 INDICATIONS AND USAGE

OPTIRAY is indicated for:

1.1 Intra-arterial

In adults

• OPTIRAY 300: cerebral arteriography and peripheral arteriography.
• 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 300: CT imaging of the head and body, venography, and intravenous excretory urography.
• 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 intravenous excretory urography.

2 DOSAGE AND ADMINISTRATION

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 and plastic containers 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 )].
• Discard unused portion of OPTIRAY from single-dose container after use.

2.2 Radio Frequency Identification (RFID)-Tagged Syringe Directions for Use

• The RFID-tagged syringe must be used with an Optivantage Injector with RFID technology [see How Supplied/Storage and Handling (16.2)]. The RFID tag allows for the exchange of product information such as lot number, expiration, concentration, and identification of the syringe as being “unused” prior to use and “used” after product administration.
• Do not operate any part of the Optivantage Injector System and RFID-tagged syringes within 6 inches (15 cm) of a pacemaker and/or defibrillator.
• If the RFID tag is damaged or otherwise non-functional, the OPTIRAY syringe with the non-functional RFID tag may still be used; however, no data will be transferred to the injector.

2.3 Intra-arterial Procedures in Adults

Cerebral Arteriography

Use OPTIRAY 300 or 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 mL to 12 mL	200 mL
aortic arch injection (four vessel study)	20 mL to 50 mL	200 mL

• ​ Peripheral Arteriography

Use OPTIRAY 300, 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 mL to 90 mL)	250 mL
common iliac, femoral	40 mL (range 10 mL to 50 mL)	250 mL
subclavian, brachial	20 mL (range 15 mL 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 mL to 80 mL)	250 mL
celiac	45 mL (range 12 mL to 60 mL)	250 mL
superior mesenteric	45 mL (range 15 mL to 60 mL)	250 mL
renal or inferior mesenteric	9 mL (range 6 mL to 15 mL)	250 mL