OPTIRAY 350- ioversol injection OPTIRAY 320- ioversol injection OPTIRAY 300- ioversol injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IOVERSOL (UNII: N3RIB7X24K) (IOVERSOL - UNII:N3RIB7X24K)

Available from:

Liebel-Flarsheim Company LLC

Administration route:

INTRA-ARTERIAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

OPTIRAY is indicated for: 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. 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. Symptomatic hyperthyroidism. Risk Summary Postmarketing data with OPTIRAY use in pregnant women are insufficient

Product summary:

OPTIRAY is a clear, colorless to pale yellow, sterile, pyrogen-free, aqueous solution available in three strengths. The products are supplied in containers from which the air has been displaced by nitrogen. OPTIRAY is supplied in the following configurations:                                                                       NDC Number OPTIRAY Pharmacy Bulk Package - 350 6x500 mL Pharmacy Bulk Packages              0019-1333-61 OPTIRAY Pharmacy Bulk Package - 320 6x500 mL Pharmacy Bulk Packages              0019-1323-61 OPTIRAY Pharmacy Bulk Package - 300 6x500 mL Pharmacy Bulk Packages              0019-1332-61

Authorization status:

New Drug Application

Summary of Product characteristics

OPTIRAY 350- IOVERSOL INJECTION
OPTIRAY 320- IOVERSOL INJECTION
OPTIRAY 300- IOVERSOL INJECTION
LIEBEL-FLARSHEIM COMPANY LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OPTIRAY PHARMACY
BULK PACKAGE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR OPTIRAY.
OPTIRAY (IOVERSOL) INJECTION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1988
WARNING: NOT FOR INTRATHECAL USE
SEE _FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
INADVERTENT INTRATHECAL ADMINISTRATION MAY CAUSE DEATH, CONVULSION,
CEREBRAL
HEMORRHAGE, COMA, PARALYSIS, ARACHNOIDITIS, ACUTE RENAL FAILURE,
CARDIAC ARREST,
SEIZURES, RHABDOMYOLYSIS, HYPERTHERMIA, AND BRAIN EDEMA _[SEE WARNINGS
AND_
_PRECAUTIONS (5.1)]._
RECENT MAJOR CHANGES
Warnings and Precautions, Thyroid Dysfunction in Pediatric Patients 0
to 3 Years of Age (5.8)
2/2023
INDICATIONS AND USAGE
OPTIRAY is a radiographic contrast agent indicated for the following:
Intra-arterial Procedures (1.1)
Adults:
Cerebral Arteriography (300, 320 mg iodine/mL)
Peripheral Arteriography (300, 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 (300, 320, 350 mg
iodine/mL)
Venography (300, 320, 350 mg iodine/mL)
Intravenous Excretory Urography (300, 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).
DOSAGE AND ADMINISTRATION
The Pharmacy 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)
DOSAGE FORMS AND STRENGTHS
OPTIRAY Pha