OMNIPAQUE- iohexol injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Iohexol (UNII: 4419T9MX03) (Iohexol - UNII:4419T9MX03)

Available from:

GE Healthcare

INN (International Name):

Iohexol

Composition:

Iodine 300 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

OMNIPAQUE Imaging Bulk Package is indicated for - Computed tomographic (CT) imaging of the head and body by intravenous administration in: adults (300 and 350 mg iodine/mL) pediatric patients (300 mg iodine/mL) - adults (300 and 350 mg iodine/mL) - pediatric patients (300 mg iodine/mL) For use only with an automated contrast injection system, contrast management system, or contrast media transfer set cleared for use with OMNIPAQUE Imaging Bulk Package. None. Risk Summary Postmarketing data with OMNIPAQUE use in pregnant women are insufficient to determine if there is a drug-associated risk of adverse developmental outcomes. Iohexol crosses the placenta and reaches fetal tissues in small amounts (see Data). In animal reproduction studies, no adverse developmental effects were observed following intravenous iohexol administration to pregnant rats and rabbits during organogenesis at doses up to 0.4 (rat) and 0.5 (rabbit) times the maximum recommended human intravenous dose (see Data) . The estimated background

Product summary:

OMNIPAQUE injection is provided as a sterile, pyrogen-free, preservative free, colorless-to-pale yellow solution available in two strengths in an Imaging Bulk Package. It is supplied in the following configurations: OMNIPAQUE Imaging Bulk Package (iohexol) Injection 300 mg iodine/mL: OMNIPAQUE Imaging Bulk Package (iohexol) Injection 350 mg iodine/mL: Protect OMNIPAQUE Imaging Bulk Package from exposure to sunlight. Store OMNIPAQUE Imaging Bulk Package at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. OMNIPAQUE Imaging Bulk Package may be stored in a contrast media warmer for up to one month at 37°C (98.6°F). Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.

Authorization status:

New Drug Application

Summary of Product characteristics

OMNIPAQUE- IOHEXOL INJECTION, SOLUTION
GE HEALTHCARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMNIPAQUE IMAGING
BULK PACKAGE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR OMNIPAQUE
IMAGING BULK PACKAGE.
OMNIPAQUE (IOHEXOL) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1985
WARNING: RISKS WITH INADVERTANT INTRATHECAL ADMINISTRATION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FOR INTRAVENOUS USE ONLY. INADVERTENT INTRATHECAL ADMINISTRATION MAY
CAUSE DEATH,
CONVULSIONS/SEIZURES, CEREBRAL HEMORRHAGE, COMA, PARALYSIS,
ARACHNOIDITIS, ACUTE RENAL
FAILURE, CARDIAC ARREST, RHABDOMYOLYSIS, HYPERTHERMIA, AND BRAIN EDEMA
(_5.1_).
RECENT MAJOR CHANGES
Warnings and Precautions, Thyroid Dysfunction in Pediatric Patients 0
to 3 Years of
Age (5.7)
4/2023
INDICATIONS AND USAGE
OMNIPAQUE Imaging Bulk Package is a radiographic contrast agent
indicated for intravenous computed
tomographic (CT) imaging of the head and body in adult and pediatric
patients. (_2.1_)
FOR USE ONLY WITH AN AUTOMATED CONTRAST INJECTION SYSTEM, CONTRAST
MANAGEMENT SYSTEM,
OR CONTRAST MEDIA TRANSFER SET CLEARED FOR USE WITH OMNIPAQUE IMAGING
BULK PACKAGE.
DOSAGE AND ADMINISTRATION
The concentration and volume required will depend on the equipment and
imaging technique used. See
full prescribing information for full dosing information. (_2.2_)
DOSAGE FORMS AND STRENGTHS
Injection: 500 mL Imaging Bulk Package available in two strengths:
300 mg of iodine per mL (647 mg of iohexol/mL) and
350 mg of iodine per mL (755 mg of iohexol/mL) (_3_)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
For intravenous use only. (_5.1_)
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 Re