ULTRAVIST- iopromide injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IOPROMIDE (UNII: 712BAC33MZ) (IOPROMIDE - UNII:712BAC33MZ)

Available from:

Bayer HealthCare Pharmaceuticals Inc.

INN (International Name):

IOPROMIDE

Composition:

IODINE 240 mg in 1 mL

Administration route:

INTRA-ARTERIAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ULTRAVIST® Injection is an iodinated contrast agent indicated for: *For information on the concentrations and doses for the Pediatric Population [see Dosage and Administration (2.3) and Use in Specific Populations (8.4)]. Risk Summary There are no data on ULTRAVIST Injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Iopromide crosses the placenta and reaches fetal tissues in small amounts (see Data). In animal reproduction studies, intravenous administration of iopromide to pregnant rats and rabbits during organogenesis at doses up to 0.35 and 0.7 times, respectively, the maximum recommended human dose based on body surface area resulted in no relevant adverse developmental effects (see Data). . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general p

Product summary:

ULTRAVIST Injection is a sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution available in three strengths. ULTRAVIST Injection 300 mg Iodine per mL Pharmacy Bulk Package (Multiple-Dose container) ULTRAVIST Injection 370 mg Iodine per mL Pharmacy Bulk Package (Multiple-Dose container) Store ULTRAVIST at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) and protected from light [see USP Controlled Room Temperature] . Directions for Proper Use of ULTRAVIST Injection PHARMACY BULK PACKAGE

Authorization status:

New Drug Application

Summary of Product characteristics

ULTRAVIST- IOPROMIDE INJECTION
BAYER HEALTHCARE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ULTRAVIST PHARMACY
BULK PACKAGE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR ULTRAVIST
PHARMACY BULK PACKAGE.
ULTRAVIST (IOPROMIDE) INJECTION, FOR INTRAVENOUS OR INTRA-ARTERIAL USE
INITIAL U.S. APPROVAL: 1995
WARNING: NOT FOR INTRATHECAL USE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INADVERTENT INTRATHECAL ADMINISTRATION MAY CAUSE DEATH, CONVULSIONS,
CEREBRAL
HEMORRHAGE, COMA, PARALYSIS, ARACHNOIDITIS, ACUTE RENAL FAILURE,
CARDIAC ARREST,
SEIZURES, RHABDOMYOLYSIS, HYPERTHERMIA, AND BRAIN EDEMA.
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
ULTRAVIST (iopromide) Injection is a radiographic contrast agent
indicated for:
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DOSAGE AND ADMINISTRATION
ULTRAVIST PHARMACY BULK PACKAGE IS NOT FOR DIRECT INFUSION
Carefully individualize the volume and concentration of ULTRAVIST
Injection to be used for a vascular
procedure, according to the specific dosing tables. Adjust the dose
accounting for factors such as age,
body weight, size of the vessel and the rate of blood flow within the
vessel. (2)
DOSAGE FORMS AND STRENGTHS
ULTRAVIST Injection PHARMACY BULK PACKAGE is available in two
strengths: 300 mg Iodine per mL; 370
mg Iodine per mL. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Warning and Precautions, Thyroid Dysfunction in Pediatric Patients 0
to 3 Years of Age (5.6) 4/2023
Cerebral arteriography and peripheral arteriography (300 mg Iodine per
mL) (1.1)
Coronary arteriography and left ventriculography, visceral angiography
and aortography (370 mg
Iodine per mL) (1.1)
Excretory urography (300 mg Iodine per mL) (1.2)
Contrast computed tomography (CT) imaging of head and body (300 mg
Iodine per mL and 370 mg
Iodine per mL) (1.2)
ULTRAVIST Injection is contraindicated for intrathecal use. (4)
Preparatory dehydration (for example, prolonged fasting and the
administr