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.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ULTRAVIST® Injection is an iodinated contrast agent indicated for: ULTRAVIST is indicated for: ULTRAVIST is indicated for: † Specific concentrations and presentations of ULTRAVIST are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2, 2.3, 2.4)]. There are no data on ULTRAVIST 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 to0.35 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 advers

Product summary:

ULTRAVIST injection is a sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution available in the following presentations: ULTRAVIST 300 mg Iodine per mL Package Type Volume Sale Unit NDC Single-Dose Vials 50 mL Carton of 10 50419-344-05 100 mL Carton of 10 50419-344-10 125 mL Carton of 10 50419-344-12 150 mL Carton of 10 50419-344-15 Pharmacy Bulk Package 200 mL Carton of 10 50419-344-21 500 mL Carton of 8 50419-344-58 Imaging Bulk Package 200 mL Carton of 10 50419-344-23 500 mL Carton of 8 50419-344-65 ULTRAVIST 370 mg Iodine per mL Package Type Volume Sale Unit NDC Single-Dose Vials 50 mL Carton of 10 50419-346-05 100 mL Carton of 10 50419-346-10 150 mL Carton of 10 50419-346-15 200 mL Carton of 10 50419-346-20 Pharmacy Bulk Package 200 mL Carton of 10 50419-346-26 500 mL Carton of 8 50419-346-58 Imaging Bulk Package 200 mL Carton of 10 50419-346-28 500 mL Carton of 8 50419-346-65 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Protect from light.

Authorization status:

New Drug Application

Summary of Product characteristics

ULTRAVIST- IOPROMIDE INJECTION
BAYER HEALTHCARE PHARMACEUTICALS INC.
REFERENCE LABEL SET ID: 65647318-27E4-4F37-BD68-50EEA52D6C5B
REFERENCE LABEL SET ID: D96A7883-D160-40A1-BDBD-2E8D7877CD18
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ULTRAVIST INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ULTRAVIST
INJECTION.
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._
Intrathecal administration, even if inadvertent, may cause death,
convulsions, cerebral hemorrhage,
coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest,
seizures, rhabdomyolysis,
hyperthermia, and brain edema. ULTRAVIST is not approved for
intrathecal use. (5.1)
RECENT MAJOR CHANGES
Indications and Usage (1.2) 5/2023
Dosage and Administration (2.3, 2.5) 5/2023
Warning and Precautions (5.8) 4/2023
INDICATIONS AND USAGE
ULTRAVIST is a radiographic contrast agent indicated for:
Intra-Arterial Procedures
•
•
•
Intravenous Procedures
•
•
•
Specific concentrations and presentations are recommended for each
type of imaging procedure. (2.2,
2.3, 2.4)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Injection: 300 mg Iodine per mL and 370 mg Iodine per mL in
single-dose vials, pharmacy bulk packages,
and imaging bulk packages. (3)
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
†
Cerebral arteriography and peripheral arteriography in adults (1.1)
Coronary arteriography and left ventriculography, visceral
angiography, and aortography in adults
(1.1)
Radiographic evaluation of cardiac chambers and related arteries in
pediatric patients aged 2 years
and older (1.1)
†
Excretory urography in adults and pediatric patients aged 2 years and
older (1.2)
Contrast computed tomography (CT) of head and body in adults and
pediatric patients aged 2 years
and older (1.2)
Contrast mammography in adults as