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  • Ultravist®

Ultravist®: Experience and versatility for today’s radiology practice

An integral part of our Computed Tomography (CT) portfolio, Ultravist® is a proven X-ray contrast medium with a broad range of FDA-approved indications.

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As a proven X-ray contrast medium with 30+ years of experience behind it, Ultravist® has a broad range of indications for intravenous and intra-arterial uses:

  • Intra-arterial Procedures*
    • 300 mg Iodine per mL for cerebral arteriography and peripheral arteriography
    • 370 mg Iodine per mL for coronary arteriography and left ventriculography, visceral angiography, and aortography
  • Intravenous Procedures*
    • 300 mg Iodine per mL for excretory urography
    • 300 mg Iodine per mL and 370 mg Iodine per mL for contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions
    • The usefulness of contrast enhancement for the investigation of the retrobulbar space and of low grade or infiltrative glioma has not been demonstrated

*For information on the concentrations and doses for the Pediatric Population [see Dosage and Administration (2.3) and Use in Specific Populations (8.4)].

Ultravist® is contraindicated for intrathecal use. Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.

Preparatory dehydration (for example, prolonged fasting and the administration of a laxative) before Ultravist® injection is contraindicated in pediatric patients because of risk of acute renal failure.

 

The following table of incidence of reactions is based upon controlled clinical trials in which Ultravist® injection was administered to 1,142 patients. This listing includes all reported adverse reactions regardless of attribution.

Adverse reactions are listed by System Organ Class and in decreasing order of occurrence for rates greater than 1% in the Ultravist® group.

Adverse reactions reported in >1% of patients who received Ultravist® injection in clinical trials:

 Ultravist_Safety_Table 1@2x.jpg

 

The volume and rate of injection of the contrast agent will vary depending on the injection site and the area being examined. Inject contrast at rates approximately equal to the flow rate in the vessel being injected.

 

  • Cerebral Arteriography (300 mg Iodine per mL), Coronary Arteriography and Left Ventriculography (370 mg Iodine per mL), Peripheral Arteriography (300 mg Iodine per mL): see Table 1.
  • Aortography and Visceral Angiography (370 mg Iodine per mL): Use a volume and rate of contrast injection proportional to the blood flow and related to the vascular and pathological characteristics of the specific vessels being studied. Do not exceed 225 mL as total dose for the procedure.
     
 Ultravist_Intra-arterial Dosing_Table 2@2x.jpg

 

  • Contrast Computed Tomography (CT) (300 mg Iodine per mL and 370 mg Iodine per mL) and Excretory Urography (300 mg Iodine per mL): see Table 2.
Ultravist_Intravenous Dosing_Table 3@2x.jpg

 

The recommended dose in children over 2 years of age for the following evaluations is:

  • Intra-arterial: Cardiac chambers and related arteries (370 mg Iodine per mL): Inject 1 to 2 milliliters per kilogram (mL/kg). Do not exceed 4 mL/kg as total dose.
  • Intravenous: Contrast Computerized Tomography or Excretory Urography (300 mg Iodine per mL): Inject 1 to 2 mL/kg. Do not exceed 3 mL/kg as total dose.

The safety and efficacy relationships of other doses, concentrations or procedures have not been established [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3) in the Full Prescribing Information].
 

Ultravist® injection is nonionic, sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution of iopromide, containing 2.42 mg Iodine per mL tromethamine buffer and 0.1 mg/mL edetate calcium disodium stabilizer. Ultravist® injection is available in three strengths:

  • 300 mg Iodine per mL provides 623.4 mg/mL iopromide  
  • 370 mg Iodine per mL provides 768.86 mg/mL iopromide

Dosing

  • Visually inspect Ultravist® for particulate matter and/or discoloration, whenever solution and container permit. Do not administer Ultravist® if particulate matter (including crystals) and/or discoloration is observed or if containers are defective. As Ultravist® Injection is a highly concentrated solution, crystallization (milky-cloudy appearance and/or sediment at bottom, or floating crystals) may occur.
  • Determine the volume and concentration of Ultravist® Injection to be used, considering factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel; consider also extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed. Specific dose adjustments for age, gender, weight and renal function have not been studied for Ultravist® Injection. As with all iodinated contrast agents, lower doses may have less risk. The efficacy of Ultravist® Injection below doses recommended has not been established.
  • The maximum recommended total dose of iodine in adults is 86 grams; a maximum recommended total dose of iodine has not been established for pediatric patients.
  • Hydrate patients adequately prior to and following the administration of Ultravist® [see Warnings and Precautions in the Full Prescribing Information]
  • Warming Ultravist® to body temperature shortly before administration may help improve tolerability and ease of injection

Ultravist

 

Ultravist® Injection is available as a stable, ready-to-use aqueous solution of iopromide in vials or bottles in concentrations of 300 mg Iodine per mL, and 370 mg Iodine per mL. Ultravist® is available in a number of vial sizes, including the 500 mL Pharmacy Bulk Package.

  • Color-coded vials for easy identification of concentration
  • Integrated hanger labels
  • Clear glass vials/bottles for examination of product clarity
  • Peel-off product identification labels
  • Pharmacy Bulk Package offers 10-hour stand time, allowing flexibility to use doses as needed

   

Ultravist Injection

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IMPORTANT SAFETY INFORMATION and INDICATIONS