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:
*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:
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.
The recommended dose in children over 2 years of age for the following evaluations is:
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:
Dosing
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.
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Note: The Bayer in Radiology contrast and device products should be used in accordance with the Prescribing Information and Instructions For Use, respectively.
Note: The Bayer in Radiology contrast and device products should be used in accordance with the Prescribing Information and Instructions For Use, respectively.