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Ultravist

Ultravist®

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Ultravist® is an iodine-containing X-ray contrast agent, approved for X-ray techniques

  • Launched in 1985
  • Over 250 million applications to patients (Ref A)
  • Available in +100 countries (Ref A)
  • Currently being applied more than 16 million times a year (Ref A)
  • Over 150.000 patients in observational studies (Ref B, C
Ultravist®

What is Ultravist®?

Ultravist® is an Iodine based non-ionic monomeric low osmolar extracellular X-ray contrast medium (LOCM). It can be used for X-ray techniques requiring contrast enhancement such as conventional radiography, angiography and computed tomography (see Product Information.)

Indications and Clinical Use

ULTRAVIST (iopromide) in its three strengths, is indicated for intravascular use to provide diagnostic information in a number of radiographic contrast procedures. It is also indicated for the visualization of various body cavities, eg, arthrography and hysterosalpingography.

ULTRAVIST 300

Computed tomography (CT)

Excretory urography

Pediatric excretory urography

Renal arteriography

Peripheral arteriography (bifemoral pelvis/leg)

Cerebral arteriography

Phlebography of the extremities

Arthrography

ULTRAVIST 370

Computed tomography (CT)

Excretory urography

Coronary arteriography (including PTCA), with or without left

ventriculography

Pediatric angiocardiography

Arthrography

 

* Please read the Product Monograph for approved indications

Name of the medicinal product: Ultravist 300/370 solution for injection / infusion

Composition: Ultravist® 300, 370: 1 mL contains 0.623 g/ 0.769 g iopromide (equivalent to 300 mg / 370 mg iodine).

Each ml contains 0.000534 mmol (equivalent to 0.0123 mg) of sodium.

Indications: This medicinal product is for diagnostic use only.

Ultravist® 300/370: For intravascular use and use in body cavities. Contrast enhancement in computerized tomography (CT), arteriography and venography, intravenous/intraarterial digital subtraction angiography (DSA); intravenous urography, use for ERCP, arthrography and examination of other body cavities.

Ultravist® 370: Especially for angiocardiography.

Contraindications

Ultravist® (iopromide) is not indicated for use in myelography, cerebral ventriculography, and cisternography.

ULTRAVIST should not be administered to patients with known hypersensitivity to the drug, or with manifest hyperthyroidism.

Warnings

Contrast media-induced nephrotoxicity, presenting as transient impairment of renal function, may occur after intravascular ULTRAVIST administration. Patients with pre-existing renal impairment, diabetes mellitus, sepsis, hypotension, dehydration, cardiovascular disease, elderly patients, and patients with multiple myeloma, hypertension, patients on medications which alter renal function and patients with hyperuricemia, are at increased risk of this condition. Patients with both renal impairment and diabetes are at the highest risk for contrast media-induced nephrotoxicity.

ULTRAVIST should only be administered to patients with a history of renal or combined renal and hepatic impairment after careful risk/benefit assessment by the prescriber. The general health condition and co-morbidity of the patients as well as the medical need for a contrast enhanced examination should be assessed. ULTRAVIST should only be used where the benefit clearly outweighs the risk. In patients with renal impairment, postpone a new contrast medium examination until renal function returns to pre-examination levels.

Nonionic iodinated contrast media inhibit blood coagulation less than ionic contrast media. Clotting has been reported in vivo and in vitro when blood remains in contact with syringes, catheters or tubes containing nonionic contrast media. Nonionic contrast media are not suitable flush solutions.

Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both nonionic and ionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. Numerous factors, including length of procedure, number of injections, catheter and syringe material, underlying disease state, and concomitant medication may contribute to the development of thromboembolic events.

ULTRAVIST (iopromide) has been associated with serious and fatal reactions. Therefore, clear indication and evaluation of the benefit/risk ratio for every patient should precede each examination with contrast media. Also, it is of utmost importance that adequate facilities and appropriate personnel be readily available and a course of action be planned in advance for the immediate treatment of any serious untoward reaction. Diagnostic procedures utilizing a radiopaque contrast agent should be conducted only by a physician with the requisite training and a thorough knowledge of the particular procedure to be performed. The physician must also be thoroughly familiar with the emergency treatment of all adverse effects.

Dosage and Administration

Solutions of ULTRAVIST (iopromide), like those of other radiopaque contrast agents, should be at or close to body temperature when injected. As with other sterile parenteral products, ULTRAVIST should not be withdrawn from the vial except immediately prior to use. ULTRAVIST should not be mixed with other medicinal products to avoid the risk of possible incompatibilities. Any unused portion should be discarded.

For additional instructions see Stability and Storage Recommendations in the Product Monograph

Vials containing contrast medium solutions are not intended for the withdrawal of multiple doses, with the exception of ULTRAVIST Pharmacy Bulk Vials. The rubber stopper should never be pierced more than once. The use of a cannula or needle with a long tip and a maximum diameter of 18 G is recommended for piercing the stopper and drawing up the contrast medium. With the exception of ULTRAVIST Pharmacy Bulk Vials, any contrast solution not used in one examination for a given patient is to be discarded.

In the case of abdominal angiography and urography, the diagnostic yield is increased if the bowels are empty of fecal matter and gas. It may be necessary to administer an enema or laxative in the evening prior to examination, provided purging of the bowels is not contraindicated.

In infants and young children, prolonged fasting, restriction of fluids and the administration of a laxative before the examination are contraindicated.

Please visit the Product Monograph for additional product information.

If you want to report a side effect or quality complaint, please contact your healthcare professional (e.g. physician or pharmacist) or your local health authority.

Side effects can also be reported to Bayer Inc. by clicking here.

Key Studies

Since the market introduction in 1985 (FDA approval 1995) the safety profile of Ultravist® has been investigated in a number of large-scale studies (clinical, observational, preclinical).

Ultravist

Clinical Safety Overview

Summary of a total of 1367 patients from controlled clinical trials (Iopromide 708, comparators 659) – Berlex Laboratories, NDA 20-220 to FDA, USA (1994)

Palkowitsch PK et al. Acta Radiol 2014;55(6):707–14.

Safety and tolerability of iopromide intravascular use: a pooled analysis of three non-interventional studies in 132,012 patients.

This pooled analysis confirms the well-established good safety profile of iopromide in clinical practice in Asian and European countries and the US

https://journals.sagepub.com/doi/10.1177/0284185113504753

Mortelé KJ et al. AJR 2005;184(1):31-4.

Universal use of nonionic iodinated contrast medium for CT: evaluation of safety in a large urban teaching hospital.

This 2 year study followed 29,508 consecutive patients. Results showed low rates of adverse reactions, the most common being urticaria (0.55%) and nausea and vomiting (0.03%). Contrast quality was rated as either ‘good’ or ‘excellent’ for the vast majority of patients (94.8%).

https://www.ajronline.org/doi/10.2214/ajr.184.1.01840031 

Krause W et al. Eur J Clin Pharmacol 1994;46(4):339–43.

Dose proportionality of iopromide pharmakokinetics and tolerability after IV injection in healthy volunteers.

Iopromide is almost completely excreted via glomerular filtration. Only a negligible amount of the compound is eliminated with the feces. The total clearance of iopromide equals its renal clearance.

 

References

 

Ref A Bayer data reported to Health Authorities (Status July 2018), PERIODIC BENEFIT-RISK EVALUATION REPORT/PERIODIC SAFETY UPDATE REPORT (PBRER/PSUR) Ultravist® 150/240/300/370 BAY No. 86-4877 (Iopromide)

No 241. 28 AUG 2018, Bayer AG

Ref B Palkowitsch, Bostelmann, Lengsfeld. Safety and tolerability of Iopromide intravascular use: a pooled analysis of three non-interventional studies in 132,012 patients Acta Radiologica, 55(6) 707–714 (2014)

Ref C Chen et al. Safety and tolerability of iopromide in patients undergoing cardiac catheterization: real-world multicenter experience with 17,513 patients from the TRUST trial Int J Cardiovasc Imaging 31:1281–1291 (2015)