Ultravist

Ultravist®

A World of Efficiency

01 As Bayer's first X-Ray contrast agent to be granted a multi-patient use approval in Australia, you can have confidence in the safety and efficacy of Ultravist® as your CT contrast agent of choice.12

02 With a 500ml bottle of Ultravist® now available for use in Australia12, enabling workflow efficiencies when used with a dedicated multi-use injection system, you can now focus on your patients.

What is Ultravist®?

Clear Direction. Experience gives U confidence.

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)12. For Ultravist® presentations available in Australia please contact your local Bayer representative or customer service on 1800 008 757.

  • Launched in 1985 (Australian TGA approval in 1991).12
  • +275 million applications to patients.1
  • Available in +100 countries.1
  • Currently being applied more than 16 million times a year.1
  • +150,000 patients in observational studies.2,3

Confidence in

.

    Image quality is important to ensure that diagnostic questions are answered correctly and quickly.

    Iodine Delivery Rate (IDR) is a key parameter for diagnostic results in CT-angiography (CTA).4
     

    Ultravist Image Quality

     

    Ultravist® with its low viscosity is suitable for applying the IDR concept.4

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    CT examinations have increased by 56% i.e. from 94.7 to 147.8 per 1,000 inhabitants.5

    Use of iodinated contrast media (ICM) is growing accordingly.6

    Consequently, incidence of hypersensitivity reactions (HSRs) increases.6,7
     

    Ultravist General Safety

     

    In a 2019 paper Iopromide (Ultravist®) showed the lowest prevalence of HSRs6

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    AMACING investigations provide new insights into renal safety.

    The recent A MAastricht Contrast-Induced Nephropathy Guideline (AMACING) trial, conducted with Ultravist® , was the first randomised trial prospectively comparing prophylactic i.v hydration against non-hydration in renal impaired patients.8,9,10,11
     

    Ultravist Renal Safety

     

    The results of the trial suggested that CKD 3 patients do not benefit from prophylactic i.v hydration and should no longer be considered high-risk.9

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    Impacts both image quality and renal safety of patients

    Iodinated contrast media with high viscosity can:

    • Damage and deteriorate renal function in high-risk patients with impaired renal function.13
    • Require greater injector pressure to achieve the desired flow rate delivery.4
    Ultravist Renal Safety

     

    Low viscosity contrast media allows for a reduction in injection pressure for smaller diameter (< 6 French) catheters, making it appropriate for radial access.15

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    500mL Bottle with Multi-Use Injection Systems

    With a 500mL bottle of Ultravist® now available for use in Australia12, enabling workflow efficiencies when used with a dedicated multi-use injection system, you can now focus on your patients.

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    Contemporary clinical practices in CT and Angiography are changing. Growing workloads and the search for efficiencies has resulted in an increased focus towards multi-patient solutions.

    Bayer offers a complete range of approved solutions for multi-patient use enabling workflow efficiencies. Ranging from the MEDRAD Centargo® Injection system and MEDRAD Stellant® Multi-Patient (MP) solutions in CT, to the MEDRAD Avanta® fluid management system for Cardiac Catheter Laboratories (CCL). Our range of fluid delivery systems can be used together with large volume (500mL bottle) presentations of Ultravist for a complete solution offering.12

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    .

      PBS Information: This product is not listed on the PBS.

      ULTRAVIST® (iopromide)

      INDICATIONS: ULTRAVIST is indicated for all angiographic and urographic examinations and for contrast enhancement in computerised tomography. ULTRAVIST 240 is additionally indicated for lumbar myelography in adults. CONTRAINDICATIONS: known hypersensitivity or previous reaction to iodinated contrast media or excipients, immediate repeat myelography. PRECAUTIONS: anaphylactoid/hypersensitivity or other idiosyncratic reactions; pretesting/sensitivity testing is not recommended, evaluate potential risk of hypothyroidism in patients with known or suspected thyroid dysfunction, monitor thyroid function in neonates who have been exposed to ULTRAVIST; patients with CNS disorders, exercise caution in situations of reduced seizure threshold; patients with pronounced states of excitement, anxiety and pain; patients with significant cardiac disease or severe coronary artery disease; thromboembolic events; patients with severely impaired renal function, combined renal and hepatic disease, combined renal and cardiac disease, anuria or when large doses are administered; ensure adequate hydration status before i.v. or i.t. administration to minimise PC-AKI and especially in renally impaired patients; patients with known or suspected pheochromocytoma; intravascular use in patients with autoimmune disorders, myasthenia gravis, cerebral angiography or peripheral angiography; intrathecal use in patients with seizure history; not for use in thoracic, cervical or total columnar myelography, cerebral ventriculography or cisternography; paediatrics; pregnancy (Category B2); effects on diagnosis and treatment of thyroid disorders with thyrotropic radioisotopes; avoid driving or operating machinery for the first 24 h after administration. INTERACTIONS WITH OTHER MEDICINES: metformin; neuroleptics and antidepressants; beta-blockers; interleukin-2. ADVERSE EFFECTS:Common: dizziness, headache, dysgeusia, blurred/disturbed vision, chest pain/discomfort, hypertension, vasodilation, vomiting, nausea, pain, injection site reactions, feeling hot. Refer to full PI for a complete list. DOSAGE AND ADMINISTRATION: Dosage should be adapted to age, weight, clinical question, examination technique and region to be investigated. Can be used with single-use or multi-patient use injector system. Administration may be intravascular or intrathecal depending on clinical problem and region to be investigated. For intrathecal use in myelography, only ULTRAVIST 240 is recommended and allow at least 48 h before repeat examination. Refer to full PI for details. DATE OF PREPARATION: Based on PI dated 17 November 2021.

      Please review the full Product Information before prescribing. Approved PI available at https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2020-PI-02293-1 or upon request from Bayer Australia Ltd, ABN 22 000 138 714, 875 Pacific Highway, Pymble NSW 2073, phone 1800 008 757.

      ®Registered trademark of the Bayer Group, Germany

      Downloads

      For more information contact your local Bayer

      representative via our contact page.

      References

      1 Bayer internal correspondence dated 22-July-2020. REF-ULT-AU-0033

      2 Palkowitsch PK, Bostelmann S, Lengsfeld P. 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)

      3 Chen J, Liu Y, Zhou YL, Tan N, Zhang B, Chen PY, Chen LB. 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)

      4 Rengo M, Dharampal A, Lubbers M, Kock M, Wildberger JE, Das M, Niezen A, Tilborg F, Kofflard M, Laghi A, Krestin G, Neiman K. Impact of iodine concentration and iodine delivery rate on contrast enhancement in coronary CT angiography: a randomised multicenter trial (CT-CON) Eur Radiol. Nov;29(11): 6109-6118 (2019)

      5 OECD (2019), “CT exams, 2007 and 2017 (or nearest year)”, in Health care activities, OECD Publishing, Paris, https://doi.org/10.1787/da83b311-en.

      6 Cha MJ, Kang DY, Lee W, Yoon SH, Choi YH, Byun JS, Lee J, Kim YH, Choo KS, Cho BS, Jeon KN, Jung JW, Kang HR. Hypersensitivity Reactions to Iodinated Contrast Media: A multicenter study of 196081 patients. Radiology. Oct;293(1):117-124 (2019)

      7 Park SJ, Kang DY, Sohn KH, Yoon SH, Lee W, Choi YH, Cho SH, Kang HR. Immediate mild reactions to CT with iodinated contrast media: Strategy of contrast media readministration without corticosteroids. Radiology. Sep;288(3):710-716 (2018).

      8 Nijssen EC, Rennenberg RJ, Nelemans PJ, Essers BA, Janssen MM, Vermeeren MA. Prophylactic hydration to protect nenal function from intravascular iodinated contrast material in patients at high risk of contrast-induced nephropathy (AMACING: a prospective, randomized, phase 3, controlled, open-label, non-inferiority trial. The Lancet. Apr 1;389(10076):1312-1322 (2017)

      9 Nijssen EC, Nelemans PJ, Rennenberg RJ, Ommen V, Wilberger JE.Prophylactic intravenous hydration to protect renal function from intravascular iodinated contrast material (AMACING): Long-term results of a prospectice, randomized controlled trial. EClinicalMedicine. Nov 9;4-5:109-116 (2018)

      10 Nijssen EC, Nelemans PJ, Rennenberg RJ, Theunissen RA, Ommen V and Wildberger J. Prophylaxis in High-Risk Patients With eGFR < 30mL/min/1.73 m2: Get the Balance Right. Investigative Radiology. 54(9):580-588, September 2019.

      11 Nijssen EC, Nelemans PJ, Rennenberg RJ Ommen V, Wildberger J. Evaluation of safety guidelines on the use of iodinated contrast material: conundrum continued. Invest Radiol. Oct;53(10):616-622 (2018)

      12 Ultravist® Iopromide Product Information
      https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2020-PI-02293-1

      13 Persson et al, Nature Review 2016

      14 Refer to Product Information Iohexol 350 – dated August 2019, Iopamidol 370 – dated 7 August 2020 and Iodixanol 320 dated 15 April 2020

      15 Roth et al.,1991