DOCSLIB.ORG

Not for Immediate Release

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Not for Immediate Release Press Contact: David Pitts Argot Partners 212.600.1902 [email protected] Bracco Imaging Continues its Investment in Delivering Radiological Solutions Growing Breadth of Portfolio, Research, Education and Innovation Initiatives Highlighted at the 2011 RSNA CHICAGO, November 27, 2011 – Bracco Imaging S.p.A. – one of the world’s leading companies in the diagnostic imaging business and part of the Bracco Group – is highlighting the Company’s investment and commitment to imaging agents and radiology solutions across modalities through its growing product portfolio, as well as research, education and innovation, at the 97th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), which is being held November 27 - December 2, 2011 at Chicago’s McCormick Place, booth #4839. "Bracco remains committed to the diagnostic imaging sector, investing in imaging across modalities, including X-ray, Computed Tomography (CT), Cath Lab, Magnetic Resonance Imaging (MRI), Nuclear Medicine and Ultrasound," according to Fulvio Renoldi Bracco, head of Bracco Imaging, S.p.A. "In a difficult economic climate, where investing in the future is not top of mind, Bracco remains at the forefront. We believe that imaging agents and integrated imaging solutions are critical to support radiologists and other imaging specialists in making an effective diagnosis. Our commitment to providing the market with industry-leading products and solutions, and our partnership with the medical community, therefore remains unchanged." Fulvio Renoldi Bracco concluded: "We perceive this period in the industry, and indeed in the broader markets, as an opportunity to invest and to continue to deliver the best contrast imaging solutions to market. Our investments span the gamut from new product additions to acquiring key distribution channels such as the Nycomed manufacturing facilities in Singen, where Bracco contrast agents are manufactured, to establishing a direct presence early next year in Poland, Slovakia and the Czech republic.” In the last few years, Bracco acquired and developed solutions for contrast administration. The ACIST CVi® injectors are today the leader in the cardiac catheterization segment and the Empower injectors for CT and MRI are gaining market acceptance all around the world. At the 2011 RSNA, Bracco presents a further evolution of the Empower CTA injector with a significant improvement in efficiency and with new connectivity breakthrough features allowing exchange of data with radiology information systems (RIS) and picture archiving and communication systems (PACS). This connectivity simplifies workflow allowing users to effectively document and communicate injection information. The information is automatically structured and sent into the PACS so that the radiologist can see it. - more - Bracco Imaging at RSNA 2011 Continuing on this solutions path, in August 2011, Bracco announced the acquisition of Swiss Medical Care, a company engaged in the research, production and marketing of automated systems for the administration of contrast agents for diagnostic imaging. Swiss Medical Care’s primary product, CT Exprés 3D™, an automated, 3-channel syringe-less contrast media injector for CT examinations, represents significant advances in cost management, workflow and automation. “The acquisition of Swiss Medical Care is a key example of our global investment and continued commitment to being the ‘complete contrast imaging solutions provider’," added Carlo Medici, Head of Global Commercial Operations of Bracco Imaging S.p.A. and President and Chief Executive Officer, Bracco Diagnostics Inc. Our value proposition of providing clinically proven products with an array of support services distinguishes us as a preferred choice for optimal and effective patient management in the diagnostic imaging industry. This customer preference is demonstrated by our holding the number one position in X-ray with Isovue® (iopamidol injection), and our being a formidable number two player in MR imaging, based on U.S. market share figures. Our GPO footprint expansion continues as evidenced by our recent award of Premier.” Bracco’s products provide market leading contrast solutions in X-ray, CT, Cardiac Cath Lab, Diagnostic Radiology and MR suites including products Isovue, MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL, ProHance® (gadoteridol) injection, 279.3 mg/mL, and barium contrast products. Bracco contrast solutions offer safe and effective contrast enhancement while offering efficient and optimal protocols and imaging performance. Mr. Medici concluded: "In addition to investing in our expansion, Bracco has put significant resources behind research which distinguishes our market leading products. MultiHance, for example, has demonstrated that it can provide increased visualization thanks to its higher relaxivity. Such investments are hallmarks of Bracco's commitment to clinical and scientific evidence." About Isovue More than 290 million doses of iopamidol have been administered worldwide since 1992.1 Indicated for a wide variety of radiographic, angiographic and CT indications, Isovue offers desired flexibility by providing a wide range of iodine concentrations and packaging options. Isovue-M is specifically packaged and labeled for intrathecal use. Clinical applications for Isovue-M include intrathecal administration in adult neuroradiology, including myelography, contrast enhancement of CT cisternography and ventriculography, and thoraco-lumbar myelography, in children over the age of two years old. - more - 1 Periodic Safety Update Report Data, 2011, data on file, Bracco Diagnostics Inc. Bracco Imaging at RSNA 2011 IMPORTANT SAFETY INFORMATION for Isovue: Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media. Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. As with all injectable contrast agents, the possibility of severe reactions should be borne in mind, regardless of the patient’s pre-existing medical history. As with any other iodinated contrast media, caution must be exercised in patients with severely impaired renal function, combined renal and hepatic disease, combined renal and cardiac disease, severe thyrotoxicosis, myelomatosis, or anuria, particularly when large doses are administered. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. About MultiHance MultiHance is the highest relaxivity gadolinium-based MRI contrast agent approved for use in the U.S. for MRI of the central nervous system (CNS). MultiHance is also highly stable, with high thermodynamic and conditional stability and no excess chelate.2 The clinical experience with MultiHance exceeds 10 million doses administered worldwide.1 MultiHance is indicated for intravenous use in CNS MRI in adults and children over two years of age, to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine and associated tissues.3 It has approximately twice the relaxivity of other tested gadolinium-based contrast agents approved for CNS MRI in the U.S., providing a marked increase in signal, and in signal-to-noise ratio (SNR).3,4,5 MultiHance, with its higher relaxivity, and higher signal and SNR, has been shown to improve visualization of smaller lesions and delineation of larger lesions of the CNS compared to Magnevist®6 and Omniscan™7 at equivalent doses of 0.1 mmol/kg.4,5 - more - 2 Idée JM, Port C, Raynal I, et al. Clinical and biological consequences of transmetallation induced by contrast agents for magnetic resonance imaging: a review. Fundamental and Clinical Pharmacology. 2006; 20:563-576 3 MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL, Full Prescribing Information. Princeton, NJ: Bracco Diagnostics Inc., 2011 4 Maravilla KR et al. Contrast Enhancement of Central Nervous System Lesions: Multicenter Intraindividual Crossover Comparative Study of Two MR Contrast Agents. Radiology 2006; 240: 389-400 5 Rowley HA et al. Contrast-Enhanced MR Imaging of Brain Lesions: a Large-Scale Intraindividual Crossover Comparison of Gadobenate Dimeglumine versus Gadodiamide. Am J Neuoradiology October 2008 29:1684-91 6 MAGNEVIST® (brand of gadopentetate dimeglumine) injection, Full Prescribing Information. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc.; 2010 7 OMNISCAN™ (gadodiamide) injection, Full Prescribing Information, Princeton, NJ: GE Healthcare Inc.; 2010 Bracco Imaging at RSNA 2011 Lastly, a recent study by Seidl, et al. (n=123) (the MERIT Study, in press at the American Journal of Neuroradiology)8, comparing MultiHance and Gadavist™9 (gadobutrol) injection, a high concentration MRI contrast agent, at equivalent approved doses for CNS MRI, showed that blinded readers reported statistically significant, (p<0.0001), global preference for MultiHance when a preference was expressed. Similar statistically significant preference was demonstrated for each individual endpoint. Reader preference was based on superior contrast enhancement and better delineation of lesion and/or internal lesion structure.
Load more

Recommended publications
  • Radiopharmaceuticals and Contrast Media – Oxford Clinical Policy
    UnitedHealthcare® Oxford Clinical Policy Radiopharmaceuticals and Contrast Media Policy Number: RADIOLOGY 034.19 T0 Effective Date: January 1, 2021 Instructions for Use Table of Contents Page Related Policies Coverage Rationale ....................................................................... 1 • Cardiology Procedures Requiring Prior Definitions .................................................................................... 10 Authorization for eviCore Healthcare Arrangement Prior Authorization Requirements .............................................. 10 • Radiation Therapy Procedures Requiring Prior Applicable Codes ........................................................................ 10 Authorization for eviCore Healthcare Arrangement Description of Services ............................................................... 13 • Radiology Procedures Requiring Prior Authorization References ................................................................................... 13 for eviCore Healthcare Arrangement Policy History/Revision Information ........................................... 14 Instructions for Use ..................................................................... 14 Coverage Rationale eviCore healthcare administers claims on behalf of Oxford Health Plans for the following services that may be billed in conjunction with radiopharmaceuticals and/or contrast media: • Radiology Services: Refer to Radiology Procedures Requiring Prior Authorization for eviCore Healthcare Arrangement for additional information.
    [Show full text]
  • ACR Manual on Contrast Media
    ACR Manual On Contrast Media 2021 ACR Committee on Drugs and Contrast Media Preface 2 ACR Manual on Contrast Media 2021 ACR Committee on Drugs and Contrast Media © Copyright 2021 American College of Radiology ISBN: 978-1-55903-012-0 TABLE OF CONTENTS Topic Page 1. Preface 1 2. Version History 2 3. Introduction 4 4. Patient Selection and Preparation Strategies Before Contrast 5 Medium Administration 5. Fasting Prior to Intravascular Contrast Media Administration 14 6. Safe Injection of Contrast Media 15 7. Extravasation of Contrast Media 18 8. Allergic-Like And Physiologic Reactions to Intravascular 22 Iodinated Contrast Media 9. Contrast Media Warming 29 10. Contrast-Associated Acute Kidney Injury and Contrast 33 Induced Acute Kidney Injury in Adults 11. Metformin 45 12. Contrast Media in Children 48 13. Gastrointestinal (GI) Contrast Media in Adults: Indications and 57 Guidelines 14. ACR–ASNR Position Statement On the Use of Gadolinium 78 Contrast Agents 15. Adverse Reactions To Gadolinium-Based Contrast Media 79 16. Nephrogenic Systemic Fibrosis (NSF) 83 17. Ultrasound Contrast Media 92 18. Treatment of Contrast Reactions 95 19. Administration of Contrast Media to Pregnant or Potentially 97 Pregnant Patients 20. Administration of Contrast Media to Women Who are Breast- 101 Feeding Table 1 – Categories Of Acute Reactions 103 Table 2 – Treatment Of Acute Reactions To Contrast Media In 105 Children Table 3 – Management Of Acute Reactions To Contrast Media In 114 Adults Table 4 – Equipment For Contrast Reaction Kits In Radiology 122 Appendix A – Contrast Media Specifications 124 PREFACE This edition of the ACR Manual on Contrast Media replaces all earlier editions.
    [Show full text]
  • Gadolinium Based Contrast Agents
    CE Credits Available CONSIDERATIONS IN THE SELECTION OF A NEW GADOLINIUM-BASED CONTRAST AGENT SUPPLEMENT TO MAY 2014 THE JOURNAL OF PRACTICAL MEDICAL IMAGING AND MANAGEMENT Considerations in the Selection of a New Gadolinium-Based Contrast Agent Michael F. Tweedle, PhD Emanuel Kanal, MD, FACR, FISMRM Robert Muller, PhD Stefanie Spielman Professor of Radiology Professor of Radiology and Neuroradiology Department of General, Organic & The Ohio State University University of Pittsburgh Medical Center Biochemical Chemistry Columbus, OH Pittsburgh, PA University of Mons Mons, Belgium Supported by an unrestricted educational grant from © May 2014 www.appliedradiology.com SUPPLEMENT TO APPLIED RADIOLOGY n 1 Publisher Kieran Anderson Executive Editor Cristen Bolan Art and Production Barbara A. Shopiro Applied Radiology and this supplement, Considerations in the Selection of a New Gadolinium-Based Contrast Agent, are published by Anderson Publishing, Ltd. The journal does not warrant the expertise of any author in a particular field, nor is it responsible for any statements by such authors. The opinions expressed in this supplement are those of the authors. They do not imply endorsement of advertised products and do not necessarily reflect the opinions or recommendations of our sponsors or the editors and staff of Applied Radiology. Copyright © 2014 by Anderson Publishing, Ltd., 180 Glenside Avenue, Scotch Plains, NJ 07076 All rights reserved. Cover images courtesy of Howard A. Rowley, MD. Considerations in the Selection of a New Gadolinium-Based Contrast Agent Our 3 esteemed faculty summarize the similarities and differences among the gadolinium-based contrast agents (GBCAs) currently utilized for magnetic resonance imaging (MRI), with emphasis on stability and relaxivity.
    [Show full text]
  • DISSERTATION INVESTIGATION of CATIONIC CONTRAST-ENHANCED COMPUTED TOMOGRAPHY for the EVALUATION of EQUINE ARTICULAR CARTILAGE Su
    DISSERTATION INVESTIGATION OF CATIONIC CONTRAST-ENHANCED COMPUTED TOMOGRAPHY FOR THE EVALUATION OF EQUINE ARTICULAR CARTILAGE Submitted by Bradley B. Nelson Department of Clinical Sciences In partial fulfillment of the requirements For the Degree of Doctor of Philosophy Colorado State University Fort Collins, Colorado Fall 2017 Doctoral Committee: Advisor: Christopher E. Kawcak Co-Advisor: Laurie R. Goodrich C. Wayne McIlwraith Mark W. Grinstaff Myra F. Barrett Copyright by Bradley Bernard Nelson 2017 All Rights Reserved ABSTRACT INVESTIGATION OF CATIONIC CONTRAST-ENHANCED COMPUTED TOMOGRAPHY FOR THE EVALUATION OF EQUINE ARTICULAR CARTILAGE Osteoarthritis and articular cartilage injury are substantial problems in horses causing joint pain, lameness and decreased athleticism resonant of the afflictions that occur in humans. This debilitating joint disease causes progressive articular cartilage degeneration and coupled with a poor capacity to heal necessitates that articular cartilage injury is detected early before irreparable damage ensues. The use of diagnostic imaging is critical to identify and characterize articular cartilage injury, though currently available methods are unable to identify these early degenerative changes. Cationic contrast-enhanced computed tomography (CECT) uses a cationic contrast media (CA4+) to detect the early molecular changes that occur in the extracellular matrix. Glycosaminoglycans (GAGs) within the extracellular matrix are important for the providing the compressive stiffness of articular cartilage and their degradation is an early event in the development of osteoarthritis. Cationic CECT imaging capitalizes on the electrostatic attraction between CA4+ and GAGs; exposing the proportional relationship between the amount of GAGs present within and the amount of CA4+ that diffuses into the tissue. The amount of CA4+ that resides in the tissue is then quantified through CECT imaging and estimates tissue integrity through nondestructive assessment.
    [Show full text]
  • Advisory Committee Briefing Document Medical Imaging Drugs Advisory Committee (MIDAC) September 8, 2017
    Dotarem® (gadoterate meglumine) Injection – NDA# 204781 Advisory Committee Optimark® (gadoversetamide) Injection - NDAs# 020937, 020975 & 020976 Briefing Document Advisory Committee Briefing Document Medical Imaging Drugs Advisory Committee (MIDAC) September 8, 2017 DOTAREM® (gadoterate meglumine) Injection NDA 204781 Guerbet LLC, 821 Alexander Rd, Princeton, NJ 08540 OPTIMARK® (gadoversetamide) Injection NDAs 020937, 020975 & 020976 Liebel-Flarsheim Company LLC, 1034 Brentwood Blvd., Richmond Heights, MO 63117 ADVISORY COMMITTEE BRIEFING MATERIALS AVAILABLE FOR PUBLIC RELEASE Information provided within this briefing document is based upon medical and scientific information available to date. ADVISORY COMMITTEE BRIEFING MATERIALS AVAILABLE FOR PUBLIC RELEASE Page 1 / 168 Dotarem® (gadoterate meglumine) Injection – NDA# 204781 Advisory Committee Optimark® (gadoversetamide) Injection - NDAs# 020937, 020975 & 020976 Briefing Document EXECUTIVE SUMMARY Gadolinium-based contrast agents (GdCAs) are essential for use in magnetic resonance imaging (MRI). Although non-contrast-enhanced MRI may be sufficient for use in some clinical conditions, contrast-enhanced MRI (CE-MRI) using GdCA provides additional vital diagnostic information in a number of diseases. It is widely recognized that CE-MRI increases diagnostic accuracy and confidence, and thus can impact the medical and/or surgical management of patients. Based on the chemical structure of the complexing ligand, GdCA are classified as linear (L-GdCA) or macrocyclic (M-GdCA) and can be ionic or nonionic and those characteristics have a dramatic influence on the stability of the GdCA. Dotarem®, a M-GdCA, was first approved in France in 1989. US-FDA approval was obtained in March 2013 for “intravenous use with MRI of the brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity”, at the dose of 0.1 mmol/kg BW.
    [Show full text]
  • Estonian Statistics on Medicines 2016 1/41
    Estonian Statistics on Medicines 2016 ATC code ATC group / Active substance (rout of admin.) Quantity sold Unit DDD Unit DDD/1000/ day A ALIMENTARY TRACT AND METABOLISM 167,8985 A01 STOMATOLOGICAL PREPARATIONS 0,0738 A01A STOMATOLOGICAL PREPARATIONS 0,0738 A01AB Antiinfectives and antiseptics for local oral treatment 0,0738 A01AB09 Miconazole (O) 7088 g 0,2 g 0,0738 A01AB12 Hexetidine (O) 1951200 ml A01AB81 Neomycin+ Benzocaine (dental) 30200 pieces A01AB82 Demeclocycline+ Triamcinolone (dental) 680 g A01AC Corticosteroids for local oral treatment A01AC81 Dexamethasone+ Thymol (dental) 3094 ml A01AD Other agents for local oral treatment A01AD80 Lidocaine+ Cetylpyridinium chloride (gingival) 227150 g A01AD81 Lidocaine+ Cetrimide (O) 30900 g A01AD82 Choline salicylate (O) 864720 pieces A01AD83 Lidocaine+ Chamomille extract (O) 370080 g A01AD90 Lidocaine+ Paraformaldehyde (dental) 405 g A02 DRUGS FOR ACID RELATED DISORDERS 47,1312 A02A ANTACIDS 1,0133 Combinations and complexes of aluminium, calcium and A02AD 1,0133 magnesium compounds A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 811120 pieces 10 pieces 0,1689 A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 3101974 ml 50 ml 0,1292 A02AD83 Calcium carbonate+ Magnesium carbonate (O) 3434232 pieces 10 pieces 0,7152 DRUGS FOR PEPTIC ULCER AND GASTRO- A02B 46,1179 OESOPHAGEAL REFLUX DISEASE (GORD) A02BA H2-receptor antagonists 2,3855 A02BA02 Ranitidine (O) 340327,5 g 0,3 g 2,3624 A02BA02 Ranitidine (P) 3318,25 g 0,3 g 0,0230 A02BC Proton pump inhibitors 43,7324 A02BC01 Omeprazole
    [Show full text]
  • PRESS RELEASE Blue Earth Diagnostics Continues to Expand Access to Axumin® (Fluciclovine (18F)) with First Commercial Supply In
    PRESS RELEASE Blue Earth Diagnostics continues to expand access to Axumin® (fluciclovine (18F)) with first commercial supply in Slovakia, Europe Oxford, UK – April 21, 2020 – Blue Earth Diagnostics Ltd, a Bracco company focused on molecular imaging diagnostics, today announced expanded access to Axumin® (fluciclovine (18F)) in Europe. The first commercial delivery of Axumin was made in Slovakia in April 2020. This was possible through the Blue Earth Diagnostics’ distribution partner in Slovakia, MGP, spol. s r. o. Axumin is a PET imaging agent approved in the European Union for use in in men with suspected recurrence of prostate cancer. Axumin is commercially available in Belgium, Luxembourg, Italy, France, Norway, the Czech Republic, The Netherlands, Austria and, now, Slovakia, with further European countries set to follow soon. Prostate cancer is a leading cause of cancer death in men. While most primary prostate cancer can be successfully treated, recurrence occurs in up to one-third of patients. Recurrent disease is typically detected by a rise in PSA levels but often the location and extent of the disease cannot be detected by conventional imaging. Of those who suffer biochemical recurrence, approximately one-third develop metastatic prostate cancer. Axumin was developed to target the increased amino acid transport that occurs in many cancers, including prostate cancer. It is labelled with the radioisotope (18F), enabling it to be visualized in the body with PET imaging. Dr. Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics
    [Show full text]
  • EUROPEAN PHARMACOPOEIA 10.0 Index 1. General Notices
    EUROPEAN PHARMACOPOEIA 10.0 Index 1. General notices......................................................................... 3 2.2.66. Detection and measurement of radioactivity........... 119 2.1. Apparatus ............................................................................. 15 2.2.7. Optical rotation................................................................ 26 2.1.1. Droppers ........................................................................... 15 2.2.8. Viscosity ............................................................................ 27 2.1.2. Comparative table of porosity of sintered-glass filters.. 15 2.2.9. Capillary viscometer method ......................................... 27 2.1.3. Ultraviolet ray lamps for analytical purposes............... 15 2.3. Identification...................................................................... 129 2.1.4. Sieves ................................................................................. 16 2.3.1. Identification reactions of ions and functional 2.1.5. Tubes for comparative tests ............................................ 17 groups ...................................................................................... 129 2.1.6. Gas detector tubes............................................................ 17 2.3.2. Identification of fatty oils by thin-layer 2.2. Physical and physico-chemical methods.......................... 21 chromatography...................................................................... 132 2.2.1. Clarity and degree of opalescence of
    [Show full text]
  • Comparison of Gadoterate Meglumine and Gadobutrol in the MRI
    LEVEL 1 EBM EXPEDITED PUBLICATION ADULT BRAIN Comparison of Gadoterate Meglumine and Gadobutrol in the MRI Diagnosis of Primary Brain Tumors: A Double-Blind Randomized Controlled Intraindividual Crossover Study (the REMIND Study) X K.R. Maravilla, X D. San-Juan, X S.J. Kim, X G. Elizondo-Riojas, X J.R. Fink, X W. Escobar, X A. Bag, X D.R. Roberts, X J. Hao, X C. Pitrou, X A.J. Tsiouris, X E. Herskovits, and X J.B. Fiebach EBM 1 ABSTRACT BACKGROUND AND PURPOSE: Effective management of patients with brain tumors depends on accurate detection and characteriza- tion of lesions. This study aimed to demonstrate the noninferiority of gadoterate meglumine versus gadobutrol for overall visualization and characterization of primary brain tumors. MATERIALS AND METHODS: This multicenter, double-blind, randomized, controlled intraindividual, crossover, noninferiority study included 279 patients. Both contrast agents (dose ϭ 0.1 mmol/kg of body weight) were assessed with 2 identical MRIs at a time interval of 2–14 days. The primary end point was overall lesion visualization and characterization, scored independently by 3 off-site readers on a 4-point scale, ranging from “poor” to “excellent.” Secondary end points were qualitative assessments (lesion border delineation, internal morphology, degree of contrast enhancement, diagnostic confidence), quantitative measurements (signal intensity), and safety (adverse events). All qualitative assessments were also performed on-site. RESULTS: For all 3 readers, images of most patients (Ͼ90%) were scored good or excellent for overall lesion visualization and character- ization with either contrast agent; and the noninferiority of gadoterate meglumine versus gadobutrol was statistically demonstrated.
    [Show full text]
  • Art. 31 Gadolinium
    Annex I List of nationally authorised medicinal products 1 Annex IA – medicinal products containing intravenous gadobenic acid, gadobutrol, gadoteric acid, gadoteridol, gadoxetic acid and intra-articular gadopentetic acid and intra-articular gadoteric acid Member State Marketing Invented name INN + Strength Pharmaceutical form Route of EU/EEA authorisation holder administration Austria Bayer Austria GmbH Magnevist Gadopentetate solution for injection intra-aintra-articular use Dimeglumine 1.876mg/Ml Austria Bayer Austria GmbH Dotagraf Gadoteric Acid solution for injection intravenous use 279.32mg/Ml Austria Bayer Austria GmbH Gadovist Gadobutrol solution for injection intravenous use 604.72mg/Ml Austria Bayer Austria GmbH Primovist Gadoxetic Acid, solution for injection intravenous use Disodium 181.43mg/Ml Austria Bracco Imaging S.p.A. Prohance Gadoteridol solution for injection intravenous use 279.3mg/Ml Austria Guerbet Artirem Gadoteric Acid solution for injection intra-articular use 1.397mg/Ml Austria Guerbet Dotarem Gadoteric Acid solution for injection intravenous use 279.32mg/Ml Austria Sanochemia Cyclolux Gadoteric Acid solution for injection intravenous use Pharmazeutika AG 0.5mmol/Ml Austria Bracco Imaging S.p.A. Multihance Gadobenate solution for injection intravenous use Dimeglumine 529mg/Ml Belgium Agfa Healthcare Imaging Dotagita Gadoteric Acid solution for injection intravenous use Agents GmbH 279.32mg/Ml Belgium Bayer SA NV Dotagraph Gadoteric Acid solution for injection intravenous use 279.32mg/Ml 2 Member State Marketing
    [Show full text]
  • E-Tender Document
    ALL INDIA INSTITUTE OF MEDICAL SCIENCES (AIIMS) BHOPAL Saket Nagar, Bhopal-462020 (India) Website : www.aiimsbhopal.edu.in [email protected] E-Tendering Portal: https://www.tenderwizard.com/AIIMSBHOPAL E-Tender Document E-TENDER Id: AIIMSBPLHOSP161700509092016 Rate Contact for Supply of Contrast Media to Department of Radiodiagnosis at AIIMS Bhopal Hospital, Saket Nagar, Bhopal-462 020 (India) Notice Inviting Tender On behalf of Director, AIIMS Bhopal, Medical Superintendent invites open E-Bids in the Three Bid System (i.e. Pre-qualification Bid , Technical Bid and Financial Bid) from eligible Manufacturers/Firms/Companies/Authorized Agents/Distributors/ Dealers on line through E- procurement solution portal of AIIMS Bhopal (https://www.tenderwizard.com/AIIMSBHOPAL) on mutually agreed terms and conditions and satisfactory performance for the Supply of Contrast Media to Department of Radiodiagnosis at AIIMS Bhopal Hospital, Saket Nagar, Bhopal-462 020, India and supply of items as per the Specifications details at Annexure-I for approved valid for Two years. Further Six Months may be extended under special circumstances and on mutual agreement on same terms and conditions basis. Important: The Bidder is expected to examine all instructions, forms, terms and specifications in the bidding document. The bid should be precise, complete and in the prescribed format as per the requirement of the bid document. The bid should not be conditional. Failure to furnish all information required by the bidding document or submission of a bid not responsive to the bidding documents in every respect will be at the Bidder’s risk and may result in rejection of the bid. The Bidder shall bear all costs associated with the preparation and submission of its bid and Client will in no case be held responsible or liable for these costs, regardless of the conduct or outcome of the bidding process.
    [Show full text]
  • Overview on the Efficacy and Safety of Gadobutrol: an MRI Contrast Agent for the CNS, Body and Vessels
    CONTRAST AGENT EVALUATION Overview on the efficacy and safety of gadobutrol: an MRI contrast agent for the CNS, body and vessels Contrast-enhanced MRI has become a mainstay of clinical imaging with unlimited applications. However, a limitation of conventional contrast agents in MRI is the insufficient signal-to-noise ratios due to relaxivity. Gadobutrol (1.0 mmol/ml), an extracellular macrocyclic contrast agent of high stability, is indicated for contrast-enhanced MRI of adults, adolescents and children 2 years of age and older. Gadobutrol offers increased T1 relaxivity, which improves MR image quality and clinical use of the technique. 1 KEYWORDS: contrast-enhanced MRA n contrast-enhanced MRI n CNS n Gadavist™ Juan E Gutierrez* , n gadobutrol n gadolinium-based contrast agent n Gadovist™ n kidney n liver Sara Koenig1 & Josy Breuer2 The use of gadolinium-based contrast agents As with other GBCAs, the paramagnetic 1University of Texas at San Antonio, (GBCAs) to improve MRI has been well qualities of the gadolinium ion shortens the Health Science Center 7703 Floyd Curl Drive, San Antonio, TX 78229-3900, established for over 20 years [1,2]. Unenhanced T1 relaxation times of nearby water protons USA MRI of the CNS, abdomen/pelvis, breast and and results in increased signal on T -weighted 2Bayer-Schering AG, Berlin, Germany 1 *Author for correspondence: vascular system has mainly been used to dis- images improving the lesion detection (sensitiv- Tel.: +1 210 567 1978 play/demarcate focal pathologies or areas of ity), characterization (specificity) and staging. Fax: +1 210 567 6464 stenosis; however, GBCAs have improved the Besides the registered trade name (GADAVIST® [email protected] detection, characterization and visualization of Injection, USA and GADOVIST®, in the rest lesions involved in such pathologies, improving of the world, the generic name (gadobutrol) the diagnostic work-up, therapy planning and and the laboratory nomenclature (Gd-DO3A- monitoring evolution after therapeutic inter- butriol or ZK 135079) have been used in some ventions [3].
    [Show full text]