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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. -
The Study Programme for the Quality Management of Essential Medicines - Good Manufacturing Practical (GMP) and Inspection
The Study Programme for the Quality Management of Essential Medicines - Good Manufacturing Practical (GMP) and Inspection - Country Reports Japan International Corporation of Welfare Services (JICWELS) Contents 1. Cambodia 1 2. Indonesia 70 3. Malaysia 91 4. Philippines 116 5. Sri Lanka 141 6. Thailand 161 The Study Programme for the Quality Management of Essential Medicines - Good Manufacturing Practical (GMP) and Inspection - Cambodia -1- KINGDOM OF CAMBODIA Nation Religion King Ministry of Health Department of Drugs and Food Country Report The Study Program on Quality Management of Essential Medicines Good Manufacturing Practice (GMP) and Inspection November 4, 2012 – November 30, 2012 Sponsored by : The Government of Japan Japan International Cooperation Agency (JICA) Department of Drugs and Food Ministry of Health, Cambodia. -2- I- COUNTRY PROFILE -3- A-Geography Cambodia is an agricultural country located in South East Asia which bordering the Gulf of Thailand, between Thailand, Vietnam, and Laos. Its approximate geographical coordinates are 13°N 105°E. Its 2,572 km border is split among Vietnam (1,228 km), Thailand (803 km) and Laos (541 km), as well as 443 km of coastline. Cambodia covers 181,035 square kilometers in the southwestern part of the Indochina, Cambodia lies completely within the tropics; its southernmost points are only slightly more than 10° above the equator. The country is bounded on the north by Thailand and by Laos, on the east and southeast by Vietnam, and on the west by the Gulf of Thailand and by Thailand. It consists of the Tonle Sap Basin and the Mekong Lowlands. To the southeast of this great basin is the Mekong Delta, which extends through Vietnam to the South China Sea. -
Xx250 Spc 2015 Uk
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT XENETIX 250 (250 mgI/ml) Solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION per ml 50 ml 100 ml 200 ml 500 ml Iobitridol (INN) 548.4 mg 27.42 g 54.84 g 109.68 g 274.2 g Iodine corresponding to 250 mg 12.5 g 25 g 50 g 125 g Excipient with known effect : Sodium (up to 3.5 mg per 100 mL). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless to pale yellow solution 4. CLINICAL PARTICULARS 4.1. Therapeutic indications For adults and children undergoing: . whole-body CT . venography . intra-arterial digital subtraction angiography . ERP/ERCP This medicinal product is for diagnostic use only. 4.2. Posology and method of administration The dosage may vary depending on the type of examination, the age, weight, cardiac output and general condition of the patient and the technique used. Usually the same iodine concentration and volume are used as with other iodinated X-ray contrast in current use. As with all contrast media, the lowest dose necessary to obtain adequate visualisation should be used. Adequate hydration should be assured before and after administration as for other contrast media. As a guideline, the recommended dosages are as follows: Indications Recommended dosage Whole-body CT The doses of contrast medium and the rates of administration depend on the organs under investigation, the diagnostic problem and, in particular, the different scan and image-reconstruction times of the scanners in use. -
01012100 Pure-Bred Horses 0 0 0 0 0 01012900 Lives Horses, Except
AR BR UY Mercosu PY applied NCM Description applied applied applied r Final Comments tariff tariff tariff tariff Offer 01012100 Pure-bred horses 0 0 0 0 0 01012900 Lives horses, except pure-bred breeding 2 2 2 2 0 01013000 Asses, pure-bred breeding 4 4 4 4 4 01019000 Asses, except pure-bred breeding 4 4 4 4 4 01022110 Purebred breeding cattle, pregnant or lactating 0 0 0 0 0 01022190 Other pure-bred cattle, for breeding 0 0 0 0 0 Other bovine animals for breeding,pregnant or 01022911 lactating 2 2 2 2 0 01022919 Other bovine animals for breeding 2 2 2 2 4 01022990 Other live catlle 2 2 2 2 0 01023110 Pure-bred breeding buffalo, pregnant or lactating 0 0 0 0 0 01023190 Other pure-bred breeding buffalo 0 0 0 0 0 Other buffalo for breeding, ex. pure-bred or 01023911 pregnant 2 2 2 2 0 Other buffalo for breeding, except pure-bred 01023919 breeding 2 2 2 2 4 01023990 Other buffalos 2 2 2 2 0 01029000 Other live animals of bovine species 0 0 0 0 0 01031000 Pure-bred breedig swines 0 0 0 0 0 01039100 Other live swine, weighing less than 50 kg 2 2 2 2 0 01039200 Other live swine, weighing 50 kg or more 2 2 2 2 0 01041011 Pure-bred breeding, pregnant or lactating, sheep 0 0 0 0 0 01041019 Other pure-bred breeding sheep 0 0 0 0 0 01041090 Others live sheep 2 2 2 2 0 01042010 Pure-bred breeding goats 0 0 0 0 0 01042090 Other live goats 2 2 2 2 0 Fowls spec.gallus domestic.w<=185g pure-bred 01051110 breeding 0 0 0 0 0 Oth.live fowls spec.gall.domest.weig.not more than 01051190 185g 2 2 2 2 0 01051200 Live turkeys, weighing not more than 185g 2 2 -
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. -
Page 1 Note: Within Nine Months from the Publication of the Mention
Europäisches Patentamt (19) European Patent Office & Office européen des brevets (11) EP 1 411 992 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 49/04 (2006.01) A61K 49/18 (2006.01) 13.12.2006 Bulletin 2006/50 (86) International application number: (21) Application number: 02758379.8 PCT/EP2002/008183 (22) Date of filing: 23.07.2002 (87) International publication number: WO 2003/013616 (20.02.2003 Gazette 2003/08) (54) IONIC AND NON-IONIC RADIOGRAPHIC CONTRAST AGENTS FOR USE IN COMBINED X-RAY AND NUCLEAR MAGNETIC RESONANCE DIAGNOSTICS IONISCHES UND NICHT-IONISCHES RADIOGRAPHISCHES KONTRASTMITTEL ZUR VERWENDUNG IN DER KOMBINIERTEN ROENTGEN- UND KERNSPINTOMOGRAPHIEDIAGNOSTIK SUBSTANCES IONIQUES ET NON-IONIQUES DE CONTRASTE RADIOGRAPHIQUE UTILISEES POUR ETABLIR DES DIAGNOSTICS FAISANT APPEL AUX RAYONS X ET A L’IMAGERIE PAR RESONANCE MAGNETIQUE (84) Designated Contracting States: (74) Representative: Minoja, Fabrizio AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Bianchetti Bracco Minoja S.r.l. IE IT LI LU MC NL PT SE SK TR Via Plinio, 63 20129 Milano (IT) (30) Priority: 03.08.2001 IT MI20011706 (56) References cited: (43) Date of publication of application: EP-A- 0 759 785 WO-A-00/75141 28.04.2004 Bulletin 2004/18 US-A- 5 648 536 (73) Proprietor: BRACCO IMAGING S.p.A. • K HERGAN, W. DORINGER, M. LÄNGLE W.OSER: 20134 Milano (IT) "Effects of iodinated contrast agents in MR imaging" EUROPEAN JOURNAL OF (72) Inventors: RADIOLOGY, vol. 21, 1995, pages 11-17, • AIME, Silvio XP002227102 20134 Milano (IT) • K.M. -
Harmonised Bds Suppl 20070
ABCDEF 1 EU Harmonised Birth Dates and related Data Lock Points, Supplementary list, 7 February 2007 Innovator brand name First DLP after Proposed Active substance name (INN) (for fixed combination 30 October Firm's Name Comments EU HBD products only) 2005 2 3 Aceclofenac 19900319 20080331 Almirall / UCB 4 Aciclovir 19810610 20060630 GSK 5 Adrafinil 19810710 20060131 Cephalon 6 Aldesleukine 19890703 20051231 Novartis NL=RMS Pfizer/Schwarz 7 Alprostadil (erectile dysfunction) 19840128 20080131 Pharma UK=RMS Alprostadil (peripheral arterial 19810723 20060731 Pfizer product differs from Schwarz Pharma 8 occlusive diseases) product Alprostadil (peripheral arterial 19841128 20051128 Schwarz Pharma product differs from Pfizer product 9 occlusive diseases) 10 Atenolol + chlorthalidone Tenoretic 19970909 20080908 AstraZeneca Azelaic acid 19881027 20060102 Schering AG / Pfizer AT = RMS 11 12 Aztreonam 19840804 20060803 BMS 13 Benazepril 19891128 20071130 Novartis Benazepril + hydrochlorothiazide Cibadrex 19920519 20070531 Novartis 14 15 Bisoprolol 19860128 20070930 Merck AG Bisoprolol + hydrochlorothiazide many product names 19920130 20061103 Merck AG 16 17 Botulinum Toxin A 19960906 20061030 Allergan currently 6-monthly PSURs 18 Brimonidine 19960906 20080930 Allergan UK=RMS 19 Brimonidine + timolol Combigan 19960906 20080930 Allergan UK=RMS 20 Bromperidol 20061115 J&J 21 Brotizolam 19830515 20071231 Boehringer Ingelheim 22 Budesonide 19920430 20070430 AstraZeneca 23 Budesonide + formoterol Symbicort 20000825 20070825 AstraZeneca 24 Buflomedil -
A General MRI-CEST Ratiometric Approach for Ph Imaging: Demonstration of in Vivo Ph Mapping with Iobitridol
A General MRI-CEST Ratiometric Approach for pH Imaging: Demonstration of in Vivo pH Mapping with Iobitridol The Harvard community has made this article openly available. Please share how this access benefits you. Your story matters Citation Longo, Dario L., Phillip Zhe Sun, Lorena Consolino, Filippo C. Michelotti, Fulvio Uggeri, and Silvio Aime. 2014. “A General MRI- CEST Ratiometric Approach for pH Imaging: Demonstration of in Vivo pH Mapping with Iobitridol.” Journal of the American Chemical Society 136 (41): 14333-14336. doi:10.1021/ja5059313. http:// dx.doi.org/10.1021/ja5059313. Published Version doi:10.1021/ja5059313 Citable link http://nrs.harvard.edu/urn-3:HUL.InstRepos:22856989 Terms of Use This article was downloaded from Harvard University’s DASH repository, and is made available under the terms and conditions applicable to Other Posted Material, as set forth at http:// nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of- use#LAA Communication pubs.acs.org/JACS Terms of Use A General MRI-CEST Ratiometric Approach for pH Imaging: Demonstration of in Vivo pH Mapping with Iobitridol † # ‡ # § § ⊥ ∥ Dario L. Longo, , Phillip Zhe Sun, , Lorena Consolino, Filippo C. Michelotti, , Fulvio Uggeri, § and Silvio Aime*, † § Institute of Biostructures and Bioimages (CNR) c/o Molecular Biotechnology Center and Department of Molecular Biotechnology and Health Sciences, Molecular Imaging Center, University of Torino, Torino 10126, Italy ‡ Athinoula A. Martinos Center for Biomedical Imaging, MGH and Harvard Medical School, Charlestown, Massachusetts 02129, United States ∥ Bracco Research Center, Bracco Imaging SpA, Colleretto Giacosa, Torino 10010, Italy *S Supporting Information facilitating in vivo imaging. This has been achieved by ratiometric ABSTRACT: Chemical exchange saturation transfer CEST MRI of agents with multiple magnetically non-equivalent (CEST) is a novel contrast mechanism for magnetic protons, whose CEST effects, upon ratioing, constitute the resonance imaging (MRI). -
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. -
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. -
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. -
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.