DOCSLIB.ORG

^Nuacio 5,662.930 Page 2

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

US00566293OA United States Patent (19) 11 Patent Number: 5,662.930 Ahl et al. I45 Date of Patent: *Sep. 2, 1997 54 REDUCTION OF LPOSOME-INDUCED 5,030,453 7/1991 Lenk et al............................... 424/450 ADVERSE PHYSOLOGICAL REACTIONS 5,041278 8/1991 Janoff et al. .. ... 424/1.1 5,077.056 12/1991 Bally et al. ... ... 424/450 75 Inventors: Patrick L. Ahl, Princeton; Suresh K. 5,213,804 5/1993 Martin et al. ........................... 424/450 Bhatia, Plainsboro; Sharma R. Minchey, Monmouth Junction, all of FOREIGN PATENT DOCUMENTS N.J.; Andrew S. Janoff, Yardley, Pa. O 213 523 3/1987 European Pat. Off. ......... A61K 9/50 0312 212 4/1989 European Pat. Off. ..... G01N 33/531 73) Assignee: The Liposome Company, Inc., 61-088887 5/1986 Japan ............... ... A61K 3/127 Princeton, N.J. 85/00968 3/1985 WIPO .............................. A61K 9/22 86/00238 1/1986 WTPO ............................ B01D 13/00 86/01102 2/1986 WIPO .............................. A61K 9/60 * Notice: The term of this patent shall not extend 37/00043 1/1987 WEPO .............................. A61K 9/00 beyond the expiration date of Pat. No. 87/02219 4/1987 WIPO ............................ A01N 25/28 5,614,214. 88/06443 9/1988 WIPO .............................. A61K 9/66 88/09165 5/1989 WIPO .............................. A61K 9/50 90/14105 11/1990 WIPO ............................ A61K 43/00 21 Appl. No.: 433,665 92/05773 4/1992 WIPO ............................ A61K 9/27 22 Filed: May 4, 1995 OTHER PUBLICATIONS Related U.S. Application Data Bangham, et al., “Diffusion of Univalent Ions across the 60) Division of Ser. No. 247,053, May 20, 1994, which is a Lamellae of Swollen Phospholipids”. J. Mol. Biol., continuation-in-part of Ser. No. 207,651, Mar. 7, 1994, 13:238-252 (1965). abandoned, which is a continuation-in-part of Ser. No. Deamer and Uster, "Liposome Preparation: Methods and 65,928, May 21, 1993, abandoned. Materials.” in: Liposomes. Marcel Dekker, Inc., New York 51 Int. Cl. ... A61K9/127; A61 K9/133 (1983) 27-51. 52 U.S. Cl. ... 424/450; 424/1.21 58) Field of Search ................................... 424/450, 1.21; (List continued on next page.) 436/829 Primary Examiner-Gollamudi S. Kishore Attorney, Agent, or Firm-Kenneth B. Rubin 56) References Cited 57 ABSTRACT U.S. PATENT DOCUMENTS Provided herein is a method of administering a liposome 3,577,446 5/1971 Rakhit .................................... 260/403 3,993,754 11/1976 Rahman et al. ... 424/177 composition to an animal, the method involving adminster 4,145,410 3/1979 Sears ......................................... 424/19 ing to the animal a liposome composition containing an 4.224,179 9/1980 Schneider ........ 252/316 adverse physiological reaction-reducing effective amount of 4229,360 10/1980 Schneider et al. .......... ... 260/403 a liposome which has, in addition to a bioactive agent, a lipid 4,235,871 11/1980 Papahadjopoulos et al. ............ 424/19 bilayer containing a lipid and a surface agent-modified 4,522,803 6/1985 Lenk et al. ............................... 424/1.1 molecule. An adverse physiological reaction which may be 4,588,578 5/1986 Fountain et al. ......................... 424/1.1 experienced by the animal upon administration of a lipo 4,721,612 1/1988 Janoff et al. ............................. 424/1.1 some composition is reduced by way of the presence of the 4,861,580 8/1989 Janoff et al. ............................. 424/1.1 surface agent-modified molecule in the liposome's lipid 4,880,635 11/1989 Janoff et al. ... ... 424/450 bilayer. 4,975,282 12/1990 Bally et al. ..... ... 424/450 5,008,050 4/1991 Cullis et al. ............................. 264/4.3 5,013,556 5/1991 Woodle et al. ......................... 424/450 17 Claims, 16 Drawing Sheets o ^nuacio 5,662.930 Page 2 OTHER PUBLICATIONS Mayer, et al., "Solute distributions and trapping efficiencies observed in freeze-thawed multimalar vesicles”, Biochim. Ivancev et al., “Effect of Intravenously Injected Iodinated Biophys. Acta, 1985, 817:193-196. Lipis Emulsions on the Liver", Acta Radiologica, 30, Papahadjopoulos, et al., “Phospholipid Model Membrane, I. (1989), 291-298. Structural Characteristics of hydrated Liquid Crystals". Bio chim. Biophys. Acta, 1968, 135:624-638. Ivancev, et al., "Experimental Investigation of a New Iodi Park, et al., "Some negatively charged phospholipid deriva nated Lipid Emulsion for Computed Tomography of the tives prolong the liposome circulation time in vivo” Bio Liver". Acta Radiologica 30 (1989), Fasc. 4, p407-413. chimica et Biophysica Acta, 1992, 1108(2), 257-60. U.S. Patent Sep. 2, 1997 Sheet 1 of 16 5,662.930 OO=t b U.S. Patent Sep. 2, 1997 Sheet 2 of 16 5,662.930 R 9 3 s OO O VO O R euSe u e SOO % U.S. Patent Sep. 2, 1997 Sheet 3 of 16 5,662,930 S 2 2 O O O O O O O O 3 N O V N V buSe u e SOO % U.S. Patent Sep. 2, 1997 Sheet 5 of 16 5,662.930 9| U.S. Patent Sep. 2, 1997 Sheet 6 of 16 5,662,930 Fig. 6 o A. o V so SR o ve O O i i O O O O O O O O O O O Vr R O O O Vr N y ve vur qvan v 6H uu anssed pools jeuauvueew U.S. Patent Sep. 2, 1997 Sheet 7 of 16 5,662.930 Fig. 7 S N O o co st N s y yon O O O O OW peZeuoN U.S. Patent Sep. 2, 1997 Sheet 8 of 16 5,662.930 9. Oy 0£ OZ 004 09 07 Oz f5H uu U.S. Patent Sep. 2, 1997 Sheet 9 of 16 5,662.930 Fig. 9 an . E Nu 2 r E -> H 1 9 -O- U.S. Patent Sep. 2, 1997 Sheet 10 of 16 5,662.930 Fig. 10 2 an E -- E & C) E C H O 2 E 3 S s 8 S3 S3 9. S. O U.S. Patent Sep. 2, 1997 Sheet 11 of 16 5,662.930 Fig. 11 9. s g S 9 U.S. Patent Sep. 2, 1997 Sheet 12 of 16 5,662.930 Fig. 12 f N . E Nus? * d) E H s U.S. Patent Sep. 2, 1997 Sheet 13 of 16 5,662.930 Fig. 13 s R e Se O C O O O O C O CD s CO N up r N vis euSe u eSOO % U.S. Patent Sep. 2, 1997 Sheet 14 of 16 5,662.930 Fig. 14 7O.OO 60.00 50.00 40.00 : 30.00 20.00 1.O.OO O.OO E O - Sp e (s) (S) 5 V O up 2 g"O g9 (S) ; Co o O U.S. Patent Sep. 2, 1997 Sheet 15 of 16 5,662.930 Fig. 15 7O.OO 60.00 50.00 40.00 30.00 2O.OO O.OO O.OO O 2 (S) 5 to (S) C3 ar.9 o O U.S. Patent Sep. 2, 1997 Sheet 16 of 16 5,662,930 Fig. 16 (esopjo%9z)•Mºna6||6uu1ºg 06 09 5,662,930 1. 2 REDUCTION OF LPOSOME-ENDUCED lether (Woodie et al., U.S. Pat. No. 5,013,556 "Liposomes ADVERSE PHYSOLOGICAL REACTIONS with Enhanced Circulation Time", issued May 7, 1991, the contents of which are incorporated herein by reference). This application is a division of U.S. application Ser. No. 247,053, filed May 20, 1994, pending which is a 5 SUMMARY OF THE INVENTON continuation-on-part of U.S. application Ser. No. 207,651, This invention provides a method of administering a filed Mar. 7, 1994 and now abandoned, which in turn is a liposcome composition to an animal which comprises continuation-in-part of U.S. application Ser. No. 065.928, administering to the animal a liposome composition com filed May 21, 1993 and now abandoned. prising an adverse physiological reaction-reducing effective This invention relates to a method for the reduction of amount of a liposome comprising a bioactive agent and a liposome induced adverse physiological reactions when lipid bilayer having a lipid and a surface agent-modified liposome compositions are administered to animals, includ molecule which comprises a Surface-modifying agent and an ing mammals such as humans. These liposome compositions anchor. The liposome used in the method of this invention can be used to encapsulate bioactive agents. typically has a diameter of from about 200 nm to about 5000 Liposomes are completely closed lipid bilayer mem 15 nm, more preferably, from about 400 nm to about 5000 nm, branes containing an entrapped aqueous volume. The bilayer and most preferably, presently, from about 400 nm to about is composed of lipid molecules which comprise monolayers 1000 nm. Liposomes having such diameters are preferably having a hydrophobic region and a hydrophilic region. The interdigitation-fusion liposomes (IFVs), but can also be structure of the bilayer is such that the hydrophobic large unilamellar liposomes (LUVs) or multilamellar lipo (nonpolar) acyl chain region of the lipid monolayers orient somes (MLVs). The concentration of the surface agent toward the center of the bilayer while the hydrophilic (polar) modified molecule in the bilayer is typically at least about 2 lipid headgroups orient towards the aqueous phase. mole %, more preferably at least about 5 mole %, and most In a liposome-drug delivery system, a bioactive agent preferably at least about 10 mole %. Preferably, the adverse such as a drug is entrapped in the liposome and then physiological reaction-reducing effective amount of the administered to the patient to be treated (Rahman et al., U.S. 25 liposome is about 50 mg of the liposome per kg of the Pat.
Recommended publications
  • Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017

    Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017

    Q UO N T FA R U T A F E BERMUDA PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 BR 111 / 2017 The Minister responsible for health, in exercise of the power conferred by section 48A(1) of the Pharmacy and Poisons Act 1979, makes the following Order: Citation 1 This Order may be cited as the Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017. Repeals and replaces the Third and Fourth Schedule of the Pharmacy and Poisons Act 1979 2 The Third and Fourth Schedules to the Pharmacy and Poisons Act 1979 are repealed and replaced with— “THIRD SCHEDULE (Sections 25(6); 27(1))) DRUGS OBTAINABLE ONLY ON PRESCRIPTION EXCEPT WHERE SPECIFIED IN THE FOURTH SCHEDULE (PART I AND PART II) Note: The following annotations used in this Schedule have the following meanings: md (maximum dose) i.e. the maximum quantity of the substance contained in the amount of a medicinal product which is recommended to be taken or administered at any one time. 1 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 mdd (maximum daily dose) i.e. the maximum quantity of the substance that is contained in the amount of a medicinal product which is recommended to be taken or administered in any period of 24 hours. mg milligram ms (maximum strength) i.e. either or, if so specified, both of the following: (a) the maximum quantity of the substance by weight or volume that is contained in the dosage unit of a medicinal product; or (b) the maximum percentage of the substance contained in a medicinal product calculated in terms of w/w, w/v, v/w, or v/v, as appropriate.
  • NON-HAZARDOUS CHEMICALS May Be Disposed of Via Sanitary Sewer Or Solid Waste

    NON-HAZARDOUS CHEMICALS May Be Disposed of Via Sanitary Sewer Or Solid Waste

    NON-HAZARDOUS CHEMICALS May Be Disposed Of Via Sanitary Sewer or Solid Waste (+)-A-TOCOPHEROL ACID SUCCINATE (+,-)-VERAPAMIL, HYDROCHLORIDE 1-AMINOANTHRAQUINONE 1-AMINO-1-CYCLOHEXANECARBOXYLIC ACID 1-BROMOOCTADECANE 1-CARBOXYNAPHTHALENE 1-DECENE 1-HYDROXYANTHRAQUINONE 1-METHYL-4-PHENYL-1,2,5,6-TETRAHYDROPYRIDINE HYDROCHLORIDE 1-NONENE 1-TETRADECENE 1-THIO-B-D-GLUCOSE 1-TRIDECENE 1-UNDECENE 2-ACETAMIDO-1-AZIDO-1,2-DIDEOXY-B-D-GLYCOPYRANOSE 2-ACETAMIDOACRYLIC ACID 2-AMINO-4-CHLOROBENZOTHIAZOLE 2-AMINO-2-(HYDROXY METHYL)-1,3-PROPONEDIOL 2-AMINOBENZOTHIAZOLE 2-AMINOIMIDAZOLE 2-AMINO-5-METHYLBENZENESULFONIC ACID 2-AMINOPURINE 2-ANILINOETHANOL 2-BUTENE-1,4-DIOL 2-CHLOROBENZYLALCOHOL 2-DEOXYCYTIDINE 5-MONOPHOSPHATE 2-DEOXY-D-GLUCOSE 2-DEOXY-D-RIBOSE 2'-DEOXYURIDINE 2'-DEOXYURIDINE 5'-MONOPHOSPHATE 2-HYDROETHYL ACETATE 2-HYDROXY-4-(METHYLTHIO)BUTYRIC ACID 2-METHYLFLUORENE 2-METHYL-2-THIOPSEUDOUREA SULFATE 2-MORPHOLINOETHANESULFONIC ACID 2-NAPHTHOIC ACID 2-OXYGLUTARIC ACID 2-PHENYLPROPIONIC ACID 2-PYRIDINEALDOXIME METHIODIDE 2-STEP CHEMISTRY STEP 1 PART D 2-STEP CHEMISTRY STEP 2 PART A 2-THIOLHISTIDINE 2-THIOPHENECARBOXYLIC ACID 2-THIOPHENECARBOXYLIC HYDRAZIDE 3-ACETYLINDOLE 3-AMINO-1,2,4-TRIAZINE 3-AMINO-L-TYROSINE DIHYDROCHLORIDE MONOHYDRATE 3-CARBETHOXY-2-PIPERIDONE 3-CHLOROCYCLOBUTANONE SOLUTION 3-CHLORO-2-NITROBENZOIC ACID 3-(DIETHYLAMINO)-7-[[P-(DIMETHYLAMINO)PHENYL]AZO]-5-PHENAZINIUM CHLORIDE 3-HYDROXYTROSINE 1 9/26/2005 NON-HAZARDOUS CHEMICALS May Be Disposed Of Via Sanitary Sewer or Solid Waste 3-HYDROXYTYRAMINE HYDROCHLORIDE 3-METHYL-1-PHENYL-2-PYRAZOLIN-5-ONE
  • Page 1 Note: Within Nine Months from the Publication of the Mention

    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.
  • ACR Manual on Contrast Media

    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.
  • Clinical Practice Guidelines for Diagnosis and Management Of

    Clinical Practice Guidelines for Diagnosis and Management Of

    REVIEWS Clinical Practice Guidelines for Diagnosis and Management of Hypersensitivity Reactions to Contrast Media Rosado Ingelmo A1, Doña Diaz I2, Cabañas Moreno R3, Moya Quesada MC4, García-Avilés C5, García Nuñez I6, Martínez Tadeo JI7, Mielgo Ballesteros R8, Ortega-Rodríguez N9, Padial Vilchez MA10, Sánchez-Morillas L11, Vila Albelda C1, Moreno Rodilla E12*, Torres Jaén MJ2* 1Unidad de Alergia, Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain 2Allergy Unit, IBIMA-Regional University Hospital of Málaga, UMA, Málaga, Spain 3Department of Allergy, Hospital La Paz, Health Research Institute (IdiPAZ), Madrid, Spain 4Sección de Alergia CH Torrecárdenas, Almería, Spain 5Unidad de Alergia, Hospital Moncloa, Madrid, Spain 6Servicio de Alergología, Hospital Quirón Málaga, Málaga, Spain 7Servicio de Alergología, Hospital Universitario Ntra Sra de Candelaria, Santa Cruz de Tenerife, Tenerife, Spain 8Servicio de Alergología, Hospital Universitario 12 de Octubre, Madrid, Spain 9Servicio de Alergia, Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria, Spain 10Servicio de Alergologia, Hospital Infanta Sofía, San Sebastián de los Reyes, Madrid, Spain 11Servicio de Alergologia, Hospital Clínico San Carlos, Madrid, Spain 12Servicio de Alergología, Complejo Asistencial Universitario de Salamanca, Salamanca, Spain *Both authors contributed equally to this study. On behalf of the Drug Allergy Committee of Spanish Society of Allergy and Clinical Immunology (SEAIC) J Investig Allergol Clin Immunol 2016; Vol. 26(3): 144-155 doi: 10.18176/jiaci.0058 Abstract The objective of these guidelines is to ensure efficient and effective clinical practice. The panel of experts who produced this consensus document developed a research protocol based on a review of the literature. The prevalence of allergic reactions to iodinated contrast media (ICM) is estimated to be 1:170 000, that is, 0.05%-0.1% of patients undergoing radiologic studies with ICM (more than 75 million examinations per year worldwide).
  • Update on Ionis Pharmaceuticals June 7, 2016

    Update on Ionis Pharmaceuticals June 7, 2016

    Update on Ionis Pharmaceuticals June 7, 2016 Due to recent announcements and ongoing price weakness in the stock of Ionis Pharmaceuticals, we wanted to provide you an update on our thinking relating to your investment in the company. Background: Buena Vista Investment Management began investing in Ionis Pharmaceuticals (previously known as Isis Pharmaceuticals) in 2004 based on our belief that their genetic research and unique approach to discovering new drugs through the use of Antisense Technology would eventually lead to a much higher stock price. Since that first investment 12 years ago we have seen many ups and downs in the stock price but through it all the company’s technology continues to improve and its balance sheet has never been better. As investors, we entered 2016 with the potential for a lot of good news. First, the company had three phase 3 trials coming to endpoints within 18 months. Second, the company’s new subsidiary, Akcea Therapeutics, which was created to focus on their lipid franchise, was now up and running. The company had an exceptionally strong balance sheet for a biotechnology company, with approximately $700 million in cash and marketable securities. And most importantly, the company now had 38 compounds in clinical trials, an unheard of number for a company of this size. Yet with all of these potential positive catalysts for the stock, we are now sitting at the same price level as we were in the beginning of 2014. The price of Ionis stock has dropped from a high of $77 per share in April of 2015 to the mid 20’s today.
  • Ehealth DSI [Ehdsi V2.2.2-OR] Ehealth DSI – Master Value Set

    Ehealth DSI [Ehdsi V2.2.2-OR] Ehealth DSI – Master Value Set

    MTC eHealth DSI [eHDSI v2.2.2-OR] eHealth DSI – Master Value Set Catalogue Responsible : eHDSI Solution Provider PublishDate : Wed Nov 08 16:16:10 CET 2017 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 1 of 490 MTC Table of Contents epSOSActiveIngredient 4 epSOSAdministrativeGender 148 epSOSAdverseEventType 149 epSOSAllergenNoDrugs 150 epSOSBloodGroup 155 epSOSBloodPressure 156 epSOSCodeNoMedication 157 epSOSCodeProb 158 epSOSConfidentiality 159 epSOSCountry 160 epSOSDisplayLabel 167 epSOSDocumentCode 170 epSOSDoseForm 171 epSOSHealthcareProfessionalRoles 184 epSOSIllnessesandDisorders 186 epSOSLanguage 448 epSOSMedicalDevices 458 epSOSNullFavor 461 epSOSPackage 462 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 2 of 490 MTC epSOSPersonalRelationship 464 epSOSPregnancyInformation 466 epSOSProcedures 467 epSOSReactionAllergy 470 epSOSResolutionOutcome 472 epSOSRoleClass 473 epSOSRouteofAdministration 474 epSOSSections 477 epSOSSeverity 478 epSOSSocialHistory 479 epSOSStatusCode 480 epSOSSubstitutionCode 481 epSOSTelecomAddress 482 epSOSTimingEvent 483 epSOSUnits 484 epSOSUnknownInformation 487 epSOSVaccine 488 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 3 of 490 MTC epSOSActiveIngredient epSOSActiveIngredient Value Set ID 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 TRANSLATIONS Code System ID Code System Version Concept Code Description (FSN) 2.16.840.1.113883.6.73 2017-01 A ALIMENTARY TRACT AND METABOLISM 2.16.840.1.113883.6.73 2017-01
  • Review Article Contrast Media Viscosity Versus Osmolality in Kidney Injury: Lessons from Animal Studies

    Review Article Contrast Media Viscosity Versus Osmolality in Kidney Injury: Lessons from Animal Studies

    Hindawi Publishing Corporation BioMed Research International Volume 2014, Article ID 358136, 15 pages http://dx.doi.org/10.1155/2014/358136 Review Article Contrast Media Viscosity versus Osmolality in Kidney Injury: Lessons from Animal Studies Erdmann Seeliger, Diana C. Lenhard, and Pontus B. Persson Institute of Physiology and Center for Cardiovascular Research, Charite-University´ Medicine Berlin, Campus Mitte, Hessische Straße 3-4, 10115 Berlin, Germany Correspondence should be addressed to Erdmann Seeliger; [email protected] Received 18 October 2013; Accepted 29 December 2013; Published 23 February 2014 Academic Editor: Richard Solomon Copyright © 2014 Erdmann Seeliger et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Iodinated contrast media (CM) can induce acute kidney injury (AKI). CM share common iodine-related cytotoxic features but differ considerably with regard to osmolality and viscosity. Meta-analyses of clinical trials generally failed to reveal renal safety differences of modern CM with regard to these physicochemical properties. While most trials’ reliance on serum creatinine as outcome measure contributes to this lack of clinical evidence, it largely relies on the nature of prospective clinical trials: effective prophylaxis by ample hydration must be employed. In everyday life, patients are often not well hydrated; here we lack clinical data. However, preclinical studies that directly measured glomerular filtration rate, intrarenal perfusion and oxygenation, and various markers of AKI have shown that the viscosity of CM is of vast importance. In the renal tubules, CM become enriched, as water is reabsorbed, but CM are not.
  • The International Pharmacopoeia

    The International Pharmacopoeia

    The International Pharmacopoeia THIRD EDITION Pharmacopoea internationalis Editio tertia Volume 4 Tests, methods, and general requirements Quality specifications for pharmaceutical substances, excipients, and dosage forms World Health Organization Geneva 1994 WHO Library Cataloguing in Publication Data The International Pharmacopoeia.- 3rd ed. Contents: v. 4. Tests, methods, and general requirements 1. Drugs -analysis 2. Drugs -standards ISBN 92 4 154462 7 (NLM Classification: QV 25) The World Health Organization welcomes requests for permission to reproduce or translate its publica- tions, in part or in full. Applications and enquiries should be addressed to the Of£ice of Publications, World Health Organization, Geneva, Switzerland, which will be glad to provide the latest information on any changes made to the text, plans for new editions, and reprints and translations already available. O World Health Organization, 1994 Publications of the World Health Organization enjoy copyright protection in accordance with the provi- sions of Protocol 2 of the Universal Copyright Convention. All rights reserved. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distin- guished by initial capital letters.
  • Diatrizoate Sodium)

    Diatrizoate Sodium)

    PRESCRIBING INFORMATION HYPAQUE ORAL POWDER (Diatrizoate Sodium) Contrast Medium GE Healthcare Canada Inc. Date of Preparation: 2300 Meadowvale Blvd. March 20, 2006 Mississauga, ON L5N 5P9 Control # 104484 HYPAQUE ORAL (Diatrizoate Sodium) CONTRAST MEDIUM INDICATIONS: Radiography of gastrointestinal tract following oral or rectal administration. PRECAUTIONS: Not for parenteral injection. Do not use for myelography. It is advisable to correct any electrolyte disturbances before using solutions that are extremely hypertonic. Caution is advised in patients with severe renal or hepatic disease, known hypersensitivity to diatrizoic acid compounds or hyperthyroidism. Pregnancy: The safety of orally administered diatrizoate sodium solutions during pregnancy has not been established. Therefore, before administration of the drug to women of childbearing potential, the benefit to the patient should be carefully weighed against the possible risk to the fetus. In addition, most authorities consider elective contrast radiography of the abdomen contraindicated during pregnancy. Lactation: Diatrizoate sodium administered intravascularly has been found to be excreted in breast milk. Because small amounts may be absorbed from oral administration, caution should be exercised when diatrizoate sodium solutions are administered to a nursing woman. Children: Solutions of diatrizoate sodium employed clinically are hypertonic, which may lead to intraluminal movement of fluid and may lead to hypovolemia. In infants and young children (under 10 kg), the loss of plasma fluid may be sufficient to cause a shock-like state; therefore, low concentrations (achieved by further dilution) must be used. Diatrizoate sodium may be preferred over the diatrizoate meglumine/diatrizoate sodium combination, since the wetting agent (Tween 80) in the latter preparation may be injurious to the colonic mucosa.
  • Pharmaceuticals As Environmental Contaminants

    Pharmaceuticals As Environmental Contaminants

    PharmaceuticalsPharmaceuticals asas EnvironmentalEnvironmental Contaminants:Contaminants: anan OverviewOverview ofof thethe ScienceScience Christian G. Daughton, Ph.D. Chief, Environmental Chemistry Branch Environmental Sciences Division National Exposure Research Laboratory Office of Research and Development Environmental Protection Agency Las Vegas, Nevada 89119 [email protected] Office of Research and Development National Exposure Research Laboratory, Environmental Sciences Division, Las Vegas, Nevada Why and how do drugs contaminate the environment? What might it all mean? How do we prevent it? Office of Research and Development National Exposure Research Laboratory, Environmental Sciences Division, Las Vegas, Nevada This talk presents only a cursory overview of some of the many science issues surrounding the topic of pharmaceuticals as environmental contaminants Office of Research and Development National Exposure Research Laboratory, Environmental Sciences Division, Las Vegas, Nevada A Clarification We sometimes loosely (but incorrectly) refer to drugs, medicines, medications, or pharmaceuticals as being the substances that contaminant the environment. The actual environmental contaminants, however, are the active pharmaceutical ingredients – APIs. These terms are all often used interchangeably Office of Research and Development National Exposure Research Laboratory, Environmental Sciences Division, Las Vegas, Nevada Office of Research and Development Available: http://www.epa.gov/nerlesd1/chemistry/pharma/image/drawing.pdfNational
  • EUROPEAN PHARMACOPOEIA 10.0 Index 1. General Notices

    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