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Wo 2009/081169 A2
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date PCT 2 July 2009 (02.07.2009) WO 2009/081169 A2 (51) International Patent Classification: KJELLSON, Fred [SE/SE]; IoPharma Technologies AB, A61K 49/04 (2006.01) Ideon Science Park, Ole Romers Vag 12, SE-223 70 Lund (SE). KLAVENESS, J o [NO/SE]; IoPharma Technologies (21) International Application Number: AB, Ideon Science Park, Ole Romers Vag 12, SE-223 70 PCT/GB2008/004268 Lund (SE). (22) International Filing Date: (74) Agent: KIDD, Sara; Frank B. Dehn 6 Co., St. Bride's 22 December 2008 (22.12.2008) House, 10 Salisbury Square, London EC4Y 8ID (GB). (25) Filing Language: English (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, (26) Publication Language: English AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, (30) Priority Data: EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, 0725070.7 21 December 2007 (21.12.2007) GB IL, IN, IS, IP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, (71) Applicant (for all designated States except US): IO- LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, PHARMA TECHNOLOGIES AB [SE/SE]; Ideon MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, Science Park, Ole Romers Vag 12, SE-223 70 Lund (SE). -
Pharmacy Reengineering (PRE) V.0.5 Pre-Release Implementation
PHARMACY REENGINEERING (PRE) Version 0.5 Pre-Release Implementation Guide PSS*1*129 & PSS*1*147 February 2010 Department of Veterans Affairs Office of Enterprise Development Revision History Date Revised Patch Description Pages Number 02/2010 All PSS*1*147 Added Revision History page. Updated patch references to include PSS*1*147. Described files, fields, options and routines added/modified as part of this patch. Added Chapter 5, Additive Frequency for IV Additives, to describe the steps needed to ensure correct data is in the new IV Additive REDACTED 01/2009 All PSS*1*129 Original version REDACTED February 2010 Pharmacy Reengineering (PRE) V. 0.5 Pre-Release i Implementation Guide PSS*1*129 & PSS*1*147 Revision History (This page included for two-sided copying.) ii Pharmacy Reengineering (PRE) V. 0.5 Pre-Release February 2010 Implementation Guide PSS*1*129 & PSS*1*147 Table of Contents Introduction ................................................................................................................................. 1 Purpose ....................................................................................................................................1 Project Description ....................................................................................................................1 Scope ........................................................................................................................................3 Menu Changes ..........................................................................................................................4 -
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. -
Title 16. Crimes and Offenses Chapter 13. Controlled Substances Article 1
TITLE 16. CRIMES AND OFFENSES CHAPTER 13. CONTROLLED SUBSTANCES ARTICLE 1. GENERAL PROVISIONS § 16-13-1. Drug related objects (a) As used in this Code section, the term: (1) "Controlled substance" shall have the same meaning as defined in Article 2 of this chapter, relating to controlled substances. For the purposes of this Code section, the term "controlled substance" shall include marijuana as defined by paragraph (16) of Code Section 16-13-21. (2) "Dangerous drug" shall have the same meaning as defined in Article 3 of this chapter, relating to dangerous drugs. (3) "Drug related object" means any machine, instrument, tool, equipment, contrivance, or device which an average person would reasonably conclude is intended to be used for one or more of the following purposes: (A) To introduce into the human body any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (B) To enhance the effect on the human body of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (C) To conceal any quantity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; or (D) To test the strength, effectiveness, or purity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state. (4) "Knowingly" means having general knowledge that a machine, instrument, tool, item of equipment, contrivance, or device is a drug related object or having reasonable grounds to believe that any such object is or may, to an average person, appear to be a drug related object. -
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. -
Biosimilar Branded Iodinated Contrast Agents Related to the Largest Number of Reports to the Who-Pharmacovigilance System Over the First 40 Years of the Programme
Pharmacologyonline 2: 929-962 (2011) Newsletter Bradu and Rossini BIOSIMILAR BRANDED IODINATED CONTRAST AGENTS RELATED TO THE LARGEST NUMBER OF REPORTS TO THE WHO-PHARMACOVIGILANCE SYSTEM OVER THE FIRST 40 YEARS OF THE PROGRAMME. FIFTH WHO-ITA/ITA-OMS 2010-2011 CONTRIBUTION Dan Bradu and Luigi Rossini* Servizio Nazionale collaborativo WHO-ITA/ITA-OMS, Universita’ Politecnica delle Marche e Progetto di Farmacotossicovigilanza pre-, post-marketing, Azienda Ospedaliera Universitaria Ospedali Riuniti di Ancona, Regione Marche, Italia Summary Analysis of the side-events, and suspicious or confirmed adverse drug reactions (SADRs), accounting for a total of 67,232 reports, based on the model and on a Matlab program (as described in the fourth contribution of our current series) showed broadly inhomogeneous profiles of all of the 10 products categorized as “biosimilar” that have been the object of the largest number of reports in the first 40 years of the WHO Pharmacovigilance Programme. The analysis highlighted striking differences both when they were subdivided into system-organ class disorders (SOCDs) or studied together, and when they were analyzed in terms of five pairs of biosimilars and their respective, agreed, generic reference products. These conclusions add to the data, already reported by the authors, of the preclinical experiments and the pre-marketing conventional standardized clinical trials regulations. Key words: WHO International Drug Monitoring, Pharmacovigilance Programme. Correlation objective autoclassificative and confirmatory clustering comparisons between couples of ATC- 929 Pharmacologyonline 2: 929-962 (2011) Newsletter Bradu and Rossini V08A-A 8 Amidotrizoate, Iotalamate, Ioxitalamate and Metrizoate, and ATC-V08A-B 2 Ioxaglate “biosimilars”. ----------------------------------------------------------------------------------------------------------------------- -* Corresponding author, retired October 31, 2008. -
ACR Manual on Contrast Media – Version 9, 2013 Table of Contents / I
ACR Manual on Contrast Media Version 9 2013 ACR Committee on Drugs and Contrast Media ACR Manual on Contrast Media – Version 9, 2013 Table of Contents / i ACR Manual on Contrast Media Version 9 2013 ACR Committee on Drugs and Contrast Media © Copyright 2013 American College of Radiology ISBN: 978-1-55903-012-0 Table of Contents Topic Last Updated Page 1. Preface. V9 – 2013 . 3 2. Introduction . V7 – 2010 . 4 3. Patient Selection And Preparation Strategies . V7 – 2010 . 5 4. Injection of Contrast Media . V7 – 2010 . 13 5. Extravasation Of Contrast Media . V7 – 2010 . 17 6. Allergic-Like And Physiologic Reactions To Intravascular Iodinated Contrast Media . V9 – 2013 . 21 7. Contrast Media Warming . V8 – 2012 . 29 8. Contrast-Induced Nephrotoxicity . V8 – 2012 . 33 9. Metformin . V7 – 2010 . 43 10. Contrast Media In Children . V7 – 2010 . 47 11. Gastrointestinal (GI) Contrast Media In Adults: Indications And Guidelines V9 – 2013 . 55 12. Adverse Reactions To Gadolinium-Based Contrast Media . V7 – 2010 . 77 13. Nephrogenic Systemic Fibrosis . V8 – 2012 . 81 14. Treatment Of Contrast Reactions . V9 – 2013 . 91 15. Administration Of Contrast Media To Pregnant Or Potentially Pregnant Patients . V9 – 2013 . 93 16. Administration Of Contrast Media To Women Who Are Breast-Feeding . V9 – 2013 . 97 Table 1 – Indications for Use of Iodinated Contrast Media . V9 – 2013 . 99 Table 2 – Organ and System-Specific Adverse Effects from the Administration of Iodine-Based or Gadolinium-Based Contrast Agents. V9 – 2013 . 100 Table 3 – Categories of Acute Reactions . V9 – 2013 . 101 Table 4 – Treatment of Acute Reactions to Contrast Media in Children . V9 – 2013 . -
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 -
Potential Interference of Agents on Radioiodide Thyroid Uptake in the Euthyroid Rat
Potential Interference of Agents on Radioiodide Thyroid Uptake in the Euthyroid Rat Ming-Der Yu, PhD1; and Stanley M. Shaw, PhD2 1Department of Nuclear Medicine, Tri-Service General Hospital, Taipei, Taiwan; and 2Division of Nuclear Pharmacy, School of Pharmacy and Pharmacal Sciences, Purdue University, West Lafayette, Indiana problems have been documented (1–10), but data are con- The objective of this research was to investigate the merits of flicting in regard to the extent of the problem. The interfer- controlled studies with euthyroid rats as a means of determining ence time of propylthiouracil (PTU) has been reported to the influence of dose and time after administration of agents vary from days to 1–2 wk. The interference time of dia- that may interfere with radioiodide uptake in the thyroid. Meth- trizoate meglumine has been reported to be from 2 wk to ods: Potassium iodide (KI), propylthiouracil (PTU), diatrizoate meglumine, and iohexol were selected to represent interfering about 2 mo. The duration of interference from iodides has agents. Two dose levels per agent were investigated. Doses been noted as 1, 2, or 4 wk. Many reports on drug–radiophar- used were 1 and 2 mg/kg of body weight for KI, 3.5 and 7 mg/kg maceutical interactions are anecdotal and in situations that of body weight for PTU, 1 mL/kg (282 mg I/kg) and 2 mL/kg (564 make comparisons between agents difficult. mg I/kg) of body weight for diatrizoate meglumine, and 1 mL/kg It would appear beneficial to conduct controlled studies (300 mg I/kg) and 2 mL/kg (600 mg I/kg) of body weight for between agents and at various doses to gain additional iohexol. -
Radiocontrast Media and Breastfeeding
Radiocontrast media and breastfeeding X-rays, MRIs, CAT scans, Intravenous Pyelogram (IVP), ultrasound, mammograms, etc. do not affect breastfeeding. Barium is sometimes used as a contrast agent; it is not absorbed orally and thus does not affect breastfeeding. Sometimes radiocontrast dyes are used to aid the imaging - these dyes do not require that mom interrupt breastfeeding. “Although most package inserts for these products suggest that nursing mothers postpone breastfeeding their babies for 24 hours after use, research indicates that this is not necessary (Kubik-Huch 2000; Rofsky 1993; Nielson 1987; Fitz-John 1982). In Medications and Mothers' Milk (2002), Dr. Thomas Hale explains that 'Although under usual circumstances iodine products are contraindicated in nursing mothers (due to ion trapping in milk), these products are unique in that they are extremely inert and do not release free iodine... They are virtually unabsorbed after oral administration' (Hale, p. 480). In mothers who have used these agents while breastfeeding, no effects have been reported in their nursing babies (Kubik- Huch 2000; Nielson 1987). These preparations are also used in children for diagnostic purposes." From: Mohrbacher N, Stock J. The Breastfeeding Answer Book. 3rd Revised Edition. Schaumburg, Illinois: La Leche League International; 2003:508. "Because of the very small percentage of iodinated contrast medium that is excreted into the breast milk and absorbed by the infant’s gut, we believe that the available data suggest that it is safe for the mother and infant to continue breastfeeding after receiving such an agent... Review of the literature shows no evidence to suggest that oral ingestion by an infant of the tiny amount of gadolinium contrast agent excreted into breast milk would cause toxic effects. -
Verg(H)Ulde Pillen – Casestudie Lumc, Leiden Verg(H)Ulde Pillen
STICHTING TOEGEPAST ONDERZOEK WATERBEHEER VERG(H)ULDE PILLEN – CASESTUDIE LUMC, LEIDEN VERG(H)ULDE PILLEN [email protected] WWW.stowa.nl TEL 030 232 11 99 FAX 030 232 17 66 CASESTUDIE LUMC, LEIDEN Arthur van Schendelstraat 816 POSTBUS 8090 35 03 RB UTRECHT 2009 RAPPORT W02 2009 W02 VERG(H)ULDE PILLEN CASESTUDIE LUMC TE LEIDEN 2009 RAPPORT W02 ISBN 978.90.5773.428.1 [email protected] WWW.stowa.nl Publicaties van de STOWA kunt u bestellen op www.stowa.nl. TEL 030 232 11 99 FAX 030 231 79 80 Deze publicatie is ook digitaal beschikbaar. Arthur van Schendelstraat 816 POSTBUS 8090 3503 RB UTRECHT STOWA 2009-W02 VERG(H)ULDE PILLEN – DEEL B LUMC – LEIDEN COLOFON Utrecht, 2009 Uitgave STOWA 2009 Arthur van Schendelstraat 816 Postbus 8090 3503 RB Utrecht Tel 030 2321199 Fax: 030 2321766 e-mail: [email protected] http://www.stowa.nl Auteur(s) dr. S.A.E. Kools dr. ir. M.W. Kuiper dr. ir. J.H. Roorda ir. J.G.M. Derksen De begeleidingscommissie was opgebouwd uit vertegenwoordigers vanuit de waterwereld en vertegenwoordigers vanuit de ziekenhuizen. Deze bestond uit de volgende personen: Harm Baten (Hoogheemraadschap van Rijnland) Pieter de Bekker (Hoogheemraadschap de Stichtse Rijnlanden) Marja Bogaards (Reinier de Graaf Gasthuis) Bart Hellings (Ministerie van VROM) Desiree Hoefnagel (Ministerie van VWS) Bert Palsma (STOWA) Ellen Parma (Milieuplatform Zorg; de helft van alle Nederlandse ziekenhuizen is hierbij aangesloten ) Percival Stubbs (Nederlandse Vereniging van Ziekenhuizen; alle Nederlandse ziekenhuizen zijn hierbij aangesloten) Ferdinand Kiestra (Waterschap Aa en Maas) Erica Mosch (Waterschap Hunze en Aa’s) Gerard Rijs (Waterdienst – Rijkswaterstaat) Esther Willems (MPZ) Peter van Zundert (Ministerie Verkeer en Waterstaat) Deze publicatie is ook digitaal beschikbaar Prepress/druk Van de Garde | Jémé STOWA Rapportnummer 2009-W02 STOWA 2009-W02 VERG(H)ULDE PILLEN – DEEL B LUMC – LEIDEN SAMENVATTING In Nederland worden 12.000 verschillende geneesmiddelen met ongeveer 850 verschillende actieve stoffen gebruikt, waarbij het geneesmiddelengebruik per inwoner jaarlijks stijgt. -
Lääkealan Turvallisuus- Ja Kehittämiskeskuksen Päätös
Lääkealan turvallisuus- ja kehittämiskeskuksen päätös N:o xxxx lääkeluettelosta Annettu Helsingissä xx päivänä maaliskuuta 2016 ————— Lääkealan turvallisuus- ja kehittämiskeskus on 10 päivänä huhtikuuta 1987 annetun lääke- lain (395/1987) 83 §:n nojalla päättänyt vahvistaa seuraavan lääkeluettelon: 1 § Lääkeaineet ovat valmisteessa suolamuodossa Luettelon tarkoitus teknisen käsiteltävyyden vuoksi. Lääkeaine ja sen suolamuoto ovat biologisesti samanarvoisia. Tämä päätös sisältää luettelon Suomessa lääk- Liitteen 1 A aineet ovat lääkeaineanalogeja ja keellisessä käytössä olevista aineista ja rohdoksis- prohormoneja. Kaikki liitteen 1 A aineet rinnaste- ta. Lääkeluettelo laaditaan ottaen huomioon lää- taan aina vaikutuksen perusteella ainoastaan lää- kelain 3 ja 5 §:n säännökset. kemääräyksellä toimitettaviin lääkkeisiin. Lääkkeellä tarkoitetaan valmistetta tai ainetta, jonka tarkoituksena on sisäisesti tai ulkoisesti 2 § käytettynä parantaa, lievittää tai ehkäistä sairautta Lääkkeitä ovat tai sen oireita ihmisessä tai eläimessä. Lääkkeeksi 1) tämän päätöksen liitteessä 1 luetellut aineet, katsotaan myös sisäisesti tai ulkoisesti käytettävä niiden suolat ja esterit; aine tai aineiden yhdistelmä, jota voidaan käyttää 2) rikoslain 44 luvun 16 §:n 1 momentissa tar- ihmisen tai eläimen elintoimintojen palauttami- koitetuista dopingaineista annetussa valtioneuvos- seksi, korjaamiseksi tai muuttamiseksi farmako- ton asetuksessa kulloinkin luetellut dopingaineet; logisen, immunologisen tai metabolisen vaikutuk- ja sen avulla taikka terveydentilan