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Subject Index
52_1107_1136_SI 16.11.2005 9:35 Uhr Seite 1107 Subject Index A – tape 264, 368, 940 α-adjustment 154 AAS, see atomic absorption spectrophotometry adrenocorticotrophic hormone (ACTH) 21 abietic acid 909, 943 adverse drug reaction 401 abrasion 174, 283 aeroallergen 391 absorption through appendage 169 – atopic eczema 391 α-acaridial 329 – avoidance 391 accident 889 aerospace 726 acebutolol hydrochloride 909 African aceclofenac 909 –ebony783 acetaldehyde 943 – mahagony 783 acetone 118, 666 – red padauk wood 783 acetylacetone 697 Agave acetylsalicylic acid 84, 909 – americana 354 Achillea millefolium (yarrow extract) 909 – tequilana 225 aciclovir 909 age 279 acid 110 agent orange 806 – black 48 (CI 65005) 909 AGEP 404 – dye 689 Agfa TSS 355 – halogenated 259 aggravation 204 –hydrochloric261 agricultural worker 272 –nitric261 agriculture 725 –red AICD, see activation-induced cell death – – 14 (azorubine) 909 airborne – – 118 (CI 26410) 909 – allergic contact dermatitis 218, 228, 315, 467, 477, 484, 598, ––359909 627, 654, 788 – violet 17 (CI 42650) 909 – contact urticaria 753, 758 – yellow – irritant contact dermatitis 625 – – 36 (CI 13065, metanil yellow) 909 aircraft manufacture 560 – – 61 (CI 18968) 909 airway symptom 520 acitretin 341 alachlor 953 acneiform alantolactone 55, 789, 909, 954 – folliculitis 229 alclometasone-17,21-dipropionate 909 –lesion265 alclometasone-17-propionate 58 acrodermatitis enteropathica 241 alcohol, see also ethyl 909 acrovesicular dermatitis 401 aldehyde 110, 607, 886 acrylamide 592, 944 algicide 562 acrylate -
List of Union Reference Dates A
Active substance name (INN) EU DLP BfArM / BAH DLP yearly PSUR 6-month-PSUR yearly PSUR bis DLP (List of Union PSUR Submission Reference Dates and Frequency (List of Union Frequency of Reference Dates and submission of Periodic Frequency of submission of Safety Update Reports, Periodic Safety Update 30 Nov. 2012) Reports, 30 Nov. -
Guideline on Core Smpc and Package Leaflet for Gadoteric Acid EMA/CHMP/337820/2016 Page 2/23
1 26 May 2016 2 EMA/CHMP/337820/2016 3 Committee for Medicinal Products for Human Use (CHMP) 4 Guideline on core SmPC and Package Leaflet for gadoteric 5 acid 6 Draft Draft agreed by Radiopharmaceutical Drafting Group April 2016 Adopted by CHMP for release for consultation 26 May 2016 Start of public consultation 1 June 2016 End of consultation (deadline for comments) 30 September 2016 7 Comments should be provided using this template. The completed comments form should be sent to [email protected]. 8 Keywords Magnetic resonance, contrast media, gadolinium compounds, core SmPC, core Package Leaflet, gadoteric acid 9 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. 10 Guideline on core SmPC and Package Leaflet for gadoteric 11 acid 12 Table of contents 13 Executive summary ..................................................................................... 3 14 1. Introduction (background) ...................................................................... 3 15 2. Scope....................................................................................................... 3 16 3. Legal basis .............................................................................................. 3 17 4. Core SmPC and Package Leaflet for gadoteric acid ................................. -
Drug-Induced Anaphylaxis in China: a 10 Year Retrospective Analysis of The
Int J Clin Pharm DOI 10.1007/s11096-017-0535-2 RESEARCH ARTICLE Drug‑induced anaphylaxis in China: a 10 year retrospective analysis of the Beijing Pharmacovigilance Database Ying Zhao1,2,3 · Shusen Sun4 · Xiaotong Li1,3 · Xiang Ma1 · Huilin Tang5 · Lulu Sun2 · Suodi Zhai1 · Tiansheng Wang1,3,6 Received: 9 May 2017 / Accepted: 19 September 2017 © The Author(s) 2017. This article is an open access publication Abstract Background Few studies on the causes of (50.1%), mucocutaneous (47.4%), and gastrointestinal symp- drug-induced anaphylaxis (DIA) in the hospital setting are toms (31.3%). A total of 249 diferent drugs were involved. available. Objective We aimed to use the Beijing Pharma- DIAs were mainly caused by antibiotics (39.3%), traditional covigilance Database (BPD) to identify the causes of DIA Chinese medicines (TCM) (11.9%), radiocontrast agents in Beijing, China. Setting Anaphylactic case reports from (11.9%), and antineoplastic agents (10.3%). Cephalospor- the BPD provided by the Beijing Center for Adverse Drug ins accounted for majority (34.5%) of antibiotic-induced Reaction Monitoring. Method DIA cases collected by the anaphylaxis, followed by fuoroquinolones (29.6%), beta- BPD from January 2004 to December 2014 were adjudi- lactam/beta-lactamase inhibitors (15.4%) and penicillins cated. Cases were analyzed for demographics, causative (7.9%). Blood products and biological agents (3.1%), and drugs and route of administration, and clinical signs and plasma substitutes (2.1%) were also important contributors outcomes. Main outcome measure Drugs implicated in DIAs to DIAs. Conclusion A variety of drug classes were impli- were identifed and the signs and symptoms of the DIA cases cated in DIAs. -
Local Anesthetics
Local Anesthetics Introduction and History Cocaine is a naturally occurring compound indigenous to the Andes Mountains, West Indies, and Java. It was the first anesthetic to be discovered and is the only naturally occurring local anesthetic; all others are synthetically derived. Cocaine was introduced into Europe in the 1800s following its isolation from coca beans. Sigmund Freud, the noted Austrian psychoanalyst, used cocaine on his patients and became addicted through self-experimentation. In the latter half of the 1800s, interest in the drug became widespread, and many of cocaine's pharmacologic actions and adverse effects were elucidated during this time. In the 1880s, Koller introduced cocaine to the field of ophthalmology, and Hall introduced it to dentistry Overwiev Local anesthetics (LAs) are drugs that block the sensation of pain in the region where they are administered. LAs act by reversibly blocking the sodium channels of nerve fibers, thereby inhibiting the conduction of nerve impulses. Nerve fibers which carry pain sensation have the smallest diameter and are the first to be blocked by LAs. Loss of motor function and sensation of touch and pressure follow, depending on the duration of action and dose of the LA used. LAs can be infiltrated into skin/subcutaneous tissues to achieve local anesthesia or into the epidural/subarachnoid space to achieve regional anesthesia (e.g., spinal anesthesia, epidural anesthesia, etc.). Some LAs (lidocaine, prilocaine, tetracaine) are effective on topical application and are used before minor invasive procedures (venipuncture, bladder catheterization, endoscopy/laryngoscopy). LAs are divided into two groups based on their chemical structure. The amide group (lidocaine, prilocaine, mepivacaine, etc.) is safer and, hence, more commonly used in clinical practice. -
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 -
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. -
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 . -
Local Anesthetics – Substances with Multiple Application in Medicine
ISSN 2411-958X (Print) European Journal of January-April 2016 ISSN 2411-4138 (Online) Interdisciplinary Studies Volume 2, Issue 1 Local Anesthetics – Substances with Multiple Application in Medicine Rodica SÎRBU Ovidius University of Constanta, Faculty of Pharmacy, Campus Corp B, University Alley No. 1, Constanta, Romania Emin CADAR UMF Carol Davila Bucharest, Faculty of Pharmacy, Str. Traian Vuia No. 6, Sector 2, Bucharest, Romania Cezar Laurențiu TOMESCU Ovidius University of Constanta, Faculty of Medicine, Campus Corp B, University Alley No. 1, Constanta, Romania Cristina-Luiza ERIMIA Corresponding author, [email protected] Ovidius University of Constanta, Faculty of Pharmacy, Campus Corp B, University Alley No. 1, Constanta, Romania Stelian PARIS Ovidius University of Constanta, Faculty of Pharmacy, Campus Corp B, University Alley No. 1, Constanta, Romania Aneta TOMESCU Ovidius University of Constanta, Faculty of Medicine, Campus Corp B, University Alley No. 1, Constanta, Romania Abstract Local anesthetics are substances which, by local action groups on the runners, cause loss of reversible a painful sensation, delimited corresponding to the application. They allow small surgery, short in duration and the endoscopic maneuvers. May be useful in soothe teething pain of short duration and in the locking of the nervous disorders in medical care. Local anesthesia is a process useful for the carrying out of surgery and of endoscopic maneuvers, to soothe teething pain in certain conditions, for depriving the temporary structures peripheral nervous control. Reversible locking of the transmission nociceptive, the set of the vegetative and with a local anesthetic at the level of the innervations peripheral nerve, roots and runners, a trunk nervous, around the components of a ganglion or coolant is cefalorahidian practice anesthesia loco-regional. -
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. -
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 -
PRESCRIBING INFORMATION CLARISCAN™ – Gadoteric Acid Please Refer to Full National Summary of Product Characteristics (Smpc) Before Prescribing
PRESCRIBING INFORMATION CLARISCAN™ – gadoteric acid Please refer to full national Summary of Product Characteristics (SmPC) before prescribing. Further information available on request. PRESENTATION Clariscan 0.5 mmol/mL solution for injection. Solution for injection containing 279.3 mg/ml gadoteric acid (as gadoterate meglumine) equivalent to 0.5 mmol/mL. INDICATIONS For diagnostic use only. Clariscan should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI). Contrast agent for contrast enhancement in MRI for a better visualisation/delineation. Adult and paediatric population (0-18 years): lesions of the brain, spine, and surrounding tissues. Adults and children over 6 months Whole body MRI. Non-coronary angiography in adults only. DOSAGE AND METHOD OF ADMINISTRATION This medicinal product should only be administered by trained healthcare professionals with technical expertise in performing and interpreting gadolinium enhanced MRI. The lowest dose that provides sufficient enhancement for diagnostic purposes should be used. The dose should be calculated based on the patient’s body weight, and should not exceed the recommended dose per kilogram of body weight detailed in this section. MRI of brain and spine: Adults: The recommended dose is 0.1 mmol/kg BW, i.e. 0.2 mL/kg BW. In patients with brain tumours, an additional dose of 0.2 mmol/kg BW, i.e. 0.4 mL/kg BW, may improve tumor characterisation and facilitate therapeutic decision making. Children (0-18 years): The recommended and maximum dose of Clariscan is 0.1 mmol/kg body weight. Do not use more than one dose during a scan.