Anticoagulant Residues in Rats and Secondary Non-Target Risk
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Enoxaparin Sodium Solution for Injection, Manufacturer's Standard
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrLOVENOX® Enoxaparin sodium solution for injection 30 mg in 0.3 mL solution (100 mg/mL), pre-filled syringes for subcutaneous or intravenous injection 40 mg in 0.4 mL solution (100 mg/mL), pre-filled syringes for subcutaneous or intravenous injection 60 mg in 0.6 mL solution (100 mg/mL), pre-filled syringes for subcutaneous or intravenous injection 80 mg in 0.8 mL solution (100 mg/mL), pre-filled syringes for subcutaneous or intravenous injection 100 mg in 1 mL solution (100 mg/mL), pre-filled syringes for subcutaneous or intravenous injection 300 mg in 3 mL solution (100 mg/mL), multidose vials for subcutaneous or intravenous injection PrLOVENOX® HP Enoxaparin sodium (High Potency) solution for injection 120 mg in 0.8 mL solution (150 mg/mL), pre-filled syringes for subcutaneous or intravenous injection 150 mg in 1 mL solution (150 mg/mL), pre-filled syringes for subcutaneous or intravenous injection Manufacturer’s standard Anticoagulant/Antithrombotic Agent ATC Code: B01AB05 Product Monograph – LOVENOX (enoxaparin) Page 1 of 113 sanofi-aventis Canada Inc. Date of Initial Approval: 2905 Place Louis-R.-Renaud February 9, 1993 Laval, Quebec H7V 0A3 Date of Revision September 7, 2021 Submission Control Number: 252514 s-a version 15.0 dated September 7, 2021 Product Monograph – LOVENOX (enoxaparin) Page 2 of 113 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS .............................................................................................................. -
Rivaroxaban Versus Warfarin for Treatment and Prevention Of
Costa et al. Thrombosis Journal (2020) 18:6 https://doi.org/10.1186/s12959-020-00219-w RESEARCH Open Access Rivaroxaban versus warfarin for treatment and prevention of recurrence of venous thromboembolism in African American patients: a retrospective cohort analysis Olivia S. Costa1,2, Stanley Thompson3, Veronica Ashton4, Michael Palladino5, Thomas J. Bunz6 and Craig I. Coleman1,2* Abstract Background: African Americans are under-represented in trials evaluating oral anticoagulants for the treatment of acute venous thromboembolism (VTE). The aim of this study was to evaluate the effectiveness and safety of rivaroxaban versus warfarin for the treatment of VTE in African Americans. Methods: We utilized Optum® De-Identified Electronic Health Record data from 11/1/2012–9/30/2018. We included African Americans experiencing an acute VTE during a hospital or emergency department visit, who received rivaroxaban or warfarin as their first oral anticoagulant within 7-days of the acute VTE event and had ≥1 provider visit in the prior 12-months. Differences in baseline characteristics between cohorts were adjusted using inverse probability-of-treatment weighting based on propensity scores (standard differences < 0.10 were achieved for all covariates). Our primary endpoint was the composite of recurrent VTE or major bleeding at 6-months. Three- and 12-month timepoints were also assessed. Secondary endpoints included recurrent VTE and major bleeding as individual endpoints. Cohort risk was compared using Cox regression and reported as hazard ratios (HRs) with 95% confidence intervals (CIs). Results: We identified 2097 rivaroxaban and 2842 warfarin users with incident VTE. At 6-months, no significant differences in the composite endpoint (HR = 0.96, 95%CI = 0.75–1.24), recurrent VTE (HR = 1.02, 95%CI = 0.76–1.36) or major bleeding alone (HR = 0.93, 95%CI = 0.59–1.47) were observed between cohorts. -
Occurrence, Elimination, and Risk of Anticoagulant Rodenticides in Wastewater and Sludge
Occurrence, elimination, and risk of anticoagulant rodenticides in wastewater and sludge Silvia Lacorte, Cristian Gómez- Canela Department of Environmental Chemistry, IDAEA-CSIC, Jordi Girona 18-26, 08034 Barcelona Rats and super-rats Neverending story 1967 Coumachlor 1 tn rodenticides /city per campaign “It will be the LAST ONE” Rodenticides Biocides: use regulated according to EU. Used mainly as bait formulations. First generation: multiple feedings, less persistent in tissues, commensal and outdoor use. Second generation: single feeding (more toxic), more persistent in tissue, commensal use only. Toxic: vitamin K antagonists that cause mortality by blocking an animal’s ability to produce several key blood clotting factors. High oral, dermal and inhalation toxicity. Origin and fate of rodenticides Study site: Catalonia (7.5 M inhabitants) 1693 km of sewage corridor 13 fluvial tanks (70.000 m3) 130,000,000 € / 8 YEARS 32,000 km2 378,742 kg/y AI 2,077,000 € Objectives 1. To develop an analytical method to determine most widely used rodenticides in wastewater and sludge. 2. To monitor the presence of rodenticides within 9 WWTP receiving urban and agricultural waters. 3. To evaluate the risk of rodenticides using Daphnia magna as aquatic toxicological model. 4. To study the accumulation of rodenticides in sludge. Compounds studied Coumachlor* Pindone C19H15ClO4 C14H14O3 Dicoumarol Warfarin C19H12O6 C19H16O4 Coumatetralyl Ferulenol FGARs C19H16O3 C24H30O3 Acenocoumarol Chlorophacinone • Solubility C19H15NO6 C23H15ClO3 0.001-128 mg/L • pKa 3.4-6.6 Flocoumafen Bromadiolone C H F O C H BrO 33 25 3 40 30 23 4 • Log P 1.92-8.5 Brodifacoum Fluindione C H BrO 31 23 3 C15H9FO2 SGARs Difenacoum Fenindione C31H24O3 C15H10O2 1. -
Wastewater-Borne Exposure of Limnic Fish to Anticoagulant Rodenticides
Water Research 167 (2019) 115090 Contents lists available at ScienceDirect Water Research journal homepage: www.elsevier.com/locate/watres Wastewater-borne exposure of limnic fish to anticoagulant rodenticides * Julia Regnery a, , Pia Parrhysius a, Robert S. Schulz a, Christel Mohlenkamp€ a, Georgia Buchmeier b, Georg Reifferscheid a, Marvin Brinke a a Department of Biochemistry, Ecotoxicology, Federal Institute of Hydrology, Am Mainzer Tor 1, 56068 Koblenz, Germany b Unit Aquatic Ecotoxicology, Microbial Ecology, Bavarian Environment Agency, Demollstr. 31, 82407 Wielenbach, Germany article info abstract Article history: The recent emergence of second-generation anticoagulant rodenticides (AR) in the aquatic environment Received 18 June 2019 emphasizes the relevance and impact of aquatic exposure pathways during rodent control. Pest control Received in revised form in municipal sewer systems of urban and suburban areas is thought to be an important emission 12 September 2019 pathway for AR to reach wastewater and municipal wastewater treatment plants (WWTP), respectively. Accepted 13 September 2019 To circumstantiate that AR will enter streams via effluent discharges and bioaccumulate in aquatic or- Available online 14 September 2019 ganisms despite very low predicted environmental emissions, we conducted a retrospective biological monitoring of fish tissue samples from different WWTP fish monitoring ponds exclusively fed by Keywords: fl Bioaccumulation municipal ef uents in Bavaria, Germany. At the same time, information about rodent control in asso- Biocides ciated sewer systems was collected by telephone survey to assess relationships between sewer baiting Monitoring and rodenticide residues in fish. In addition, mussel and fish tissue samples from several Bavarian surface PBT-Substances waters with different effluent impact were analyzed to evaluate the prevalence of anticoagulants in Sewer baiting indigenous aquatic organisms. -
Pharmacokinetics of Anticoagulant Rodenticides in Target and Non-Target Organisms Katherine Horak U.S
University of Nebraska - Lincoln DigitalCommons@University of Nebraska - Lincoln USDA National Wildlife Research Center - Staff U.S. Department of Agriculture: Animal and Plant Publications Health Inspection Service 2018 Pharmacokinetics of Anticoagulant Rodenticides in Target and Non-target Organisms Katherine Horak U.S. Department of Agriculture, [email protected] Penny M. Fisher Landcare Research Brian M. Hopkins Landcare Research Follow this and additional works at: https://digitalcommons.unl.edu/icwdm_usdanwrc Part of the Life Sciences Commons Horak, Katherine; Fisher, Penny M.; and Hopkins, Brian M., "Pharmacokinetics of Anticoagulant Rodenticides in Target and Non- target Organisms" (2018). USDA National Wildlife Research Center - Staff Publications. 2091. https://digitalcommons.unl.edu/icwdm_usdanwrc/2091 This Article is brought to you for free and open access by the U.S. Department of Agriculture: Animal and Plant Health Inspection Service at DigitalCommons@University of Nebraska - Lincoln. It has been accepted for inclusion in USDA National Wildlife Research Center - Staff ubP lications by an authorized administrator of DigitalCommons@University of Nebraska - Lincoln. Chapter 4 Pharmacokinetics of Anticoagulant Rodenticides in Target and Non-target Organisms Katherine E. Horak, Penny M. Fisher, and Brian Hopkins 1 Introduction The concentration of a compound at the site of action is a determinant of its toxicity. This principle is affected by a variety of factors including the chemical properties of the compound (pKa, lipophilicity, molecular size), receptor binding affinity, route of exposure, and physiological properties of the organism. Many compounds have to undergo chemical changes, biotransformation, into more toxic or less toxic forms. Because of all of these variables, predicting toxic effects and performing risk assess- ments of compounds based solely on dose are less accurate than those that include data on absorption, distribution, metabolism (biotransformation), and excretion of the compound. -
Some Rodenticidal Properties of Coumatetralyl
J.Hyg.,Camb. (1969), 67, 311 311 Printed in Great Britain Some rodenticidal properties of coumatetralyl BY J. H. GREAVES AND PRISCILLA AYRES Infestation Control Laboratory, Ministry of Agriculture, Fisheries and Food, Tolworth, Surrey {Received 26 September 1968) INTRODUCTION Coumatetralyl (3-(a-tetralyl)-4-hydroxycoumarin), an anti-coagulant rodenti- cide developed by Farbenfabriken Bayer A.G., has been used extensively against rats in Germany (Schultze, 1965). Comparatively little information is available, however, concerning its rodenticidal properties. The present laboratory study was therefore undertaken to investigate the toxicity of the anti-coagulant to warfarin- resistant and warfarin-susceptible rats (Rattus norvegicus Berk.) and to compare its palatability with that of warfarin (3-(<x-acetonylbenzyl)-4-hydroxycoumarin). METHODS Wild rats, presumed not to be resistant to warfarin (NR rats) were caught in a Midlands refuse destructor and on a Surrey farm. Warfarin-resistant (WR) rats were trapped on farms in three different areas of Britain: Nottinghamshire (WR Notts), Gloucestershire (WR Glos) and the Salop-Montgomeryshire area (WR Welsh). Field investigations had shown that the rats on the Nottinghamshire and Gloucestershire farms could not be controlled with warfarin. All ten WR Glos rats used in tests with coumatetralyl had first been given, and had survived, un- restricted feeding for 6 days on 0-005 % warfarin in the laboratory and similarly all but six of the 23 WR Notts rats had first been given periods of from 3 to 6 days on warfarin. The 53 WR Welsh animals had survived either 6 days feeding on 0-005 % warfarin or a single subcutaneous injection of 200 mg./kg. -
Heavy Rainfall Provokes Anticoagulant Rodenticides' Release from Baited
Journal Pre-proof Heavy rainfall provokes anticoagulant rodenticides’ release from baited sewer systems and outdoor surfaces into receiving streams Julia Regnery1,*, Robert S. Schulz1, Pia Parrhysius1, Julia Bachtin1, Marvin Brinke1, Sabine Schäfer1, Georg Reifferscheid1, Anton Friesen2 1 Department of Biochemistry, Ecotoxicology, Federal Institute of Hydrology, 56068 Koblenz, Germany 2 Section IV 1.2 Biocides, German Environment Agency, 06813 Dessau-Rosslau, Germany *Corresponding author. Email: [email protected] (J. Regnery); phone: +49 261 1306 5987 Journal Pre-proof A manuscript prepared for possible publication in: Science of the Total Environment May 2020 1 Journal Pre-proof Abstract Prevalent findings of anticoagulant rodenticide (AR) residues in liver tissue of freshwater fish recently emphasized the existence of aquatic exposure pathways. Thus, a comprehensive wastewater treatment plant and surface water monitoring campaign was conducted at two urban catchments in Germany in 2018 and 2019 to investigate potential emission sources of ARs into the aquatic environment. Over several months, the occurrence and fate of all eight ARs authorized in the European Union as well as two pharmaceutical anticoagulants was monitored in a variety of aqueous, solid, and biological environmental matrices during and after widespread sewer baiting with AR-containing bait. As a result, sewer baiting in combined sewer systems, besides outdoor rodent control at the surface, was identified as a substantial contributor of these biocidal active ingredients in the aquatic environment. In conjunction with heavy or prolonged precipitation during bait application in combined sewer systems, a direct link between sewer baiting and AR residues in wastewater treatment plant influent, effluent, and the liver of freshwater fish was established. -
Authorisation of Anticoagulant Rodenticides in Germany FAQ on Environmental Risks, Risk Mitigation Measures and Best Practice
background // december 2019 Authorisation of Anticoagulant Rodenticides in Germany FAQ on Environmental Risks, Risk Mitigation Measures and Best Practice For our environment Imprint Publisher: Image sources: German Environment Agency Front page: Fotolia/tomatito26 Section IV 1.2 Biocides Page 3: UBA/Agnes Kalle & Susanne Hein Section IV 1.4 Health Pests and their Control Page 7: Alex Yeung PO Box 14 06 Page 8: Taton Moïse/Unsplash 06813 Dessau-Roßlau Page 10: autark – Photocase Tel.: +49 340-2103-0 Page 11: UBA/Figure 1 [email protected] Page 12: Fotolia/silvioheidler/Figure A Internet: www.umweltbundesamt.de/en Page 12: Fotolia/Jolanta Mayerberg/Figure B Page 12: Fotolia/Erni/Figure C /umweltbundesamt.de Page 12: Fotolia/Hans and Crista Ede/Figure D /umweltbundesamt Page 12: Fotolia/Sergey Ryzhkov/Figure E /umweltbundesamt Page 12: Fotolia/phototrip.cz/Figure F /umweltbundesamt Page 14: Fotolia/Loveleen/Silhouette of a rat Page 17: Photocase/marsj/Mouse in building Authors: Page 17: UBA/Erik Schmolz/Bait station Juliane Fischer, Anton Friesen, Anke Geduhn, Susanne Page 17: Fotolia/SB/Rat burrow in open area Hein, Stefanie Jacob, Barbara Jahn, Agnes Kalle, Anja Page 18: Mella/Photocase Kehrer, Ingrid Nöh, Eleonora Petersohn, Caroline Page 20: Fotolia/fotocejen/Barn owl Riedhammer, Ricarda Rissel, Annika Schlötelburg, Erik Page 21: Fotolia/Stefan/Kestrel Schmolz, Beatrice Schwarz-Schulz, Christiane Stahr, Ute Page 21: Fotolia/Romuald/Stoat Trauer-Kizilelma, Kristina Wege, Stefanie Wieck Page 22: Fotolia/Valeriy Kirsanov/Red fox Page -
Sound Management of Pesticides and Diagnosis and Treatment Of
* Revision of the“IPCS - Multilevel Course on the Safe Use of Pesticides and on the Diagnosis and Treatment of Presticide Poisoning, 1994” © World Health Organization 2006 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 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. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. 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 distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. CONTENTS Preface Acknowledgement Part I. Overview 1. Introduction 1.1 Background 1.2 Objectives 2. Overview of the resource tool 2.1 Moduledescription 2.2 Training levels 2.3 Visual aids 2.4 Informationsources 3. Using the resource tool 3.1 Introduction 3.2 Training trainers 3.2.1 Organizational aspects 3.2.2 Coordinator’s preparation 3.2.3 Selection of participants 3.2.4 Before training trainers 3.2.5 Specimen module 3.3 Trainers 3.3.1 Trainer preparation 3.3.2 Selection of participants 3.3.3 Organizational aspects 3.3.4 Before a course 4. -
RRAC Guidelines on Anticoagulant Rodenticide Resistance Management Editor: Rodenticide Resistance Action Committee (RRAC) of Croplife International Aim
RRAC guidelines on Anticoagulant Rodenticide Resistance Management Editor: Rodenticide Resistance Action Committee (RRAC) of CropLife International Aim This document provides guidance to advisors, national authorities, professionals, practitioners and others on the nature of anticoagulant resistance in rodents, the identification of anticoagulant resistance, strategies for rodenticide application that will avoid the development of resistance and the management of resistance where it occurs. The Rodenticide Resistance Action Committee (RRAC) is a working group within the framework of CropLife International. Participating companies include: Bayer CropScience, BASF, LiphaTech S. A., PelGar, Rentokil Initial, Syngenta and Zapi. Senior technical specialists, with specific expertise in rodenticides, represent their companies on this committee. The RRAC is grateful to the following co-authors: Stefan Endepols, Alan Buckle, Charlie Eason, Hans-Joachim Pelz, Adrian Meyer, Philippe Berny, Kristof Baert and Colin Prescott. Photos provided by Stefan Endepols. Contents 1. Introduction ............................................................................................................................................................................................................. 2 2. Classification and history of rodenticide compounds ..............................................................................................3 3. Mode of action of anticoagulant rodenticides, resistance mechanisms, and resistance mutations ......................................................................................................6 -
Warfarin in Antiphospholipid Syndrome — Time to Explore New Horizons
Editorial Warfarin in Antiphospholipid Syndrome — Time to Explore New Horizons Antiphospholipid syndrome (APS) constitutes vascular boembolism have significant reduction in the risk of recur- thrombosis and/or pregnancy morbidity occurring in per- rent venous thrombosis when they continue to receive war- sons with antiphospholipid antibodies (aPL), most com- farin with a target international normalized ratio (INR) of monly a positive lupus anticoagulant (LAC) test, anticardi- 1.5 to 2.019. The risk of venous thromboembolism is rough- ly 10% per year whether warfarin is stopped after 3, 6, 12, olipin antibodies (aCL), and anti-ß2-glycoprotein I antibod- 1 or 27 months in aPL-negative patients with unprovoked ies (ß2-GPI) . Given the wide spectrum of aPL-related clin- ical manifestations and significant morbidity and mortality thrombosis20. due to APS2, primary and secondary thrombosis prevention Thus, no compelling data exist about the optimal dura- is crucial. Primary thrombosis prevention lacks an evidence- tion of therapy or when anticoagulation can be discontinued based approach; controlled, prospective, and randomized in APS patients. Ideally, anticoagulation should be stopped studies are in progress3,4. For secondary thrombosis preven- when the risks of treatment outweigh the risks of thrombo- tion, the current recommendation is life-long warfarin; the sis21. Currently it is not possible to predict which patients necessity, duration, and intensity of warfarin treatment are with APS will develop recurrent thrombosis when warfarin still under debate. Further, warfarin use is cumbersome due treatment is stopped, and there is no evidence for or against to bleeding complications, frequent blood monitoring, and indefinite anticoagulation in patients with APS who devel- teratogenicity. -
Warfarin I G Y H H O S I - L W T U A
Read this important information before taking: Warfarin Brought to you by the Institute for Safe Medication Practices [ Extra care is needed because warfarin is a high-alert medicine. ] High-alert medicines have been proven to be safe and effective. But these medicines can cause serious injury if a mistake happens while taking them. This means that it is very important for you to know about this medicine and take it exactly as directed. When taking warfarin (blood thinner) 1 Take exactly as directed. Take your medicine at the same time each day. Do not take extra doses or skip any doses. n i When the doctor changes your dose r a 2 Keep a record of telephone calls. f When your doctor, nurse, or pharmacist calls to r change your dose: write down the dose and any other instructions; read the dose and in - a structions back to him or her to make sure you understand them; and date the instructions W so they won’t be mixed up with older instructions. r o f 3 A D M I N Know your dose. U Always tell your doctor the strength of warfarin tablets that you have on O U M A D C O I N C s hand. Then ask him or her how much warfarin to take, and how many tablets in that strength p i to take to equal the dose. If you are running low on tablets, ask for a new prescription. T y 4 t Keep instructions nearby. Keep the dated instructions near the medicine, and read RX e f them every time before taking your warfarin.