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Low Molecular Weight Heparin Versus Acenocoumarol in the Secondary Prophylaxis of Deep Vein Thrombosis
Thromb Haemost 1999; 81: 26–31 © 1999 Schattauer Verlag, Stuttgart Low Molecular Weight Heparin versus Acenocoumarol in the Secondary Prophylaxis of Deep Vein Thrombosis S. Lopaciuk, H. Bielska-Falda1, W. Noszczyk1, M. Bielawiec 2, W. Witkiewicz 3, S. Filipecki 4, J. Michalak 5, L. Ciesielski 6, Z. Mackiewicz 7, E. Czestochowska 8, K. Zawilska 9, A. Cencora 10, among others* From the Institute of Hematology and Blood Transfusion, Warsaw, 1st 1Department of Surgery, Medical School, Warsaw, 2Department of Hematology, Medical School, Bialystok, 3Department of Vascular Surgery, District General Hospital, Wroclaw, 4Department of Internal Medicine, Institute of Tuberculosis and Lung Diseases, Warsaw, 5Department of Vascular Surgery, Medical School, Lublin, 1st 6Department of Surgery, Medical School, Lodz, 7Department of Vascular Surgery, Medical School, Bydgoszcz, 3rd 8Department of Internal Medicine, Medical School, Gdansk, 9Department of Hematology, Medical School, Poznan, and 10Department of Vascular Surgery, District General Hospital, Krakow, Poland Summary oral anticoagulant for at least 3 months (secondary prophylaxis). Al- though long-term anticoagulation with coumarin drugs, the most popu- The aim of this study was to determine the efficacy and safety of lar of which are warfarin and acenocoumarol, has been repeatedly dem- subcutaneous weight-adjusted dose low molecular weight heparin onstrated effective in the prevention of recurrent venous thromboembo- (LMWH) compared with oral anticoagulant (OA) in the prevention of lism, it suffers from a number of limitations. This treatment requires recurrent venous thromboembolism. In a prospective multicenter trial, strict laboratory control and consequent adjustments of the drug dosage 202 patients with symptomatic proximal deep vein thrombosis (DVT) and carries a substantial risk of bleeding complications (1). -
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. -
Characterising the Risk of Major Bleeding in Patients With
EU PE&PV Research Network under the Framework Service Contract (nr. EMA/2015/27/PH) Study Protocol Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU Version 3.0 1 June 2018 EU PAS Register No: 16014 EMA/2015/27/PH EUPAS16014 Version 3.0 1 June 2018 1 TABLE OF CONTENTS 1 Title ........................................................................................................................................... 5 2 Marketing authorization holder ................................................................................................. 5 3 Responsible parties ................................................................................................................... 5 4 Abstract ..................................................................................................................................... 6 5 Amendments and updates ......................................................................................................... 7 6 Milestones ................................................................................................................................. 8 7 Rationale and background ......................................................................................................... 9 8 Research question and objectives .............................................................................................. 9 9 Research methods .................................................................................................................... -
STUDY PROTOCOL Study Information Title Apixaban Drug
Apixaban B0661076NON-INTERVENTIONAL STUDY PROTOCOL Final, 15-Feb-2016 NON-INTERVENTIONAL (NI) STUDY PROTOCOL Study information Title Apixaban drug utilization study in Stroke prevention in atrial fibrillation (SPAF) Protocol number B0661076 AEMPS Code PFI-API-2016-01 Protocol version identifier 4.0 Date of last version of protocol 15-Feb-2016 Active substance Apixaban B01AF02 Medicinal product Eliquis® Research question and objectives Evaluate the apixaban utilization according to the approved SPAF indication and recommendations by EMA. The study objectives are: Objective 1: To characterise patients using apixaban according to demographics, comorbidity, risk of thromboembolic events (CHADS2 and CHA2DS2-Vasc scores), risk of bleeding events (HAS-BLED score), comedications and compare it with the profile of patients treated with VKA, dabigatran and rivaroxaban. Objective 2: Describe the level of appropriate usage according to the posology recommended in the apixaban SmPC. Objective 3: Describe the potential interactions with other drugs prescribed concomitantly according with the SmPC recommendations. Objective 4: Estimate the level of apixaban adherence by the medication possession ratio (MPR) and discontinuation rates and compare it with VKA, dabigatran and CT24-GSOP-RF03 NI Study Protocol Template; Version 3.0, Effective Date 10-Oct-2014 Pfizer Confidential Page 1 of 28 Apixaban B0661076NON-INTERVENTIONAL STUDY PROTOCOL Final, 15-Feb-2016 rivaroxaban cohort. Objective 5: To analyze INR (International Normalized Ratio) values during the last 12 months and to obtain TTR (Time in Therapeutic Range) values in patients previously treated with VKA and, during the whole study period for those in the cohort treated with VKA Author Ángeles Quijada Manuitt, IDIAP Jordi Gol Rosa Morros Pedrós, IDIAP Jordi Gol Jordi Cortés, IDIAP Jordi Gol José Chaves Puertas, Pfizer SLU Sponsor Pfizer S.L.U Avda. -
Thromboprophylaxis for Venous Thromboembolism UHL Guideline
Guidelines for Pharmacological and Mechanical Thromboprophylaxis for venous thromboembolism. Approved By: Policy and Guideline Committee Date Approved: 12 February 2016 Trust Reference: B9/2016 Version: V4 – 16 August 2019 Policy and Guideline Committee Supersedes: V3 February 2016 Author / Originator(s): Simon Rudge, Venous Thrombosis Nurse Name of Responsible Thrombosis Prevention Committee Committee/Individual: Review Date: August 2022 CONTENTS Section Page 1. Introduction 3 2. Policy Scope 5 VTE Risk Assessment and Pharmacological and Mechanical venous 3. 6 thromboprophylaxis 4. Patient information 8 5. Mechanical thromboprophylaxis. Application and management guide 9 6. Nursing care 12 7. References 12 8. Legal Liability Guideline Statement 12 Appendix 1 Derogation from NICE NG89: VTE risk assessment of 16 & 17yr olds 13 Appendix 2a/2a1/2b/2c VTE risk assessment tools 14-18 Appendix 3 NICE CG92 algorithm for VTE thromboprophylaxis in medical patients 19 Appendix 4 Consensus of risk factors for VTE in surgical patients 20 Appendix 5 UHL and East Midlands approved List of cohort Day Case procedures 21 Appendix 6 Thromboprophylaxis administration guide: Dalteparin 22 Appendix 7 Derogation from NICE NG89: minimum of 7 days low molecular weight 23 heparin for acutely unwell medical patients Appendix 8 Indications for mechanical thromboprophylaxis algorithm 24 Appendix 8a Indications for mechanical thromboprophylaxis with intermittent 25 pneumatic compression devices algorithm Appendix 9 Quick reference guide of NICE NG89 26 Summary of key changes: Addition of procedure specific recommendations from NG89. Inclusion of discharge recommendations. Inclusion of statement regarding medicines of animal origin. Inclusion of training requirements Inclusion of statements of derogation from NG89 Addition of quick reference guide of NG89. -
Hemosil ® Liquid Anti-Xa
H E M O S I L® LIQUID ANTI-XA Measuring heparin and apixaban: Simple, fast, 24/7 • Liquid formulation, ready-to-use • One-stage, chromogenic anti-Xa assay • Universal calibration for unfractionated heparin (UFH) and low molecular weight heparin (LMWH) • Drug specific calibrators and controls for measurement of apixaban Measuring heparin and apixaban Unfractionated and low molecular weight heparin Heparin is a highly sulfated polysaccharide Laboratory monitoring is extremely important to characterized by a wide molecular weight range and assess the appropriate level of anticoagulation in potent anticoagulant activity. It exists either as UFH patients receiving UFH. Anti-Xa is recommended for or as depolymerized LMWH. UFH and LMWH have measuring both UFH and LMWH. a rapid anticoagulant effect and are used in the prevention and treatment of venous thrombosis and Anti-Xa testing for measuring UFH helps improve acute coronary syndrome. quality of care and patient experience while reducing costs, when compared with APTT testing.1 UFH and LMWH anticoagulant activity occurs when The advantages include: a complex with antithrombin (AT) is formed, • Higher precision potentiating its anticoagulant activity up to • Lower levels of discordant results1,2,4 1,000-fold, which inactivates both thrombin (FIIa) • Faster time to achieve therapeutic levels1,3,4 and Factor Xa (FXa). UFH acts through both FIIa 1,3,4,5 and FXa inhibition, while LMWH is a more efficient • Fewer tests and dosage changes catalyst for FXa inhibition. Direct Xa inhibitors Anticoagulation for patients with venous DOACs do not require routine monitoring. However, thromboembolism (VTE) previously included there are specific instances when an understanding heparin, heparin derivatives and/or oral vitamin K of the DOAC concentration in a patient sample may antagonists. -
Reseptregisteret 2013–2017 the Norwegian Prescription Database
LEGEMIDDELSTATISTIKK 2018:2 Reseptregisteret 2013–2017 Tema: Legemidler og eldre The Norwegian Prescription Database 2013–2017 Topic: Drug use in the elderly Reseptregisteret 2013–2017 Tema: Legemidler og eldre The Norwegian Prescription Database 2013–2017 Topic: Drug use in the elderly Christian Berg Hege Salvesen Blix Olaug Fenne Kari Furu Vidar Hjellvik Kari Jansdotter Husabø Irene Litleskare Marit Rønning Solveig Sakshaug Randi Selmer Anne-Johanne Søgaard Sissel Torheim Utgitt av Folkehelseinstituttet/Published by Norwegian Institute of Public Health Område for Helsedata og digitalisering Avdeling for Legemiddelstatistikk Juni 2018 Tittel/Title: Legemiddelstatistikk 2018:2 Reseptregisteret 2013–2017 / The Norwegian Prescription Database 2013–2017 Forfattere/Authors: Christian Berg, redaktør/editor Hege Salvesen Blix Olaug Fenne Kari Furu Vidar Hjellvik Kari Jansdotter Husabø Irene Litleskare Marit Rønning Solveig Sakshaug Randi Selmer Anne-Johanne Søgaard Sissel Torheim Acknowledgement: Julie D. W. Johansen (English text) Bestilling/Order: Rapporten kan lastes ned som pdf på Folkehelseinstituttets nettsider: www.fhi.no The report can be downloaded from www.fhi.no Grafisk design omslag: Fete Typer Ombrekking: Houston911 Kontaktinformasjon/Contact information: Folkehelseinstituttet/Norwegian Institute of Public Health Postboks 222 Skøyen N-0213 Oslo Tel: +47 21 07 70 00 ISSN: 1890-9647 ISBN: 978-82-8082-926-9 Sitering/Citation: Berg, C (red), Reseptregisteret 2013–2017 [The Norwegian Prescription Database 2013–2017] Legemiddelstatistikk 2018:2, Oslo, Norge: Folkehelseinstituttet, 2018. Tidligere utgaver / Previous editions: 2008: Reseptregisteret 2004–2007 / The Norwegian Prescription Database 2004–2007 2009: Legemiddelstatistikk 2009:2: Reseptregisteret 2004–2008 / The Norwegian Prescription Database 2004–2008 2010: Legemiddelstatistikk 2010:2: Reseptregisteret 2005–2009. Tema: Vanedannende legemidler / The Norwegian Prescription Database 2005–2009. -
MIRADON FPO Brand of Anisindione Tablets
R 1 2 3 4 5 3 4 F-16099775 1898 ® MIRADON FPO brand of anisindione Tablets DESCRIPTION MIRADON Tablets contain a syn- thetic anticoagulant, anisindione, an indanedione derivative. Each tablet contains 50 mg anisin- dione. They also contain: corn starch, FD&C Red No. 3, gelatin, lactose, and hydrogenated cotton- seed oil. ACTIONS Like phenindione, to which it is re- lated chemically, anisindione exercises its thera- peutic action by reducing the prothrombin activity of the blood. INDICATIONS Anisindione is indicated for the prophylaxis and treatment of venous thrombosis and its extension, the treatment of atrial fibrilla- tion with embolization, the prophylaxis and treat- ment of pulmonary embolism, and as an adjunct in the treatment of coronary occlusion. CONTRAINDICATIONS All contraindications to oral anticoagulant therapy are relative rather than absolute. Contraindications should be evaluated for each patient, giving consideration to the need for and the benefits to be achieved by anticoagu- lant therapy, the potential dangers of hemor- rhage, the expected duration of therapy, and the quality of patient monitoring and compliance. Hemorrhagic Tendencies or Blood Dyscrasias: In general, oral anticoagulants are contraindi- cated in patients who are bleeding or who have hemorrhagic blood dyscrasias or hemorrhagic tendencies (eg, hemophilia, polycythemia vera, purpura, leukemia) or a history of bleeding dia- thesis. They are contraindicated in patients with recent cerebral hemorrhage, active ulceration of the gastrointestinal tract, including ulcerative colitis, or open ulcerative, traumatic, or surgical wounds. Oral anticoagulants may be contraindi- cated in patients with recent or contemplated brain, eye, or spinal cord surgery or prostatec- tomy, and in those undergoing regional or lumbar block anesthesia or continuous tube drainage of the small intestine. -
The Management of Anticoagulants Using the Chart: – Low Molecular Weight Heparins (I.E
WA Adult Anticoagulation Medication Chart Overview This presentation will provide an overview of: • The layout of the WA Anticoagulation Medication Chart (WA AMC) • The management of anticoagulants using the chart: – Low Molecular Weight Heparins (i.e. enoxaparin) – Unfractionated heparin (UFH) – Warfarin – Direct oral anticoagulants (DOACs) Anticoagulants – High Risk Medications • Anticoagulants are consistently identified as causing preventable harm to patients. • Top 20 medications involved in medication errors (July 2016 - June 2017) 1. Paracetamol 11. Buprenorphine 2. Enoxaparin 12. Targin (Oxycodone / naloxone) 3. Novorapid Insulin 13. Warfarin 4. Tramadol 14. Diazepam 5. Heparin 15. Tapentadol 6. Fentanyl 16. Metformin 7. Piperacillin & Tazobactam 17. Clonazepam 8. Oxycodone 18. Frusemide 9. Lantus Insulin 19. Hydromorphone 10. Vancomycin 20. Quetiapine • When used in error or omitted, they can cause life-threatening or fatal bleeding or thrombosis. Those most commonly prescribed anticoagulants are: –unfractionated heparin –low-molecular weight heparin (LMWH) • enoxaparin sodium (Clexane®) • dalteparin sodium (Fragmin®) and – warfarin. Direct oral anticoagulants are also available and are being prescribed more frequently: –dabigatran (Pradaxa®) –rivaroxaban (Xarelto®) –apixaban (Eliquis®). Factors that increase the potential for error and harm include: • Low margin for error – over-dose → bleeding – under-dose or omission → thrombosis • Wide variation in individual patient response – multiple indications – wide range and complexity of dosage – frequent dose adjustment/monitoring – interaction with other medicines, herbals, over-the-counter products, food and alcohol. Benefits of the WA Anticoagulant Medication Chart • Provides one chart for all anticoagulant prescriptions to reduce the risk of duplicate prescribing. • Point of care guidelines for initiation, monitoring and reversal of anticoagulants. • Enables the effective achievement of therapeutic levels. -
Dalteparin Sodium Injection) in Children with Venous Thromboembolism with Or Without Malignancies
FRAG-A001-201 (A6301094) Final Protocol Amendment 9, 18 October 2016 CLINICAL STUDY PROTOCOL A THREE MONTH PROSPECTIVE OPEN LABEL STUDY OF THERAPY WITH FRAGMIN® (DALTEPARIN SODIUM INJECTION) IN CHILDREN WITH VENOUS THROMBOEMBOLISM WITH OR WITHOUT MALIGNANCIES Compound: PN180524 Compound Name : Dalteparin Sodium Injection (Fragmin®) United States (US) Investigational New IND 79,617 Drug (IND) Number: European Clinical Trials Database 2016-000394-21 (EudraCT) #: Protocol Number: FRAG-A001-201 (A6301094) Phase: II Version #: Amendment 9 – 18 October 2016 Pfizer Inc 235 East 42nd Street New York, NY 10017 - Do Not Distribute Page 1 FRAG-A001-201 (A6301094) Final Protocol Amendment 9, 18 October 2016 Document History This amendment incorporates all revisions to date, including amendments made at the request of country health authorities, institutional review boards/ethics committees (IRBs/ECs), etc. Document Date Summary of Changes and Rationale Original Protocol June 23, 2008 Legacy Eisai Inc Protocol Protocol Amendment 1 September 04, 2008 Legacy Eisai Inc Protocol Correction to Amendment 1 January 05, 2009 Legacy Eisai Inc Protocol Protocol Amendment 2 February 20, 2009 Legacy Eisai Inc Protocol Protocol Amendment 3 September 15, 2010 Legacy Eisai Inc Protocol Protocol Amendment 4 September 01, 2011 Legacy Eisai Inc Protocol Protocol Amendment 5 April 21, 2015 Administrative changes per transition of study to Pfizer Inc from Eisai; Updating of Safety Section per Pfizer safety reporting processes and procedures, and other relevant sections per Pfizer Inc processes and procedures. Protocol Amendment 6 09 September 2015 This version was never finalized or submitted and was replaced by Amendment 7. Protocol Amendment 7 18 November 2015 Includes protocol modifications endorsed by FDA in a Type C Meeting conducted on 05 November 2015, including updating age cohort groups, inclusion of all patients with VTE and removal of the central imaging reader and Adjudication Committee. -
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. -
Oral Anticoagulants (VKA and DOAC) Guidelines for Prescribing, Monitoring and Management
Clinical Guidance Oral Anticoagulants (VKA and DOAC) Guidelines for prescribing, monitoring and management Anticoagulants are one of the classes of medicines which frequently cause harm and admission to hospital. Managing the risk associated with anticoagulants was the subject of The National Patient Safety Agency Patient Safety Alert number 18 March 2007. High risks identified with prescribing anticoagulation include: • Failure to initiate oral anticoagulant therapy where indicated • Poor documentation of reason and treatment plan at commencement of therapy • Incorrect prescribing of oral anticoagulant doses (especially loading doses) The formulary has 5 different anticoagulants to choose from. For the majority of patients, the choice of anticoagulant is guided by indication, clinician and patient choice after appropriate discussion of risks and benefits of the different options. Anticoagulation is not advisable if the risk of harm is likely to outweigh the benefits of treatment. Consideration should be given to the safety of initiating oral anticoagulants in patients with: • cognitive impairment • risk of falls/ with a history of falls, • history of bleeding, • excess alcohol intake • liver disease • impaired visual acuity The HASBLED score can be used to give an indication of the overall risk of bleeding. This scoring system has been validated in patients with atrial fibrillation (it is not validated in the VTE setting). Clinical characteristic Points awarded H Hypertension 1 A Abnormal renal and liver function (1 point each) 1 or 2 S Stroke 1 B Bleeding 1 L Labile INRs 1 E Elderly (age >65 years) 1 D Drugs or alcohol (1 point each) 1 or 2 Maximum 9 points A score of 3 or more indicates increased one year bleed risk on anticoagulation sufficient to justify caution or more regular review.