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Deliverable 5.A Interim Report on the Study Results APPENDIX 2
Deliverable 5.a Interim report on the study results APPENDIX 2: Algorithms used to identify study variables for service contract EMA/2011/38/CN ‐ PIOGLITAZONE November 28th 2012 D5.a Interim report on the study results (Appendix 2) for Service Contract EMA/2011/38/CN PIOGLITAZONE Author(s): Vera Ehrenstein (AUH‐AS) APPENDIX 2. ALGORITHMS USED TO IDENTIFY STUDY VARIABLES Algorithms for AU Database DISEASE/CONDITION ICD-8 CODE (1977-1993) ICD-10 CODE (1994-) Diabetes type 2 250.00; 250.06; 250.07; 250.09 E11.0; E11.1; E11.9 Cancer of bladder 188 C67 Haematuria N/A R31 Haematuria, unspecified B18, K70.0–K70.3, K70.9, K71, K73, Mild hepatic impairment 571, 573.01, 573.04 K74, K76.0 Moderate to severe hepatic 070.00, 070.02, 070.04, 070.06, B15.0, B16.0, B16.2, B19.0, K70.4, impairment 070.08, 573.00, 456.00–456.09 K72, K76.6, I85 Acute myocardial infarction 410 I21-I23 Acute coronary syndrome 410, 413 I20-I24 Ischemic heart disease 410-414 I20-I25 427.09, 427.10, 427.11, 427.19, Congestive heart failure I50, I11.0, I13.0,I13.2 428.99, 782.49; Acute renal failure N/A N17 Diabetic coma N/A E10.0, E11.0, E12.0,E13.0, E14.0 Diabetic acidosis N/A E10.1, E11.1, E12.1,E13.1, E14.1 F10.1-F10.9, G31.2, G62.1, G72.1, Alcoholism 291, 303, 577.10, 571.09, 571.10 I42.6, K29.2, K86.0, Z72.1 Obesity 277.99 E65-E66 D5.a Interim report on the study results (Appendix 2) for Service Contract EMA/2011/38/CN PIOGLITAZONE Author(s): Vera Ehrenstein (AUH‐AS) Algorithms for defining acute events in Denmark, ICD-10 code Event ICD-10 code I21.x, I23.x http://apps.who.int/classifications/icd10/browse/2010/en#/I21 -
Time in Therapeutic Range and Outcomes After Warfarin Initiation in Newly Diagnosed Atrial Fibrillation Patients with Renal Dysfunction
http://www.diva-portal.org This is the published version of a paper published in Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease. Citation for the original published paper (version of record): Szummer, K., Gasparini, A., Eliasson, S., Ärnlöv, J., Qureshi, A R. et al. (2017) time in therapeutic range and outcomes after warfarin initiation in newly diagnosed atrial fibrillation patients with renal dysfunction. Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, 6(3): e004925 https://doi.org/10.1161/JAHA.116.004925 Access to the published version may require subscription. N.B. When citing this work, cite the original published paper. Permanent link to this version: http://urn.kb.se/resolve?urn=urn:nbn:se:du-24516 ORIGINAL RESEARCH Time in Therapeutic Range and Outcomes After Warfarin Initiation in Newly Diagnosed Atrial Fibrillation Patients With Renal Dysfunction Karolina Szummer, MD, PhD; Alessandro Gasparini, MSc; Staffan Eliasson, MD; Johan Arnl€ ov,€ MD, PhD; Abdul Rashid Qureshi, MD, PhD; Peter Barany, MD, PhD; Marie Evans, MD, PhD; Leif Friberg, MD, PhD; Juan Jesus Carrero, PharmMed, PhD Background-—It is unknown whether renal dysfunction conveys poor anticoagulation control in warfarin-treated patients with atrial fibrillation and whether poor anticoagulation control associates with the risk of adverse outcomes in these patients. Methods and Results-—This was an observational study from the Stockholm CREatinine Measurements (SCREAM) cohort including all newly diagnosed atrial fibrillation patients initiating treatment with warfarin (n=7738) in Stockholm, Sweden, between 2006 and 2011. Estimated glomerular filtration rate (eGFR; mL/min per 1.73 m2) was calculated from serum creatinine. -
Evaluating Onco-Geriatric Scores and Medication Risks to Improve Cancer Care for Older Patients
Evaluating onco-geriatric scores and medication risks to improve cancer care for older patients Dissertation zur Erlangung des Doktorgrades (Dr. rer. nat.) der Mathematisch-Naturwissenschaftlichen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn vorgelegt von IMKE ORTLAND aus Quakenbrück Bonn 2019 Angefertigt mit Genehmigung der Mathematisch-Naturwissenschaftlichen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn. Diese Dissertation ist auf dem Hochschulschriftenserver der ULB Bonn elektronisch publiziert. https://nbn-resolving.org/urn:nbn:de:hbz:5-58042 Erstgutachter: Prof. Dr. Ulrich Jaehde Zweitgutachter: Prof. Dr. Andreas Jacobs Tag der Promotion: 28. Februar 2020 Erscheinungsjahr: 2020 Danksagung Auf dem Weg zur Promotion haben mich viele Menschen begleitet und in ganz unterschiedlicher Weise unterstützt. All diesen Menschen möchte ich an dieser Stelle ganz herzlich danken. Mein aufrichtiger Dank gilt meinem Doktorvater Prof. Dr. Ulrich Jaehde für das in mich gesetzte Vertrauen, sowie für die Überlassung dieses spannenden Dissertationsthemas. Die uneingeschränkte Unterstützung, wertvollen Diskussionen und die mitreißende Begeisterung für die Wissenschaft haben mich während aller Phasen der Dissertation stets motiviert, unterstützt und sehr viel Wertvolles gelehrt. Prof. Dr. Andreas Jacobs danke ich herzlich für die Initiierung dieses interessanten Projekts, für die stetige Begeisterung und Unterstützung, sowie für das mir entgegengebrachte Vertrauen. Die ausgezeichnete Zusammenarbeit mit dem Johanniter Krankenhaus Bonn hat ganz maßgeblich zum Gelingen dieser Arbeit beigetragen. Auch danke ich Prof. Dr. Andreas Jacobs herzlich für die Bereitschaft, das Koreferat dieser Arbeit zu übernehmen. Ebenfalls danke ich herzlich Prof. Dr. Yon-Dschun Ko für seine fortwährende Motivation und seinen Einsatz, sowie für das mir geschenkte Vertrauen, dieses Projekt am Johanniter Krankenhaus zu realisieren. Ebenfalls danke ich Prof. -
Presentazione Standard Di Powerpoint
EVALUATION OF ADHERENCE TO NEW ORAL ANTICOAGULANTS THERAPY BASED ON THERAPEUTIC SWITCHES: A DESCRIPTIVE STUDY. L. Gasperoni1, F. Ambrosini Spinella1, A.M. Resta1. 1 ASUR Marche, Territorial Pharmaceutical Service AV1, Fano, Italy Abstract number: 5PSQ-011 ATC code: B01 - Antithrombotic agents Background Regarding therapeutic adherence to new oral ITALY: the prescription of NOAC is possible from anticoagulants (NOAC), several studies [1] have shown Dabigatram July 2013 lower adherence in Dabigatran treated patients compared to Rivaroxaban and Apixaban. The NOAC Rivaroxaban October 2013 introduction has fueled the phenomenon of switch Apixaban March 2014 from vitamin K antagonists (VKA) to NOAC, and vice Edoxaban October 2016 versa, and also from NOAC to other NOAC. Purpose The aim of this descriptive study is to evaluate adherence to therapy among NOAC treated patients by basing the analysis on the therapeutic switches, ie the passages to another NOAC or VKA. Material and methods Through the informatic flow of pharmaceutical prescriptions, we extracted the NOAC prescriptions from July 2013 to June 2016 in the Area Vasta 1 of the Region. Patients who have taken Dabigatran, Rivaroxaban and Apixaban have emerged from these prescriptions (Edoxaban is excluded because it is available since October 2016). Adherent patient was that who did not switch to other anticoagulant therapy (NOAC or VKA) during the analysis period and in the following 6 months (until December 2016). Patients who had taken VKA before starting treatment with NOAC (the flow of prescriptions was investigated since January 2013) and patients who died during the analysis period or in the following 6 months were excluded from the study. -
Floods, Flood Management and Climate Change in the Netherlands Olsthoorn, A.A.; Tol, R.S.J
VU Research Portal Floods, flood management and climate change in the Netherlands Olsthoorn, A.A.; Tol, R.S.J. 2001 document version Publisher's PDF, also known as Version of record Link to publication in VU Research Portal citation for published version (APA) Olsthoorn, A. A., & Tol, R. S. J. (2001). Floods, flood management and climate change in the Netherlands. (IVM Report; No. R-01/04). Dept. of Economics and Technology. General rights Copyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright owners and it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights. • Users may download and print one copy of any publication from the public portal for the purpose of private study or research. • You may not further distribute the material or use it for any profit-making activity or commercial gain • You may freely distribute the URL identifying the publication in the public portal ? Take down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. E-mail address: [email protected] Download date: 27. Sep. 2021 Floods, flood management and climate change in The Netherlands Editors: A.A. Olsthoorn R.S.J. Tol Floods, flood management and climate change in The Netherlands Edited by A.A. Olsthoorn and R.S.J. Tol Reportnumber R-01/04 February, 2001 IVM Institute for Environmental Studies Vrije Universiteit De Boelelaan 1115 1081 HV Amsterdam The Netherlands Tel. -
Annex I Summary of Product Characteristics
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Revasc 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of Revasc contains 15 mg desirudin (INN) corresponding to approximately 270 000 antithrombin units (ATU) or 18 000 ATU per mg of desirudin with reference to the WHO Second International Standard for α-thrombin. Desirudin is a recombinant DNA product derived from yeast cells. Desirudin is a single chain polypeptide consisting of 65 amino acid residues and 3 disulphide bridges. Vials of desirudin are supplied with solvent ampoules containing pyrogen-free Mannitol Ph. Eur. in Water for injections Ph. Eur. 3. PHARMACEUTICAL FORM Powder for injection to be reconstituted prior to subcutaneous injection with 0.5 ml mannitol solvent for solution (3%) which is supplied with the product. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of deep venous thrombosis in patients undergoing elective hip and knee replacement surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adult and elderly patients The recommended dose is 15 mg twice daily. The first injection should be initiated 5 to 15 minutes before surgery but after induction of regional block anaesthesia, if used. Treatment with desirudin is then continued twice daily post-operatively for 9 to a maximum of 12 days or until the patient is fully ambulant, whichever occurs first. Currently, there is no clinical experience to support the use of desirudin beyond 12 days. Administration is by subcutaneous injection, preferably at an abdominal site. Injections should be rotated between at least four different sites. Children There is no clinical experience with desirudin in children. -
Flood-Resilient Urbanity Along the Meuse
Flood-resilient urbanity along the Meuse Safe-fail design suggestions Johnny Boers & Simon Pille - Thesis landscape Architecture 1 Flood-resilient urbanity along the Meuse June 2009 Wageningen University and Research Centre Master Landscape Architecture & Spatial Planning Major Thesis Landscape Architecture (lar 80436) Signature Date Author: J. (Johnny) Boers Bsc Signature Date Author: S.C. (Simon) Pille Bsc Signature Date Examiner Wageningen University: Prof.Dr. J. (Jusuck) Koh Signature Date Supervisor and examiner Wageningen University: Dr.Ir. I. (Ingrid) Duchhart Co-supervisor Deltares: Ir. M.Q. (Maaike) Bos © Johnny Boers & Simon Pille, Wageningen University, 2009 All rights reserved. No parts of this report may be reproduced in any form without permission from one of the authors. [email protected] - [email protected] Flood-resilient urbanity along the Meuse Safe-fail design suggestions Johnny Boers & Simon Pille - Thesis landscape Architecture 6 Preface For eight long years, we have studied landscape architecture at the will actually work. Disappointed, but not defeated, we went on in Wageningen University and Research Centre. During this period, our search for a safe urban environment. With a lot of effort and we were educated in designing new functioning and attractive regained positive energy, we were able to do so. In this thesis, you landscapes by using the existing landscape and its processes. Now, will find the result. we are able to end our study with this thesis, which will show what we have learned in this phase of our lifetime. We would never have been able to finish this thesis without some people though. Foremost we would like to thank Ingrid Duchhart, We have chosen for a thesis that focuses on water and urban our supervisor. -
Clexane® 2.000 IE – 10.000 IE / Clexane® Multidose 50.000 IE
FACHINFORMATION Clexane ® Clexane ® multidose 1. BEZEICHNUNG DER ARZNEIMITTEL Clexane multidose 100.000 I. E. (1000 mg)/ 4.2 Dosierung und Art der Anwendung 10 ml Injektionslösung und Clexane multi- Clexane 2.000 I. E. (20 mg)/0,2 ml Dosierung dose 100.000 I. E. (1000 mg)/10 ml Praxis Injektionslösung in einer Fertigspritze Prophylaxe venöser thromboembolischer Injektionslösung Clexane 2.000 I. E. (20 mg)/0,2 ml Klinik Erkrankungen bei chirurgischen Patienten Eine Durchstechflasche enthält 100.000 I. E. Injektionslösung in einer Fertigspritze mit mäßigem und hohem Risiko Clexane 2.000 I. E. (20 mg)/0,2 ml Praxis Anti-Xa-Aktivität Enoxaparin-Natrium (ent- Durch ein validiertes Risikostratifizierungs- Injektionslösung in einer Fertigspritze sprechend 1000 mg) + 150 mg Benzylal- modell kann ein individuelles Thromboem- Clexane 4.000 I. E. (40 mg)/0,4 ml kohol in 10,0 ml Wasser für Injektionszwecke. bolierisiko abgeschätzt werden. Injektionslösung in einer Fertigspritze • Bei Patienten mit mäßigem Risiko für Clexane multidose Clexane 4.000 I. E. (40 mg)/0,4 ml Klinik Thromboembolien beträgt die empfohlene Sonstiger Bestandteil mit bekannter Wir- Injektionslösung in einer Fertigspritze Dosis einmal täg lich 2.000 I. E. (20 mg) Clexane 4.000 I. E. (40 mg)/0,4 ml Praxis kung: Benzylalkohol. Enoxaparin-Natrium mittels subkutaner Injektionslösung in einer Fertigspritze Dieses Arzneimittel enthält 15 mg Benzyl- (s. c.) Injektion. Eine präoperative Gabe Clexane 6.000 I. E. (60 mg)/0,6 ml Injektions- alkohol pro 1 ml (siehe Abschnitte 4.3, 4.4 der ersten Injektion (zwei Stunden vor lösung in einer Fertigspritze und 4.8). Benzylalkohol kann allergische der Operation) von 2.000 I. -
4 Annex I Summary of Product Characteristics
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 4 1. NAME OF THE MEDICINAL PRODUCT Revasc 15 mg powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of Revasc contains 15 mg desirudin (INN) corresponding to approximately 270 000 antithrombin units (ATU) or 18 000 ATU per mg of desirudin with reference to the WHO Second International Standard for α-thrombin. Desirudin is a recombinant DNA product derived from yeast cells. Desirudin is a single chain polypeptide consisting of 65 amino acid residues and 3 disulphide bridges. Vials of desirudin are supplied with solvent ampoules containing pyrogen-free Mannitol Ph. Eur. in Water for injections Ph. Eur. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Prevention of deep venous thrombosis in patients undergoing elective hip and knee replacement surgery. 4.2 Posology and method of administration Adult and elderly patients The recommended dose is 15 mg twice daily. The first injection should be initiated 5 to 15 minutes before surgery but after induction of regional block anaesthesia, if used. Treatment with desirudin is then continued twice daily post-operatively for 9 to a maximum of 12 days or until the patient is fully ambulant, whichever occurs first. Currently, there is no clinical experience to support the use of desirudin beyond 12 days. Administration is by subcutaneous injection, preferably at an abdominal site. Injections should be rotated between at least four different sites. Children There is no clinical experience with desirudin in children. Patients with renal impairment Desirudin is contraindicated in patients with severe renal impairment (creatinine clearance of less than 30 ml/min corresponding to a serum creatinine > 2.5 mg/dl or 221 μmol/l). -
Summary of Product Characteristics
SUMMARY OF PRODUCT CHARACTERISTICS 4 1. NAME OF THE MEDICINAL PRODUCT Revasc 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of Revasc contains 15 mg desirudin (INN) corresponding to approximately 270 000 antithrombin units (ATU) or 18 000 ATU per mg of desirudin with reference to the WHO Second International Standard for α-thrombin. Desirudin is a recombinant DNA product derived from yeast cells. Desirudin is a single chain polypeptide consisting of 65 amino acid residues and 3 disulphide bridges. Vials of desirudin are supplied with solvent ampoules containing pyrogen-free Mannitol Ph. Eur. in Water for injections Ph. Eur. 3. PHARMACEUTICAL FORM Powder for injection to be reconstituted prior to subcutaneous injection with 0.5 ml mannitol solvent for solution (3%) which is supplied with the product. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of deep venous thrombosis in patients undergoing elective hip and knee replacement surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adult and elderly patients The recommended dose is 15 mg twice daily. The first injection should be initiated 5 to 15 minutes before surgery but after induction of regional block anaesthesia, if used. Treatment with desirudin is then continued twice daily post-operatively for 9 to a maximum of 12 days or until the patient is fully ambulant, whichever occurs first. Currently, there is no clinical experience to support the use of desirudin beyond 12 days. Administration is by subcutaneous injection, preferably at an abdominal site. Injections should be rotated between at least four different sites. Children There is no clinical experience with desirudin in children. -
STATIN ADHERENCE, UTILISATION, and PRESCRIBING PATTERNS Improving Effectiveness of Treatment
STATIN ADHERENCE, UTILISATION, AND PRESCRIBING PATTERNS Improving effectiveness of treatment Heli Halava TURUN YLIOPISTON JULKAISUJA – ANNALES UNIVERSITATIS TURKUENSIS Sarja - ser. D osa - tom. 1231 | Medica - Odontologica | Turku 2016 University of Turku Faculty of Medicine Department of Public Health and Department of Pharmacology, Drug Development and Therapeutics Doctoral Programme of Clinical Investigation, Turku, Finland Supervised by Professor Risto Huupponen, MD, PhD Professor Jussi Vahtera, MD, PhD Department of Pharmacology, Department of Public Health, Drug Development and Therapeutics, University of Turku and University of Turku and Finnish Institute of Occupational Health, and Unit of Clinical Pharmacology, Turku University Hospital, Turku, Finland Turku University Hospital, Turku, Finland Reviewed by Professor Reijo Laaksonen, MD, PhD Professor Morten Andersen, MD, PhD School of Medicine, University of Tampere, Centre for Pharmacoepidemiology, Tampere, Karolinska Institutet Finland Karolinska University Hospital, Stockholm, Sweden Opponent Docent, Professor h.c. Mikko Syvänne, MD, PhD, FESC Finnish Heart Association, Helsinki Finland Cover photo: Vili Halava The originality of this thesis has been checked in accordance with the University of Turku quality assurance system using the Turnitin OriginalityCheck service. ISBN 978-951-29-6500-7 (PRINT) ISBN 978-951-29-6501-4 (PDF) ISSN 0355-9483 (Print) ISSN 2343-3213 (Online) Painosalama Oy - Turku, Finland 2016 To my loved ones: Vesa, Vili, Minka, Vilma and Pihla There are things -
Analysis of Individual Case Safety Reports of Severe Cutaneous Adverse Reactions in Korea
Original Article Yonsei Med J 2019 Feb;60(2):208-215 https://doi.org/10.3349/ymj.2019.60.2.208 pISSN: 0513-5796 · eISSN: 1976-2437 Analysis of Individual Case Safety Reports of Severe Cutaneous Adverse Reactions in Korea Min-Gyu Kang1,2,3, Kyung-Hee Sohn1,4, Dong-Yoon Kang5,6, Han-Ki Park1,7, Min-Suk Yang1,8, Ju-Yeun Lee9, and Hye-Ryun Kang1,5,6,10 1Institute of Allergy and Clinical Immunology, Seoul National University Medical Research Center, Seoul; 2Department of Internal Medicine, Chungbuk National University Hospital, Cheongju; 3Regional Pharmacovigilance Center, Chungbuk National University Hospital, Cheongju; 4Department of Internal Medicine, Kyung-Hee University Hospital, Seoul; 5Regional Pharmacovigilance Center, Seoul National University Hospital, Seoul; 6Drug Safety Monitoring Center, Seoul National University Hospital, Seoul; 7Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Chilgok Hospital, Daegu; 8Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul; 9College of Pharmacy, Seoul National University, Seoul; 10Division of Allergy and Clinical Immunology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea. Purpose: Despite morbidities and fatalities, nationwide epidemiologic data for severe cutaneous adverse reactions (SCARs), in- cluding Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), are not widely available. We aimed to investigate SCAR epidemiology over the last two decades in Korea. Materials and Methods: We analyzed individual case safety reports (ICSRs) of SCARs in the Korea Adverse Event Reporting Sys- tem from 1988 to 2013. Administered drugs, demographic profiles, and causality assessment according to the World Health Orga- nization-Uppsala Monitoring Center system were analyzed.