Pharmacoepidemiological Profile and Polypharmacy Indicators in Elderly Outpatients
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Side Effects of Labor Market Policies
DISCUSSION PAPER SERIES IZA DP No. 13846 Side Effects of Labor Market Policies Marco Caliendo Robert Mahlstedt Gerard J. van den Berg Johan Vikström NOVEMBER 2020 DISCUSSION PAPER SERIES IZA DP No. 13846 Side Effects of Labor Market Policies Marco Caliendo University of Potsdam, IZA, DIW and IAB Robert Mahlstedt University of Copenhagen and IZA Gerard J. van den Berg University of Bristol, University of Groningen, IFAU, IZA, ZEW, CEPR, CESifo and UCLS Johan Vikström IFAU, Uppsala University and UCLS NOVEMBER 2020 Any opinions expressed in this paper are those of the author(s) and not those of IZA. Research published in this series may include views on policy, but IZA takes no institutional policy positions. The IZA research network is committed to the IZA Guiding Principles of Research Integrity. The IZA Institute of Labor Economics is an independent economic research institute that conducts research in labor economics and offers evidence-based policy advice on labor market issues. Supported by the Deutsche Post Foundation, IZA runs the world’s largest network of economists, whose research aims to provide answers to the global labor market challenges of our time. Our key objective is to build bridges between academic research, policymakers and society. IZA Discussion Papers often represent preliminary work and are circulated to encourage discussion. Citation of such a paper should account for its provisional character. A revised version may be available directly from the author. ISSN: 2365-9793 IZA – Institute of Labor Economics Schaumburg-Lippe-Straße 5–9 Phone: +49-228-3894-0 53113 Bonn, Germany Email: [email protected] www.iza.org IZA DP No. -
Summary of Product Characteristics
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT *IPERTEN/ARTEDIL/MANYPER 10mg tablets IPERTEN/ARTEDIL/MANYPER 20mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION IPERTEN/ARTEDIL/MANYPER 10 mg tablets Each tablet contains: Manidipine hydrochloride 10mg Excipient with known effect: 119,61 mg lactose monohydrate/tablet IPERTEN/ARTEDIL/MANYPER 20 mg tablets Each tablet contains: Manidipine hydrochloride 20mg Excipient with known effect: 131,80 mg lactose monohydrate/tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet IPERTEN/ARTEDIL/MANYPER 10mg: pale yellow, round, scored tablet; IPERTEN/ARTEDIL/MANYPER 20mg: yellow-orange, oblong, scored tablet. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Mild to moderate essential hypertension 4.2 Posology and method of administration The recommended starting dose is 10 mg once a day. Should the antihypertensive effect be still insufficient after 2-4 weeks of treatment, it is advisable to increase the dosage to the usual maintenance dose of 20 mg once a day. Elderly In view of the slowing down of metabolism in the elderly, the recommended dose is 10mg once daily. This dosage is sufficient in most elderly patients; the risk/benefit of any dose increase should be considered with caution on an individual basis. Renal impairment In patients with mild to moderate renal dysfunction care should be taken when increasing the dosage from 10 to 20mg once a day. Hepatic impairment Due to the extensive hepatic metabolisation of manidipine, patients with mild hepatic dysfunction should not exceed 10mg once a day (see also Section 4.3 Contraindications). Tablet must be swallowed in the morning after breakfast, without chewing it, with a few liquid. -
The Repurposing Drugs in Oncology Database
ReDO_DB: the repurposing drugs in oncology database Pan Pantziarka1,2, Ciska Verbaanderd1,3, Vidula Sukhatme4, Rica Capistrano I1, Sergio Crispino1, Bishal Gyawali1,5, Ilse Rooman1,6, An MT Van Nuffel1, Lydie Meheus1, Vikas P Sukhatme4,7 and Gauthier Bouche1 1The Anticancer Fund, Brussels, 1853 Strombeek-Bever, Belgium 2The George Pantziarka TP53 Trust, London, UK 3Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium 4GlobalCures Inc., Newton, MA 02459 USA 5Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02115 USA 6Oncology Research Centre, Vrije Universiteit Brussel, Brussels, Belgium 7Emory University School of Medicine, Atlanta, GA 30322 USA Correspondence to: Pan Pantziarka. Email: [email protected] Abstract Repurposing is a drug development strategy that seeks to use existing medications for new indications. In oncology, there is an increased level of activity looking at the use of non-cancer drugs as possible cancer treatments. The Repurposing Drugs in Oncology (ReDO) project has used a literature-based approach to identify licensed non-cancer drugs with published evidence of anticancer activity. Data from 268 drugs have been included in a database (ReDO_DB) developed by the ReDO project. Summary results are outlined and an assessment Research of clinical trial activity also described. The database has been made available as an online open-access resource (http://www.redo-project. org/db/). Keywords: drug repurposing, repositioning, ReDO project, cancer drugs, online database Published: 06/12/2018 Received: 27/09/2018 ecancer 2018, 12:886 https://doi.org/10.3332/ecancer.2018.886 Copyright: © the authors; licensee ecancermedicalscience. -
Welfare Effects of Physician-Industry Interactions: Evidence from Patent
Welfare Effects of Physician-industry Interactions: Evidence From Patent Expiration (PRELIMINARY — do not cite without permission) Aaron Chatterji∗, Matthew Grennany, Kyle Myersz, Ashley Swansony December 29, 2017 Abstract Many transactions occur via expert advisors, especially in the healthcare sector, and as such, firms frequently implement strategies to influence these advisors. The effi- ciency of these interactions is an empirical question. Using data on physician-industry interactions and prescribing behavior during the entry of a major generic statin drug, we examine the causal effect and welfare implications of the most common type of interaction: meals. Guided by a theoretical model of endogenous meals, we develop an instrumental variables identification strategy and document reduced form evidence that these meals directly influence prescribing decisions. We find a significant degree of negative selection and primarily extensive margin effects, whereby firms target small meals to prescribers with an otherwise low propensity to use the target drug. Given this evidence, we estimate a structural model of drug choice that allows us to predict counterfactual outcomes in a world where these meals are banned. Results from these counterfactuals are in line with theoretical predictions that these interactions can offset efficiency losses due to pricing with market power. However, this offset does not appear large enough to justify their existence in this particular market. ∗Duke University, The Fuqua School & NBER yUniversity of Pennsylvania, The Wharton School & NBER zNBER Please direct correspondence to [email protected]. The data used in this paper were generously provided, in part, by the Kyruus, Inc. We gratefully acknowledge financial support from the Wharton Dean’s Research Fund, Mack Institute, and Public Policy Initiative. -
Diplomarbeit/Diploma Thesis
DIPLOMARBEIT/DIPLOMA THESIS Titel der Diplomarbeit / Title of the Diploma Thesis “An evaluation of the accuracy of drug – related InChI & InChIKey on ChemSpider, DrugBank, PharmXplorer, PubChem and Wikipedia“ verfasst von / submitted by Joachim Tscherny angestrebter akademischer Grad / in partial fulfilment of the requirements for the degree of Magister der Pharmazie (Mag.pharm.) Wien, 2018 / Vienna, 2018 Studienkennzahl lt. Studienblatt / A 449 degree programme code as it appears on the student record sheet: Studienrichtung lt. Studienblatt / Diplomstudium Pharmazie degree programme as it appears on the student record sheet: Betreut von / Supervisor: Univ.-Prof. Mag. Dr. Gerhard Ecker II Acknowledgments Foremost, I would like to thank my supervisor Gerhard Ecker for the opportunity for realizing this project. Through these thesis, I was able to expand my knowledge extensively. Furthermore, I would like to thank Daniela Digles, who especially supported me at the beginning of my work with the Knime Analytics Platform. I would also like to express my gratitude to Norbert Haider, who provided the data from PharmXplorer. I would like to express my appreciation to the developers of the KNIME Analytical Platform – I could not have carried out the type of computational work without access to this software. I would like to take this opportunity to thank my family, especially Mom, Dad and my sister Katharina, for the continuous and unconditional support they have given me throughout my duration of study. And finally, I extend my personal gratitude to Martina for all the love, patience, and guidance she has given me during the last years. “lucundi acti labores” (Marcus Tullius Cicero, Brutus 70) III IV Abstract Freely available online resources such as ChemSpider, DrugBank, PubChem, and Wikipedia are widely used for obtaining information on drugs. -
1.5Mg Prolonged-Release Tablets Indapamide
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT /…/ 1.5 mg Prolonged-release Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 1.5 mg of indapamide. Excipient with known effect: 144.22 mg of lactose monohydrate/prolonged-release tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet White to off white, round, biconvex prolonged-release film-coated tablets. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Essential hypertension. 4.2 Posology and method of administration Posology One tablet per 24 hours, preferably in the morning, to be swallowed whole with water and not chewed. At higher doses the antihypertensive action of indapamide is not enhanced but the saluretic effect is increased. Renal failure (see sections 4.3 and 4.4) In severe renal failure (creatinine clearance below 30 ml/min), treatment is contraindicated. Thiazide and related diuretics are fully effective only when renal function is normal or only minimally impaired. Elderly (see section 4.4) In the elderly, this plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated with /…/ 1.5 mg Prolonged-release Tablets when renal function is normal or only minimally impaired. Patients with hepatic impairment (see sections 4.3 and 4.4) In severe hepatic impairment, treatment is contraindicated. Children and adolescents: /…/ 1.5 mg Prolonged-release Tablets are not recommended for use in children and adolescents due to a lack of data on safety and efficacy. Method of administration For oral administration. 4.3 Contraindications - Hypersensitivity to indapamide, other sulfonamides or to any of the excipients listed in section 6.1. -
Investigations Into the Role of Nitric Oxide in Disease
INVESTIGATIONS INTO THE ROLE OF NITRIC OXIDE IN CARDIOVASCULAR DEVXLOPMENT DISEASE: INSIGHTS GAINED FROM GENETICALLY ENGINEERED MOUSE MODELS OF HUMAN DISEASE Tony Lee A thesis submitted in conformity with the requirements for the degree of Master's of Science Institute of Medicai Science University of Toronto @ Copyright by Tony C. Lee (2000) National Library Bibliothèque nationale I*I of Canada du Canada Acquisitions and Acquisitions et Bibliogaphic Services services bibliogaphiques 395 Wellington Street 395, rue Wellington Ottawa ON K1A ON4 Ottawa ON KIA ON4 Canada Canada The author has granted a non- L'auteur a accordé une licence non exclusive licence allowing the exclusive permettant à la National Library of Canada to Bibliothèque nationale du Canada de reproduce, loan, distribute or sell reproduire, prêter, distribuer ou copies of this thesis in microfonn, vendre des copies de cette thèse sous paper or electronic formats. la forme de microfiche/nlm, de reproduction sur papier ou sur format électronique. The author retains ownership of the L'auteur conserve la propriété du copyright in this thesis. Neither the droit d'auteur qui protège cette thèse. thesis nor substantial extracts fkom it Ni la thèse ni des extraits substantiels may be printed or othewise de celle-ci ne doivent être imprimés reproduced without the author's ou autrement reproduits sans son permission. autorisation. INVESTIGATIONS INTO THE ROLE OF MTNC OXIDE IN CARDIOVASCULAR DEVELOPMENT AND DISEASE: INSIGHTS GAiNED FROM GENETICALLY ENGINEERED MOUSE MODELS OF HUMAN DISEASE B y Tony Lee A thesis submitted in conformity with the requirements for the degree of Master's of Science (2000) Instinite of Medical Science, University of Toronto In the first expenmental series, the antiatherosclerotic effects of Enalûpril vrrsus Irbesartan were compared in the LDL-R knockout mouse model. -
Public Assessment Report Scientific Discussion Normodiab Tablets 80 Mg Gliclazide IS/H/0145/001/DC
Public Assessment Report Scientific discussion Normodiab tablets 80 mg Gliclazide IS/H/0145/001/DC This module reflects the scientific discussion for the approval of Nemodiab. The procedure was finalised at 13 December 2009. For information on changes after this date please refer to the module ‘Update’. I. INTRODUCTION Based on the review of the quality, safety and efficacy data, the Member States have granted a marketing authorisation for Normodiab tablets 80 mg from Actavis. The product is indicated for non- insulin dependent diabetes mellitus. A comprehensive description of the indications and posology is given in the SmPC. The marketing authorisation has been granted pursuant to Article 10(1) of Directive 2001/83/EC. Gliclazide is a second-generation sulphonylurea compound that is used in the treatment of non- Insulin-Dependent Diabetes Mellitus (NIDDM) where dietary regulation is insufficient. The primary effect of sulphonylurea-like drugs is to potentiate glucose-stimulated insulin release from functioning pancreatic islet-ß-cells by induction of a decrease in potassium efflux from these cells. ATC code: A 10 BB 09. Gliclazide is indicated for the treatment of non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose. No discussions were held with CMDh during the procedure. II. QUALITY ASPECTS II.1 Introduction The drug product is a conventional tablet with 80 mg of the active substance gliclazide. The tablets are white, flat, round, bevelled-edged and with score on both faces. The tablet diameter is 8.0 mm and "GZ" is engraved in either side of a central break line on one face. -
Summary of Product Characteristics
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Isalok 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 23.75 mg metoprolol succinate equivalent to 25 mg metoprolol tartrate. 47.5 mg metoprolol succinate equivalent to 50 mg metoprolol tartrate. 95 mg metoprolol succinate equivalent to 100 mg metoprolol tartrate. 190 mg metoprolol succinate equivalent to 200 mg metoprolol tartrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet Metoprolol succinate, 23.75 mg, prolonged release tablet is a white, oval biconvex, film- coated tablet, approx. 9 by 5 mm, scored on both sides. Metoprolol succinate 47.5 mg, prolonged release tablet is a white, oval biconvex film- coated tablet, approx. 11 by 6 mm, scored on both sides. Metoprolol succinate 95 mg, prolonged release tablet is a white, oval biconvex, film- coated tablet, approx. 16 by 8 mm, scored on both sides. Metoprolol succinate 190 mg, prolonged release tablet is a white, oval biconvex, film- coated tablet, approx. 19 by 10 mm scored on both sides. The tablets can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications – Hypertension – Angina pectoris – Heart arrhythmia, particularly supraventricular tachycardia – Prophylactic treatment to prevent cardiac death and re-infarction following the acute phase of a myocardial infarction – Palpitations due to functional cardiac disorders – Prophylaxis of migraine – Stable symptomatic heart failure (NYHA II-IV, left ventricular ejection fraction < 40 %), combined with other therapies for heart failure (see section 5.1). 4.2 Posology and method of administration Metoprolol succinate tablets should be taken once daily in the morning. -
Adherence to Risk Management Guidelines for Drugs Which Cause Vitamin D Deficiency – Big Data from the Swedish Health System
Journal name: Drug, Healthcare and Patient Safety Article Designation: Original Research Year: 2019 Volume: 11 Drug, Healthcare and Patient Safety Dovepress Running head verso: Nordqvist et al Running head recto: Nordqvist et al open access to scientific and medical research DOI: http://dx.doi.org/10.2147/DHPS.S188187 Open Access Full Text Article ORIGINAL RESEARCH Adherence to risk management guidelines for drugs which cause vitamin D deficiency – big data from the Swedish health system Ola Nordqvist1,2 Purpose: Several medications are known to cause vitamin D deficiency. The aim of this study Ulrika Lönnbom Svensson3 is to describe vitamin D testing and supplementation in patients using these “risk medications”, Lars Brudin4,5 thereby assessing adherence to medical guidelines. Pär Wanby2,6 Patients and methods: A database with electronic health records for the population in a ≈ Martin Carlsson2,7 Swedish County ( 240,000 inhabitants) was screened for patients prescribed the pre-defined “risk medications” during a 2-year period (2014–2015). In total, 12,194 patients were prescribed 1 The Pharmaceutical Department, “risk medications” pertaining to one of the three included pharmaceutical groups. Vitamin D Region Kalmar County, Kalmar, Sweden; 2eHealth Institute, Data testing and concomitant vitamin D supplementation, including differences between the included Intensive Sciences and Applications pharmaceutical groups, was explored by matching personal identification numbers. (DISA), Department of Medicine For personal use only. and Optometry, Linnaeus University, Results: Corticosteroids were prescribed to 10,003 of the patients, antiepileptic drugs to 1,101, Kalmar, Sweden; 3Department of and drugs mainly reducing vitamin D uptake to 864. Two hundred twenty-six patients were Chemistry and Biomedical Sciences, prescribed >1 “risk medication”. -
Study Protocol
Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Study Title Healthy Adults NCT Number NCT03828149 Document Description Clinical Protocol, Version: V04_0 Document Date 08 Jan 2019 TRIAL PROTOCOL EVALUATION OF SAFETY AND PHARMACODYNAMICS OF OP0201 COMPARED TO PLACEBO IN HEALTHY ADULTS Novus Therapeutics, Inc. xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 19900 MacArthur Blvd., Suite 550 xxxxxxxxxxxxxxxxxxxxxxxxxxxxx Irvine, California 92612, U.S.A. xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx (Sponsor) xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx represented by xxxxxxxxxxxxxxxxxxxxxxxxxxx University of Cologne xxxxxxxxxxxxxxxxxxx Albertus-Magnus-Platz xxxxxxxxxxxxx 50923 Cologne Germany xxxxxxx (EU Sponsor Representative) Novus TherapeuticsTrial Protocol Code: OP0201-C001 University of Cologne Internal Trial Protocol Code: Uni-Koeln-2809 EudraCT number: 2016-003667-19 08-01-2018, Version V04_0 The information in this trial protocol is strictly confidential. It is for the use of the Sponsor, investigator, trial personnel, ethics committee, the authorities, and trial subjects only. This trial protocol may not be passed on to third parties without the express agreement of the Sponsor or the Principal Coordinating Investigator (PCI, “Leiter der klinischen Prüfung (LKP)”). Trial protocol V04_0 of 08-01-2018 Novus Therapeutics, Inc. by University of Cologne OP0201-C001 Page 2 of 66 I. Signatures xxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Signature Date xxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxx -
Prescribing Information
LAMICTAL Lamotrigine QUALITATIVE AND QUANTITATIVE COMPOSITION LAMICTAL Tablets: Each film-coated tablet contains 25, 50 and 100 mg lamotrigine. LAMICTAL Dispersible/Chewable Tablets: Each tablet contains 5 mg lamotrigine, which may be chewed, dispersed in a liquid or swallowed whole. CLINICAL INFORMATION Indications EPILEPSY • Adults and Adolescents (over 12 years of age) LAMICTAL is indicated for use as adjunctive or monotherapy in the treatment of epilepsy, for partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome. • Children (2 to 12 years of age) LAMICTAL is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome. Initial monotherapy treatment in newly diagnosed paediatric patients is not recommended. After epileptic control has been achieved during adjunctive therapy, concomitant anti- epileptic drugs (AEDs) may be withdrawn and patients continued on LAMICTAL monotherapy. LAMICTAL 2 mg dispersible/chewable tablet is not available locally. If the calculated dose in children is less than 2.5 mg daily, then LAMICTAL cannot be used. DO NOT attempt to administer partial quantities of the dispersible/chewable tablets. BIPOLAR DISORDER • Adults (18 years of age and over) 1 LAMICTAL is indicated for the prevention of depressive episodes in patients with bipolar disorder. Safety and efficacy of LAMICTAL in the acute treatment of mood episodes has not been established. The physician who elects to use LAMICTAL for periods extending beyond 18 months should periodically re-evaluate the long-term usefulness of the drug for the individual patient.