DOCSLIB.ORG

Medication of Adults in Germany Results of the German Health Interview and Examination Survey for Adults (DEGS1)

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Medication of Adults in Germany Results of the German Health Interview and Examination Survey for Adults (DEGS1) Main topic English version of “Arzneimittelanwendung H. Knopf · D. Grams von Erwachsenen in Deutschland. Ergebnisse Department of Epidemiology and Health Monitoring, Robert Koch Institute, Berlin der Studie zur Gesundheit Erwachsener in Deutschland (DEGS1)” Bundesgesundheitsbl 2013 · 56:868–877 DOI 10.1007/s00103-013-1667-8 © Springer-Verlag Berlin Heidelberg 2013 Medication of adults in Germany Results of the German Health Interview and Examination Survey for Adults (DEGS1) Background and purpose users, they also result in unnecessary costs supplements in association with sociode- within the health system and for the in- mographic and socioeconomic parame- Medication is an essential pillar in the pre- dividuals. To estimate the use of medici- ters stratified by self-medication and pre- vention and therapy of illnesses. Detailed nal products, it is of decisive importance scribed medication. knowledge of medication at population to include the entire spectrum of drugs in level is indispensable for estimating mor- the observation. The data provided by the Materials and methods bidity and the related health care needs for health insurance funds can only reflect the population, and thus of great relevance the segment of medication prescribed by The German Health Interview and Exam- for public health [1]. Information on the a physician and reimbursed by the insur- ination Survey for Adults (“Studie zur Ge- use of medicine is also interesting in terms ance funds but information on prepara- sundheit Erwachsener in Deutschland”, of health economics. Roughly 17% of the tions used for self-medication cannot be DEGS) is part of the health monitoring expenditure of the statutory health insur- derived from this data. system at the Robert Koch Institute (RKI). ance funds went towards medication ther- A further restriction when assessing The concept and design of DEGS are de- apies in 2010 [2]. It should be noted that medication via prescription data is that scribed in detail elsewhere [14, 16, 17, 18]. in addition to the therapeutic effect, me- actual consumption cannot be derived The first wave (DEGS1) was conduct- dicinal products can also cause adverse ef- directly from the available data. Patient ed from 2008–2011 and comprised inter- fects which can impair or even endanger compliance with and adherence to the views, examinations and tests [19, 20]. The the health of users to a greater or lesser prescribed medication is decisive of what target population comprises the residents extent. In particular, the simultaneous use is actually consumed [11, 12, 13]. Against of Germany aged 18–79 years. DEGS1 has of several preparations can produce risks. this background, the medication data col- a mixed design which permits both cross- Studies have demonstrated the correlation lected in the first wave of the German sectional and longitudinal analyses. For between the number of preparations used Health Interview and Examination Sur- this purpose, a random sample from local and the risk of drug interactions as well as vey for Adults (DEGS1) proves to be suit- population registries was drawn to com- adverse drug reactions [3, 4, 5, 6]. In addi- able for filling information gaps on the use plete the participants of the German Na- tion to prescription drugs, over-the-coun- of drugs because it reflects all medicinal tional Health Interview and Examination ter (OTC) drugs acquired without a pre- products (prescribed and self-medicated) Survey 1998 (GNHIES98), who re-partic- scription are also used. According to in- as well as the extent and patterns of actu- ipated. There were 8,152 persons who par- formation provided by the pharmaceuti- al usage behaviour. Because of the linkage ticipated, including 4,193 first-time partic- cal manufacturers’ association “Bundes- of this data with health-relevant informa- ipants (response rate 42%) and 3,959 re- verband der Arzneimittelhersteller e. V.”, tion on living conditions and behaviour, visiting participants of GNHIES98 (re- people in Germany spent an average of it is also possible to provide a description sponse rate 62%). A total of 7,238 persons roughly 60 € per person on OTC prepa- of the determinants and profiles of med- attended one of the 180 examination cen- rations in 2010 [7]. The use of self-medi- icine use. tres, and 914 were interviewed only. The cation and dietary supplements on top of The objective of this study is to de- net sample (n=7,988) permits representa- prescribed medicinal products is proven scribe the prevalence and spectrum of tive cross-sectional and time trend analy- to increase the risk of drug interactions [8, medication among the adult population ses for the age range of 18–79 years in com- 9, 10]. Drug interactions may not only im- in Germany. The focus of this study is the parison with GNHIES98 (n=7,124). The pair the health and quality of life of drug evaluation of the use of drugs and dietary data of the revisiting participants can be Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz 5/6 · 2013 | 1 Main topic Tab. 1 Prevalence of medication use by sex, age and social status, DEGS1 2008–2011 Age Group n 18–29 years 30–39 years 40–49 years 50–59 years 60–69 years 70–79 years Total Sex Women 3,692 81.9% 78.1% 83.0% 83.9% 92.3% 96.3% 85.4% (95% CI) (77.6–85.6%) (72.8–82.5%) (79.4–86.0%) (80.9–86.6%) (88.5–94.9%) (93.8–97.8%) (83.9–86.9%) Men 3,400 41.2% 52.7% 58.8% 67.0% 85.4% 94.9% 63.8% (95% CI) (36.2–46.4%) (46.4–58.9%) (53.7–63.7%) (62.3–71.4%) (82.0–88.2%) (92.0–96.8%) (61.6–66.1%) Total 7,092 61.2% 65.2% 70.6% 75.5% 88.9% 95.7% 74.7% (95% CI) (57.4–64.9%) (60.9–69.2%) (67.3–73.7%) (72.6–78.1%) (86.4–91.0%) (94.0–96.9%) (73.3–76.0%) Social status Women Low 611 79.4% 65.7% 75.7% 85.8% 89.1% 93.2% 83.0% (95% CI) (70.3–86.3%) (45.4–81.6%) (63.8–84.5%) (76.1–91.9%) (76.9–95.2%) (85.7–96.9%) (78.8–86.4%) Medium 2283 84.1% 82.2% 85.1% 81.7% 93.3% 98.3% 86.9% (95% CI) (78.9–88.2%) (75.8–87.2%) (80.9–88.6%) (77.2–85.5%) (89.2–95.9%) (96.4–99.2%) (85.0–88.7%) High 774 80.0% 73.5% 81.1% 88.8% 94.0% 93.1% 83.5% (95% CI) (68.1–88.3%) (62.6–82.1%) (73.0–87.2%) (81.2–93.6%) (87.2–97.3%) (83.2–97.4%) (79.4–86.9%) Men Low 545 41.5% 60.3% 60.9% 65.1% 85.5% 95.8% 65.4% (95% CI) (32.0–51.7%) (44.9–73.9%) (47.8–72.6%) (54.7–74.3%) (76.0–91.7%) (87.9–98.6%) (60.8–69.8%) Medium 1919 40.9% 49.4% 57.2% 69.0% 84.9% 94.0% 62.7% (95% CI) (34.8–47.2%) (41.2–57.5%) (51.0–63.3%) (63.2–74.3%) (79.6–89.1%) (89.4–96.7%) (59.8–65.5%) High 896 41.6% 56.1% 63.0% 62.2% 86.4% 98.4% 66.1% (95% CI) (29.7–54.6%) (44.5–66.9%) (54.5–70.7%) (51.7–71.7%) (80.1–91.0%) (95.7–99.4%) (61.6–70.4%) used for longitudinal analyses. The cross- professional status and net household in- (NVS) are integrated into the data record- sectional and trend analyses are conduct- come (weighted by household needs), al- ing program (“Arzneimittel Erfassungs- ed with a weighting factor which corrects lowing for a classification into low, middle Datenbank”, AmEDa, Medication Record- deviations in the sample from the popu- and high status groups [21]. ing Database) [19]. The supplements da- lation structure (as of 31 Dec 2010) with Current medication intake is record- tabase enables the collection of informa- regard to age, sex, region and nationali- ed via a computer-assisted personal inter- tion on vitamin and mineral preparations ty, as well as community type and educa- view (CAPI) by an appropriately trained which are not authorised medicinal prod- tion [18]. A separate weighting factor was interviewer. In the letter of invitation, the ucts. The “Central Pharmaceutical Num- prepared for the examination part. Calcu- survey participants are asked to bring ber” (PZN) is scanned at the study centre, lation of the weighting factor also consid- with them all of the original packages of thereby automatically recording the name ered re-participation probability of GN- the medicines they have used in the last of the preparation, the “Anatomical Ther- HIES98 participants, based on a logistic 7 days prior to the examination date. With apeutic Chemical” (ATC) code, the in- regression model. A non-response analy- the question: “Have you taken any me- dication group, the dosage form and the sis and a comparison of selected indicators dicinal products or dietary supplements standard package size. If there is no PZN with data from census statistics indicate a within the last 7 days, such as vitamins or available, the brand name is documented. high level of representativity of the net minerals? Please don’t forget any painkill- In addition to this, the indication and ori- sample for the residential population aged ers, insulin preparations, medications is- gin (prescribed vs. self-medicated) are re- 18–79 years of Germany [18].
Load more

Recommended publications
  • Department of Economics
    DEPARTMENT OF ECONOMICS JOHANNES KEPLER UNIVERSITY OF LINZ Birth Order, Parental Health Investment, and Health in Childhood by Gerald J. Pruckner Nicole Schneeweis Thomas Schober Martina Zweimüller Working Paper No. 1916 August 2019 Johannes Kepler University of Linz Department of Economics Altenberger Strasse 69 A-4040 Linz - Auhof, Austria www.econ.jku.at [email protected] Birth Order, Parental Health Investment, and Health in Childhood∗ Gerald J. Prucknera,b, Nicole Schneeweisa,c,d, Thomas Schobera,b, Martina Zweimuller¨ a aJohannes Kepler University Linz, Austria bChristian Doppler Laboratory for Aging, Health, and the Labor Market, Austria cIZA, Institute for the Study of Labor, Bonn, Germany dCEPR, Centre for Economic Policy Research, London August 9, 2019 Abstract Research has shown that cognitive and non-cognitive skills, education and earn- ings decrease with birth order. Less is known about birth order effects on health. This paper provides a comprehensive analysis of the relationship between birth or- der, health at birth and in childhood, and parental health investment. High-quality administrative data on children born in Austria between 1984 and 2015 allow us to exploit within-family variation in birth order to account for confounding family- level factors. In a sample of families with two to four children, we find statistically significant and quantitatively important birth order effects on health at birth and in primary school. These birth order effects are positive, in that later-born siblings are healthier than the first-born child, and increase with birth order. Consequently, first-born children are more likely to consume medical drugs and to utilize inpatient and outpatient medical services.
    [Show full text]
  • Common SUMMARY of PRODUCT CHARACTERISTICS for Fucidin® H
    Common SUMMARY OF PRODUCT CHARACTERISTICS for Fucidin® H cream MRP: DK/H/0130/001 1 1. NAME OF THE MEDICINAL PRODUCT Fucidin H, 20 mg/g + 10 mg/g Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fusidic acid 20 mg/g and hydrocortisone acetate 10 mg/g. Excipients with known effect Butyl hydroxyanisole E320 (40 microgram/g), cetyl alcohol (111 mg/g) and potassium sorbate E202 (2.7 mg/g). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream White water-miscible cream 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of infected atopic dermatitis. 4.2 Posology and method of administration Adults and paediatric population: Fucidin H cream should be applied to the affected area of the skin 3 times daily, for max. 2 weeks. 4.3 Contraindications Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Due to the content of corticosteroid, Fucidin H is contraindicated in the following conditions: Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by appropriate treatment (see section 4.4). Skin manifestations in relation to tuberculosis, either untreated or uncontrolled by appropriate therapy. Perioral dermatitis and rosacea. 4.4 Special warnings and precautions for use Long-term continuous topical therapy with Fucidin H should be avoided. Depending on the application site, possible systemic absorption of hydrocortisone acetate should always be considered during treatment with Fucidin H. 2 Due to the content of corticosteroid, Fucidin H should be used with care near the eyes. Avoid getting Fucidin H into the eyes (see section 4.8).
    [Show full text]
  • Summary of Product Characteristics
    Proposed var 24 psusa cilazapril SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT [Fosinopril sodium 10 mg, tablets] [Fosinopril sodium 20 mg, tablets] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 or 20 mg fosinopril sodium. Excipient with known effect: Each tablet fosinopril sodium 10 mg contains 87 mg of lactose, anhydrous. Each tablet fosinopril sodium 20 mg contains 174 mg of lactose, anhydrous. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. The 10 mg tablets are white and shaped like a capsule with indents. On one side they are engraved with the letters “APO” and on the other side with “FOS-10”. The 20 mg tablets are white and their shape is oval. On one side they are engraved with the letters “APO” and on the other side with “FOS-20”. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications - Treatment of hypertension. - Treatment of symptomatic heart failure. 4.2 Posology and method of administration Posology Fosinopril sodium should be administered orally in a single daily dose. As with all other medicinal products taken once daily, it should be taken at approximately the same time each day. The absorption of fosinopril sodium is not affected by food. The dose should be individualised according to patient profile and blood pressure response (see section 4.4). Hypertension: Fosinopril sodium may be used as a monotherapy or in combination with other classes of antihypertensive medicinal products (see section 4.3, 4.4, 4.5 and 5.1). Hypertensive patients not being treated with diuretics: Starting dose The initial recommended dose is 10 mg once a day.
    [Show full text]
  • A Side Effect Resource to Capture Phenotypic Effects of Drugs
    Molecular Systems Biology 6; Article number 343; doi:10.1038/msb.2009.98 Citation: Molecular Systems Biology 6:343 & 2010 EMBO and Macmillan Publishers Limited All rights reserved 1744-4292/10 www.molecularsystemsbiology.com REPORT A side effect resource to capture phenotypic effects of drugs Michael Kuhn1,4, Monica Campillos1, Ivica Letunic1, Lars Juhl Jensen1,2 and Peer Bork1,3,* 1 Structural and Computational Biology Unit, European Molecular Biology Laboratory, Heidelberg, Germany, 2 Novo Nordisk Foundation Center for Protein Research, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark and 3 Max-Delbru¨ck-Centre for Molecular Medicine, Berlin, Germany 4 Present address: Biotechnology Center, TU Dresden, 01062 Dresden, Germany * Corresponding author. Structural and Computational Biology Unit, European Molecular Biology Laboratory, Meyerhofstrasse 1, Heidelberg 69117, Germany. Tel.: þ 49 6221 387 8526; Fax: þ 49 6221 387 517; E-mail: [email protected] Received 9.7.09; accepted 30.11.09 The molecular understanding of phenotypes caused by drugs in humans is essential for elucidating mechanisms of action and for developing personalized medicines. Side effects of drugs (also known as adverse drug reactions) are an important source of human phenotypic information, but so far research on this topic has been hampered by insufficient accessibility of data. Consequently, we have developed a public, computer-readable side effect resource (SIDER) that connects 888 drugs to 1450 side effect terms. It contains information on frequency in patients for one-third of the drug–side effect pairs. For 199 drugs, the side effect frequency of placebo administration could also be extracted. We illustrate the potential of SIDER with a number of analyses.
    [Show full text]
  • Summary of Product Characteristics 1. Name Of
    SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ramipril/Amlodipine Glenmark, 5 mg/5 mg, hard capsules Ramipril/Amlodipine Glenmark, 5 mg/10 mg, hard capsules Ramipril/Amlodipine Glenmark, 10 mg/5 mg, hard capsules Ramipril/Amlodipine Glenmark, 10 mg/10 mg, hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ramipril/Amlodipine Glenmark, 5 mg/5 mg, hard capsules: each capsule contains 5 mg ramipril and amlodipine besilate equivalent to 5 mg amlodipine. Ramipril/Amlodipine Glenmark, 5 mg/10 mg, hard capsules: each capsule contains 5 mg ramipril and amlodipine besilate equivalent to 10 mg amlodipine and . Ramipril/Amlodipine Glenmark, 10 mg/5 mg, hard capsules: each capsule contains 10 mg ramipril and amlodipine besilate equivalent to5 mg amlodipine. Ramipril/Amlodipine Glenmark, 10 mg/10 mg, hard capsules: each capsule contains 10 mg ramipril and amlodipine besilate equivalent to 10 mg amlodipine . For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule Ramipril/Amlodipine Glenmark, 5 mg/5 mg, hard capsules: hard gelatin capsules with a length of 19 mm, cap: opaque pink colour, body: opaque white colour. Content of capsules: white or almost white powder. Ramipril/Amlodipine Glenmark, 5 mg/10 mg, hard capsules: hard gelatin capsules with a length of 19 mm, cap: opaque red - brown colour, body: opaque white colour. Content of capsules: white or almost white powder. Ramipril/Amlodipine Glenmark, 10 mg/5 mg, hard capsules: hard gelatin capsules with a length of 19 mm, cap: opaque dark pink colour, body: opaque white colour. Content of capsules: white or almost white powder.
    [Show full text]
  • Medication Risks in Older Patients with Cancer
    Medication risks in older patients with cancer 1 Medication risks in older patients (70+) with cancer and their association with therapy-related toxicity Imke Ortland1, Monique Mendel Ott1, Michael Kowar2, Christoph Sippel3, Yon-Dschun Ko3#, Andreas H. Jacobs2#, Ulrich Jaehde1# 1 Institute of Pharmacy, Department of Clinical Pharmacy, University of Bonn, An der Immenburg 4, 53121 Bonn, Germany 2 Department of Geriatrics and Neurology, Johanniter Hospital Bonn, Johanniterstr. 1-3, 53113 Bonn, Germany 3 Department of Oncology and Hematology, Johanniter Hospital Bonn, Johanniterstr. 1-3, 53113 Bonn, Germany # equal contribution Corresponding author Ulrich Jaehde Institute of Pharmacy University of Bonn An der Immenburg 4 53121 Bonn, Germany Phone: +49 228-73-5252 Fax: +49-228-73-9757 [email protected] Medication risks in older patients with cancer 2 Abstract Objectives To evaluate medication-related risks in older patients with cancer and their association with severe toxicity during antineoplastic therapy. Methods This is a secondary analysis of two prospective, single-center observational studies which included patients ≥ 70 years with cancer. The patients’ medication was investigated regarding possible risks: polymedication (defined as the use of ≥ 5 drugs), potentially inadequate medication (PIM; defined by the EU(7)-PIM list), and relevant potential drug- drug interactions (rPDDI; analyzed by the ABDA interaction database). The risks were analyzed at two different time points: before and after start of cancer therapy. Severe toxicity during antineoplastic therapy was captured from medical records according to the Common Terminology Criteria for Adverse Events (CTCAE). The association between Grade ≥ 3 toxicity and medication risks was evaluated by univariate regression.
    [Show full text]
  • Summary of Product Characteristics 1. NAME of the MEDICINAL
    Summary of product characteristics 1. NAME OF THE MEDICINAL PRODUCT Losartan Potassium 50 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of losartan potassium, equivalent to 45.8mg of Losartan. Excipient: 52mg of lactose/film-coated tablet. For the full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet White to off white, round, biconvex, film-coated tablets with breakline on one side and “50” debossing on other side. The break line is only to facilitate breaking for ease of swallowing and not to divide into equal doses 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of essential hypertension in adults and in children and adolescents 6-18 years of age. Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria 0.5 g/day as part of an antihypertensive treatment (see sections 4.3, 4.4, 4.5 and 5.1). Treatment of chronic heart failure in adult patients when treatment with Angiotensin converting enzyme (ACE) inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication. Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan. The patients should have a left ventricular ejection fraction ≤ 40% and should be clinically stable and on an established treatment regimen for chronic heart failure. Reduction in the risk of stroke in adult hypertensive patients with left ventricular hypertrophy documented by ECG (see section 5.1 LIFE study, Race). 4.2 Posology and method of administration Posology Hypertension The usual starting and maintenance dose is 50 mg once daily for most patients.
    [Show full text]
  • Part1 Gendiff.Qxp
    Sex Differences in Health Status, Health Care Use, and Quality of Care: A Population-Based Analysis for Manitoba’s Regional Health Authorities November 2005 Manitoba Centre for Health Policy Department of Community Health Sciences Faculty of Medicine, University of Manitoba Randy Fransoo, MSc Patricia Martens, PhD The Need to KnowTeam (funded through CIHR) Elaine Burland, MSc Heather Prior, MSc Charles Burchill, MSc Dan Chateau, PhD Randy Walld, BSc, BComm (Hons) This report is produced and published by the Manitoba Centre for Health Policy (MCHP). It is also available in PDF format on our website at http://www.umanitoba.ca/centres/mchp/reports.htm Information concerning this report or any other report produced by MCHP can be obtained by contacting: Manitoba Centre for Health Policy Dept. of Community Health Sciences Faculty of Medicine, University of Manitoba 4th Floor, Room 408 727 McDermot Avenue Winnipeg, Manitoba, Canada R3E 3P5 Email: [email protected] Order line: (204) 789 3805 Reception: (204) 789 3819 Fax: (204) 789 3910 How to cite this report: Fransoo R, Martens P, The Need To Know Team (funded through CIHR), Burland E, Prior H, Burchill C, Chateau D, Walld R. Sex Differences in Health Status, Health Care Use and Quality of Care: A Population-Based Analysis for Manitoba’s Regional Health Authorities. Winnipeg, Manitoba Centre for Health Policy, November 2005. Legal Deposit: Manitoba Legislative Library National Library of Canada ISBN 1-896489-20-6 ©Manitoba Health This report may be reproduced, in whole or in part, provided the source is cited. 1st Printing 10/27/2005 THE MANITOBA CENTRE FOR HEALTH POLICY The Manitoba Centre for Health Policy (MCHP) is located within the Department of Community Health Sciences, Faculty of Medicine, University of Manitoba.
    [Show full text]
  • 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”.
    [Show full text]
  • 5 Mg Film-Coated Tablets [Nationally Completed Name] 10 Mg Film-Coated Tablets [Nationally Completed Name] 20 Mg Film-Coated Tablets
    SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT [nationally completed name] 5 mg film-coated tablets [nationally completed name] 10 mg film-coated tablets [nationally completed name] 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 5/10/20 mg Benazepril hydrochloride. For the full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet [nationally completed name] 5 mg film-coated tablets: Oval (4 x 8 mm), light yellow film-coated tablets with score on both sides. [nationally completed name] 10 mg film-coated tablets: Oval (11 x 5.5 mm) yellow film-coated tablets with score on both sides. [nationally completed name] 20 mg film-coated tablets: Oval (11 x 5.5 mm) light red film-coated tablet with score on both sides. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Essential hypertension, congestive heart failure - in addition to diuretics and especially to digitalis glycosides in cases of severe congestive heart failure 4.2 Posology and method of administration Posology Paediatric population [nationally completed name] is not recommended for use in children due to insufficient data on safety and efficacy (see section 4.4). Essential hypertension 10 to 20 mg daily divided in one or two doses. Maximum daily dose is 40 mg. Congestive heart failure Initially 2.5 mg daily. After 2-4 weeks the dosage can be increased to 5 mg daily. Maximum dose is 20 mg daily. Dosage at renal impairment For the treatment of essential hypertension the dose should be reduced if creatinine clearance is below 30 ml/min.
    [Show full text]
  • DK H 2355 001 Finalspc.Pdf
    SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fucicort Lipid 20 mg/g + 1 mg/g cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fusidic acid 20 mg/g and betamethasone as betamethasone valerate 1 mg/g. Excipients with known effect Methylparahydroxy benzoat, E 218 Propylparahydroxy benzoat, E 216 Cetostearyl alcohol Potassium sorbate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream White cream 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Infected atopic dermatitis. Dermatitis, especially allergic and toxic eczema infected by microorganisms sensitive to fusidic acid. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 Posology and method of administration Posology Adults and children: A thin layer should be applied 2 or 3 times daily for no more than 14 days at a time. Special Populations Elderly No specific risks for elderly patients have been identified for Fucicort Lipid. No special precautions or dosage adjustment are necessary. Renal impairment No specific risks for patients with renal impairment have been identified for Fucicort Lipid. No special precautions or dosage adjustment are necessary. Hepatic impairment No specific risks for patients with hepatic impairment have been identified for Fucicort Lipid. No special precautions or dosage adjustment are necessary. 4.3 Contraindications Hypersensitivity to fusidic acid or betamethasone valerate or to any of the excipients listed in section 6.1. Due to the content of corticosteroid, Fucicort is contraindicated in the following conditions: Systemic fungal infections Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by appropriate treatment (see section 4.4) Skin manifestations in relation to tuberculosis, either untreated or uncontrolled by appropriate therapy Perioral dermatitis, rosacea and acne vulgaris.
    [Show full text]
  • 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
    [Show full text]