Reseptregisteret 2011-2015 / Norwegian Prescription
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DE H 2281 001 PAR.Pdf
Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure RMS Public Assessment Report Latanoprost Malcosa 0,005% Xalaprost 0,005% Laxatan 0,005% Pharmecol 0.005% DE/H/1999/001/DC DE/H/2281/001/DC DE/H/2282/001/DC DE/H/2382/001/DC Applicant: Malcosa Ltd. Reference Member State DE Date of this report: 06.12.2010 The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health. 1/30 CONTENTS ADMINISTRATIVE INFORMATION .............................................................................................. 3 I. RECOMMENDATION ................................................................................................................ 4 II. EXECUTIVE SUMMARY....................................................................................................... 4 II.1 Problem statement..................................................................................................................... 4 II.2 About the product ..................................................................................................................... 4 II.3 General comments on the submitted dossier .......................................................................... 5 II.4 General comments on compliance with GMP, GLP, GCP and agreed ethical principles..6 III. SCIENTIFIC OVERVIEW AND DISCUSSION ................................................................... 6 III.1 Quality aspects...................................................................................................................... -
Drugs for Glaucoma
Australian Prescriber Vol. 25 No. 6 2002 Drugs for glaucoma Ivan Goldberg, Eye Associates and Glaucoma Service, Sydney Eye Hospital and the Save Sight Institute, University of Sydney, Sydney SYNOPSIS is not uncommon and the pressure slowly rises. Withdrawing Older drugs for glaucoma reduce intra-ocular pressure, the drug for a few months often re-establishes its efficacy. but often have unpleasant adverse effects. They still The main problem with timolol or levobunolol is their potential have a role in therapy, but there are now newer for systemic adverse effects. These are the same as the adverse drugs which overcome some of the problems. The topical effects of oral beta blockers, the most important of which are carbonic anhydrase inhibitors decrease the secretion of bronchoconstriction, bradyarrhythmias, and an increase in aqueous humour, while lipid-receptor agonists increase falls in the elderly. uveoscleral outflow. Alpha agonists use both mechanisms 2 As betaxolol is relatively selective for beta1 receptors it should to reduce intra-ocular pressure. If a patient needs more pose less respiratory risk. Its pharmacokinetic properties than one drug to control their glaucoma, the new drugs (higher plasma binding and larger volume of distribution) also generally have an additive effect when used in combination make it less likely to provoke other systemic effects. regimens. Miotics Index words: beta blockers, carbonic anhydrase inhibitors, Miotics (pilocarpine and carbachol) are rapidly falling out of lipid-receptor agonists. favour. While their ocular hypotensive efficacy is undisputed, (Aust Prescr 2002;25:142–6) and their systemic safety margin wide (abdominal cramping or diarrhoea are rarely reported), their use is declining because Introduction of their local effects and the need to instill them up to four Glaucoma is the second commonest cause of visual disability times daily. -
Partial Agreement in the Social and Public Health Field
COUNCIL OF EUROPE COMMITTEE OF MINISTERS (PARTIAL AGREEMENT IN THE SOCIAL AND PUBLIC HEALTH FIELD) RESOLUTION AP (88) 2 ON THE CLASSIFICATION OF MEDICINES WHICH ARE OBTAINABLE ONLY ON MEDICAL PRESCRIPTION (Adopted by the Committee of Ministers on 22 September 1988 at the 419th meeting of the Ministers' Deputies, and superseding Resolution AP (82) 2) AND APPENDIX I Alphabetical list of medicines adopted by the Public Health Committee (Partial Agreement) updated to 1 July 1988 APPENDIX II Pharmaco-therapeutic classification of medicines appearing in the alphabetical list in Appendix I updated to 1 July 1988 RESOLUTION AP (88) 2 ON THE CLASSIFICATION OF MEDICINES WHICH ARE OBTAINABLE ONLY ON MEDICAL PRESCRIPTION (superseding Resolution AP (82) 2) (Adopted by the Committee of Ministers on 22 September 1988 at the 419th meeting of the Ministers' Deputies) The Representatives on the Committee of Ministers of Belgium, France, the Federal Republic of Germany, Italy, Luxembourg, the Netherlands and the United Kingdom of Great Britain and Northern Ireland, these states being parties to the Partial Agreement in the social and public health field, and the Representatives of Austria, Denmark, Ireland, Spain and Switzerland, states which have participated in the public health activities carried out within the above-mentioned Partial Agreement since 1 October 1974, 2 April 1968, 23 September 1969, 21 April 1988 and 5 May 1964, respectively, Considering that the aim of the Council of Europe is to achieve greater unity between its members and that this -
Systematic Review in Drug's Safety and Clinical
Ana Sofia Martins Penedones SYSTEMATIC REVIEW: METHODOLOGICAL ASPECTS OF ITS ROLE IN DRUG SAFETY ASSESSMENT Tese no âmbito do Doutoramento em Ciências Farmacêuticas, ramo de Farmácia Clínica orientada pelo Professor Doutor Francisco Jorge Batel Marques e apresentada à Faculdade de Farmácia da Universidade de Coimbra. Março de 2020 Faculdade de Farmácia da Universidade de Coimbra Systematic review: methodological aspects of its role in drug safety assessment Ana Sofia Martins Penedones Tese no âmbito do Doutoramento em Ciências Farmacêuticas, ramo de Farmácia Clínica orientada pelo Professor Doutor Francisco Jorge Batel Marques e apresentada à Faculdade de Farmácia da Universidade de Coimbra. Março de 2020 2 All the research work presented in this thesis was performed in strict collaboration of the Laboratory of Social Pharmacy and Public Health, Faculty of Pharmacy, University of Coimbra and the Centre for Health Technology Assessment and Drug Research, Association for Innovation and Biomedical Research on Light and Image, under the supervision of Professor Francisco Jorge Batel Marques. Todos os trabalhos apresentados nesta tese foram realizados em estreita colaboração entre o Laboratório de Sociofarmácia e Saúde Pública da Faculdade de Farmácia da Universidade de Coimbra e o Centro de Avaliação de Tecnologias em Saúde e Investigação do Medicamento da Associação para Investigação Biomédica e Inovação em Luz e Imagem, sob a supervisão do Professor Doutor Francisco Jorge Batel Marques. 3 4 Agradecimentos Ao meu orientador, Professor Doutor Francisco Batel Marques, pela oportunidade em integrar o seu grupo de trabalho no CHAD – Centre for Health Technology Assessment and Drug Research na AIBILI – Innovation and Biomedical Research on Light and Image. -
Bergamot Oil: Botany, Production, Pharmacology
Entry Bergamot Oil: Botany, Production, Pharmacology Marco Valussi 1,* , Davide Donelli 2 , Fabio Firenzuoli 3 and Michele Antonelli 2 1 Herbal and Traditional Medicine Practitioners Association (EHTPA), Norwich NR3 1HG, UK 2 AUSL-IRCCS Reggio Emilia, 42122 Reggio Emilia RE, Italy; [email protected] (D.D.); [email protected] (M.A.) 3 CERFIT, Careggi University Hospital, 50139 Firenze FI, Italy; fabio.firenzuoli@unifi.it * Correspondence: [email protected] Definition: Bergamot essential oil (BEO) is the result of the mechanical manipulation (cold pressing) of the exocarp (flavedo) of the hesperidium of Citrus limon (L.) Osbeck Bergamot Group (synonym Citrus × bergamia Risso & Poit.), resulting in the bursting of the oil cavities embedded in the flavedo and the release of their contents. It is chemically dominated by monoterpene hydrocarbons (i.e., limonene), but with significant percentages of oxygenated monoterpenes (i.e., linalyl acetate) and of non-volatile oxygen heterocyclic compounds (i.e., bergapten). Keywords: bergamot; citrus; essential oil; production; review 1. Introduction The taxonomy, and consequently the nomenclature, of the genus Citrus, is particularly complicated and has been rapidly changing in recent years (see Table1). For over 400 years, the centre of origin and biodiversity, along with the evolution and phylogeny of the Citrus species, have all been puzzling problems for botanists and the confusing and changing Citation: Valussi, M.; Donelli, D.; nomenclature of this taxon over the years can reflect intrinsic reproductive features of Firenzuoli, F.; Antonelli, M. Bergamot Oil: Botany, Production, the species included in this genus, the cultural and geographical issues, and the rapidly Pharmacology. Encyclopedia 2021, 1, evolving techniques used to clarify its phylogeny [1]. -
Ehealth DSI [Ehdsi V2.2.2-OR] Ehealth DSI – Master Value Set
MTC eHealth DSI [eHDSI v2.2.2-OR] eHealth DSI – Master Value Set Catalogue Responsible : eHDSI Solution Provider PublishDate : Wed Nov 08 16:16:10 CET 2017 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 1 of 490 MTC Table of Contents epSOSActiveIngredient 4 epSOSAdministrativeGender 148 epSOSAdverseEventType 149 epSOSAllergenNoDrugs 150 epSOSBloodGroup 155 epSOSBloodPressure 156 epSOSCodeNoMedication 157 epSOSCodeProb 158 epSOSConfidentiality 159 epSOSCountry 160 epSOSDisplayLabel 167 epSOSDocumentCode 170 epSOSDoseForm 171 epSOSHealthcareProfessionalRoles 184 epSOSIllnessesandDisorders 186 epSOSLanguage 448 epSOSMedicalDevices 458 epSOSNullFavor 461 epSOSPackage 462 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 2 of 490 MTC epSOSPersonalRelationship 464 epSOSPregnancyInformation 466 epSOSProcedures 467 epSOSReactionAllergy 470 epSOSResolutionOutcome 472 epSOSRoleClass 473 epSOSRouteofAdministration 474 epSOSSections 477 epSOSSeverity 478 epSOSSocialHistory 479 epSOSStatusCode 480 epSOSSubstitutionCode 481 epSOSTelecomAddress 482 epSOSTimingEvent 483 epSOSUnits 484 epSOSUnknownInformation 487 epSOSVaccine 488 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 3 of 490 MTC epSOSActiveIngredient epSOSActiveIngredient Value Set ID 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 TRANSLATIONS Code System ID Code System Version Concept Code Description (FSN) 2.16.840.1.113883.6.73 2017-01 A ALIMENTARY TRACT AND METABOLISM 2.16.840.1.113883.6.73 2017-01 -
Central Nervous System 5 Objectives
B978-0-7234-3630-0.00005-4, 00005 Central nervous system 5 Objectives After reading this chapter, you will: ● Understand the functions of the central nervous system and the diseases that can occur ● Know the drug classes used to treat these conditions, their mechanisms of action and adverse effects. Parkinson’s disease is progressive, with continued BASIC CONCEPTS loss of dopaminergic neurons in the substantia nigra correlating with worsening of clinical symptoms. The The central nervous system consists of the brain and the possibility of a neurotoxic cause has been strengthe- spinal cord, which are continuous with one another. ned by the finding that 1-methyl-4-phenyl-1,2,3, The brain is composed of the cerebrum (which consists 6-tetrahydropyridine (MPTP), a chemical contaminant of the frontal, temporal, parietal and occipital lobes), of heroin, causes irreversible damage to the nigrostriatal the diencephalon (which includes the thalamus and dopaminergic pathway. Thus, this damage can lead hypothalamus), the brainstem (which consists of the mid- to the development of symptoms similar to those of brain, pons and medulla oblongata) and the cerebellum. idiopathic Parkinson’s disease. Drugs that block The brain functions to interpret sensory information dopamine receptors can also induce parkinsonism. obtained about the internal and external environments Neuroleptic drugs (p. 000) used in the treatment of TS1 and send messages to effector organs in response to a schizophrenia can produce parkinsonian symptoms as situation. Different parts of the brain are associated an adverse effect. Rare causes of parkinsonism are cere- with specific functions (Fig. 5.1). However, the brain is a bral ischaemia (progressive atherosclerosis or stroke), complex organ and is not yet completely understood. -
The Title Is in Blue Arial 32 Bold
Recent Developments to Detect Lemon Juice Adulteration Authors: Ramin Jahromi, Hayley Pratt, Yang Zhou, Lars Reimann: Eurofins Nutrition Analysis Center, 2200 Rittenhouse St, Suite 175, Des Moines, IA 50321, USA ([email protected]) Dr. David A Hammond : Eurofins Scientific Analytics, Rue Pierre Adolphe Bobierre, F-44323, Nantes, France. Citropten Abstract: One of the possible adulterants of lemon juice is lime. The pattern of PMFs seen in lemon and lime juices are very different, which allow a much easier identification of substitution and/or addition of lime to lemon. This poster describes the method for the polymethoxyflavones “lime” markers. Introduction Discussion: Figure 2: PMF profile for lemon juice Unfortunately there is a long history of economic adulteration of fruit juices. The first well Experts from the European juice association (AIJN) have drawn up the typical ranges for a number publicized case of juice fraud was in 1989 with Beech-nut(1). This and subsequent events (10) of important juice components in 25 fruits and vegetables , which are extremely useful in the Citropten have meant that juice packers normally have a “verification” program for their raw assessment of the quality and authenticity of these products. They also working on a reference materials to ensure that they are authentic. Although in 2009 the FDA officially recognized guide for lime at present. food fraud as an emerging risk to the consumer, in fringe industries that use juice based Lemon and lime juices are normally adulterated by substitution of some or all of the juice solids by products, this risk had not been recognized and few companies have QA programs in place. -
Phototherapy* Fototerapia*
RevABDV81N1.qxd 17.02.06 15:55 Page 74 74 Artigo de Revisão Fototerapia* Phototherapy* Ida Duarte 1 Roberta Buense 2 Clarice Kobata 3 Resumo: Fototerapia é utilizada para tratar uma grande variedade de dermatoses. Desde o século pas- sado a fototerapia tem sido utilizada em várias modalidades, com irradiação UVA ou UVB. Está indica- da para todos os tipo de dermatoses inflamatórias e com período crônico de evolução, como vitiligo, pasoríase, parapsoríase, linfomas cutâneos de células T, eczemas crônicos, demonstrando bons resulta- dos terapêuticos. Pode ser utilizada como monoterapia ou associada a outras drogas, como retinóides, metotrexate, ciclos- porina, com objetivo de diminuir o tempo de tratamento e as doses das medicações mencionadas. Como os demais tipos de tratamento, a fototerapia apresenta algumas limitações, como a necessidade de equipamentos específicos, a adesão do paciente, a possibilidade de indicação ao paciente e a dose cumulativa de irradiação UV. A fototerapia deve ser conduzida com seguimento criterioso para a obtenção de resposta efetiva com poucos efeitos colaterais. Palavras-chave: Fototerapia; Inflamação; Raios ultravioleta; Terapia PUVA Abstract: Phototherapy has been used to treat a large variety of dermatoses since the past century. It is classified according to the type of irradiation (UVA or UVB). Phototherapy is indicated for all types of inflammatory and chronic skin diseases, such as vitiligo, psoriasis, parapsoriasis, cutaneous T-cell lymphomas and chronic eczemas, with good therapeutic results. It can be used as monotherapy or associated with others drugs, such as retinoids, methotrexate and cyclosporine, aiming to reduce length of treatment and doses. Like other treatments, phototherapy has some limitations - it requires specific equipment, patient's compliance, has restricted indications and leads to cumulative UV doses. -
And Citrus Fruits
Journal of the Science of Food and Agriculture J Sci Food Agric 87:2152–2163 (2007) Analysis of furanocoumarins in vegetables (Apiaceae) and citrus fruits (Rutaceae) Radek Peroutka, Veraˇ Schulzova,´ ∗ Petr Botek and Jana Hajslovˇ a´ Institute of Chemical Technology, Department of Food Chemistry and Analysis, Technicka´ 3, 166 28 Prague 6, Czech Republic Abstract: Several alternative approaches applicable for the analysis of furanocoumarins, toxic components occurring in some fruits and vegetables representing both Apiaceae and Rutaceae families, were tested in our study. Limits of detection (LODs) for angelicin, psoralen, bergapten, xanthotoxin, trioxsalen, isopimpinellin, sphondin, pimpinellin and isobergapten obtained by GC/MS (SIM) were in the range 0.01–0.08 µgg−1.Slightly higher LODs (0.02–0.20 µgg−1) were achieved by LC/MS–MS. The latter is the only alternative for analysis of bergamottin (LOD = 0.01 µgg−1) in citrus fruits because this furanocoumarin is unstable under GC conditions. Regardless of the determination step used, the repeatability of the measurements (expressed as RSD) did not exceed 10%. As shown in our study the levels of furanocoumarins in celery, celeriac, parsnip, carrot, lemon and other foods obtained at a retail market varied over a wide range; the highest contents were determined in parsnip, while the levels of these toxins in carrots and citrus pulps were relatively low. 2007 Society of Chemical Industry Keywords: furanocoumarins; GC/MS; LC/MS–MS; fruits; vegetables INTRODUCTION and fruit of some of these, e.g. figs, representing the Furanocoumarins are toxic secondary metabolites that last family, is also used for human consumption. -
Alphabetical Listing of ATC Drugs & Codes
Alphabetical Listing of ATC drugs & codes. Introduction This file is an alphabetical listing of ATC codes as supplied to us in November 1999. It is supplied free as a service to those who care about good medicine use by mSupply support. To get an overview of the ATC system, use the “ATC categories.pdf” document also alvailable from www.msupply.org.nz Thanks to the WHO collaborating centre for Drug Statistics & Methodology, Norway, for supplying the raw data. I have intentionally supplied these files as PDFs so that they are not quite so easily manipulated and redistributed. I am told there is no copyright on the files, but it still seems polite to ask before using other people’s work, so please contact <[email protected]> for permission before asking us for text files. mSupply support also distributes mSupply software for inventory control, which has an inbuilt system for reporting on medicine usage using the ATC system You can download a full working version from www.msupply.org.nz Craig Drown, mSupply Support <[email protected]> April 2000 A (2-benzhydryloxyethyl)diethyl-methylammonium iodide A03AB16 0.3 g O 2-(4-chlorphenoxy)-ethanol D01AE06 4-dimethylaminophenol V03AB27 Abciximab B01AC13 25 mg P Absorbable gelatin sponge B02BC01 Acadesine C01EB13 Acamprosate V03AA03 2 g O Acarbose A10BF01 0.3 g O Acebutolol C07AB04 0.4 g O,P Acebutolol and thiazides C07BB04 Aceclidine S01EB08 Aceclidine, combinations S01EB58 Aceclofenac M01AB16 0.2 g O Acefylline piperazine R03DA09 Acemetacin M01AB11 Acenocoumarol B01AA07 5 mg O Acepromazine N05AA04 -
Bergapten Improves Scopolamine-Induced Memory Impairment in Mice Via Cholinergic and Antioxidative Mechanisms
fnins-14-00730 August 4, 2020 Time: 15:39 # 1 ORIGINAL RESEARCH published: 06 August 2020 doi: 10.3389/fnins.2020.00730 Bergapten Improves Scopolamine-Induced Memory Impairment in Mice via Cholinergic and Antioxidative Mechanisms Joanna Kowalczyk1,2, Łukasz Kurach2, Anna Boguszewska-Czubara3, Krystyna Skalicka-Wo´zniak4, Marta Kruk-Słomka5, Jacek Kurzepa3, Małgorzata Wydrzynska-Ku´zma5, Grazyna˙ Biała5, Adrianna Skiba4 and Barbara Budzynska´ 2* 1 Chair and Department of Applied Pharmacy, Medical University of Lublin, Lublin, Poland, 2 Independent Laboratory of Behavioral Studies, Medical University of Lublin, Lublin, Poland, 3 Chair and Department of Medicinal Chemistry, Medical University of Lublin, Lublin, Poland, 4 Chair and Department of Pharmacognosy with Medicinal Plant Unit, Medical University Edited by: of Lublin, Lublin, Poland, 5 Chair and Department of Pharmacology and Pharmacodynamics, Medical University of Lublin, Maria Javier Ramirez, Lublin, Poland University of Navarra, Spain Reviewed by: Patrizio Blandina, Bergapten is a furanocoumarin naturally occurring in the Apiaceae family and it is a well- University of Florence, Italy known photosensitizing agent used in photochemotherapy. In this study, we investigated Mariela Fernanda Perez, the influence of bergapten on cognitive function and mechanism underlying these effects National University of Córdoba, Argentina in scopolamine-induced memory impairment in male Swiss mice. The passive avoidance *Correspondence: test was used to evaluate the efficiency of memory acquisition and consolidation. Barbara Budzynska´ The results demonstrated that both single and repeated administration of bergapten [email protected] improved not only the acquisition but also consolidation of memory. The behavioral Specialty section: tests showed that bergapten prevented memory impairment induced by administration This article was submitted to of scopolamine.