Appendix 3: List of Product Codes in Clinical Practice Research Datalink (CPRD). All for Antiplatelet Agents (Aspirin, Clopidogr
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Oral Dosage Forms That Should Not Be Crushed Formulary-Specific List for VCMC and SPH
Oral Dosage Forms That Should Not be Crushed Formulary-Specific List for VCMC and SPH Generic Brand Dosage Form(s) Reasons/Comments amoxicillin-clavulanate Augmentin XR Tablet Slow-release (b,h) aspirin Aspirin EC Caplet; Tablet Slow-release; Enteric-coated aspirin and dipyridamole Aggrenox XR Capsule Slow-release atazanavir Reyataz Capsule Note: an oral powder is available, see prescribing information for administration instructions atomoxetine Strattera Capsule Note: capsule contents can cause ocular irritation - Do not open capsules as contents are an ocular irritant benzonatate Tessalon Perles Capsule Note: swallow whole; local anesthesia of the oral mucosa; choking could occur - Capsules are liquid-filled “perles” - Do not alter (break, cut, chew) integrity of dosage form; local mucosal irritant and anesthetic bisacodyl Dulcolax Capsule; Tablet Enteric-coated (c) bosentan Tracleer Tablet Note: women who are, or may become, pregnant, should not handle crushed or broken tablets brivaracetam Briviact Tablet Film-coated (b) budesonide Entocort EC Capsule Enteric-coated (a) - Capsules contain enteric-coated granules in extended-release matrix; can open capsules but do not crush contents - Products are formulated to release active drug at mid- to late small intestine buPROPion Wellbutrin XL Tablet Slow-release - Do not crush extended-release tablets - Immediate-release tablet products may be film-coated March 2019 carvedilol phosphate Coreg CR Capsule Slow-release (a) (Note: may add contents of capsule to chilled, not warm, applesauce -
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Methods in Molecular Biology 2000 Volkmar Weissig Tamer Elbayoumi Editors Pharmaceutical Nanotechnology Basic Protocols M ETHODS IN M OLECULAR B IOLOGY Series Editor John M. Walker School of Life and Medical Sciences University of Hertfordshire Hatfield, Hertfordshire AL10 9AB, UK For further volumes: http://www.springer.com/series/7651 Pharmaceutical Nanotechnology Basic Protocols Edited by Volkmar Weissig and Tamer Elbayoumi Department of Pharmaceutical Sciences, College of Pharmacy, Midwestern University, Glendale, AZ, USA Nanomedicine Center of Excellence in Translational Cancer Research, Midwestern University, Glendale, AZ, USA Editors Volkmar Weissig Tamer Elbayoumi Department of Pharmaceutical Sciences Department of Pharmaceutical Sciences College of Pharmacy, Midwestern University College of Pharmacy, Midwestern University Glendale, AZ, USA Glendale, AZ, USA Nanomedicine Center of Excellence Nanomedicine Center of Excellence in Translational Cancer Research in Translational Cancer Research Midwestern University Midwestern University Glendale, AZ, USA Glendale, AZ, USA ISSN 1064-3745 ISSN 1940-6029 (electronic) Methods in Molecular Biology ISBN 978-1-4939-9515-8 ISBN 978-1-4939-9516-5 (eBook) https://doi.org/10.1007/978-1-4939-9516-5 © Springer Science+Business Media, LLC, part of Springer Nature 2019 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. -
Characterising the Risk of Major Bleeding in Patients With
EU PE&PV Research Network under the Framework Service Contract (nr. EMA/2015/27/PH) Study Protocol Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU Version 3.0 1 June 2018 EU PAS Register No: 16014 EMA/2015/27/PH EUPAS16014 Version 3.0 1 June 2018 1 TABLE OF CONTENTS 1 Title ........................................................................................................................................... 5 2 Marketing authorization holder ................................................................................................. 5 3 Responsible parties ................................................................................................................... 5 4 Abstract ..................................................................................................................................... 6 5 Amendments and updates ......................................................................................................... 7 6 Milestones ................................................................................................................................. 8 7 Rationale and background ......................................................................................................... 9 8 Research question and objectives .............................................................................................. 9 9 Research methods .................................................................................................................... -
Reseptregisteret 2013–2017 the Norwegian Prescription Database
LEGEMIDDELSTATISTIKK 2018:2 Reseptregisteret 2013–2017 Tema: Legemidler og eldre The Norwegian Prescription Database 2013–2017 Topic: Drug use in the elderly Reseptregisteret 2013–2017 Tema: Legemidler og eldre The Norwegian Prescription Database 2013–2017 Topic: Drug use in the elderly Christian Berg Hege Salvesen Blix Olaug Fenne Kari Furu Vidar Hjellvik Kari Jansdotter Husabø Irene Litleskare Marit Rønning Solveig Sakshaug Randi Selmer Anne-Johanne Søgaard Sissel Torheim Utgitt av Folkehelseinstituttet/Published by Norwegian Institute of Public Health Område for Helsedata og digitalisering Avdeling for Legemiddelstatistikk Juni 2018 Tittel/Title: Legemiddelstatistikk 2018:2 Reseptregisteret 2013–2017 / The Norwegian Prescription Database 2013–2017 Forfattere/Authors: Christian Berg, redaktør/editor Hege Salvesen Blix Olaug Fenne Kari Furu Vidar Hjellvik Kari Jansdotter Husabø Irene Litleskare Marit Rønning Solveig Sakshaug Randi Selmer Anne-Johanne Søgaard Sissel Torheim Acknowledgement: Julie D. W. Johansen (English text) Bestilling/Order: Rapporten kan lastes ned som pdf på Folkehelseinstituttets nettsider: www.fhi.no The report can be downloaded from www.fhi.no Grafisk design omslag: Fete Typer Ombrekking: Houston911 Kontaktinformasjon/Contact information: Folkehelseinstituttet/Norwegian Institute of Public Health Postboks 222 Skøyen N-0213 Oslo Tel: +47 21 07 70 00 ISSN: 1890-9647 ISBN: 978-82-8082-926-9 Sitering/Citation: Berg, C (red), Reseptregisteret 2013–2017 [The Norwegian Prescription Database 2013–2017] Legemiddelstatistikk 2018:2, Oslo, Norge: Folkehelseinstituttet, 2018. Tidligere utgaver / Previous editions: 2008: Reseptregisteret 2004–2007 / The Norwegian Prescription Database 2004–2007 2009: Legemiddelstatistikk 2009:2: Reseptregisteret 2004–2008 / The Norwegian Prescription Database 2004–2008 2010: Legemiddelstatistikk 2010:2: Reseptregisteret 2005–2009. Tema: Vanedannende legemidler / The Norwegian Prescription Database 2005–2009. -
MIRADON FPO Brand of Anisindione Tablets
R 1 2 3 4 5 3 4 F-16099775 1898 ® MIRADON FPO brand of anisindione Tablets DESCRIPTION MIRADON Tablets contain a syn- thetic anticoagulant, anisindione, an indanedione derivative. Each tablet contains 50 mg anisin- dione. They also contain: corn starch, FD&C Red No. 3, gelatin, lactose, and hydrogenated cotton- seed oil. ACTIONS Like phenindione, to which it is re- lated chemically, anisindione exercises its thera- peutic action by reducing the prothrombin activity of the blood. INDICATIONS Anisindione is indicated for the prophylaxis and treatment of venous thrombosis and its extension, the treatment of atrial fibrilla- tion with embolization, the prophylaxis and treat- ment of pulmonary embolism, and as an adjunct in the treatment of coronary occlusion. CONTRAINDICATIONS All contraindications to oral anticoagulant therapy are relative rather than absolute. Contraindications should be evaluated for each patient, giving consideration to the need for and the benefits to be achieved by anticoagu- lant therapy, the potential dangers of hemor- rhage, the expected duration of therapy, and the quality of patient monitoring and compliance. Hemorrhagic Tendencies or Blood Dyscrasias: In general, oral anticoagulants are contraindi- cated in patients who are bleeding or who have hemorrhagic blood dyscrasias or hemorrhagic tendencies (eg, hemophilia, polycythemia vera, purpura, leukemia) or a history of bleeding dia- thesis. They are contraindicated in patients with recent cerebral hemorrhage, active ulceration of the gastrointestinal tract, including ulcerative colitis, or open ulcerative, traumatic, or surgical wounds. Oral anticoagulants may be contraindi- cated in patients with recent or contemplated brain, eye, or spinal cord surgery or prostatec- tomy, and in those undergoing regional or lumbar block anesthesia or continuous tube drainage of the small intestine. -
SUMMARY of PRODUCT CHARACTERISTICS 2.1 General Description 2.2 Qualitative and Quantitative Composition
THERADOL 50 mg Effervescent tablets 1 Summary of product characteristics SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT THERADOL 50 mg Effervescent tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 General description Round, biplane white or off-white tablets with bevel-edges on both sides. 2.2 Qualitative and quantitative composition Tramadol hydrochloride 50 mg per effervescent tablet. This product also contains sodium 214 mg, lactose 75 mg and aspartame 10 mg per tablet. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Effervescent tablet. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications Treatment of moderate to severe acute and chronic pain, such as pain due to surgery, trauma, malignancy. 4.2. Posology and method of administration Posology As with all analgesic drugs, the dose of THERADOL 50 mg Effervescent tablets should be adjusted according to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. Adults and children aged 12 years and over: The usual dose is 50 to 100 mg (1 to 2 effervescent tablets), 3 to 4 times a day. In children from 12 to 14 years, it is recommended to use the lowest dose. Geriatric patients THERADOL 50 mg Effervescent tablets 2 Summary of product characteristics A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient's requirements. -
Immediate Hypersensitivity Reactions Caused by Drug Excipients: a Literature Review Caballero ML, Quirce S
REVIEWS Immediate Hypersensitivity Reactions Caused by Drug Excipients: A Literature Review Caballero ML, Quirce S Department of Allergy, La Paz University Hospital, IdiPAZ, Madrid, Spain J Investig Allergol Clin Immunol 2020; Vol. 30(2): 86-100 doi: 10.18176/jiaci.0476 Abstract The European Medicines Agency defines excipients as the constituents of a pharmaceutical form apart from the active substance. Immediate hypersensitivity reactions (IHRs) caused by excipients contained in the formulation of medications have been described. However, there are no data on the prevalence of IHRs due to drug excipients. Clinical manifestations of allergy to excipients can range from skin disorders to life-threatening systemic reactions. The aim of this study was to review the literature on allergy to pharmaceutical excipients and to record the IHRs described with various types of medications, specifically reactions due to the excipients contained in their formulations. The cases reported were sorted alphabetically by type of medication and excipient in order to obtain a list of the excipients most frequently involved for each type of medication. Key words: Allergy. Drug immediate hypersensitivity reaction. Excipient. Pharmaceutical excipients. Resumen La Agencia Europea de Medicamentos define los excipientes como los componentes de una forma farmacéutica diferenciados del principio activo. Se han descrito reacciones de hipersensibilidad inmediata causadas por los excipientes contenidos en la formulación de medicamentos. Sin embargo, no hay datos sobre la prevalencia de dichas reacciones. Las manifestaciones clínicas de la alergia a los excipientes pueden ir desde trastornos de la piel hasta reacciones sistémicas que ponen en peligro la vida. El objetivo de este estudio fue realizar una revisión de la literatura sobre la alergia a los excipientes farmacéuticos y recopilar las reacciones inmediatas descritas con diferentes tipos de medicamento, debido solo a excipientes contenidos en sus formulaciones. -
Spanish 2018 Rx4 Traditional Drug List
Cambios Anuales de Rx4 Traditional 2018 Fecha de entrada en vigor: 01/01/2018 Para visualizarlo en español, haga clic aquí. To view your full Drug List, click here. ¡Bienvenido a Humana! Los cambios al formulario adjunto, o Lista de medicamentos, entran en vigor el 1 de enero de 2018. Visite Humana.com e inicie sesión en MyHumana –su cuenta en línea segura y personal– a partir de la fecha de su renovación para ver los beneficios de medicamentos recetados específicos, incluidos los copagos o el costo compartido, las limitaciones y las exclusiones. También puede consultar su Certificado de cobertura/seguro o su Descripción resumida del plan/Póliza de seguro. Si tiene preguntas: • Posibles afiliados: llamar a Atención al Cliente al número que aparece en los materiales de inscripción • Afiliados actuales: llamar al número indicado al reverso de su tarjeta de identificación de Humana Cómo leer los cambios a su Lista de medicamentos anual Algunos medicamentos cubiertos pueden tener requisitos adicionales o límites en la cobertura. Hable con su médico o proveedor de atención médica si su medicamento tiene un requisito adicional. Estos requisitos y límites pueden incluir: Estatus de la cobertura (CVG, por sus siglas en inglés): Ciertos medicamentos que anteriormente no estaban cubiertos en virtud de los beneficios de su plan se agregarán a su Lista de medicamentos para 2018, mientras que otros medicamentos que quizás estaban cubiertos en el pasado, se eliminarán. Tenga en cuenta que si usted surte o repite la receta de cualquier medicamento no cubierto en virtud de los beneficios de su plan, quizás deba pagar el costo total de su medicamento recetado. -
Oral Anticoagulants (VKA and DOAC) Guidelines for Prescribing, Monitoring and Management
Clinical Guidance Oral Anticoagulants (VKA and DOAC) Guidelines for prescribing, monitoring and management Anticoagulants are one of the classes of medicines which frequently cause harm and admission to hospital. Managing the risk associated with anticoagulants was the subject of The National Patient Safety Agency Patient Safety Alert number 18 March 2007. High risks identified with prescribing anticoagulation include: • Failure to initiate oral anticoagulant therapy where indicated • Poor documentation of reason and treatment plan at commencement of therapy • Incorrect prescribing of oral anticoagulant doses (especially loading doses) The formulary has 5 different anticoagulants to choose from. For the majority of patients, the choice of anticoagulant is guided by indication, clinician and patient choice after appropriate discussion of risks and benefits of the different options. Anticoagulation is not advisable if the risk of harm is likely to outweigh the benefits of treatment. Consideration should be given to the safety of initiating oral anticoagulants in patients with: • cognitive impairment • risk of falls/ with a history of falls, • history of bleeding, • excess alcohol intake • liver disease • impaired visual acuity The HASBLED score can be used to give an indication of the overall risk of bleeding. This scoring system has been validated in patients with atrial fibrillation (it is not validated in the VTE setting). Clinical characteristic Points awarded H Hypertension 1 A Abnormal renal and liver function (1 point each) 1 or 2 S Stroke 1 B Bleeding 1 L Labile INRs 1 E Elderly (age >65 years) 1 D Drugs or alcohol (1 point each) 1 or 2 Maximum 9 points A score of 3 or more indicates increased one year bleed risk on anticoagulation sufficient to justify caution or more regular review. -
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 -
Effervescent Proliposomes for Aerosol Delivery to Paranasal Sinuses
EFFERVESCENT PROLIPOSOMES FOR AEROSOL DELIVERY TO PARANASAL SINUSES BY OSHADIE KORALE A thesis submitted in partial fulfilment for the requirements for the degree of PhD at the University of Central Lancashire June, 2016 Dedication I dedicate this achievement to my parents, fiancé, brother, my grandmother and friends; without their encouragement and love this would not have been possible. 1 University of Central Lancashire STUDENT DECLARATION FORM Concurrent registration for two or more academic awards I declare that while registered as a candidate for the research degree, I have not been a registered candidate or enrolled student for another award of the University or other academic or professional institution ____________________________________________________________________________ Material submitted for another award I declare that no material contained in the thesis has been used in any other submission for an academic award and is solely my own work ____________________________________________________________________________ Signature of Candidate Type of Award Doctor of Philosophy (PhD) School Pharmacy and Biomedical Science, University of Central Lancashire 2 Abstract This study aims to design and develop effervescent proliposomes that could disintegrate in water and liberate liposomes, and to investigate the potential suitability of liposomes generated for aerosolization to target paranasal sinuses. Novel effervescent proliposomes prepared with Soya phosphatidylcholine (SPC) and Dipalmitoylphosphatidylcholine (DPPC) successfully generated stable liposomes with an improved disintegration time of less than 5 min. Differences in lipid composition were found to influence liposome size and drug entrapment of the hydrophobic drug Beclometasone dipropionate (BDP). Mannitol-based formulations developed with DPPC:Chol (1:1) produced liposomes of 7.54±0.15 µm with a drug entrapment efficiency of 82.15±8.29%. -
MERCHANT SHIPPING (SEAFARERS) (MEDICAL STORES) REGULATION (Cap
MERCHANT SHIPPING (SEAFARERS) (MEDICAL STORES) REGULATION (Cap. 478 sections 96, 100 and 134) [2 September 1996] PART I PRELIMINARY 1. (Omitted as spent) 2. Interpretation (1) In this Regulation, unless the context otherwise requires— “chemical” ( 化 學 品 ) means any chemical listed in the following International Maritime Organization publications— (a) the General Index of the International Maritime Dangerous Goods Code; (b) the Index of Dangerous Chemicals Carried in Bulk; or (c) Chapter XIX of the International Code for the Construction and Equipment of Ships Carrying Liquefied Gases in Bulk; “crew” (船員) means all seafarers employed on board a ship; “employer” (僱主) means the person for the time being employing the master; “IMDG Code” (《國際海運危險貨物守則》) means the 1988 edition of the International Maritime Dangerous Goods Code published by the International Maritime Organization; “offshore installation” (離岸裝置) means any installation which is maintained, or is intended to be established, for underwater exploitation or exploration; “seagoing” (海域航行), in relation to a ship, means any ship other than a ship which navigates exclusively within inland waters or in areas where port regulations apply; “submersible craft” (潛水艇) means any vessel used or designed for use under the surface of any waters; “voyage” (航程) means a journey from a port to the next port of call of a ship (which may be the same port). (2) Any reference in this Regulation to the British Pharmacopoeia, the European Pharmacopoeia, or the British National Formulary shall in its application to a particular case be construed as a reference to the edition thereof current at, or not more than 3 months before, the time when any requirement of this Regulation has effect.