Nonpharmacological Treatment of Rhinoconjunctivitis and Rhinosinusitis

Total Page:16

File Type:pdf, Size:1020Kb

Nonpharmacological Treatment of Rhinoconjunctivitis and Rhinosinusitis Journal of Allergy Nonpharmacological Treatment of Rhinoconjunctivitis and Rhinosinusitis Guest Editors: Ralph Mösges, Carlos E. Baena-Cagnani, and Desiderio Passali Nonpharmacological Treatment of Rhinoconjunctivitis and Rhinosinusitis Journal of Allergy Nonpharmacological Treatment of Rhinoconjunctivitis and Rhinosinusitis Guest Editors: Ralph Mosges,¨ Carlos E. Baena-Cagnani, and Desiderio Passali Copyright © 2014 Hindawi Publishing Corporation. All rights reserved. This is a special issue published in “Journal of Allergy.” All articles are open access articles distributed under the Creative Commons At- tribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Editorial Board William E. Berger, USA Alan P. Knutsen, USA Fabienne Ranc, France Kurt Blaser, Switzerland Marek L. Kowalski, Poland Anuradha Ray, USA Eugene R. Bleecker, USA Ting Fan Leung, Hong Kong Harald Renz, Germany JandeMonchy,TheNetherlands Clare M Lloyd, UK Nima Rezaei, Iran Frank Hoebers, The Netherlands Redwan Moqbel, Canada Robert P. Schleimer, USA StephenT.Holgate,UK Desiderio Passali, Italy Massimo Triggiani, Italy Sebastian L. Johnston, UK Stephen P. Peters, USA Hugo Van Bever, Singapore Young J. Juhn, USA David G. Proud, Canada Garry Walsh, United Kingdom Contents Nonpharmacological Treatment of Rhinoconjunctivitis and Rhinosinusitis,RalphMosges,¨ Carlos E. Baena-Cagnani, and Desiderio Passali Volume 2014, Article ID 416236, 2 pages Clinical Efficacy of a Spray Containing Hyaluronic Acid and Dexpanthenol after Surgery in the Nasal Cavity (Septoplasty, Simple Ethmoid Sinus Surgery, and Turbinate Surgery), Ina Gouteva, Kija Shah-Hosseini, and Peter Meiser Volume 2014, Article ID 635490, 10 pages The Effectiveness of Acupuncture Compared to Loratadine in Patients Allergic to House Dust ,Mites Bettina Hauswald, Christina Dill, Jurgen¨ Boxberger, Eberhard Kuhlisch, Thomas Zahnert, and Yury M. Yarin Volume 2014, Article ID 654632, 7 pages Treatment of Allergic Rhinitis with Ectoine Containing Nasal Spray and Eye Drops in Comparison with Azelastine Containing Nasal Spray and Eye Drops or with Cromoglycic Acid Containing Nasal Spray, Nina Werkhauser,¨ Andreas Bilstein, and Uwe Sonnemann Volume2014,ArticleID176597,13pages Thermal Water Applications in the Treatment of Upper Respiratory Tract Diseases: A Systematic Review and Meta-Analysis,SarahKeller,VolkerKonig,¨ and Ralph Mosges¨ Volume2014,ArticleID943824,17pages Noninterventional Open-Label Trial Investigating the Efficacy and Safety of Ectoine Containing Nasal Spray in Comparison with Beclomethasone Nasal Spray in Patients with Allergic Rhinitis, Uwe Sonnemann, Marcus Moller,¨ and Andreas Bilstein Volume2014,ArticleID297203,12pages Liposomal Nasal Spray versus Guideline-Recommended Steroid Nasal Spray in Patients with Chronic Rhinosinusitis: A Comparison of Tolerability and Quality of Life,AnnaEitenmuller,¨ Lisa Piano, Myriam Bohm,¨ Kija Shah-Hosseini, Andreas Glowania, Oliver Pfaar, Ralph Mosges,¨ and Ludger Klimek Volume 2014, Article ID 146280, 8 pages Meta-Analysis of the Efficacy of Ectoine Nasal Spray in Patients with Allergic Rhinoconjunctivitis, Andrea Eichel, Andreas Bilstein, Nina Werkhauser,¨ and Ralph Mosges¨ Volume 2014, Article ID 292545, 12 pages Probiotics in the Treatment of Chronic Rhinoconjunctivitis and Chronic Rhinosinusitis, Matthias F. Kramer and Matthew D. Heath Volume 2014, Article ID 983635, 7 pages The Compatible Solute Ectoine Reduces the Exacerbating Effect of Environmental Model Particles on the Immune Response of the Airways, Klaus Unfried, Matthias Kroker, Andrea Autengruber, Marijan Gotic,´ and Ulrich Sydlik Volume 2014, Article ID 708458, 7 pages Treatment of Rhinitis Sicca Anterior with Ectoine Containing Nasal Spray, Uwe Sonnemann, Olaf Scherner, and Nina Werkhauser¨ Volume 2014, Article ID 273219, 10 pages Hindawi Publishing Corporation Journal of Allergy Volume 2014, Article ID 416236, 2 pages http://dx.doi.org/10.1155/2014/416236 Editorial Nonpharmacological Treatment of Rhinoconjunctivitis and Rhinosinusitis Ralph Mösges,1 Carlos E. Baena-Cagnani,2 and Desiderio Passali3 1 Institute of Medical Statistics, Informatics and Epidemiology (IMSIE), University Hospital of Cologne, Cologne, Germany 2Postgraduate Department of the Faculty of Medicine, Catholic University of Cordoba, Cordoba, Argentina 3University of Siena, ENT Unit, Siena, Italy Correspondence should be addressed to Ralph Mosges;¨ [email protected] Received 18 November 2014; Accepted 18 November 2014; Published 21 December 2014 Copyright © 2014 Ralph Mosges¨ et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Infectious and allergic diseases of the upper airways are In their article on the clinical efficacy of a spray containing among the most common illnesses of all age groups. Numer- hyaluronic acid and dexpanthenol after surgery in the nasal ous guidelines have been issued for the evidence-based cavity, I. Gouteva et al. demonstrate beneficial effects on treatment of these diseases. Therapy involves local or systemic wound healing for two substances that have a long history application of well-characterized pharmacologically active of local application in the nose but formerly were used medications such as glucocorticosteroids, antihistamines, separately. leukotriene-receptor antagonists, alpha-adrenergic receptor The so-called “extremolyte” ectoine is a substance, which agonists, mast-cell stabilizers, and a monoclonal antibody was introduced a few years ago as a “natural” treatment of targeting specific immunoglobulin E. In spite of the fact that allergic and inflammatory pathologies of the skin and the the various therapeutic options have proven their efficacy mucosal tissues. Five articles in this issue illuminate the and effectiveness in a myriad of well-designed clinical trials, mechanism of action and the potential benefits of a nasal many patients express their discontent with current therapies. spray containing ectoine in diseases of various aetiologies like In several surveys a majority of patients stated that they rhinitis sicca or allergic rhinitis. would prefer nonpharmacological “nonchemical” treatment A form of local treatment of the nasal mucosa that is over what is currently prescribed or recommended by their proximate to ectoine is the nasal spray containing liposomes. physicians. This desire stands in clear contrast to a systematic Its use in allergic rhinitis has been well established. A. reviewconductedsomeyearsagoprovingthattherewasprac- Eitenmuller¨ and coauthors present in their article for the first tically no evidence at that time for the efficacy of alternative time data on ectoine in chronic rhinosinusitis. forms of treatment of allergic diseases of the upper airways. For patients who are sceptical about using any sort of Ever since, several meta-analyses, systematic reviews, and active ingredients in their nasal spray, the application of mere well-designed clinical trials have been published, bearing water in the form of thermal water inhalations could be an witness to the scientific basis of some nonpharmacologic alternative. S. Keller et al. have conducted a meta-analysis options like nasal irrigation in the treatment of different which demonstrates some benefits of this least-invasive local pathologies of the upper airways, namely, for rhinosinusitis therapy. and for allergic rhinoconjunctivitis. There has been much controversy over the last decade on In this special issue, we want to highlight some new the meaningfulness of probiotics in preventing allergies. New approaches that until lately have found less public attention forms now come as treatment of chronic diseases of the upper in this domain. airways. M. F. Kramer and his coauthor M. D. Heath present 2 Journal of Allergy the latest state of knowledge of this nutritional therapeutic approach. Another much debated therapy in the field of allergic diseases is acupuncture. Most investigations have previ- ously focussed on pollen-allergic patients. It is the merit of Hauswald and coauthors to have conducted a randomized controlled clinical trial using acupuncture as an alternative to treatment with the state-of-the-art antihistamine loratadine in house dust allergic patients. Ithasbeentheintentionoftheeditorsofthisspecialissue to round up our knowledge on alternative therapies for upper airwaysdiseasesbeyondthefieldsofherbalmedicineand homeopathy.Thenumberofarticlesthathavebeensubmitted but more so their quality was a positive surprise. We are very grateful to the publishers who have had the courage of disseminating unusual ideas. Ghada Ali and Marie-JosefineJoistenwerethedrivingspiritsbehindthe scenes and without their continuous commitment this special issue would not have seen the light of the day. We are deeply obliged and thankful for their endeavours. Ralph Mosges¨ Carlos E. Baena-Cagnani Desiderio Passali Hindawi Publishing Corporation Journal of Allergy Volume 2014, Article ID 635490, 10 pages http://dx.doi.org/10.1155/2014/635490 Clinical Study Clinical Efficacy of a Spray Containing Hyaluronic Acid and Dexpanthenol after Surgery in the Nasal Cavity (Septoplasty, Simple Ethmoid Sinus Surgery, and Turbinate Surgery) Ina Gouteva,1 Kija Shah-Hosseini,1 and Peter Meiser2 1 Institute of Medical Statistics, Informatics and Epidemiology, University Hospital of Cologne,
Recommended publications
  • Modulation of Allergic Inflammation in the Nasal Mucosa of Allergic Rhinitis Sufferers with Topical Pharmaceutical Agents
    Modulation of Allergic Inflammation in the Nasal Mucosa of Allergic Rhinitis Sufferers With Topical Pharmaceutical Agents Author Watts, Annabelle M, Cripps, Allan W, West, Nicholas P, Cox, Amanda J Published 2019 Journal Title FRONTIERS IN PHARMACOLOGY Version Version of Record (VoR) DOI https://doi.org/10.3389/fphar.2019.00294 Copyright Statement © Frontiers in Pharmacology 2019. The attached file is reproduced here in accordance with the copyright policy of the publisher. Please refer to the journal's website for access to the definitive, published version. Downloaded from http://hdl.handle.net/10072/386246 Griffith Research Online https://research-repository.griffith.edu.au fphar-10-00294 March 27, 2019 Time: 17:52 # 1 REVIEW published: 29 March 2019 doi: 10.3389/fphar.2019.00294 Modulation of Allergic Inflammation in the Nasal Mucosa of Allergic Rhinitis Sufferers With Topical Pharmaceutical Agents Annabelle M. Watts1*, Allan W. Cripps2, Nicholas P. West1 and Amanda J. Cox1 1 Menzies Health Institute Queensland, School of Medical Science, Griffith University, Southport, QLD, Australia, 2 Menzies Health Institute Queensland, School of Medicine, Griffith University, Southport, QLD, Australia Allergic rhinitis (AR) is a chronic upper respiratory disease estimated to affect between 10 and 40% of the worldwide population. The mechanisms underlying AR are highly complex and involve multiple immune cells, mediators, and cytokines. As such, the development of a single drug to treat allergic inflammation and/or symptoms is confounded by the complexity of the disease pathophysiology. Complete avoidance of allergens that trigger AR symptoms is not possible and without a cure, the available therapeutic options are typically focused on achieving symptomatic relief.
    [Show full text]
  • (CD-P-PH/PHO) Report Classification/Justifica
    COMMITTEE OF EXPERTS ON THE CLASSIFICATION OF MEDICINES AS REGARDS THEIR SUPPLY (CD-P-PH/PHO) Report classification/justification of medicines belonging to the ATC group R01 (Nasal preparations) Table of Contents Page INTRODUCTION 5 DISCLAIMER 7 GLOSSARY OF TERMS USED IN THIS DOCUMENT 8 ACTIVE SUBSTANCES Cyclopentamine (ATC: R01AA02) 10 Ephedrine (ATC: R01AA03) 11 Phenylephrine (ATC: R01AA04) 14 Oxymetazoline (ATC: R01AA05) 16 Tetryzoline (ATC: R01AA06) 19 Xylometazoline (ATC: R01AA07) 20 Naphazoline (ATC: R01AA08) 23 Tramazoline (ATC: R01AA09) 26 Metizoline (ATC: R01AA10) 29 Tuaminoheptane (ATC: R01AA11) 30 Fenoxazoline (ATC: R01AA12) 31 Tymazoline (ATC: R01AA13) 32 Epinephrine (ATC: R01AA14) 33 Indanazoline (ATC: R01AA15) 34 Phenylephrine (ATC: R01AB01) 35 Naphazoline (ATC: R01AB02) 37 Tetryzoline (ATC: R01AB03) 39 Ephedrine (ATC: R01AB05) 40 Xylometazoline (ATC: R01AB06) 41 Oxymetazoline (ATC: R01AB07) 45 Tuaminoheptane (ATC: R01AB08) 46 Cromoglicic Acid (ATC: R01AC01) 49 2 Levocabastine (ATC: R01AC02) 51 Azelastine (ATC: R01AC03) 53 Antazoline (ATC: R01AC04) 56 Spaglumic Acid (ATC: R01AC05) 57 Thonzylamine (ATC: R01AC06) 58 Nedocromil (ATC: R01AC07) 59 Olopatadine (ATC: R01AC08) 60 Cromoglicic Acid, Combinations (ATC: R01AC51) 61 Beclometasone (ATC: R01AD01) 62 Prednisolone (ATC: R01AD02) 66 Dexamethasone (ATC: R01AD03) 67 Flunisolide (ATC: R01AD04) 68 Budesonide (ATC: R01AD05) 69 Betamethasone (ATC: R01AD06) 72 Tixocortol (ATC: R01AD07) 73 Fluticasone (ATC: R01AD08) 74 Mometasone (ATC: R01AD09) 78 Triamcinolone (ATC: R01AD11) 82
    [Show full text]
  • Prediction of Premature Termination Codon Suppressing Compounds for Treatment of Duchenne Muscular Dystrophy Using Machine Learning
    Prediction of Premature Termination Codon Suppressing Compounds for Treatment of Duchenne Muscular Dystrophy using Machine Learning Kate Wang et al. Supplemental Table S1. Drugs selected by Pharmacophore-based, ML-based and DL- based search in the FDA-approved drugs database Pharmacophore WEKA TF 1-Palmitoyl-2-oleoyl-sn-glycero-3- 5-O-phosphono-alpha-D- (phospho-rac-(1-glycerol)) ribofuranosyl diphosphate Acarbose Amikacin Acetylcarnitine Acetarsol Arbutamine Acetylcholine Adenosine Aldehydo-N-Acetyl-D- Benserazide Acyclovir Glucosamine Bisoprolol Adefovir dipivoxil Alendronic acid Brivudine Alfentanil Alginic acid Cefamandole Alitretinoin alpha-Arbutin Cefdinir Azithromycin Amikacin Cefixime Balsalazide Amiloride Cefonicid Bethanechol Arbutin Ceforanide Bicalutamide Ascorbic acid calcium salt Cefotetan Calcium glubionate Auranofin Ceftibuten Cangrelor Azacitidine Ceftolozane Capecitabine Benserazide Cerivastatin Carbamoylcholine Besifloxacin Chlortetracycline Carisoprodol beta-L-fructofuranose Cilastatin Chlorobutanol Bictegravir Citicoline Cidofovir Bismuth subgallate Cladribine Clodronic acid Bleomycin Clarithromycin Colistimethate Bortezomib Clindamycin Cyclandelate Bromotheophylline Clofarabine Dexpanthenol Calcium threonate Cromoglicic acid Edoxudine Capecitabine Demeclocycline Elbasvir Capreomycin Diaminopropanol tetraacetic acid Erdosteine Carbidopa Diazolidinylurea Ethchlorvynol Carbocisteine Dibekacin Ethinamate Carboplatin Dinoprostone Famotidine Cefotetan Dipyridamole Fidaxomicin Chlormerodrin Doripenem Flavin adenine dinucleotide
    [Show full text]
  • Hyaluronic Acid Introduced 2003
    Hyaluronic Acid Introduced 2003 What Is It? Are There Any Potential Drug Interactions? Hyaluronic acid, or HA, is a naturally occurring polymer found in every tissue of At this time, there are no known adverse reactions when taken in conjunction the body. It is particularly concentrated in the skin (almost 50% of all HA in the with medications. body is found in the skin) and synovial fluid. It is composed of alternating units of n-acetyl-d-glucosamine and d-glucuronate. This polymer’s functions include Hyaluronic acid attracting and retaining water in the extracellular matrix of tissues, in layers of skin, and in synovial fluid.* each vegetarian capsule contains v 3 hyaluronic acid (low molecular weight) ..............................................................................70 mg Features Include other ingredients: hypo-allergenic plant fiber (cellulose), vegetarian capsule (cellulose, water) 1–2 capsules per day, in divided doses, with or between meals. Clinically Researched Absorption: In nature, HA is a large molecular weight compound, ranging in size from 500,000-6,000,000 daltons. This is too large to ® be absorbed in the small intestines. HyaMax sodium hyaluronate provides a Hyaluronic acid liquid low molecular weight source of hyaluronic acid produced through fermentation. ® In a pharmacokinetic study, orally administered HyaMax hyaluronic acid was 2 ml (0.06 fl oz) (2 full droppers) contains v incorporated into joints, connective tissue and skin, with a particular affinity for hyaluronic acid (low molecular weight) ..............................................................................10 mg cartilaginous joints.* other ingredients: purified water, apple juice concentrate, citric acid, natural apple flavor, potassium sorbate, purified stevia extract Uses For Hyaluronic Acid serving size: 2 ml (0.06 fl oz) Skin Health: For skin cells, the ability of HA to attract and retain water is servings per container: 29 essential for proper cell-to-cell communication, hydration, nutrient delivery, and 1-2 servings daily, with or between meals.
    [Show full text]
  • Rhinitis - Allergic (1 of 15)
    Rhinitis - Allergic (1 of 15) 1 Patient presents w/ signs & symptoms of rhinitis 2 • Consider other classifi cations of rhinitis DIAGNOSIS No - Please see Rhinitis Is allergic rhinitis - Nonallergic disease confi rmed? management chart Yes 3 ASSESS DURATION & SEVERITY OF ALLERGIC RHINITIS A Non-pharmacological therapy • Allergen avoidance • Patient education VAS <5 VAS ≥5 B Pharmacological therapy B Pharmacological therapy • Antihistamines (oral/nasal), &/or • Corticosteroids (nasal), w/ or without • Corticosteroids (nasal), or • Antihistamines (nasal), or • Cromone (nasal), or • LTRA • Leukotriene receptor antagonists (LTRA)MIMS TREATMENT © See next page Specifi cally for patients w/ asthma Not all products are available or approved for above use in all countries. Specifi c prescribing information may be found in the latest MIMS. B167 © MIMS Pediatrics 2020 Rhinitis - Allergic (2 of 15) Previously treated symptomatic Previously treated symptomatic patient (VAS <5) on antihistamines patient (VAS ≥5) on intensifi ed (oral/nasal) &/or corticosteroids (nasal) therapy w/ corticosteroids (nasal) w/ or without antihistamines (nasal) Intermittent Persistent symptoms, symptoms or without allergen w/ allergen exposure exposure B Pharmacological therapy B Pharmacological therapy • Step down or discontinue therapy • Continue or step up therapy Untreated REASSESS DISEASE SEVERITY VAS symptomatic patient DAILY UP TO DAY 3 (VAS <5 or ≥5) 4 CONTINUE Yes THERAPY & STEP EVALUATION VAS <5 DOWN THERAPY1 Improvement of symptoms? No VAS ≥5 B Pharmacological therapy • Step-up therapy REASSESS DISEASE SEVERITY MIMSVAS DAILY UP TO DAY 7 4 Yes EVALUATION VAS <5 Improvement of symptoms? No TREATMENT © VAS ≥5 See next page Continue therapy if symptomatic; consider step-down or discontinuation of therapy if symptoms subside Not all products are available or approved for above use in all countries.
    [Show full text]
  • For Peer Review Only
    BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-012177 on 30 November 2016. Downloaded from Commonly prescribed drugs associated with cognition: a cross-sectional study in UK Biobank ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2016-012177 Article Type: Research Date Submitted by the Author: 06-Apr-2016 Complete List of Authors: Nevado-Holgado, Alejo; University of Oxford, Psychiatry Kim, Chi-Hun; University of Oxford, Psychiatry Winchester, Laura; University of Oxford, Psychiatry Gallacher, John; University of Oxford, Psychiatry Lovestone, Simon; University of Oxford, Psychiatry <b>Primary Subject Public health Heading</b>: Secondary Subject Heading: Mental health, Pharmacology and therapeutics, Neurology Keywords: PUBLIC HEALTH, MENTAL HEALTH, Cognition, UK biobank http://bmjopen.bmj.com/ on September 26, 2021 by guest. Protected copyright. For peer review only − http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 16 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-012177 on 30 November 2016. Downloaded from 1 2 3 Commonly prescribed drugs associate with cognition: a cross-sectional study 4 in UK Biobank 5 6 7 8 Authors 9 10 Alejo J Nevado-Holgado*, Chi-Hun Kim*, Laura Winchester, John Gallacher, Simon Lovestone 11 12 13 14 15 Address For peer review only 16 17 Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford OX3 7JX, UK 18 19 20 21 22 23 Authors’ names and positions 24 25 Alejo J Nevado-Holgado*: Postdoctoral researcher 26 27 Chi-Hun Kim*: Postdoctoral researcher 28 29 Laura Winchester: Postdoctoral researcher 30 31 John Gallacher: Professor 32 33 Simon Lovestone: Professor 34 http://bmjopen.bmj.com/ 35 *These authors contributed equally to this work.
    [Show full text]
  • Supplementary Information
    1 SUPPLEMENTARY INFORMATION 2 ATIQ – further information 3 The Asthma Treatment Intrusiveness Questionnaire (ATIQ) scale was adapted from a scale originally 4 developed by Professor Horne to assess patients’ perceptions of the intrusiveness of antiretroviral 5 therapies (HAART; the HAART intrusiveness scale).1 This scale assesses convenience and the degree 6 to which the regimen is perceived by the patient to interfere with daily living, social life, etc. The 7 HAART intrusiveness scale has been applied to study differential effects of once- vs. twice-daily 8 antiretroviral regimens2 and might be usefully applied to identify patients who are most likely to 9 benefit from once-daily treatments. 10 11 References: 12 1. Newell, A., Mendes da Costa, S. & Horne, R. Assessing the psychological and therapy-related 13 barriers to optimal adherence: an observational study. Presented at the Sixth International 14 congress on Drug Therapy in HIV Infection, Glasgow, UK (2002). 15 2. Cooper, V., Horne, R., Gellaitry, G., Vrijens, B., Lange, A. C., Fisher, M. et al. The impact of once- 16 nightly versus twice-daily dosing and baseline beliefs about HAART on adherence to efavirenz- 17 based HAART over 48 weeks: the NOCTE study. J Acquir Immune Defic Syndr 53, 369–377 18 (2010). 19 1 20 Supplementary Table S1. Asthma medications, reported by participants at the time of survey Asthma medication n (%) Salbutamol 406 (40.2) Beclometasone 212 (21.0) Salmeterol plus fluticasone 209 (20.7) Salbutamol plus ipratropium 169 (16.7) Formoterol plus budesonide 166
    [Show full text]
  • Metered Dose Inhalers Contents
    COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 23.10.1998 COM( 1998) 603 final COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT STRATEGY FOR THE PHASEOU-T OF CFCs IN METERED DOSE INHALERS CONTENTS Chapter 1 Introduction Page 3 Chapter2 Executive Summary Page4 Chapter 3 CFCs and MDis Page 6 Chapter4 Patient Needs Page 9 Chapter 5 Developing Alternatives to CFC-containing MD Is Page 13 Chapter 6 Approval of new products and post-authorisation surveillance Page 18 Chapter 7 Phasing out CFCs Page 25 Chapter 8 Awareness raising Page 34 Chapter 9 Exports of MD Is from the EC Page 38 Chapter 10 CFC production Issues Page 40 Chapter 11 The Essential Use Process -Overview and Timetable Page 43 2 CHAPTER 1 INTRODUCTION 1.1 Decision IX/19 of the Parties to the Montreal Protocol reqmres Parties requesting essential use nominations for chlorofluorocarbons CFCs for metered-dose inhalers (MDis) to present to the Ozone Secretariat an initial national or regional transition strategy if possible by 31 January 1998, and in any case by 31 January 1999. The European Community is a Party to the Montreal Proklc.'t>l, and this document is its transition strategy prepared in accordance with decision IX/19 of the Parties. The European Community believes that a transition strategy is necessary to set out how the transition out of CFCs in MD Is is to be managed such that the CFCs can be phased out as quickly as possible without putting in jeopardy supplies of necessary medicines to patients in need. 1.2 The European Community, on behalf of the Member States, submits a joint request every year to the Parties for the continued use of CFCs to.manufacture MDis.
    [Show full text]
  • Bulk Drug Substances Under Evaluation for Section 503A
    Updated July 1, 2020 Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Includes three categories of bulk drug substances: • Category 1: Bulk Drug Substances Under Evaluation • Category 2: Bulk Drug Substances that Raise Significant Safety Concerns • Category 3: Bulk Drug Substances Nominated Without Adequate Support Updates to Section 503A Categories • Removal from category 3 o Artesunate – This bulk drug substance is a component of an FDA-approved drug product (NDA 213036) and compounded drug products containing this substance may be eligible for the exemptions under section 503A of the FD&C Act pursuant to section 503A(b)(1)(A)(i)(II). This change will be effective immediately and will not have a waiting period. For more information, please see the Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A and the final rule on bulk drug substances that can be used for compounding under section 503A, which became effective on March 21, 2019. 1 Updated July 1, 2020 503A Category 1 – Bulk Drug Substances Under Evaluation • 7 Keto Dehydroepiandrosterone • Glycyrrhizin • Acetyl L Carnitine/Acetyl-L- carnitine • Kojic Acid Hydrochloride • L-Citrulline • Alanyl-L-Glutamine • Melatonin • Aloe Vera/ Aloe Vera 200:1 Freeze Dried • Methylcobalamin • Alpha Lipoic Acid • Methylsulfonylmethane (MSM) • Artemisia/Artemisinin • Nettle leaf (Urtica dioica subsp. dioica leaf) • Astragalus Extract 10:1 • Nicotinamide Adenine Dinucleotide (NAD) • Boswellia • Nicotinamide
    [Show full text]
  • Intra-Articular Corticosteroid and Hyaluronic Acid Injections in the Management of Osteoarthritis
    78 Review / Derleme Intra-Articular Corticosteroid and Hyaluronic Acid Injections in the Management of Osteoarthritis Osteoartrit Tedavisinde ‹ntraartiküler Kortikosteroid ve Hyaluronik Asit Enjeksiyonlar› G. Guy VANDERSTRAETEN, Martine De MUYNCK, Luc Vanden BOSCCHE, Tina DECORTE Ghent University Hospital, Department of Physical Medicine and Rehabilitation, Ghent, Belgium Summary Özet Intra-articular corticosteroid injections have long been used to treat oste- Eklem içi kortikosteroid enjeksiyonlar› osteoartrit tedavisinde uzun sü- oarthritis, whereas intra-articular hyaluronic acid injections for only a few reden beri kullan›lmaktad›r. Oysa eklem içi hyaluronik asit injeksiyonlar› years. In the literature, evidence-based reports on the efficacy of these sadece son y›llarda kullan›l›r hale gelmifltir. Literatürde bu ajanlar›n et- compounds are non-existent. In the presence of acute hydrops in an oste- kinli¤i aç›s›ndan kan›ta dayal› raporlar bulunmamaktad›r. Osteoartritli oarthritic knee an intra-articular corticosteroid injection following aspirati- bir dizde akut efüzyon varl›¤›nda eklemden aspirasyonu takiben eklem on of the joint can be considered. A maximum of 3 injections can be admi- içi kortikosteroid uygulamas› düflünülebilir. 8-10 günlük aralar ile en faz- nistered at intervals of 8 to 10 days, to be repeated every 6 months if ab- la 3 enjeksiyon uygulanabilir ve e¤er çok gerekli ise her 6 ayda bir tek- solutely necessary. A patient with a dry and painful osteoarthritic knee can rarlanabilir. Kuru ve a¤r›l› bir diz ise haftal›k aralar ile uygulanan eklem be a candidate for intra-articular hyaluronic acid injections at weekly inter- içi hyaluronik asit enjeksiyonu için aday olabilir.
    [Show full text]
  • Features CSA Outpatient Prescription Formulary
    FY2014 Cancer State Aid Supportive Therapies Formulary Out-Patient Prescriptions Formulary Prescription Notes To qualify for reimbursement, medications must be related to the treatment of the patient's cancer or cancer symptoms. Medications for conditions not related to the patient's cancer treatment or related symptoms are not eligible for program reimbursements. If available, generic equivalents must be used. Reimbursement will only be made for brand name drugs if there is no generic equivalent. Over-the-counter medication and strengths of medication will not be approved. For compounds, reimbursement will be made only for the amount of actual medication dispensed. All prescription medications require written and Cancer State Aid (CSA) signed prior approval on a current CSA Medication Request Form. In addition to prior approval, any medications not included on this list will require additional medical and/or financial review. Approvals of requested prescriptions and refills are limited to time periods which do not extend beyond the current state fiscal year (FY), as patient enrollments are limited to the current FY. Each State FY begins on July 1st and ends on the following June 30th. Antibiotics/Antifungals Recommended Duration of Therapy - limited to 30 days Generic Name Brand Name Amoxicillin Amoxil, Trimox Amoxicillin/clavulanate Augmentin Ampicillin Principen Azithromycin Z-Pak Cefadroxil Duricef Cefdinir Omnicef Cefuroxime Ceftin Cephalexin Keflex Ciprofloxacin Cipro Clarithromycin Biaxin Clindamycin Cleocin Clotrimazole Mycelex Dapsone Dapsone Doxycycline Doryx, Monodox, Vibra-tabs Erythromycin Eryc, Ery-tab, PCE, E.E.S. Ethambutol Myambutol Fluconazole Diflucan Gatifloxacin Tequin Ketoconazole Nizoral Levofloxacin Levaquin Metronidazole Flagyl Moxifloxacin Avelox Mupirocin Bactroban Neomycin Various combinations Rev.
    [Show full text]
  • Høring Vedrørende Indstilling Til Kommissionens Lister Over Lægemidler, Der Omfattes Af Eller Undtages Fra Kravet Om Sikkerhedsforanstaltninger / Safety Features
    Høring vedrørende indstilling til Kommissionens lister over lægemidler, der omfattes af eller undtages fra kravet om sikkerhedsforanstaltninger / safety features Sundhedsstyrelsen beder hermed om kommentarer og eventuelle yderligere oplysninger til udkast til liste over godkendte receptpligtige lægemidler der 4. september 2014 påtænkes indstillet til Europa Kommissionen med henblik på undtagelse fra Sagsnr. LMST 2014083346 kravet om sikkerhedsforanstaltninger (hvid liste ). Annex 1. Reference MBK E [email protected] Endvidere beder vi om oplysninger om hvilke godkendte ikke-receptpligtige lægemidler, der tidligere har været forfalsket og derfor skal omfattes af kravet om sikkerhedsforanstaltninger (sort liste ). Annex 2. Krav om sikkerhedsforanstaltninger på lægemidler Europa-Parlamentets og Rådets direktiv 2011/62 1 om ændring af direktiv 2001/83 2 om oprettelse af en fællesskabskodeks for humanmedicinske lægemidler for så vidt angår forhindring af, at forfalskede lægemidler kommer ind i den lovlige forsyningskæde, indfører sikkerhedsforanstaltninger på visse lægemidler. Direktivet indfører to former for sikkerhedsforanstaltninger på den ydre pakning på visse lægemidler med undtagelse af radioaktive lægemidler. Det fremgår således af artikel 54(o) i direktiv 2001/83, at sikkerhedsforanstaltningerne skal gøre det muligt, dels at kontrollere lægemidlets ægthed og identificere individuelle pakninger (en unik identifikator), dels at kontrollere om lægemidlets ydre emballage har været brudt (en anbrudsanordning). Kontrollen af sikkerhedsforanstaltningerne
    [Show full text]