DOCSLIB.ORG

Antimicrobial Resistance Benchmark 2020 Antimicrobial Resistance Benchmark 2020

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

First independent framework for assessing pharmaceutical company action Antimicrobial Resistance Benchmark 2020 Antimicrobial Resistance Benchmark 2020 ACKNOWLEDGEMENTS The Access to Medicine Foundation would like to thank the following people and organisations for their contributions to this report.1 FUNDERS The Antimicrobial Resistance Benchmark research programme is made possible with financial support from UK AID and the Dutch Ministry of Health, Welfare and Sport. Expert Review Committee Research Team Reviewers Hans Hogerzeil - Chair Gabrielle Breugelmans Christine Årdal Gregory Frank Fatema Rafiqi Karen Gallant Nina Grundmann Adrián Alonso Ruiz Hans Hogerzeil Magdalena Kettis Ruth Baron Hitesh Hurkchand Joakim Larsson Dulce Calçada Joakim Larsson Marc Mendelson Moska Hellamand Marc Mendelson Margareth Ndomondo-Sigonda Kevin Outterson Katarina Nedog Sarah Paulin (Observer) Editorial Team Andrew Singer Anna Massey Deirdre Cogan ACCESS TO MEDICINE FOUNDATION Rachel Jones The Access to Medicine Foundation is an independent Emma Ross non-profit organisation based in the Netherlands. It aims to advance access to medicine in low- and middle-income Additional contributors countries by stimulating and guiding the pharmaceutical Thomas Collin-Lefebvre industry to play a greater role in improving access to Alex Kong medicine. Nestor Papanikolaou Address Contact Naritaweg 227-A For more information about this publication, please contact 1043 CB, Amsterdam Jayasree K. Iyer, Executive Director The Netherlands [email protected] +31 (0) 20 215 35 35 www.amrbenchmark.org 1 This acknowledgement is not intended to imply that the individuals and institutions referred to above endorse About the cover: Young woman from the Antimicrobial Resistance Benchmark methodology, Brazil, where 40%-60% of infections are analyses or results. Decisions regarding the final anal- caused by drug-resistant bacteria. ysis were ultimately made by the Access to Medicine Foundation. Photo: FG Trade (Getty Images) 2 Access to Medicine Foundation The fragile antibiotic market has reached a tipping point The Antimicrobial Resistance Benchmark has evaluated for This second Benchmark provides a reality check. the second time how the most important players in the anti- Fixing the problem does not require a scientific miracle. It biotic market are addressing the rise of resistance and the demands a very human solution – albeit one that is easier said global need for appropriate access to antibiotics. Although we than done. The tough market conditions must be replaced can see progress — it’s hanging by a thread. through a mix of public and private investment to ensure a We have reached a tipping point where large and prom- healthy ecosystem of pharmaceutical innovation, production inent drugmakers have retreated from the antibiotics field and supply. and smaller innovative biotech companies have gone bank- We see good practice in multiple areas in 2020. More com- rupt due to the poor financial rewards on offer. Antibiotics are panies are stepping up – with promising ideas for tackling the taken for short courses and the most precious products are toughest pathogens, and improvements in tracking resistance reserved for emergencies. Only a handful of large research- and safeguarding the effectiveness of existing products. We based companies remain broadly engaged in developing new can’t take their commitment for granted and wait for more antibiotics, down from more than 20 in the 1980s. Losing any companies to abandon this vital area of modern medicine. It is more big suppliers and innovators will make it extremely hard not too late to prevent irreparable damage to the global sup- to ramp up effective drug discovery and development oper- ply of antibiotic medicines and vaccines. ations, while the tough economics of the market discourage investment in new manufacturing capacity. This disinvestment and industry consolidation has created an increasingly fragile manufacturing and supply chain. While the top 30 companies have more than 200 sites for produc- ing antibiotics globally, just four companies – GSK, Novartis (through its generics arm, Sandoz), Teva and Mylan – account for more than half of them. Each year, more than 90 billion packs of medicines are used worldwide to treat infections. Antimicrobial resistance is not a future problem. Jayasree K. Iyer The impact of drug resistance is already being felt today. Executive Director Antibiotic resistance causes more than 500,000 deaths each Access to Medicine Foundation year, including more than 200,000 infant deaths. In India, for example, resistance exceeds 70% for many widespread bac- teria. Most at risk are patients living in the poorest countries, where medicine choices are limited. 3 Antimicrobial Resistance Benchmark 2020 Table of contents 6 EXECUTIVE SUMMARY 91 REPORT CARDS 12 BENCHMARK PERFORMANCE 92 Abbott Laboratories 12 Antimicrobial Resistance Benchmark - 2020 95 Achaogen Inc 14 How large research-based pharmaceutical companies 98 Alkem Laboratories Ltd perform 101 Amplyx Pharmaceuticals Inc 16 How generic medicine manufacturers perform 103 Aurobindo Pharma Ltd 18 How small and medium-sized enterprises perform 106 Cidara Therapeutics 108 Cipla Ltd 20 KEY FINDINGS 111 Debiopharm 20 R&D: Signs of movement in access and stewardship 113 Entasis Therapeutics Inc planning in R&D, from a low base 116 Fresenius Kabi AG 22 Access: Pharma companies are missing opportunities 119 GlaxoSmithKline plc to make antibiotics available 123 Hainan Hailing Chemipharma Corporation Ltd 24 Stewardship: Progress in how pharma companies 126 Johnson & Johnson tackle overselling antimicrobials 130 Melinta Therapeutics Inc 26 Surveillance: Pfizer is the first company to share raw 133 Merck & Co, Inc data on the spread of resistance 137 Motif Bio plc 139 Mylan NV 28 PIPELINE & PORTFOLIO ANALYSIS 142 Nabriva Therapeutics plc 28 R&D Pipelines: Which companies are developing new 145 Novartis AG treatments for the most threatening bacteria and 149 Otsuka Pharmaceutical Co, Ltd fungi? 153 Pfizer Inc 29 Portfolios: Which companies produce the most anti- 157 Polyphor Ltd bacterial and antifungal products? 160 Sanofi 164 Scynexis 31 RESEARCH AREAS 166 Shionogi & Co, Ltd 170 Summit Therapeutics 33 RESEARCH & DEVELOPMENT 172 Sun Pharmaceutical Industries Ltd 34 How the companies compare in Research & 175 Tetraphase Pharmaceuticals Inc Development 178 Teva Pharmaceutical Industries Ltd 35 In Summary 181 Wockhardt Ltd 36 Small & medium-sized enterprises lead in priority research 185 APPENDICES 186 Appendix I: Analysis, scoring and review 51 RESPONSIBLE MANUFACTURING process 52 How the companies compare in Responsible 189 Appendix II: Limitations Manufacturing 190 Appendix III: Scoring guidelines 53 In Summary 196 Appendix IV: Identifying best practices 54 More companies set antibacterial limits for 197 Appendix V: Priority pathogens included wastewaters to minimise AMR risk for analysis in R&D 198 Appendix VI: Access countries 65 APPROPRIATE ACCESS & STEWARDSHIP 199 Appendix VII: Guide to Report Cards 66 How the companies compare in Appropriate Access & 203 Appendix VIII: Figures Stewardship 204 Appendix IX: Definitions 67 In Summary 68 Progress in safeguarding use of products, yet access is still lacking in LMICs 4 Access to Medicine Foundation About this report The second Antimicrobial Resistance Benchmark com- WHAT WE MEASURE pares how a cross-section of the pharmaceutical industry is The 2020 AMR Benchmark uses a framework of 19 indi- responding to the threat from drug-resistant infections. It cators organised into three Research Areas: Research & evaluates 30 companies with a major stake in the anti-infec- Development; Responsible Manufacturing; and Appropriate tives space, including those with the largest R&D divisions, Access and Stewardship. These correspond to pharmaceuti- the largest market presence, and leading expertise in devel- cal companies’ core responsibilities for limiting AMR: develop- oping critically needed antibiotics and antifungals. These are ing new medicines to replace ones that no longer work, make among the last companies that remain invested in keeping them accessible to those who need them, and find new ways such medicines and vaccines available and developing new to ensure antibiotics are produced and promoted responsibly. ones. The Benchmark assesses company behaviour regarding dis- The 30 companies include eight large R&D-based pharma- eases and product types and in a specific geographic scope, ceutical companies, nine generic medicine manufacturers and depending on the Research Area in question. Its metrics cor- 13 small and medium-sized enterprises. The Benchmark eval- respond to areas where experts and stakeholders agree that uates these companies in areas where they have the biggest pharmaceutical companies can and should be taking action to potential and responsibility to limit AMR, such as R&D, man- limit AMR. aging manufacturing waste and ensuring appropriate access and stewardship. HOW WE MEASURE The Antimicrobial Resistance Benchmark is used as a tool The Benchmark evaluated data gathered via a detailed sur- to guide and stimulate pharmaceutical companies to imple- vey of company behaviour regarding AMR and from pub- ment effective actions for limiting AMR and remain commit- lic sources. It reports company activities taking place during ted to developing new and existing medicines. It identifies the a period of analysis from 9 September 2017 to 21 June 2019. promising ideas now being
Recommended publications
  • Chapter 12 Antimicrobial Therapy Antibiotics

    Chapter 12 Antimicrobial Therapy Antibiotics

    Chapter 12 Antimicrobial Therapy Topics: • Ideal drug - Antimicrobial Therapy - Selective Toxicity • Terminology - Survey of Antimicrobial Drug • Antibiotics - Microbial Drug Resistance - Drug and Host Interaction An ideal antimicrobic: Chemotherapy is the use of any chemical - soluble in body fluids, agent in the treatment of disease. - selectively toxic , - nonallergenic, A chemotherapeutic agent or drug is any - reasonable half life (maintained at a chemical agent used in medical practice. constant therapeutic concentration) An antibiotic agent is usually considered to - unlikely to elicit resistance, be a chemical substance made by a - has a long shelf life, microorganism that can inhibit the growth or - reasonably priced. kill microorganisms. There is no ideal antimicrobic An antimicrobic or antimicrobial agent is Selective Toxicity - Drugs that specifically target a chemical substance similar to an microbial processes, and not the human host’s. antibiotic, but may be synthetic. Antibiotics Spectrum of antibiotics and targets • Naturally occurring antimicrobials – Metabolic products of bacteria and fungi – Reduce competition for nutrients and space • Bacteria – Streptomyces, Bacillus, • Molds – Penicillium, Cephalosporium * * 1 The mechanism of action for different 5 General Mechanisms of Action for antimicrobial drug targets in bacterial cells Antibiotics - Inhibition of Cell Wall Synthesis - Disruption of Cell Membrane Function - Inhibition of Protein Synthesis - Inhibition of Nucleic Acid Synthesis - Anti-metabolic activity Antibiotics
  • Efficacy of Amoxicillin and Amoxicillin/Clavulanic Acid in the Prevention of Infection and Dry Socket After Third Molar Extraction

    Efficacy of Amoxicillin and Amoxicillin/Clavulanic Acid in the Prevention of Infection and Dry Socket After Third Molar Extraction

    Med Oral Patol Oral Cir Bucal. 2016 Jul 1;21 (4):e494-504. Amoxicillin in the prevention of infectious complications after tooth extraction Journal section: Oral Surgery doi:10.4317/medoral.21139 Publication Types: Review http://dx.doi.org/doi:10.4317/medoral.21139 Efficacy of amoxicillin and amoxicillin/clavulanic acid in the prevention of infection and dry socket after third molar extraction. A systematic review and meta-analysis María-Iciar Arteagoitia 1, Luis Barbier 2, Joseba Santamaría 3, Gorka Santamaría 4, Eva Ramos 5 1 MD, DDS, PhD, Associate Professor, Stomatology I Department, University of the Basque Country (UPV/EHU), BioCruces Health Research Institute, Spain; Consolidated research group (UPV/EHU IT821-13) 2 MD PhD, Chair Professor, Maxillofacial Surgery Department, BioCruces Health Research Institute, Cruces University Hos- pital, University of the Basque Country (UPV/EHU), Spain; Consolidated research group (UPV/EHU IT821-13) 3 MD, DDS, PhD, Professor and Chair, Maxillofacial Surgery Department, Bio Cruces Health Research Institute, Cruces University Hospital, University of the Basque Country (UPV/EHU), Bizkaia, Spain; Consolidated research group (UPV/EHU IT821-13) 4 DDS, PhD, Associate Professor, Stomatology I Department, University of the Basque Country (UPV/EHU), BioCruces Health Research Institute, Spain; Consolidated research group (UPV/EHU IT821-13) 5 PhD, Degree in Farmacy, BioCruces Health Research Institute, Cruces University Hospital. Spain Correspondence: Servicio Cirugía Maxilofacial Hospital Universitario de Cruces Plaza de Cruces s/n Arteagoitia MI, Barbier L, Santamaría J, Santamaría G, Ramos E. Ef- Barakaldo, Bizkaia, Spain ficacy of amoxicillin and amoxicillin/clavulanic acid in the prevention [email protected] of infection and dry socket after third molar extraction.
  • New Insights Into the Effect of Amorolfine Nail Lacquer

    New Insights Into the Effect of Amorolfine Nail Lacquer

    Review article New insights into the effect of amorolfine nail lacquer C. Flagothier, C. Pie´ rard-Franchimont and G. E. Pie´ rard Department of Dermatopathology, University Hospital of Lie`ge, Lie`ge, Belgium Summary Despite improvements in antifungal strategies, the outcome of treating onychomycoses often remains uncertain. Several factors account for treatment failure, of which the pharmacokinetics and pharmacodynamics of the antifungal are of importance. The taxonomic nature and ungual location of the fungus cannot be neglected, besides the type of nail and its growth rate. In addition, the biological cycle of the fungus and the metabolic activity of the pathogen likely play a marked influence in drug response. The presence of natural antimicrobial peptides in the nail is also probably a key feature controlling the cure rates. There are many outstanding publications that cover the full spectrum of the field. The purpose of this review is to put in perspective some facets of activity of the topical treatment using amorolfine nail laquer. The antifungal activity of the drug is likely less pronounced in onychomycosis than that expected from conventional in vitro studies. However, the nail laquer formulation should reduce the propensity to form antifungal-resistant spores and limit the risk of reinfection. Key words: amorolfine, antifungal, fungus, onychomycosis, spore. Topical treatments are often considered to be less Introduction efficacious than current oral treatments. However, some During the last 2 decades, the efficacy of treating topical formulations may provide effects that cannot be onychomycoses has been considerably improved by achieved by other treatments. In discussing the treat- the introduction of new generations of potent antifun- ment of onychomycosis, it should not be forgotten that gals.
  • Making the Right Move

    Making the Right Move

    MAKING THE RIGHT MOVE Investing and Creating Jobs in the Pittsburgh Region REAL PITTSBURGH REAL PEOPLE Looking Ahead: 2014 and Beyond Imagining a Bright Future for Our Region – and Making it Happen By Charles E. Bunch In many ways, the Pittsburgh region has com- Boomers. We’re seeing this on our job search engine within Imag- pleted the economic, environmental and qual- inePittsburgh.com, where the number of open jobs across the 10- ity-of-life transformation begun 30 years ago. county Pittsburgh region numbered around 25,000 at last count. We bottomed out in 1983, with an unemploy- ment rate over 18 percent. Throughout 2013, The Conference is addressing this opportunity in a variety of ways, in- WHEN YOU INVEST IN THE cluding through our robust talent attraction and retention initiative, COMMUNITY, THE RETURNS our jobless rate outperformed the state and the nation as a whole. We’re closing the year with the largest workforce which includes ImaginePittsburgh.com. We’re also working with ARE GUARANTEED. in regional history – about 100,000 more people employed than at our partners in workforce development to increase the supply of trained At Huntington, we know how important it is to give back to workers in the region. One such program, ShaleNET, has been such the community. After all, we do more than just work here – we industrial peak in 1979. live and raise our families here too. And after everything this a success that the federal government has increased its investment to community has done for us, we’re just happy to be able to We are enjoying the fruits of three decades of hard work by countless expand it to other states.
  • Antibiotic Resistance: from the Bench to Patients

    Antibiotic Resistance: from the Bench to Patients

    antibiotics Editorial Antibiotic Resistance: From the Bench to Patients Márió Gajdács 1,* and Fernando Albericio 2,3 1 Department of Pharmacodynamics and Biopharmacy, Faculty of Pharmacy, University of Szeged, Dóm tér 10., 6720 Szeged, Hungary 2 School of Chemistry, University of KwaZulu-Natal, Durban 4001, South Africa 3 Department of Organic Chemistry, University of Barcelona, CIBER-BBN, 08028 Barcelona, Spain * Correspondence: [email protected]; Tel.: +36-62-341-330 Received: 20 August 2019; Accepted: 26 August 2019; Published: 27 August 2019 The discovery and subsequent clinical introduction of antibiotics is one of the most important game-changers in the history of medicine [1]. These drugs have saved millions of lives from infections that would previously have been fatal, and later, they allowed for the introduction of surgical interventions, organ transplantation, care of premature infants, and cancer chemotherapy [2]. Nevertheless, the therapy of bacterial infections is becoming less and less straightforward due to the emergence of multidrug resistance (MDR) in these pathogens [3]. Direct consequences of antibiotic resistance include delays in the onset of the appropriate (effective) antimicrobial therapy, the need to use older, more toxic antibiotics (e.g., colistin) with a disadvantageous side-effect profile, longer hospital stays, and an increasing burden on the healthcare infrastructure; overall, a decrease in the quality-of-life (QoL) and an increase in the mortality rate of the affected patients [4,5]. To highlight the severity of the issue, several international declarations have been published to call governments around the globe to take action on antimicrobial resistance [6–9]. Since the 1980s, pharmaceutical companies have slowly turned away from antimicrobial research and towards the drug therapy of chronic non-communicable diseases [10,11].
  • Analysis of Mutations Leading to Para-Aminosalicylic Acid Resistance in Mycobacterium Tuberculosis

    Analysis of Mutations Leading to Para-Aminosalicylic Acid Resistance in Mycobacterium Tuberculosis

    www.nature.com/scientificreports OPEN Analysis of mutations leading to para-aminosalicylic acid resistance in Mycobacterium tuberculosis Received: 9 April 2019 Bharati Pandey1, Sonam Grover2, Jagdeep Kaur1 & Abhinav Grover3 Accepted: 31 July 2019 Thymidylate synthase A (ThyA) is the key enzyme involved in the folate pathway in Mycobacterium Published: xx xx xxxx tuberculosis. Mutation of key residues of ThyA enzyme which are involved in interaction with substrate 2′-deoxyuridine-5′-monophosphate (dUMP), cofactor 5,10-methylenetetrahydrofolate (MTHF), and catalytic site have caused para-aminosalicylic acid (PAS) resistance in TB patients. Focusing on R127L, L143P, C146R, L172P, A182P, and V261G mutations, including wild-type, we performed long molecular dynamics (MD) simulations in explicit solvent to investigate the molecular principles underlying PAS resistance due to missense mutations. We found that these mutations lead to (i) extensive changes in the dUMP and MTHF binding sites, (ii) weak interaction of ThyA enzyme with dUMP and MTHF by inducing conformational changes in the structure, (iii) loss of the hydrogen bond and other atomic interactions and (iv) enhanced movement of protein atoms indicated by principal component analysis (PCA). In this study, MD simulations framework has provided considerable insight into mutation induced conformational changes in the ThyA enzyme of Mycobacterium. Antimicrobial resistance (AMR) threatens the efective treatment of tuberculosis (TB) caused by the bacteria Mycobacterium tuberculosis (Mtb) and has become a serious threat to global public health1. In 2017, there were reports of 5,58000 new TB cases with resistance to rifampicin (frst line drug), of which 82% have developed multidrug-resistant tuberculosis (MDR-TB)2. AMR has been reported to be one of the top health threats globally, so there is an urgent need to proactively address the problem by identifying new drug targets and understanding the drug resistance mechanism3,4.
  • The Management of Common Skin Conditions in General Practice

    The Management of Common Skin Conditions in General Practice

    Management of Common Skin Conditions In General Practice including the “red rash made easy” © Arroll, Fishman & Oakley, Department of General Practice and Primary Health Care University of Auckland, Tamaki Campus Reviewed by Hon A/Prof Amanda Oakley - 2019 http://www.dermnetnz.org Management of Common Skin Conditions In General Practice Contents Page Derm Map 3 Classic location: infants & children 4 Classic location: adults 5 Dermatology terminology 6 Common red rashes 7 Other common skin conditions 12 Common viral infections 14 Common bacterial infections 16 Common fungal infections 17 Arthropods 19 Eczema/dermatitis 20 Benign skin lesions 23 Skin cancers 26 Emergency dermatology 28 Clinical diagnosis of melanoma 31 Principles of diagnosis and treatment 32 Principles of treatment of eczema 33 Treatment sequence for psoriasis 34 Topical corticosteroids 35 Combination topical steroid + antimicrobial 36 Safety with topical corticosteroids 36 Emollients 37 Antipruritics 38 For further information, refer to: http://www.dermnetnz.org And http://www.derm-master.com 2 © Arroll, Fishman & Oakley, Department of General Practice and Primary Health Care, University of Auckland, Tamaki Campus. Management of Common Skin Conditions In General Practice DERM MAP Start Is the patient sick ? Yes Rash could be an infection or a drug eruption? No Insect Bites – Crop of grouped papules with a central blister or scab. Is the patient in pain or the rash Yes Infection: cellulitis / erysipelas, impetigo, boil is swelling, oozing or crusting? / folliculitis, herpes simplex / zoster. Urticaria – Smooth skin surface with weals that evolve in minutes to hours. No Is the rash in a classic location? Yes See our classic location chart .
  • )&F1y3x PHARMACEUTICAL APPENDIX to THE

    )&F1y3x PHARMACEUTICAL APPENDIX to THE

    )&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ACTODIGIN 36983-69-4 ABANOQUIL 90402-40-7 ADAFENOXATE 82168-26-1 ABCIXIMAB 143653-53-6 ADAMEXINE 54785-02-3 ABECARNIL 111841-85-1 ADAPALENE 106685-40-9 ABITESARTAN 137882-98-5 ADAPROLOL 101479-70-3 ABLUKAST 96566-25-5 ADATANSERIN 127266-56-2 ABUNIDAZOLE 91017-58-2 ADEFOVIR 106941-25-7 ACADESINE 2627-69-2 ADELMIDROL 1675-66-7 ACAMPROSATE 77337-76-9 ADEMETIONINE 17176-17-9 ACAPRAZINE 55485-20-6 ADENOSINE PHOSPHATE 61-19-8 ACARBOSE 56180-94-0 ADIBENDAN 100510-33-6 ACEBROCHOL 514-50-1 ADICILLIN 525-94-0 ACEBURIC ACID 26976-72-7 ADIMOLOL 78459-19-5 ACEBUTOLOL 37517-30-9 ADINAZOLAM 37115-32-5 ACECAINIDE 32795-44-1 ADIPHENINE 64-95-9 ACECARBROMAL 77-66-7 ADIPIODONE 606-17-7 ACECLIDINE 827-61-2 ADITEREN 56066-19-4 ACECLOFENAC 89796-99-6 ADITOPRIM 56066-63-8 ACEDAPSONE 77-46-3 ADOSOPINE 88124-26-9 ACEDIASULFONE SODIUM 127-60-6 ADOZELESIN 110314-48-2 ACEDOBEN 556-08-1 ADRAFINIL 63547-13-7 ACEFLURANOL 80595-73-9 ADRENALONE
  • Summary of Product Characteristics

    Summary of Product Characteristics

    SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Augmentin 125 mg/31.25 mg/5 ml powder for oral suspension Augmentin 250 mg/62.5 mg/5 ml powder for oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION When reconstituted, every ml of oral suspension contains amoxicillin trihydrate equivalent to 25 mg amoxicillin and potassium clavulanate equivalent to 6.25 mg of clavulanic acid. Excipients with known effect Every ml of oral suspension contains 2.5 mg aspartame (E951). The flavouring in Augmentin contains maltodextrin (glucose) (see section 4.4). This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium- free’. When reconstituted, every ml of oral suspension contains amoxicillin trihydrate equivalent to 50 mg amoxicillin and potassium clavulanate equivalent to 12.5 mg of clavulanic acid. Excipients with known effect Every ml of oral suspension contains 2.5 mg aspartame (E951). The flavouring in Augmentin contains maltodextrin (glucose) (see section 4.4). This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium- free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral suspension. Off-white powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Augmentin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1): • Acute bacterial sinusitis (adequately diagnosed) • Acute otitis media • Acute exacerbations of chronic bronchitis (adequately diagnosed) • Community acquired pneumonia • Cystitis • Pyelonephritis 2 • Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis • Bone and joint infections, in particular osteomyelitis.
  • Updated WHO MDR-TB Treatment Guidelines and the Use of New Drugs in Children

    Updated WHO MDR-TB Treatment Guidelines and the Use of New Drugs in Children

    Updated WHO MDR-TB treatment guidelines and the use of new drugs in children Annual meeting of the Childhood TB subgroup Liverpool, UK, 26 October 2016 Dr Malgosia Grzemska WHO/HQ, Global TB Programme Outline • Latest epidemiological data • Existing guidelines • 2016 update of the DR-TB treatment guidelines • New recommendations for treatment of RR-TB and MDR- TB in children • Delamanid guideline for use in children and adolescents • Research gaps • Conclusions The Global Burden of TB - 2015 Estimated number Estimated number of cases of deaths 10,4 million 1.8 million* All forms of TB • 1 million Children (10%) • 210,000 children (170,000 HIV negative and 40,000 HIV- positive) HIV-associated TB 1.2 million (11%) 390,000 Multidrug-resistant TB 480,000 190,000 +100,000 RR cases Childhood TB: MDRTB estimates Dodd P., Sismanidis B., Seddon J., Lancet Inf Dis, 21 June 2016: Global burden of drug-resistant tuberculosis in children: a mathematical modelling study • It is estimated that over 67 million children are infected with TB and therefore at risk of developing disease in the future; – 5 mln with INH resistance; 2 mln with MDR; 100,000 with XDR • Every year 25,000 children develop MDRTB and 1200 XDR TB MDR-TB in children • MDR-TB in children is mainly the result of transmission of a strain of M. tuberculosis that is MDR from an adult source case , and therefore often not suspected unless a history of contact with an adult pulmonary MDR-TB case is known. • Referral to a specialist is advised for treatment.
  • Oral Antifungals Month/Year of Review: July 2015 Date of Last

    Oral Antifungals Month/Year of Review: July 2015 Date of Last

    © Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 | Fax 503-947-1119 Class Update with New Drug Evaluation: Oral Antifungals Month/Year of Review: July 2015 Date of Last Review: March 2013 New Drug: isavuconazole (a.k.a. isavunconazonium sulfate) Brand Name (Manufacturer): Cresemba™ (Astellas Pharma US, Inc.) Current Status of PDL Class: See Appendix 1. Dossier Received: Yes1 Research Questions: Is there any new evidence of effectiveness or safety for oral antifungals since the last review that would change current PDL or prior authorization recommendations? Is there evidence of superior clinical cure rates or morbidity rates for invasive aspergillosis and invasive mucormycosis for isavuconazole over currently available oral antifungals? Is there evidence of superior safety or tolerability of isavuconazole over currently available oral antifungals? • Is there evidence of superior effectiveness or safety of isavuconazole for invasive aspergillosis and invasive mucormycosis in specific subpopulations? Conclusions: There is low level evidence that griseofulvin has lower mycological cure rates and higher relapse rates than terbinafine and itraconazole for adult 1 onychomycosis.2 There is high level evidence that terbinafine has more complete cure rates than itraconazole (55% vs. 26%) for adult onychomycosis caused by dermatophyte with similar discontinuation rates for both drugs.2 There is low
  • Antibiotic Resistance in Plant-Pathogenic Bacteria

    Antibiotic Resistance in Plant-Pathogenic Bacteria

    PY56CH08-Sundin ARI 23 May 2018 12:16 Annual Review of Phytopathology Antibiotic Resistance in Plant-Pathogenic Bacteria George W. Sundin1 and Nian Wang2 1Department of Plant, Soil, and Microbial Sciences, Michigan State University, East Lansing, Michigan 48824, USA; email: [email protected] 2Citrus Research and Education Center, Department of Microbiology and Cell Science, Institute of Food and Agricultural Sciences, University of Florida, Lake Alfred, Florida 33850, USA Annu. Rev. Phytopathol. 2018. 56:8.1–8.20 Keywords The Annual Review of Phytopathology is online at kasugamycin, oxytetracycline, streptomycin, resistome phyto.annualreviews.org https://doi.org/10.1146/annurev-phyto-080417- Abstract 045946 Antibiotics have been used for the management of relatively few bacterial Copyright c 2018 by Annual Reviews. plant diseases and are largely restricted to high-value fruit crops because of Access provided by INSEAD on 06/01/18. For personal use only. All rights reserved the expense involved. Antibiotic resistance in plant-pathogenic bacteria has Annu. Rev. Phytopathol. 2018.56. Downloaded from www.annualreviews.org become a problem in pathosystems where these antibiotics have been used for many years. Where the genetic basis for resistance has been examined, antibiotic resistance in plant pathogens has most often evolved through the acquisition of a resistance determinant via horizontal gene transfer. For ex- ample, the strAB streptomycin-resistance genes occur in Erwinia amylovora, Pseudomonas syringae,andXanthomonas campestris, and these genes have pre- sumably been acquired from nonpathogenic epiphytic bacteria colocated on plant hosts under antibiotic selection. We currently lack knowledge of the effect of the microbiome of commensal organisms on the potential of plant pathogens to evolve antibiotic resistance.