Module 2. Traitement
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Antiseptics and Disinfectants for the Treatment Of
Verstraelen et al. BMC Infectious Diseases 2012, 12:148 http://www.biomedcentral.com/1471-2334/12/148 RESEARCH ARTICLE Open Access Antiseptics and disinfectants for the treatment of bacterial vaginosis: A systematic review Hans Verstraelen1*, Rita Verhelst2, Kristien Roelens1 and Marleen Temmerman1,2 Abstract Background: The study objective was to assess the available data on efficacy and tolerability of antiseptics and disinfectants in treating bacterial vaginosis (BV). Methods: A systematic search was conducted by consulting PubMed (1966-2010), CINAHL (1982-2010), IPA (1970- 2010), and the Cochrane CENTRAL databases. Clinical trials were searched for by the generic names of all antiseptics and disinfectants listed in the Anatomical Therapeutic Chemical (ATC) Classification System under the code D08A. Clinical trials were considered eligible if the efficacy of antiseptics and disinfectants in the treatment of BV was assessed in comparison to placebo or standard antibiotic treatment with metronidazole or clindamycin and if diagnosis of BV relied on standard criteria such as Amsel’s and Nugent’s criteria. Results: A total of 262 articles were found, of which 15 reports on clinical trials were assessed. Of these, four randomised controlled trials (RCTs) were withheld from analysis. Reasons for exclusion were primarily the lack of standard criteria to diagnose BV or to assess cure, and control treatment not involving placebo or standard antibiotic treatment. Risk of bias for the included studies was assessed with the Cochrane Collaboration’s tool for assessing risk of bias. Three studies showed non-inferiority of chlorhexidine and polyhexamethylene biguanide compared to metronidazole or clindamycin. One RCT found that a single vaginal douche with hydrogen peroxide was slightly, though significantly less effective than a single oral dose of metronidazole. -
(12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 De Juan Et Al
US 200601 10428A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 de Juan et al. (43) Pub. Date: May 25, 2006 (54) METHODS AND DEVICES FOR THE Publication Classification TREATMENT OF OCULAR CONDITIONS (51) Int. Cl. (76) Inventors: Eugene de Juan, LaCanada, CA (US); A6F 2/00 (2006.01) Signe E. Varner, Los Angeles, CA (52) U.S. Cl. .............................................................. 424/427 (US); Laurie R. Lawin, New Brighton, MN (US) (57) ABSTRACT Correspondence Address: Featured is a method for instilling one or more bioactive SCOTT PRIBNOW agents into ocular tissue within an eye of a patient for the Kagan Binder, PLLC treatment of an ocular condition, the method comprising Suite 200 concurrently using at least two of the following bioactive 221 Main Street North agent delivery methods (A)-(C): Stillwater, MN 55082 (US) (A) implanting a Sustained release delivery device com (21) Appl. No.: 11/175,850 prising one or more bioactive agents in a posterior region of the eye so that it delivers the one or more (22) Filed: Jul. 5, 2005 bioactive agents into the vitreous humor of the eye; (B) instilling (e.g., injecting or implanting) one or more Related U.S. Application Data bioactive agents Subretinally; and (60) Provisional application No. 60/585,236, filed on Jul. (C) instilling (e.g., injecting or delivering by ocular ion 2, 2004. Provisional application No. 60/669,701, filed tophoresis) one or more bioactive agents into the Vit on Apr. 8, 2005. reous humor of the eye. Patent Application Publication May 25, 2006 Sheet 1 of 22 US 2006/0110428A1 R 2 2 C.6 Fig. -
Classification of Medicinal Drugs and Driving: Co-Ordination and Synthesis Report
Project No. TREN-05-FP6TR-S07.61320-518404-DRUID DRUID Driving under the Influence of Drugs, Alcohol and Medicines Integrated Project 1.6. Sustainable Development, Global Change and Ecosystem 1.6.2: Sustainable Surface Transport 6th Framework Programme Deliverable 4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Due date of deliverable: 21.07.2011 Actual submission date: 21.07.2011 Revision date: 21.07.2011 Start date of project: 15.10.2006 Duration: 48 months Organisation name of lead contractor for this deliverable: UVA Revision 0.0 Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006) Dissemination Level PU Public PP Restricted to other programme participants (including the Commission x Services) RE Restricted to a group specified by the consortium (including the Commission Services) CO Confidential, only for members of the consortium (including the Commission Services) DRUID 6th Framework Programme Deliverable D.4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Page 1 of 243 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Authors Trinidad Gómez-Talegón, Inmaculada Fierro, M. Carmen Del Río, F. Javier Álvarez (UVa, University of Valladolid, Spain) Partners - Silvia Ravera, Susana Monteiro, Han de Gier (RUGPha, University of Groningen, the Netherlands) - Gertrude Van der Linden, Sara-Ann Legrand, Kristof Pil, Alain Verstraete (UGent, Ghent University, Belgium) - Michel Mallaret, Charles Mercier-Guyon, Isabelle Mercier-Guyon (UGren, University of Grenoble, Centre Regional de Pharmacovigilance, France) - Katerina Touliou (CERT-HIT, Centre for Research and Technology Hellas, Greece) - Michael Hei βing (BASt, Bundesanstalt für Straßenwesen, Germany). -
Effect of Polyhexamethylene Biguanide in Combination with Undecylenamidopropyl Betaine Or Pslg on Biofilm Clearance
International Journal of Molecular Sciences Article Effect of Polyhexamethylene Biguanide in Combination with Undecylenamidopropyl Betaine or PslG on Biofilm Clearance Yaqian Zheng 1,2,†, Di Wang 1,† and Luyan Z. Ma 1,3,* 1 State Key Laboratory of Microbial Resources, Institute of Microbiology, Chinese Academy of Sciences, Beijing 100101, China; [email protected] (Y.Z.); [email protected] (D.W.) 2 College of Life Sciences, University of Chinese Academy of Sciences, Beijing 100049, China 3 Savaid Medical School, University of Chinese Academy of Sciences, Beijing 100049, China * Correspondence: [email protected]; Tel.: +86-10-64807437 † These authors have contributed equally to this work. Abstract: Hospital-acquired infection is a great challenge for clinical treatment due to pathogens’ biofilm formation and their antibiotic resistance. Here, we investigate the effect of antiseptic agent polyhexamethylene biguanide (PHMB) and undecylenamidopropyl betaine (UB) against biofilms of four pathogens that are often found in hospitals, including Gram-negative bacteria Pseudomonas aeruginosa and Escherichia coli, Gram-positive bacteria Staphylococcus aureus, and pathogenic fungus, Candida albicans. We show that 0.02% PHMB, which is 10-fold lower than the concentration of commercial products, has a strong inhibitory effect on the growth, initial attachment, and biofilm formation of all tested pathogens. PHMB can also disrupt the preformed biofilms of these pathogens. In contrast, 0.1% UB exhibits a mild inhibitory effect on biofilm formation of the four pathogens. This concentration inhibits the growth of S. aureus and C. albicans yet has no growth effect on P. aeruginosa or E. coli. UB only slightly enhances the anti-biofilm efficacy of PHMB on P. -
List of Union Reference Dates A
Active substance name (INN) EU DLP BfArM / BAH DLP yearly PSUR 6-month-PSUR yearly PSUR bis DLP (List of Union PSUR Submission Reference Dates and Frequency (List of Union Frequency of Reference Dates and submission of Periodic Frequency of submission of Safety Update Reports, Periodic Safety Update 30 Nov. 2012) Reports, 30 Nov. -
Antiseptic and Antibiotic Resistance in Gram-Negative Bacteria Causing Urinary Tract Infection in Spinal Cord Injured Patients
Paraplegia 19 (1981) 50-58 0031 -1 758/81/00000050 $02.00 © 1981 International Medical Society of Paraplegia ANTISEPTIC AND ANTIBIOTIC RESISTANCE IN GRAM-NEGATIVE BACTERIA CAUSING URINARY TRACT INFECTION IN SPINAL CORD INJURED PATIENTS By DAVID J. STICKLER,! B.Sc., M.A., D.Phil., BRIAN THOMAS,! B.Sc., Ph.D. and JAGDISH C. CHAWLA,2 M.B., B.S., F.R.C.S., M.D., A.M. 1 Department of Applied Biology, University of Wales Institute of Science &, Technology, Cardiff; 2 Welsh Spinal Unit, Rookwood Hospital, Cardiff, U.K. Abstract. Fifty-seven isolates of Gram-negative bacterial species from urinary tract infections in spinal cord injured patients were tested for their sensitivity to chlorhexidine, cetrimide, glutaraldehyde, phenyl mercuric nitrate (PMN), a phenolic disinfectant (Hycolin) and a proprietary antiseptic containing a mixture of picloxydine, octylphenoxy polyethoxyethanol and benzalkonium chloride (Resiguard). None of the isolates were resistant to glutaraldehyde, Hycolin or PMN but a substantial percentage were resistant to chlorhexidine (44 per cent), cetrimide (26 per cent) and Resiguard (42 per cent). The resistant organisms were members of the genera Proteus, Providencia and Pseudomonas and they were also generally resistant to five, six or seven antibiotics. Significantcorrelations were observed between multiplicity of antibiotic resistance and the minimum inhibitory concentrations of the three cationic antiseptics. It is suggested that an antiseptic policy for the bladder management of spinal cord injured patients that relies on the extensive use of cationic agents might lead to the selection of a flora of notoriously drug-resistant species. Key words: Gram-negative urinary bacterial sensitivity; Cationic agents; Drug resistance. -
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 -
Clincal Review(S)
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208288Orig1s000 CLINICAL REVIEW(S) Division Director Review NDA 208288 Chlorhexidine gluconate/isopropyl alcohol Summary Review for Regulatory Action Date September 1, 2017 Theresa M. Michele, MD From Director, Division of Nonprescription Drug Products Subject Division Director Summary Review NDA/BLA # 208288 Applicant Name 3M Health Care Business Date of Submission March 3, 2017 PDUFA Goal Date September 3, 2017 SoluPrep™ Film-Forming Sterile Solution / 2%w/v Proprietary Name / chlorhexidine gluconate and 70% v/v isopropyl Established (USAN) Name alcohol Dosage Forms / Route of Surgical solution Administration / Strength Patient Preoperative Skin Preparation (adults and pediatric patients ≥ 2 months of age) Proposed Indication(s) • For preparation of the skin prior to surgery • Helps reduce bacteria that potentially can cause skin infection Recommended Regulatory Complete response Action Material Reviewed/Consulted OND Action Package, including: Names of discipline reviewers Medical Officer Review--DNDP Teresa Podruchny/Francis Becker Statistical Review Joo-Yeon Lee/Rima Izem Pharmacology Toxicology Review Charlie Thompson/Jane Sohn CMC Review/OBP Review Elise Luong/Maria Cruz-Fisher/Erika Pfeiler/ Swapan De Clinical Microbiology Review Michelle Jackson Clinical Pharmacology Review Sojeong Yi/Dennis Bashaw CDTL Review Francis Becker OSE/DMEPA Grace Jones/Chi-Ming Tu RPM DNDP Lara Akinsanya CDTL=Cross-Discipline Team Leader DMEPA=Division of Medication Error Prevention and Analysis -
In Vitro Evaluation of Polihexanide, Octenidine and Naclo/Hclo-Based Antiseptics Against Biofilm Formed by Wound Pathogens
membranes Article In Vitro Evaluation of Polihexanide, Octenidine and NaClO/HClO-Based Antiseptics against Biofilm Formed by Wound Pathogens Grzegorz Krasowski 1, Adam Junka 2,3,* , Justyna Paleczny 2, Joanna Czajkowska 3, Elzbieta˙ Makomaska-Szaroszyk 4, Grzegorz Chodaczek 5, Michał Majkowski 5, Paweł Migdał 6, Karol Fijałkowski 7 , Beata Kowalska-Krochmal 2 and Marzenna Bartoszewicz 2 1 Nutrikon, KCZ Surgical Ward, 47-300 Krapkowice, Poland; [email protected] 2 Department of Pharmaceutical Microbiology and Parasitology, Faculty of Pharmacy, Wrocław Medical University, 50-556 Wrocław, Poland; [email protected] (J.P.); [email protected] (B.K.-K.); [email protected] (M.B.) 3 Laboratory of Microbiology, Łukasiewicz Research Network—PORT Polish Center for Technology Development, 54-066 Wrocław, Poland; [email protected] 4 Faculty of Medicine, Lazarski University, 02-662 Warszawa, Poland; [email protected] 5 Bioimaging Laboratory, Łukasiewicz Research Network—PORT Polish Center for Technology Development, 54-066 Wrocław, Poland; [email protected] (G.C.); [email protected] (M.M.) 6 Department of Environment Hygiene and Animal Welfare, Wroclaw University of Environmental and Life Sciences, 51-630 Wrocław, Poland; [email protected] 7 Department of Microbiology and Biotechnology, Faculty of Biotechnology and Animal Husbandry, West Pomeranian University of Technology, 70-311 Szczecin, Poland; karol.fi[email protected] * Correspondence: [email protected]; Tel.: +48-71-784-06-75 Citation: Krasowski, G.; Junka, A.; Paleczny, J.; Czajkowska, J.; Makomaska-Szaroszyk, E.; Abstract: Chronic wounds complicated with biofilm formed by pathogens remain one of the most Chodaczek, G.; Majkowski, M.; significant challenges of contemporary medicine. -
Polyhexamethylene Biguanide (Mn = 1600; PDI =1.8) (PHMB)
Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products Evaluation of active substances Assessment Report Polyhexamethylene biguanide (Mn = 1600; PDI =1.8) (PHMB) Product-type 2: Disinfectants and algaecides not intended for direct application to humans or animals June 2015 France Polyhexamethylene biguanide Product-type 2 June 2015 (Mn = 1600; PDI =1.8) (PHMB) TABLE OF CONTENTS 1 STATEMENT OF SUBJECT MATTER AND PURPOSE .................................... 4 1.1 Procedure followed ------------------------------------------------------- 4 1.2 Purpose of the assessment ---------------------------------------------- 4 2 OVERALL SUMMARY AND CONCLUSIONS ................................................. 6 2.1 General substance information / General product information ----- 6 2.1.1 Identity, Physico-chemical properties & Methods of analysis of the active substance ---------------------------------------------------------------------------------------------------------------------- 6 2.1.1.1 Identity .................................................................................... 6 2.1.1.2 Physico-chemical properties ........................................................ 9 2.1.1.3 Methods of analysis .................................................................... 9 2.1.2 Identity, Physico-chemical properties & Methods of analysis of the biocidal product 10 2.1.2.1 Identity ................................................................................... 10 2.1.2.2 Physico-chemical properties -
UTILISATION DES ANTI-INFECTIEUX ET GROSSESSE Ce Tableau N’A Qu’Une Valeur Indicative Et Ne Constitue Qu’Une Aide À La Prescription
UTILISATION DES ANTI-INFECTIEUX ET GROSSESSE Ce tableau n’a qu’une valeur indicative et ne constitue qu’une aide à la prescription. L’évaluation devra se faire au cas par cas. Pour plus d’information, contacter le Centre Régional de Pharmacovigilance au 04 73 75 48 31. CONDUITE A TENIR D’UTILISATION ANTI-INFECTIEUX 1er TRIMESTRE 2ème TRIMESTRE et 3ème TRIMESTRE · Possible : 1ère intention : amoxicilline, ampicilline, Pénicilline V, G, amoxicilline-acide clavulanique PENICILLINES · Possible : 2ème intention : cloxacilline, oxacilline, ampicilline-sulbactam, pipéracilline, pipéracilline-tazobactam, ticarcilline, ticarcilline-acide clavulanique · Possible : 1ère intention : C1G (céfadroxil, céfalexine, cefaclor) ; C2G (céfuroxime) ; C3G (ceftriaxone) · Possible : 2ème intention : C1G (céfalotine, céfatrizine, céfazoline, céfradine), C2G (céfamandole, cefoxitine) ; C3G (céfotaxime, ceftazidime, céfépime, CEPHALOSPORINES cefpirome, cefixime, cefotiam, cefpodoxime) · A éviter par prudence : ceftaroline AUTRES BETALACTA- · Possible : 2ème intention : imipénem –cilastatine MINES · A éviter par prudence : aztréonam, doripénème, ertapénème, méropénem · Possible 1ère intention : azithromycine, érythromycine, spiramycine · Possible 2ème intention : josamycine, clarithromycine, roxithromycine MACROLIDES · A éviter par prudence : midécamycine · Déconseillé : télithromycine STREPTOGRAMINES · Possible 2ème intention : pristinamycine · Possible 1ère intention : clindamycine · Possible 1ère intention : clindamycine LINCOSAMIDES · A éviter : lincomycine -
Chronic Venous Ulcers: a Comparative Effectiveness Review of Treatment Modalities Comparative Effectiveness Review Number 127
Comparative Effectiveness Review Number 127 Chronic Venous Ulcers: A Comparative Effectiveness Review of Treatment Modalities Comparative Effectiveness Review Number 127 Chronic Venous Ulcers: A Comparative Effectiveness Review of Treatment Modalities Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Contract No. 290-2007-10061-I Prepared by: Johns Hopkins University Evidence-based Practice Center Baltimore, MD Investigators Jonathan Zenilman, M.D. M. Frances Valle, D.N.P., M.S. Mahmoud B. Malas, M.D., M.H.S. Nisa Maruthur, M.D., M.H.S. Umair Qazi, M.P.H. Yong Suh, M.B.A., M.Sc. Lisa M. Wilson, Sc.M. Elisabeth B. Haberl, B.A. Eric B. Bass, M.D., M.P.H. Gerald Lazarus, M.D. AHRQ Publication No. 13(14)-EHC121-EF December 2013 Erratum January 2014 This report is based on research conducted by the Johns Hopkins University Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10061-I). The findings and conclusions in this document are those of the author(s), who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services.