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Antidotesu and Other Substances Used in Poisoningsu UNEDITED DRAFT REPORT th OF THE 17P P EXPERT COMMITTEE ON THE SELECTION AND USE OF ESSENTIAL MEDICINES 23 to 27 March 2009 Version: 18 May 2009 UNEDITED WHO Technical Report Series (18 May 2009) © World Health Organization 2009 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e‐ mail: [email protected] ).UH Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e‐mail: [email protected] ).UTH The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. This publication contains the collective views of an international group of experts and does not necessarily represent the decisions or the stated policy of the World Health Organization. 2 UNEDITED WHO Technical Report Series (18 May 2009) Contents th PARTTU ONE 17UP UP Expert Committee on the Selection and Use of Essential MedicinesUT ........... 9 ListTU of participants........................................................................................................................................ 11 DeclarationU of interests................................................................................................................................ 14 1.U U IntroductionU U ............................................................................................................................... 16 2.U U OpenU sessionU .............................................................................................................................. 16 3.U U ProposalU for revision of listing pharmaceutical productsU ................................................. 19 4.U U ReviewU of other mattersU ........................................................................................................... 20 5.U U ReviewU of missing essential medicines for HIVU ................................................................ 22 6.U U ReviewU of the report of the Second Subcommittee and of the provisional Second List of Essential Medicines for ChildrenU .............................. 23 7.U U NewU applications for paediatric medicinesU ......................................................................... 26 SectionU 6: U AntiU ‐infective medicinesU ..................................................................................................... 26 SectionU 6.2: U AntibacterialsU U ................................................................................................................... 26 ProcaineU benzylpenicillin (Review) ‐‐ (EMLc)U ................................................................................................. 26 SectionU 6.2.4: U AntituberculosisU medicines (Review, EMLc)U ............................................................. 27 SectionU 6.3: U AntifungalU medicinesU ..................................................................................................... 29 LiposomalU amphotericin B (Inclusion in the EMLc)U ....................................................................................... 29 SectionU 6.5: U AntiprotozoalU medicinesU ................................................................................................ 30 SectionU 6.5.3: U AntimalarialU medicinesU .................................................................................................. 30 ArtemetherU + lumefantrine (Inclusion in the EMLc)U ...................................................................................... 30 SectionU 7: U AntimigraineU medicinesU ...................................................................................................... 30 IbuprofenU (Inclusion in the EMLc)U.................................................................................................................... 30 SectionU 12: U CardiovascularU medicinesU .............................................................................................. 31 SectionU 12.4: U MedicinesU used in heart failureU .................................................................................... 31 CaptoprilU (Inclusion in the EMLc)U .................................................................................................................... 31 CarvedilolU (Inclusion in the EMLc)U................................................................................................................... 31 SectionU 17: U GastrointestinalU medicinesU ................................................................................................. 32 SectionU 17.2: U AntiemeticU medicines (Inclusion of odansetron in the EMLc)U ................................ 32 SectionU 18: U HormonesU U ............................................................................................................................... 32 SectionU 18.5: U InsulinsU and other antidiabetic agents.........................................................................U 32 AccessU to Essential Diabetes Medicines for Children in the Developing WorldU ........................................ 32 8.U U ReviewU of the comments on the Report of the Informal Expert Meeting on Dosage Forms of Medicines for ChildrenU .......................................................................................... 33 U 3 UNEDITED WHO Technical Report Series (18 May 2009) 9. ............................................................................... Applications for the 16th Model list ...................................................................................................................................................... 34U SectionU 4: U AntidotesU and other substances used in poisoningsU ...................................................... 34 SectionU 4.2: U SpecificU U .............................................................................................................................. 34 PralidoximeU (Inclusion)U ...................................................................................................................................... 34 SectionU 5: U Anticonvulsants/antiepilepticsU U .......................................................................................... 34 LamotrigineU (Inclusion)U ...................................................................................................................................... 34 AdditionU of lorazepam and midazolamU ........................................................................................................... 35 LorazepamU (Inclusion)U ....................................................................................................................................... 36 MidazolamU (Inclusion)U ....................................................................................................................................... 36 SectionU 6: U AntiU ‐infective medicinesU ..................................................................................................... 37 SectionU 6.2: U AntibacterialsU U ................................................................................................................... 37 SectionU 6.2.4: U AntituberculosisU medicinesU ........................................................................................... 37 RifabutinU (Inclusion)U ........................................................................................................................................... 37 SectionU 6.4: U AntiviralU medicinesU ......................................................................................................... 38 SectionU 6.4.2: AntiretroviralsU ....................................................................................................................... 38 AtazanavirU (Inclusion)U ........................................................................................................................................ 38 ProteaseU inhibitors (Review)U .............................................................................................................................. 39 FixedU ‐dose combinationsU ............................................................................................................................. 41 ZidovudineU + lamivudine
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