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Page 1: lista.pdfAnnexや1や 19thやWHOやModelやListやofやEssentialやMedicinesや(Aprilや2015)や Explanatoryやnotesや Theやcoreやlistやpresentsやaやlistやofやminimumやmedicineや

I documenti di:

quotidianosanità.itDossier

Documentazione legislativa

Studi e ricerche

Interventi e relazioni

Quotidiano online di informazione sanitaria

Page 2: lista.pdfAnnexや1や 19thやWHOやModelやListやofやEssentialやMedicinesや(Aprilや2015)や Explanatoryやnotesや Theやcoreやlistやpresentsやaやlistやofやminimumやmedicineや

Annexȱ1ȱ19thȱWHOȱModelȱListȱofȱEssentialȱMedicinesȱ(Aprilȱ2015)ȱ

ExplanatoryȱnotesȱTheȱcoreȱlistȱpresentsȱaȱlistȱofȱminimumȱmedicineȱneedsȱforȱaȱbasicȱhealthȬcareȱsystem,ȱlistingȱtheȱmostȱefficacious,ȱsafeȱandȱcost�effectiveȱmedicinesȱforȱpriorityȱconditions.ȱPriorityȱconditionsȱareȱselectedȱonȱtheȱbasisȱofȱcurrentȱandȱestimatedȱfutureȱpublicȱhealthȱrelevance,ȱandȱpotentialȱforȱsafeȱandȱcostȬeffectiveȱtreatment.ȱȱTheȱcomplementaryȱlistȱpresentsȱessentialȱmedicinesȱforȱpriorityȱdiseases,ȱforȱwhichȱspecializedȱdiagnosticȱorȱmonitoringȱfacilities,ȱand/orȱspecialistȱmedicalȱcare,ȱand/orȱspecialistȱtrainingȱareȱneeded.ȱInȱcaseȱofȱdoubtȱmedicinesȱmayȱalsoȱbeȱlistedȱasȱcomplementaryȱonȱtheȱbasisȱofȱconsistentȱhigherȱcostsȱorȱlessȱattractiveȱcostȬeffectivenessȱinȱaȱvarietyȱofȱsettings.ȱȱȱTheȱsquareȱboxȱsymbolȱ()ȱisȱprimarilyȱintendedȱtoȱindicateȱsimilarȱclinicalȱperformanceȱwithinȱaȱpharmacologicalȱclass.ȱTheȱlistedȱmedicineȱshouldȱbeȱtheȱexampleȱofȱtheȱclassȱforȱwhichȱthereȱisȱtheȱbestȱevidenceȱforȱeffectivenessȱandȱsafety.ȱInȱsomeȱcases,ȱthisȱmayȱbeȱtheȱfirstȱmedicineȱthatȱisȱlicensedȱforȱmarketing;ȱinȱotherȱinstances,ȱsubsequentlyȱlicensedȱcompoundsȱmayȱbeȱsaferȱorȱmoreȱeffective.ȱWhereȱthereȱisȱnoȱdifferenceȱinȱtermsȱofȱefficacyȱandȱsafetyȱdata,ȱtheȱlistedȱmedicineȱshouldȱbeȱtheȱoneȱthatȱisȱgenerallyȱavailableȱatȱtheȱlowestȱprice,ȱbasedȱonȱinternationalȱdrugȱpriceȱinformationȱsources.ȱNotȱallȱsquareȱboxesȱareȱapplicableȱtoȱmedicineȱselectionȱforȱchildrenȱ�ȱseeȱtheȱsecondȱEMLcȱforȱdetails.ȱȱTherapeuticȱequivalenceȱisȱindicatedȱonlyȱonȱtheȱbasisȱofȱreviewsȱofȱefficacyȱandȱsafetyȱandȱwhenȱconsistentȱwithȱWHOȱclinicalȱguidelines.ȱNationalȱlistsȱshouldȱnotȱuseȱaȱsimilarȱsymbolȱandȱshouldȱbeȱspecificȱinȱtheirȱfinalȱselection,ȱwhichȱwouldȱdependȱonȱlocalȱavailabilityȱandȱprice.ȱȱȱTheȱa ȱsymbolȱindicatesȱthatȱthereȱisȱanȱageȱorȱweightȱrestrictionȱonȱuseȱofȱtheȱmedicine;ȱdetailsȱforȱeachȱmedicineȱcanȱbeȱfoundȱinȱTableȱ1.1.ȱȱWhereȱtheȱ[ c] ȱsymbolȱisȱplacedȱnextȱtoȱtheȱcomplementaryȱlistȱitȱsignifiesȱthatȱtheȱmedicine(s)ȱrequire(s)ȱspecialistȱdiagnosticȱorȱmonitoringȱfacilities,ȱand/orȱspecialistȱmedicalȱcare,ȱand/orȱspecialistȱtrainingȱforȱtheirȱuseȱinȱchildren.ȱȱWhereȱtheȱ[ c] ȱsymbolȱisȱplacedȱnextȱtoȱanȱindividualȱmedicineȱorȱstrengthȱofȱmedicineȱitȱsignifiesȱthatȱthereȱisȱaȱspecificȱindicationȱforȱrestrictingȱitsȱuseȱtoȱchildren.ȱȱTheȱpresenceȱofȱanȱentryȱonȱtheȱEssentialȱMedicinesȱListȱcarriesȱnoȱassuranceȱasȱtoȱpharmaceuticalȱquality.ȱItȱisȱtheȱresponsibilityȱofȱtheȱrelevantȱnationalȱorȱregionalȱdrugȱregulatoryȱauthorityȱtoȱensureȱthatȱeachȱproductȱisȱofȱappropriateȱpharmaceuticalȱqualityȱ(includingȱstability)ȱandȱthat,ȱwhenȱrelevant,ȱdifferentȱproductsȱareȱinterchangeable.ȱȱForȱrecommendationsȱandȱadviceȱconcerningȱallȱaspectsȱofȱtheȱqualityȱassuranceȱofȱmedicinesȱseeȱtheȱWHOȱMedicinesȱwebsiteȱhttp://www.who.int/medicines/areas/quality_assurance.ȱȱMedicinesȱandȱdosageȱformsȱareȱlistedȱinȱalphabeticalȱorderȱwithinȱeachȱsectionȱandȱthereȱisȱnoȱimplicationȱofȱpreferenceȱforȱoneȱformȱoverȱanother.ȱStandardȱtreatmentȱguidelinesȱshouldȱbeȱconsultedȱforȱinformationȱonȱappropriateȱdosageȱforms.ȱTheȱmainȱtermsȱusedȱforȱdosageȱformsȱinȱtheȱEssentialȱMedicinesȱListȱcanȱbeȱfoundȱinȱTableȱ1.2.ȱȱ

Page 3: lista.pdfAnnexや1や 19thやWHOやModelやListやofやEssentialやMedicinesや(Aprilや2015)や Explanatoryやnotesや Theやcoreやlistやpresentsやaやlistやofやminimumやmedicineや

DefinitionsȱofȱmanyȱofȱtheseȱtermsȱandȱpharmaceuticalȱqualityȱrequirementsȱapplicableȱtoȱtheȱdifferentȱcategoriesȱareȱpublishedȱinȱtheȱcurrentȱeditionȱofȱTheȱInternationalȱPharmacopoeiaȱhttp://www.who.int/medicines/publications/pharmacopoeia.ȱȱȱ

Page 4: lista.pdfAnnexや1や 19thやWHOやModelやListやofやEssentialやMedicinesや(Aprilや2015)や Explanatoryやnotesや Theやcoreやlistやpresentsやaやlistやofやminimumやmedicineや

EssentialȱMedicinesȱ 19thȱeditionȱ

WHOȱModelȱListȱ ȱ ȱ ȱ ȱ ȱ ȱ

1 9 t h W HO Model List of Essent ia l Medicines ( Apr il 2 0 1 5 ) page - 1

1 . ANAESTHETI CS

1 .1 Genera l anaesthet ics and oxygen

1 .1 .1 I nhala t ional m edicines

halothaneȱȱ Inhalation.

isofluraneȱȱ Inhalation.

nitrousȱoxide Inhalation.

oxygenȱ Inhalation (medicinalȱgas).ȱ

1 .1 .2 I n jectable m edicines ȱ

ketamineȱ Injection:ȱ50 mgȱ(asȱhydrochloride)/ mLȱinȱ10ȬȱmLȱvial.ȱ

propofol*ȱ

Injection:ȱ10 mg/ mL;ȱ20 mg/ mL.

*ȱThiopentalȱmayȱbeȱusedȱasȱanȱalternativeȱdependingȱonȱlocalȱavailabilityȱandȱcost.ȱ

1 .2 Loca l anaesthet ics

ȱbupivacaineȱ

Injection: 0.25%;ȱ0.5%ȱ(hydrochloride)ȱinȱvial.ȱȱ

Injectionȱforȱspinalȱanaesthesia:ȱ0.5%ȱ(hydrochloride)ȱinȱ4ȬȱmLȱampouleȱtoȱbeȱmixedȱwithȱ7.5%ȱglucoseȱsolution.ȱ

ȱlidocaineȱ

Injection: 1%;ȱ2%ȱ(hydrochloride)ȱinȱvial.ȱ

Injectionȱforȱspinalȱanaesthesia:ȱ5%ȱ(hydrochloride)ȱinȱȱ2ȬȱmLȱampouleȱtoȱbeȱmixedȱwithȱ7.5%ȱglucoseȱsolution.ȱ

Topicalȱforms:ȱ2%ȱtoȱ4%ȱ(hydrochloride).ȱ

lidocaineȱ+ȱepinephrineȱ(adrenaline)ȱȱ

Dentalȱcartridge: 2%ȱ(hydrochloride)ȱ+ȱepinephrineȱ1:80ȱ000.

Injection:ȱ1%;ȱ2%ȱ(hydrochlorideȱorȱsulfate)ȱ+ȱepinephrineȱ1:200ȱ000ȱinȱvial.ȱ

ComplementaryȱListȱ

ephedrineȱInjection:ȱ30ȱmgȱ(hydrochloride)/ȱmLȱinȱ1ȬȱmLȱampoule.ȱ

(Forȱuseȱinȱspinalȱanaesthesiaȱduringȱdelivery,ȱtoȱpreventȱhypotension).ȱ

1 .3 Preoperat ive m edicat ion and sedat ion for shor t - term procedures

atropineȱ Injection: 1ȱmgȱ(sulfate)ȱinȱ1ȬmL ampoule.ȱ

ȱmidazolamȱ

Injection: 1ȱmg/ mL.

Oralȱliquid:ȱ2ȱmg/ȱmLȱ[ c] .ȱ

Tablet:ȱ7.5ȱmg;ȱ15ȱmg.ȱ

morphineȱ Injection: 10ȱmgȱ(sulfate orȱhydrochloride)ȱinȱ1ȬȱmLȱampoule.

Page 5: lista.pdfAnnexや1や 19thやWHOやModelやListやofやEssentialやMedicinesや(Aprilや2015)や Explanatoryやnotesや Theやcoreやlistやpresentsやaやlistやofやminimumやmedicineや

EssentialȱMedicinesȱ 19thȱeditionȱ

WHOȱModelȱListȱ ȱ ȱ ȱ ȱ ȱ ȱ

1 9 t h W HO Model List of Essent ia l Medicines ( Apr il 2 0 1 5 ) page - 2

2 . MEDI CI NES FOR PAI N AND PALLI ATI VE CARE

2 .1 Non- opioids and non- steroida l ant i- inf lam m atory m edicines ( NSAI Ms)

acetylsalicylicȱacidȱSuppository: 50ȱmgȱtoȱ150ȱmg.ȱ

Tablet:ȱ100ȱmgȱtoȱ500ȱmg.ȱ

ibuprofenȱa ȱ

Oralȱliquid: 200ȱmg/5ȱmL.

Tablet:ȱ200ȱmg;ȱ400ȱmg;ȱ600ȱmg.ȱ

a Not in children less than 3 months.

paracetamol*ȱ

Oralȱliquid: 125ȱmg/5 mL.

Suppository:ȱ100ȱmg.ȱ

Tablet:ȱ100ȱmgȱtoȱ500ȱmg.ȱ

*ȱNotȱrecommendedȱforȱantiȬinflammatoryȱuseȱdueȱtoȱlackȱofȱprovenȱbenefitȱtoȱthatȱeffect.ȱ

2 .2 Opioid analgesics

codeineȱ Tablet: 30ȱmgȱ(phosphate).

morphine*ȱȱ

Granulesȱ(slowȬrelease;ȱtoȱmixȱwithȱwater): 20ȱmg �

200ȱmgȱ(morphineȱsulfate).ȱ

Injection:ȱ10ȱmgȱ(morphineȱhydrochlorideȱorȱmorphineȱsulfate)ȱinȱ1ȬȱmLȱampoule.ȱ

Oralȱliquid:ȱ10ȱmgȱ(morphineȱhydrochlorideȱorȱmorphineȱsulfate)/5ȱȱmL.ȱ

Tabletȱ(slowȱrelease):ȱ10ȱmg�200mgȱ(morphineȱhydrochlorideȱorȱmorphineȱsulfate).ȱȱ

Tabletȱ(immediateȱrelease):ȱ10ȱmgȱ(morphineȱsulfate).ȱ

*Alternativesȱlimitedȱtoȱhydromorphoneȱandȱoxycodoneȱ

2 .3 Medicines for other com m on sym ptom s in pa llia t ive care

amitriptylineȱ Tablet:ȱ10ȱmg;ȱ25ȱmg;ȱ75ȱmg.ȱȱ

cyclizineȱ[ c] ȱInjection:ȱ50ȱmg/ mL.

Tablet:ȱ50ȱmg.ȱ

dexamethasoneȱȱ

Injection:ȱ4ȱmg/ mL inȱ1ȬmLȱampouleȱ(asȱdisodiumȱphosphateȱsalt).ȱ

Oralȱliquid:ȱ2ȱmg/5ȱȱmL.ȱȱ

Tablet:ȱ2ȱmgȱ[ c] ;ȱ4ȱmg.ȱ

Page 6: lista.pdfAnnexや1や 19thやWHOやModelやListやofやEssentialやMedicinesや(Aprilや2015)や Explanatoryやnotesや Theやcoreやlistやpresentsやaやlistやofやminimumやmedicineや

EssentialȱMedicinesȱ 19thȱeditionȱ

WHOȱModelȱListȱ ȱ ȱ ȱ ȱ ȱ ȱ

1 9 t h W HO Model List of Essent ia l Medicines ( Apr il 2 0 1 5 ) page - 3

diazepamȱȱ

Injection:ȱ5ȱmg/ mL.

Oralȱliquid:ȱ2ȱmg/5ȱȱmL.ȱ

Rectalȱsolution:ȱ2.5ȱmg;ȱ5ȱmg;ȱ10ȱmg.ȱ

Tablet:ȱ5ȱmg;ȱ10ȱmg.ȱ

docusateȱsodiumȱCapsule:ȱ100ȱmg.ȱ

Oralȱliquid:ȱ50ȱmg/5ȱȱmL.ȱ

fluoxetineȱa ȱȱSolidȱoralȱdosageȱform: 20ȱmgȱ(asȱhydrochloride).

a > 8 years.ȱ

haloperidolȱ

Injection: 5ȱmgȱinȱ1ȬmL ampoule.ȱ

Oralȱliquid:ȱ2ȱmg/ȱmL.ȱ

Solidȱoralȱdosageȱform:ȱ0.5ȱmg;ȱ2mg;ȱ5ȱmg.ȱ

hyoscineȱbutylbromideȱ Injection:ȱ20ȱmg/ȱmL.ȱ

hyoscineȱhydrobromideȱ[ c] ȱInjection:ȱ400ȱmicrograms/ mL;ȱ600ȱmicrograms/

mL.ȱ

Transdermalȱpatches:ȱ1ȱmg/72ȱhours.ȱ

lactuloseȱ[ c] ȱ Oralȱliquid:ȱ3.1�3.7ȱg/5ȱȱmL.ȱ

loperamideȱȱ Solidȱoralȱdosageȱform:ȱ2ȱmg.ȱ

metoclopramideȱ

Injection:ȱ5ȱmg (hydrochloride)/mLȱinȱ2ȬmLȱampoule.ȱ

Oralȱliquid:ȱ5ȱmg/5ȱȱmL.ȱ

Solidȱoralȱform:ȱ10ȱmgȱ(hydrochloride).ȱ

midazolamȱ

Injection:ȱ1 mg/ mL;ȱ5 mg/ mL.ȱ

Solidȱoralȱdosageȱform:ȱ7.5ȱmg;ȱ15ȱmg.ȱ

Oralȱliquid:ȱ2mg/ȱmLȱ[ c] . ȱ

ondansetronȱ[ c] ȱa ȱ

Injection:ȱ2ȱmgȱbase/ mL inȱ2ȬȱmLȱampouleȱ(asȱhydrochloride).ȱ

Oralȱliquid:ȱ4ȱmgȱbase/5ȱȱmL.ȱ

Solidȱoralȱdosageȱform:ȱEqȱ4ȱmgȱbase;ȱEqȱ8ȱmgȱbase.ȱ

a > 1 m onth.ȱ

sennaȱ Oralȱliquid:ȱ7.5ȱmg/5ȱȱmL.ȱȱ

3 . ANTI ALLERGI CS AND MEDI CI NES USED I N ANAPHYLAXI S

dexamethasone Injection:ȱ4ȱmg/ mL inȱ1ȬmLȱampouleȱ(asȱdisodiumȱphosphateȱsalt).ȱ

epinephrineȱ(adrenaline) Injection: 1ȱmgȱ(asȱhydrochlorideȱorȱhydrogenȱtartrate)ȱinȱ1ȬȱmLȱampoule.ȱ

hydrocortisone Powderȱforȱinjection: 100ȱmgȱ(asȱsodiumȱsuccinate)ȱinȱvial.ȱ

Page 7: lista.pdfAnnexや1や 19thやWHOやModelやListやofやEssentialやMedicinesや(Aprilや2015)や Explanatoryやnotesや Theやcoreやlistやpresentsやaやlistやofやminimumやmedicineや

EssentialȱMedicinesȱ 19thȱeditionȱ

WHOȱModelȱListȱ ȱ ȱ ȱ ȱ ȱ ȱ

1 9 t h W HO Model List of Essent ia l Medicines ( Apr il 2 0 1 5 ) page - 4

ȱloratadineȱ*ȱ

ȱ

Oralȱliquid:ȱ1ȱmg/ mL.

Tablet:ȱ10ȱmg.ȱ

*Thereȱmayȱbeȱaȱroleȱforȱsedatingȱantihistaminesȱforȱlimitedȱindicationsȱ(EMLc).ȱ

ȱprednisoloneȱOralȱliquid: 5 mg/ mL [ c] .

Tablet:ȱ5ȱmg;ȱ25ȱmg.ȱ

4 . ANTI DOTES AND OTHER SUBSTANCES USED I N POI SONI NG S

4 .1 Non- specif ic

charcoal,ȱactivatedȱ Powder.

4 .2 Specif ic

acetylcysteineȱInjection: 200ȱmg/ mL inȱ10ȬȱmLȱampoule.ȱ

Oralȱliquid:ȱ10%ȱ[ c] ;ȱ20%ȱ[ c] .ȱ

atropineȱ Injection: 1ȱmgȱ(sulfate)ȱinȱ1ȬȱmLȱampoule.ȱ

calciumȱgluconateȱ Injection: 100ȱmg/ mL inȱ10ȬȱmLȱampoule.ȱ

methylthioniniumȱchlorideȱȱ(methyleneȱblue)ȱ

Injection:ȱ10ȱmg/ȱmLȱinȱ10ȬȱmLȱampoule.ȱ

naloxoneȱInjection: 400ȱmicrogramsȱ(hydrochloride)ȱinȱ1ȬmL

ampoule.ȱ

penicillamineȱ Solidȱoralȱdosageȱform: 250ȱmg.ȱ

potassiumȱferricȱhexacyanoȬferrate(II)ȱȬ2H2O(Prussianȱblue)ȱ

Powderȱforȱoralȱadministration.ȱ

sodiumȱnitriteȱ Injection: 30ȱmg/ mL inȱ10ȬmLȱampoule.ȱ

sodiumȱthiosulfateȱ Injection: 250ȱmg/ mL inȱ50ȬȱmLȱampoule.ȱ

ComplementaryȱListȱ

deferoxamineȱ Powderȱforȱinjection:ȱ500ȱmgȱ(mesilate)ȱinȱvial.ȱ

dimercaprolȱ Injectionȱinȱoil:ȱ50ȱmg/ȱmLȱinȱ2ȬȱmLȱampoule.ȱ

fomepizoleȱ Injection:ȱ5ȱmg/ȱmLȱ(sulfate)ȱinȱ20ȬȱmLȱampouleȱorȱ1ȱg/ȱmLȱ(base)ȱinȱ1.5ȬȱmLȱampoule.ȱ

sodiumȱcalciumȱedetateȱȱ Injection:ȱ200ȱmg/ȱmLȱinȱ5ȬȱmLȱampoule.ȱ

succimerȱ Solidȱoralȱdosageȱform:ȱ100ȱmg.ȱ

5 . ANTI CONVULSANTS/ ANTI EPI LEPTI CS

carbamazepineȱ

Oralȱliquid: 100ȱmg/5ȱmL.

Tabletȱ(chewable):ȱ100ȱmg;ȱ200ȱmg.ȱ

Tabletȱ(scored):ȱ100ȱmg;ȱ200ȱmg.ȱ

diazepamȱGelȱorȱrectalȱsolution:ȱ5 mg/ȱmLȱinȱ0.5ȱȱmL;ȱ2ȬmL; 4ȬmLȱtubes.ȱ

Page 8: lista.pdfAnnexや1や 19thやWHOやModelやListやofやEssentialやMedicinesや(Aprilや2015)や Explanatoryやnotesや Theやcoreやlistやpresentsやaやlistやofやminimumやmedicineや

EssentialȱMedicinesȱ 19thȱeditionȱ

WHOȱModelȱListȱ ȱ ȱ ȱ ȱ ȱ ȱ

1 9 t h W HO Model List of Essent ia l Medicines ( Apr il 2 0 1 5 ) page - 5

lorazepamȱParenteralȱformulation:ȱ2ȱmg/ȱmLȱinȱ1ȬȱmLȱampoule;ȱ4ȱmg/ȱmLȱinȱ1ȬȱmLȱampoule.ȱȱ

magnesiumȱsulfate*ȱ

ȱ

Injection: 0.5g/ mL inȱ2ȬmLȱampouleȱ(equivalentȱtoȱ1ȱgȱinȱ2ȱmL;ȱ50%ȱweight/volume);ȱ0.5g/ȱmLȱinȱȱ10ȬȱmLȱampouleȱ(equivalentȱtoȱ5ȱgȱinȱ10ȱmL;ȱ50%ȱweight/volume).ȱ

*ȱForȱuseȱinȱeclampsiaȱandȱsevereȱpreȬeclampsiaȱandȱnotȱforȱotherȱconvulsantȱdisorders.ȱ

midazolamȱ

Solutionȱforȱoromucosalȱadministration:ȱȱ5ȱmg/mL;

10ȱmg/mLȱ

Ampoule*:ȱ1ȱmg/ȱmL;ȱ10ȱmg/mLȱ

*forȱbuccalȱadministrationȱwhenȱsolutionȱforȱoromucosalȱadministrationȱisȱnotȱavailableȱ

phenobarbitalȱȱ

Injection:ȱ200ȱmg/ mL (sodium).ȱ

Oralȱliquid:ȱ15ȱmg/5ȱȱmL.ȱ

Tablet:ȱ15ȱmgȱtoȱ100ȱmg.ȱ

phenytoinȱ

Injection: 50ȱmg/ mL inȱ5ȬmLȱvialȱ(sodiumȱsalt).

Oralȱliquid:ȱ25ȱmgȱtoȱ30ȱmg/5ȱȱmL.*ȱ

Solidȱoralȱdosageȱform:ȱ25ȱmg;ȱ50ȱmg;ȱ100ȱmgȱ(sodiumȱsalt).ȱ

Tabletȱ(chewable):ȱ50ȱmg.ȱ

*ȱTheȱpresenceȱofȱbothȱ25ȱmg/5ȱȱmLȱandȱ30ȱmg/5ȱȱmLȱstrengthsȱonȱtheȱsameȱmarketȱwouldȱcauseȱconfusionȱinȱprescribingȱandȱdispensingȱandȱshouldȱbeȱavoided.ȱ

valproicȱacidȱ(sodiumȱvalproate)ȱȱ

Oralȱliquid: 200ȱmg/5ȱmL.

Tabletȱ(crushable):ȱ100ȱmg.ȱ

Tabletȱ(entericȬcoated):ȱ200ȱmg;ȱ500ȱmgȱ(sodiumȱvalproate).ȱ

ComplementaryȱListȱ

ethosuximideȱCapsule:ȱ250ȱmg.ȱ

Oralȱliquid:ȱ250ȱmg/5ȱȱmL.ȱ

valproicȱacidȱ(sodiumȱvalproate)ȱ Injection:ȱȱ100ȱmg/ȱmLȱinȱ4ȬȱmLȱampoule;ȱ100ȱmg/ȱmLȱinȱ10ȬȱmLȱampoule.ȱ

6 . ANTI - I NFECTI VE MEDI CI NES

6 .1 Anthelm inthics

6 .1 .1 I ntest inal anthelm inthics

albendazoleȱ Tabletȱ(chewable): 400ȱmg.

Page 9: lista.pdfAnnexや1や 19thやWHOやModelやListやofやEssentialやMedicinesや(Aprilや2015)や Explanatoryやnotesや Theやcoreやlistやpresentsやaやlistやofやminimumやmedicineや

EssentialȱMedicinesȱ 19thȱeditionȱ

WHOȱModelȱListȱ ȱ ȱ ȱ ȱ ȱ ȱ

1 9 t h W HO Model List of Essent ia l Medicines ( Apr il 2 0 1 5 ) page - 6

levamisole Tablet: 50ȱmg;ȱ150ȱmgȱ(asȱhydrochloride).ȱ

mebendazoleȱ Tabletȱ(chewable): 100ȱmg;ȱ500ȱmg.ȱ

niclosamideȱ Tabletȱ(chewable): 500ȱmg.

praziquantelȱ Tablet: 150ȱmg;ȱ600ȱmg.

pyrantelȱ

Oralȱliquid: 50ȱmgȱ(asȱembonateȱorȱpamoate)/ mL.

Tabletȱ(chewable):ȱ250ȱmgȱ(asȱembonateȱorȱpamoate).ȱ

6 .1 .2 Ant ifilar ia ls

albendazoleȱ Tabletȱ(chewable): 400ȱmg.

diethylcarbamazineȱ Tablet: 50ȱmg;ȱ100ȱmgȱ(dihydrogenȱcitrate).ȱ

ivermectinȱ Tabletȱ(scored): 3ȱmg.

6 .1 .3 Ant ischistosom als and other ant it rem atode m edicines

praziquantelȱ Tablet: 600ȱmg.

triclabendazoleȱ Tablet: 250ȱmg.

ComplementaryȱListȱ

oxamniquine*ȱ

Capsule:ȱ250ȱmg.ȱ

Oralȱliquid:ȱ250ȱmg/5ȱȱmL.ȱ

*ȱOxamniquineȱisȱlistedȱforȱuseȱwhenȱpraziquantelȱtreatmentȱfails.ȱ

6 .2 Ant ibacter ia ls

6 .2 .1 Beta- lactam m edicines

amoxicillinȱ

Powderȱforȱoralȱliquid: 125ȱmgȱ(asȱtrihydrate)/5ȱmL;ȱ250ȱmgȱ(asȱtrihydrate)/5ȱȱmLȱ[ c] .ȱ

Solidȱoralȱdosageȱform:ȱ250ȱmg;ȱ500ȱmgȱ(asȱtrihydrate).ȱ

amoxicillinȱ+ȱclavulanicȱacidȱȱ

Oralȱliquid: 125 mgȱamoxicillinȱ+ȱ31.25ȱmgȱclavulanicȱacid/5ȱȱmLȱANDȱ250ȱmgȱamoxicillinȱ+ȱ62.5ȱmgȱclavulanicȱacid/5ȱȱmLȱ[ c] .ȱ

Tablet:ȱ500ȱmgȱ(asȱtrihydrate)ȱ+ȱ125ȱmgȱ(asȱpotassiumȱsalt).ȱ

ampicillinȱPowderȱforȱinjection: 500ȱmg;ȱ1ȱgȱ(asȱsodiumȱsalt)ȱinȱvial.ȱ

benzathineȱbenzylpenicillinȱPowderȱforȱinjection: 900 mgȱbenzylpenicillinȱ(=ȱ1.2ȱmillionȱIU)ȱinȱ5ȬȱmLȱvialȱ[ c] ;ȱ1.44ȱgȱbenzylpenicillinȱ(=ȱ2.4ȱmillionȱIU)ȱinȱ5ȬȱmLȱvial.ȱ

benzylpenicillinȱPowderȱforȱinjection: 600ȱmgȱ(=ȱ1ȱmillionȱIU);ȱ3ȱgȱ(=ȱ5ȱmillionȱIU)ȱ(sodiumȱorȱpotassiumȱsalt)ȱinȱvial.ȱ

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cefalexinȱ[ c]

Powderȱforȱreconstitutionȱwithȱwater:ȱ125ȱmg/5ȱmL;ȱ250ȱmg/5ȱȱmLȱ(anhydrous).ȱȱ

Solidȱoralȱdosageȱform:ȱ250ȱmgȱ(asȱmonohydrate).ȱ

cefazolin*ȱa ȱ

Powderȱforȱinjection:ȱ1ȱgȱ(asȱsodiumȱsalt)ȱinȱvial.

*ȱForȱsurgicalȱprophylaxis.ȱ

a > 1 m onth.ȱ

cefixime*ȱ

Capsule: 400ȱmg (asȱtrihydrate).ȱ

*ȱListedȱonlyȱforȱsingleȬdoseȱtreatmentȱofȱuncomplicatedȱanogenitalȱgonorrhoea.ȱ

ceftriaxone*ȱa ȱ

Powderȱforȱinjection: 250ȱmg;ȱ1ȱgȱ(asȱsodiumȱsalt)ȱinȱvial.ȱ

*ȱDoȱnotȱadministerȱwithȱcalciumȱandȱavoidȱinȱinfantsȱwithȱhyperbilirubinaemia.ȱ

a > 41 weeks corrected gestat ional age.ȱ

ȱcloxacillinȱ

Capsule: 500ȱmg;ȱ1ȱgȱ(asȱsodiumȱsalt).ȱ

Powderȱforȱinjection:ȱ500ȱmgȱ(asȱsodiumȱsalt)ȱinȱvial.ȱ

Powderȱforȱoralȱliquid:ȱ125ȱmgȱ(asȱsodiumȱsalt)/5ȱȱmL.ȱ

phenoxymethylpenicillinȱ

Powderȱforȱoralȱliquid: 250ȱmgȱ(asȱpotassiumȱsalt)/5ȱȱmL.ȱ

Tablet:ȱ250ȱmgȱ(asȱpotassiumȱsalt).ȱ

procaineȱbenzylpenicillin*ȱ

Powderȱforȱinjection: 1ȱgȱ(=1ȱmillionȱIU);ȱ3ȱgȱ(=3ȱmillionȱIU)ȱinȱvial.ȱȱ

*ȱProcaineȱbenzylpenicillinȱisȱnotȱrecommendedȱasȱfirstȬlineȱtreatmentȱforȱneonatalȱsepsisȱexceptȱinȱsettingsȱwithȱhighȱneonatalȱmortality,ȱwhenȱgivenȱbyȱtrainedȱhealthȱworkersȱinȱcasesȱwhereȱhospitalȱcareȱisȱnotȱachievable.ȱ

ComplementaryȱListȱ

cefotaxime*ȱ[ c] ȱȱPowderȱforȱinjection:ȱ250ȱmgȱperȱvialȱ(asȱsodiumȱsalt).ȱ

*ȱ3rdȱgenerationȱcephalosporinȱofȱchoiceȱforȱuseȱinȱhospitalizedȱneonates.ȱ

ceftazidimeȱPowderȱforȱinjection:ȱ250ȱmgȱorȱ1ȱgȱ(asȱpentahydrate)ȱinȱvial.ȱ

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imipenem*ȱ+ȱcilastatin*

Powderȱforȱinjection:ȱ250ȱmgȱ(asȱmonohydrate)ȱ+ȱ250ȱmgȱ(asȱsodiumȱsalt);ȱ500ȱmgȱ(asȱmonohydrate)ȱ+ȱ500ȱmgȱ(asȱsodiumȱsalt)ȱinȱvial.ȱ

*ȱListedȱonlyȱforȱtheȱtreatmentȱofȱlifeȬthreateningȱhospitalȬbasedȱinfectionȱdueȱtoȱsuspectedȱorȱprovenȱmultidrugȬresistantȱinfection.ȱ

Meropenemȱisȱindicatedȱforȱtheȱtreatmentȱofȱmeningitisȱandȱisȱlicensedȱforȱuseȱinȱchildrenȱoverȱtheȱageȱofȱ3ȱmonths.ȱ

6 .2 .2 Other ant ibacteria ls

azithromycin*ȱ

Capsule: 250ȱmg;ȱ500ȱmg (anhydrous).ȱ

Oralȱliquid:ȱ200ȱmg/5ȱȱmL.ȱ

*ȱOnlyȱlistedȱforȱsingleȬdoseȱtreatmentȱofȱgenitalȱChlamydiaȱtrachomatisȱandȱofȱtrachoma.ȱ

chloramphenicolȱ

Capsule: 250ȱmg.

Oilyȱsuspensionȱforȱinjection*:ȱ0.5ȱgȱ(asȱsodiumȱsuccinate)/ȱmLȱinȱ2ȬȱmLȱampoule.ȱ

*ȱOnlyȱforȱtheȱpresumptiveȱtreatmentȱofȱepidemicȱmeningitisȱinȱchildrenȱolderȱthanȱ2ȱyears.ȱ

Oralȱliquid:ȱ150ȱmgȱ(asȱpalmitate)/5ȱȱmL.ȱ

Powderȱforȱinjection:ȱ1ȱgȱ(sodiumȱsuccinate)ȱinȱvial.ȱ

ȱciprofloxacin*ȱ

Oralȱliquid: 250ȱmg/5ȱmL (anhydrous)ȱ[ c] .

SolutionȱforȱIVȱinfusion:ȱ2ȱmg/ȱmLȱ(asȱhyclate)ȱ[ c] .ȱ

Tablet:ȱ250ȱmgȱ(asȱhydrochloride).ȱ

*ȱSquareȱboxȱappliesȱtoȱadultsȱonly.ȱ

clarithromycin*ȱ

Solidȱoralȱdosageȱform: 500ȱmg.ȱ

*ȱForȱuseȱinȱcombinationȱregimensȱforȱeradicationȱofȱH.ȱPyloriȱinȱadults.ȱ

doxycyclineȱa ȱ

Oralȱliquid:ȱ25 mg/5 mL [ c] ;ȱ50ȱmg/5ȱȱmLȱ(anhydrous)ȱ[ c] .ȱ

Solidȱoralȱdosageȱform:ȱ50ȱmgȱ[ c] ;ȱ100ȱmgȱ(asȱhyclate).ȱȱ

a ȱUse in children < 8 years only for life- threatening infect ions when no alternat ive exists.ȱ

ȱerythromycinȱ

Powderȱforȱinjection: 500ȱmgȱ(asȱlactobionate)ȱinȱvial.ȱ

Powderȱforȱoralȱliquid:ȱ125ȱmg/5ȱȱmLȱ(asȱstearateȱorȱestolateȱorȱethylȱsuccinate).ȱ

Solidȱoralȱdosageȱform:ȱ250ȱmgȱ(asȱstearateȱorȱestolateȱorȱethylȱsuccinate).ȱ

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ȱgentamicinȱInjection: 10ȱmg;ȱ40ȱmgȱ(asȱsulfate)/ȱmLȱinȱ2ȬmL

vial.ȱ

ȱmetronidazoleȱ

Injection: 500ȱmgȱinȱ100ȬmLȱvial.ȱ

Oralȱliquid:ȱ200ȱmgȱ(asȱbenzoate)/5ȱȱmL.ȱ

Suppository:ȱ500ȱmg;ȱ1ȱg.ȱ

Tablet:ȱ200ȱmgȱtoȱ500ȱmg.ȱ

nitrofurantoinȱOralȱliquid: 25 mg/5 mL [ c] .ȱ

Tablet:ȱ100ȱmg.ȱ

spectinomycinȱ Powderȱforȱinjection: 2ȱgȱ(asȱhydrochloride)ȱinȱvial.

sulfamethoxazoleȱ+ȱtrimethoprimȱȱ

Injection:

80ȱmgȱ+ȱ16ȱmg/ȱmLȱinȱ5ȬȱmLȱampoule;ȱȱ80ȱmgȱ+ȱ16ȱmg/ȱmLȱinȱ10ȬȱmLȱampoule.ȱ

Oralȱliquid:ȱ200ȱmgȱ+ȱ40ȱmg/5ȱȱmL.ȱ

Tablet:ȱ100ȱmgȱ+ȱ20ȱmg;ȱ400ȱmgȱ+ȱ80ȱmg;ȱ800ȱmgȱ+ȱ160ȱmg.ȱ

trimethoprimȱa ȱ

Oralȱliquid: 50ȱmg/5 mL [ c] .ȱ

Tablet:ȱ100ȱmg;ȱ200ȱmg.ȱ

a > 6 m onths.ȱ

ComplementaryȱListȱ

clindamycinȱ

Capsule:ȱ150ȱmgȱ(asȱhydrochloride).ȱ

Injection:ȱ150ȱmgȱ(asȱphosphate)/ȱmL.ȱ

Oralȱliquid:ȱ75ȱmg/5ȱȱmLȱ(asȱpalmitate)ȱ[ c] .ȱ

vancomycinȱ Powderȱforȱinjection:ȱ250ȱmgȱ(asȱhydrochloride)ȱinȱvial.ȱ

6 .2 .3 Ant ileprosy m edicinesȱ

Medicinesȱusedȱ inȱ theȱ treatmentȱofȱ leprosyȱ shouldȱneverȱbeȱusedȱ exceptȱ inȱ combination.ȱCombinationȱtherapyȱisȱessentialȱtoȱpreventȱtheȱemergenceȱofȱdrugȱresistance.ȱColourȬcodedȱblisterȱpacksȱ(MDTȱblisterȱpacks)ȱ containingȱ standardȱ twoȬmedicineȱ (paucibacillaryȱ leprosy)ȱ orȱ threeȬmedicineȱ (multibacillaryȱleprosy)ȱcombinationsȱforȱadultȱandȱchildhoodȱleprosyȱshouldȱbeȱused.ȱMDTȱblisterȱpacksȱcanȱbeȱsuppliedȱfreeȱofȱchargeȱthroughȱWHO.ȱ

clofazimineȱ Capsule: 50ȱmg;ȱ100ȱmg.

dapsoneȱ Tablet: 25ȱmg;ȱ50ȱmg;ȱ100ȱmg.ȱ

rifampicinȱ Solidȱoralȱdosageȱform: 150ȱmg;ȱ300ȱmg.ȱ

6 .2 .4 Ant ituberculosis m edicines

WHOȱȱrecommendsȱandȱendorsesȱtheȱuseȱofȱfixedȬdoseȱcombinationsȱandȱtheȱdevelopmentȱofȱappropriateȱnewȱfixedȬdoseȱcombinations,ȱincludingȱmodifiedȱdosageȱforms,ȱnonȬrefrigeratedȱproductsȱandȱpaediatricȱdosageȱformsȱofȱassuredȱpharmaceuticalȱquality.ȱȱ

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ethambutolȱOralȱliquid: 25 mg/ mL [ c] .ȱ

Tablet:ȱ100ȱmgȱtoȱ400ȱmgȱ(hydrochloride).ȱ

ethambutolȱ+ȱisoniazidȱȱ Tablet: 400ȱmgȱ+ȱ150ȱmg.

ethambutolȱ+ȱisoniazidȱ+ȱpyrazinamideȱ+ȱrifampicinȱȱ

Tablet:ȱ275ȱmgȱ+ȱ75ȱmgȱ+ȱ400ȱmgȱ+ȱ150ȱmg.ȱ

ethambutolȱ+ȱisoniazidȱ+ȱrifampicinȱ Tablet:ȱ275ȱmgȱ+ȱ75ȱmgȱ+ȱ150ȱmg.ȱ

isoniazidȱ

Oralȱliquid: 50 mg/5 mL [ c] .ȱ

Tablet:ȱ100ȱmgȱtoȱ300ȱmg.ȱ

Tabletȱ(scored):ȱ50ȱmg.ȱȱ

isoniazidȱ+ȱpyrazinamideȱ+ȱrifampicinȱȱȱ

Tablet:

75ȱmgȱ+ȱ400ȱmgȱ+ȱ150ȱmg.ȱ150ȱmgȱ+ȱ500ȱmgȱ+ȱ150ȱmgȱ(Forȱintermittentȱuseȱthreeȱtimesȱweekly).ȱ

isoniazidȱ+ȱrifampicinȱȱ

Tablet:

75ȱmgȱ+ȱ150ȱmg;ȱ150ȱmgȱ+ȱ300ȱmg.ȱ60ȱmgȱ+ȱ60ȱmgȱ(Forȱintermittentȱuseȱthreeȱtimesȱweekly).ȱ150ȱmgȱ+ȱ150ȱmgȱ(Forȱintermittentȱuseȱthreeȱtimesȱweekly).ȱ

pyrazinamideȱ

Oralȱliquid: 30 mg/ mL [ c] .ȱ

Tablet:ȱ400ȱmg.ȱ

Tabletȱ(dispersible):ȱ150ȱmg.ȱ

Tabletȱ(scored):ȱ150ȱmg.ȱ

rifabutinȱ

Capsule: 150ȱmg.*

*ȱForȱuseȱonlyȱinȱpatientsȱwithȱHIVȱreceivingȱproteaseȱinhibitors.ȱȱ

rifampicinȱOralȱliquid: 20 mg/ mL [ c] .ȱ

Solidȱoralȱdosageȱform:ȱ150ȱmg;ȱ300ȱmg.ȱ

rifapentine*ȱTablet:ȱȱ150ȱmg

*ForȱtreatmentȱofȱlatentȱTBȱinfectionȱ(LTBI)ȱonlyȱ

streptomycinȱ Powderȱforȱinjection: 1ȱgȱ(asȱsulfate)ȱinȱvial.

ComplementaryȱListȱ

ReserveȱsecondȬlineȱdrugsȱforȱtheȱtreatmentȱofȱmultidrugȬresistantȱtuberculosisȱ(MDRȬTB)ȱshouldȱbeȱusedȱinȱspecializedȱcentresȱadheringȱtoȱWHOȱstandardsȱforȱTBȱcontrol.ȱȱ

amikacinȱPowderȱforȱinjection:ȱ100ȱmg;ȱ500ȱmg;ȱ1ȱgȱ(asȱsulfate)ȱinȱvial.ȱ

bedaquilineȱ Tablet:ȱȱ100ȱmgȱ

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capreomycinȱ Powderȱforȱinjection:ȱ1ȱgȱ(asȱsulfate)ȱinȱvial.ȱ

cycloserine*ȱSolidȱoralȱdosageȱform:ȱ250ȱmg.ȱ

*Terizidoneȱmayȱbeȱanȱalternativeȱ

delamanidȱ Tablet:ȱȱ50ȱmgȱ

ethionamide*ȱTablet:ȱ125ȱmg;ȱ250ȱmg.ȱ

*Protionamideȱmayȱbeȱanȱalternative.ȱ

kanamycinȱ Powderȱforȱinjection:ȱ1ȱgȱ(asȱsulfate)ȱinȱvial.ȱ

levofloxacin*ȱ

Tablet:ȱ250mg;ȱ500ȱmg;ȱ750ȱmg.ȱ

*ȱOfloxacinȱandȱmoxifloxacinȱmayȱbeȱalternativesȱbasedȱonȱavailabilityȱandȱprogrammeȱconsiderations.ȱ

linezolidȱ

Injectionȱforȱintravenousȱadministration:ȱȱ2ȱmg/ȱmLȱinȱ300ȱmLȱbagȱ

Powderȱforȱoralȱliquid:ȱȱ100ȱmg/5ȱmL,ȱ

Tablet:ȱȱ400ȱmg;ȱ600ȱmgȱ

pȬaminosalicylicȱacidȱGranules:ȱ4ȱgȱinȱsachet.ȱ

Tablet:ȱ500ȱmg.ȱ

streptomycinȱ[ c] ȱ Powderȱforȱinjection:ȱ1ȱgȱ(asȱsulfate)ȱinȱvial.ȱ

6 .3 Ant ifungal m edicines ȱ

amphotericinȱBȱ Powderȱforȱinjection: 50ȱmgȱinȱvialȱ(asȱsodiumȱdeoxycholateȱorȱliposomalȱcomplex).ȱ

clotrimazoleȱVaginalȱcream: 1%;ȱ10%.

Vaginalȱtablet:ȱ100ȱmg;ȱ500ȱmg.ȱ

ȱfluconazoleȱ

Capsule: 50ȱmg.

Injection:ȱ2ȱmg/ȱmLȱinȱvial.ȱ

Oralȱliquid:ȱ50ȱmg/5ȱȱmL.ȱ

flucytosineȱCapsule: 250ȱmg.

Infusion:ȱ2.5ȱgȱinȱ250ȱȱmL.ȱ

griseofulvinȱOralȱliquid:ȱ125ȱmg/5ȱmL [ c] .ȱ

Solidȱoralȱdosageȱform:ȱ125ȱmg;ȱ250ȱmg.ȱ

nystatinȱ

Lozenge: 100ȱ000ȱIU.

Oralȱliquid:ȱ50ȱmg/5ȱȱmLȱ[ c] ;ȱ100ȱ000ȱIU/ȱmLȱ[ c] .ȱ

Pessary:ȱ100ȱ000ȱIU.ȱ

Tablet:ȱ100ȱ000ȱIU;ȱ500ȱ000ȱIU.ȱ

ComplementaryȱListȱ

potassiumȱiodideȱ Saturatedȱsolution.ȱ

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6 .4 Ant ivira l m edicines

6 .4 .1 Ant iherpes m edicines

ȱaciclovirȱ

Oralȱliquid: 200ȱmg/5 mL [ c] .ȱ

Powderȱforȱinjection:ȱ250ȱmgȱ(asȱsodiumȱsalt)ȱinȱvial.ȱ

Tablet:ȱ200ȱmg.ȱ

6 .4 .2 Ant iret rovirals

Basedȱ onȱ currentȱ evidenceȱ andȱ experienceȱ ofȱ use,ȱ medicinesȱ inȱ theȱ followingȱ threeȱ classesȱ ofȱantiretroviralsȱ areȱ includedȱ asȱ essentialȱmedicinesȱ forȱ treatmentȱ andȱpreventionȱofȱHIVȱ (preventionȱofȱmotherȬtoȬchildȱtransmissionȱandȱpostȬexposureȱprophylaxis).ȱWHOȱemphasizesȱtheȱimportanceȱofȱusingȱtheseȱproductsȱ inȱaccordanceȱwithȱglobalȱandȱnationalȱguidelines.ȱ ȱWHOȱrecommendsȱandȱendorsesȱtheȱuseȱ ofȱ fixedȬdoseȱ combinationsȱ andȱ theȱ developmentȱ ofȱ appropriateȱ newȱ fixedȬdoseȱ combinations,ȱincludingȱmodifiedȱ dosageȱ forms,ȱ nonȬrefrigeratedȱ productsȱ andȱ paediatricȱ dosageȱ formsȱ ofȱ assuredȱpharmaceuticalȱquality.ȱ

Scoredȱ tabletsȱ canȱ beȱ usedȱ inȱ childrenȱ andȱ thereforeȱ canȱ beȱ consideredȱ forȱ inclusionȱ inȱ theȱ listingȱ ofȱtablets,ȱprovidedȱthatȱadequateȱqualityȱproductsȱareȱavailable.ȱ

6 .4 .2 .1 Nucleoside/ Nucleot ide reverse t ranscriptase inhibitors

abacavirȱ(ABC)ȱOralȱliquid: 100ȱmgȱ(asȱsulfate)/5ȱȱmL.ȱ

Tablet:ȱ300ȱmgȱ(asȱsulfate).ȱ

lamivudineȱ(3TC)ȱOralȱliquid: 50ȱmg/5 mL.

Tablet:ȱ150ȱmg.ȱ

stavudineȱ(d4T)ȱCapsule: 15 mg;ȱ20ȱmg;ȱ30ȱmg.ȱ

Powderȱforȱoralȱliquid:ȱ5ȱmg/5ȱȱmL.ȱ

tenofovirȱdisoproxilȱfumarateȱ(TDF)ȱTablet:ȱ300ȱmgȱ(tenofovirȱdisoproxilȱfumarateȱ�equivalentȱtoȱ245ȱmgȱtenofovirȱdisoproxil).ȱ

zidovudineȱ(ZDVȱorȱAZT)ȱ

Capsule: 100ȱmg;ȱ250ȱmg.

Oralȱliquid:ȱ50ȱmg/5ȱȱmL.ȱ

SolutionȱforȱIVȱinfusionȱinjection:ȱ10ȱmg/ȱmLȱinȱȱ20ȬȱmLȱvial.ȱ

Tablet:ȱ300ȱmg.ȱ

6 .4 .2 .2 Non- nucleoside reverse t ranscriptase inhibitors

efavirenzȱ(EFVȱorȱEFZ)ȱa ȱ

Capsule: 50ȱmg;ȱ100ȱmg;ȱ200ȱmg.ȱ

Tablet:ȱ200ȱmgȱ(scored);ȱ600ȱmg.ȱ

a > 3 years or > 10 kg weight .ȱ

nevirapineȱ(NVP)ȱOralȱliquid: 50ȱmg/5ȱmL.

Tablet:ȱȱ50ȱmgȱ(dispersible);ȱ200ȱmg.ȱ

6 .4 .2 .3 Protease inhibitorsȱ

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Selectionȱofȱproteaseȱ inhibitor(s)ȱ fromȱ theȱModelȱListȱwillȱneedȱ toȱbeȱdeterminedȱbyȱeachȱcountryȱafterȱconsiderationȱ ofȱ internationalȱ andȱ nationalȱ treatmentȱ guidelinesȱ andȱ experience.ȱ Ritonavirȱ isȱrecommendedȱforȱuseȱinȱcombinationȱasȱaȱpharmacologicalȱbooster,ȱandȱnotȱasȱanȱantiretroviralȱinȱitsȱownȱright.ȱAllȱotherȱproteaseȱinhibitorsȱshouldȱbeȱusedȱinȱboostedȱformsȱ(e.g.ȱwithȱritonavir).ȱ

atazanavirȱa ȱ

Solidȱoralȱdosageȱform:ȱ100ȱmg;ȱ150ȱmg;ȱ300ȱmg (asȱsulfate).ȱ

a > 25 kg.ȱȱ

darunavir a ȱTablet:ȱȱ75ȱmg;ȱ400ȱmg;ȱ600ȱmg;ȱ800ȱmgȱ

a > 3 yearsȱ

lopinavirȱ+ȱritonavirȱ(LPV/r)ȱȱOralȱliquid: 400ȱmgȱ+ȱ100ȱmg/5ȱȱmL.ȱ

Tabletȱ(heatȱstable):ȱ100ȱmgȱ+ȱ25ȱmg;ȱ200ȱmgȱ+ȱ50ȱmg.ȱ

ritonavirȱOralȱliquid: 400ȱmg/5 mL.

Tabletȱ(heatȱstable):ȱ25ȱmg;ȱ100ȱmg.ȱȱ

saquinavirȱ(SQV)ȱa ȱ

Solidȱoralȱdosageȱform: 200ȱmg;ȱ500ȱmgȱ(asȱmesilate).ȱ

a > 25 kg.ȱ

FI XED- DOSE COMBI NATI ONSȱ

abacavirȱ+ȱlamivudineȱTabletȱ(dispersible,ȱscored):ȱȱ60ȱmgȱ(asȱsulfate)ȱ+ȱ30ȱmgȱ

efavirenzȱ+ȱemtricitabineȱ+ȱtenofovirȱȱ

Tablet:ȱ600ȱmgȱ+ȱ200ȱmgȱ+ȱ300ȱmgȱ(disoproxilȱfumarateȱequivalentȱtoȱ245ȱmgȱtenofovirȱdisoproxil).ȱ

ȱ

emtricitabineȱ+ȱtenofovirȱȱ

Tablet: 200ȱmgȱ+ȱ300ȱmg (disoproxilȱfumarateȱequivalentȱtoȱ245ȱmgȱtenofovirȱdisoproxil).ȱ

ȱ

lamivudineȱ+ȱnevirapineȱ+ȱstavudineȱȱTablet: 150ȱmgȱ+ȱ200ȱmgȱ+ȱ30ȱmg.ȱ

Tabletȱ(dispersible):ȱ30ȱmgȱ+ȱ50ȱmgȱ+ȱ6ȱmgȱ[ c] .ȱȱ

lamivudineȱ+ȱnevirapineȱ+ȱzidovudineȱȱ Tablet: 30ȱmgȱ+ȱ50ȱmgȱ+ȱ60ȱmgȱ[ c] ;ȱ150ȱmgȱ+ȱ200 mgȱ+ȱ300ȱmg.ȱ

lamivudineȱ+ȱzidovudineȱ Tablet: 30ȱmgȱ+ȱ60ȱmgȱ[ c] ;ȱ150ȱmgȱ+ȱ300ȱmg.

6 .4 .3 Other ant ivira ls

oseltamivir*ȱȱȱ

Capsule:ȱ30ȱmg;ȱ45ȱmg;ȱ75ȱmgȱ(asȱphosphate).

Oralȱpowder:ȱ12ȱmg/ȱmL.ȱ

*ȱpotentiallyȱsevereȱorȱcomplicatedȱillnessȱdueȱtoȱconfirmedȱorȱsuspectedȱinfluenzaȱvirusȱinfectionȱinȱaccordanceȱwithȱWHOȱtreatmentȱguidelines.ȱȱ

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ribavirin*ȱȱ

Injectionȱforȱintravenousȱadministration:ȱ800ȱmgȱandȱ1ȱgȱinȱ10ȬȱmLȱphosphateȱbufferȱsolution.ȱ

Solidȱoralȱdosageȱform:ȱ200ȱmg;ȱ400ȱmg;ȱ600ȱmg.ȱ

*ȱForȱtheȱtreatmentȱofȱviralȱhaemorrhagicȱfeversȱȱ

valganciclovir*ȱ

ȱ

Tablet:ȱȱ450ȱmg.ȱ

*Forȱtheȱtreatmentȱofȱcytomegalovirusȱretinitisȱ(CMV).ȱ

6 .4 .4 Ant ihepat it is m edicinesȱ

6 .4 .4 .1 Medicines for hepat it is B

6 .4 .4 .1 .1 Nucleoside/ Nucleot ide reverse t ranscriptase inhibitors

entecavirȱOralȱliquid:ȱȱ0.05ȱmg/ȱmL

Tablet:ȱȱ0.5ȱmg;ȱ1ȱmgȱ

tenofovirȱdisoproxilȱfumarateȱ(TDF)ȱTablet:ȱ300ȱmgȱ(tenofovirȱdisoproxilȱfumarateȱ�equivalentȱtoȱ245ȱmgȱtenofovirȱdisoproxil).ȱ

6 .4 .4 .2 Medicines for hepat it is C

Basedȱonȱcurrentȱevidence,ȱmedicinesȱinȱtheȱfollowingȱclassesȱofȱdirectȱactingȱantiviralȱmedicinesȱareȱincludedȱasȱessentialȱmedicinesȱforȱtreatmentȱofȱhepatitisȱCȱvirusȱinfection.ȱȱWHOȱguidelinesȱrecommendȱspecificȱcombinationȱtherapyȱȱutilisingȱmedicinesȱfromȱdifferentȱclasses.ȱ[\url]

6 .4 .4 .2 .1 Nucleot ide polym erase inhibitors

sofosbuvirȱȱ Tablet:ȱȱ400ȱmg

6 .4 .4 .2 .2 Protease inhibitors

simeprevirȱ Capsuleȱȱ150ȱmg

6 .4 .4 .2 .3 NS5 A inhibitors

daclatasvirȱ Tablet:ȱȱ30ȱmgȱ(asȱhydrochloride)ȱ

6 .4 .4 .2 .4 Non- nucleoside polym erase inhibitors

dasabuvirȱ Tablet: ȱ250ȱmg

6 .4 .4 .2 .5 Other ant ivira ls

ribavirin*ȱȱ

Injectionȱforȱintravenousȱadministration:ȱ800ȱmgȱandȱ1ȱgȱinȱ10ȬȱmLȱphosphateȱbufferȱsolution.ȱ

Solidȱoralȱdosageȱform:ȱ200ȱmg;ȱ400ȱmg;ȱ600ȱmg.ȱ

*ȱForȱtheȱtreatmentȱofȱhepatitisȱC,ȱinȱcombinationȱwithȱpeginterferonȱand/orȱdirectȱactingȱantiȬviralȱmedicinesȱ

ComplementaryȱListȱ

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pegylatedȱinterferonȱalfaȱ(2aȱorȱ2b)ȱ*ȱ

Vialȱorȱprefilledȱsyringe:ȱȱ

180ȱmicrogramsȱ(peginterferonȱalfaȬ2a),ȱȱȱ

80ȱmicrogram,ȱ100ȱmicrogramȱ(peginterferonȱalfaȬ2b).ȱȱ

*ȱToȱbeȱusedȱinȱcombinationȱwithȱribavirin.ȱȱ

FI XED- DOSE COMBI NATI ONS

Alternat ive com binat ions of DAAs from different pharm acological classes are possible

ledipasvirȱ+ȱsofosbuvirȱȱȱ Tablet:ȱȱ90ȱmgȱ+ȱ400ȱmg.

ombitasvirȱ+ȱparitaprevirȱ+ȱritonavirȱȱȱ Tablet:ȱ12.5ȱmgȱ+ȱ75ȱmgȱ+ȱ50ȱmgȱ

6 .5 Ant iprotozoal m edicines ȱ

6 .5 .1 Ant iam oebic and ant igiardiasis m edicines

diloxanideȱa ȱȱTablet: 500ȱmgȱ(furoate).

a > 25 kg.

ȱmetronidazoleȱ

Injection: 500ȱmgȱinȱ100ȬmLȱvial.ȱ

Oralȱliquid:ȱ200ȱmgȱ(asȱbenzoate)/5ȱȱmL.ȱ

Tablet:ȱ200ȱmgȱtoȱ500ȱmg.ȱ

6 .5 .2 Ant ile ishm aniasis m edicines

amphotericinȱBȱ Powderȱforȱinjection: 50ȱmgȱinȱvialȱ(asȱsodiumȱdeoxycholateȱorȱliposomalȱcomplex).ȱ

miltefosineȱ Solidȱoralȱdosageȱform:ȱ10ȱmg;ȱ50ȱmg.ȱ

paromomycin Solutionȱforȱintramuscularȱinjection:ȱ750ȱmgȱofȱparomomycinȱbaseȱ(asȱtheȱsulfate).ȱ

sodiumȱstibogluconateȱorȱmeglumineȱantimoniateȱInjection: 100ȱmg/ mL,ȱ1ȱvialȱ=ȱ30ȱȱmLȱorȱ30%,ȱequivalentȱtoȱapproximatelyȱ8.1%ȱantimonyȱ(pentavalent)ȱinȱ5ȬȱmLȱampoule.ȱȱ

6 .5 .3 Ant im alar ia l m edicines

6 .5 .3 .1 For curat ive t reatm ent

Medicinesȱ forȱ theȱ treatmentȱ ofȱ P.ȱ falciparumȱmalariaȱ casesȱ shouldȱ beȱ usedȱ inȱ combination.ȱ ȱ Theȱ listȱcurrentlyȱrecommendsȱcombinationsȱaccordingȱtoȱtreatmentȱguidelines.ȱ ȱWHOȱrecognizesȱthatȱnotȱallȱofȱtheȱ fixedȱ doseȱ combinationsȱ (FDCs)ȱ inȱ theȱ WHOȱ treatmentȱ guidelinesȱ exist,ȱ andȱ encouragesȱ theirȱdevelopmentȱ andȱ rigorousȱ testing.ȱ ȱWHOȱ alsoȱ encouragesȱ developmentȱ andȱ testingȱ ofȱ rectalȱ dosageȱformulations.ȱ

amodiaquine*ȱTablet: 153ȱmg orȱ200ȱmgȱ(asȱhydrochloride).

*ȱToȱbeȱusedȱinȱcombinationȱwithȱartesunateȱ50ȱmg.ȱ

artemether*ȱOilyȱinjection: 80ȱmg/ mL inȱ1ȬȱmLȱampoule.

*ȱForȱuseȱinȱtheȱmanagementȱofȱsevereȱmalaria.ȱ

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artemetherȱ+ȱlumefantrine*ȱ

Tablet: 20ȱmgȱ+ȱ120ȱmg.

Tabletȱ(dispersible):ȱ20ȱmgȱ+ȱ120ȱmgȱ[ c] .ȱ

*ȱNotȱrecommendedȱinȱtheȱfirstȱtrimesterȱofȱpregnancyȱorȱinȱchildrenȱbelowȱ5ȱkg.ȱ

artesunate*ȱ

Injection: ampoules,ȱcontainingȱ60ȱmgȱanhydrousȱartesunicȱacidȱwithȱaȱseparateȱampouleȱofȱ5%ȱsodiumȱbicarbonateȱsolution.ȱForȱuseȱinȱtheȱmanagementȱofȱsevereȱmalaria.ȱ

Rectalȱdosageȱform:ȱ50ȱmgȱ[ c] ;ȱ200ȱmgȱcapsulesȱ(forȱpreȬreferralȱtreatmentȱofȱsevereȱmalariaȱonly;ȱpatientsȱshouldȱbeȱtakenȱtoȱanȱappropriateȱhealthȱfacilityȱforȱfollowȬupȱcare)ȱ[ c] .ȱ

Tablet:ȱ50ȱmg.ȱ

*ȱToȱbeȱusedȱinȱcombinationȱwithȱeitherȱamodiaquine,ȱmefloquineȱorȱsulfadoxineȱ+ȱpyrimethamine.ȱ

artesunateȱ+ȱamodiaquine*ȱ

Tablet: 25 mgȱ+ 67.5 mg;ȱ50 mgȱ+ȱ135ȱmg;ȱ100 mgȱ+ȱ270ȱmg.ȱ

*ȱOtherȱcombinationsȱthatȱdeliverȱtheȱtargetȱdosesȱrequiredȱsuchȱasȱ153ȱmgȱorȱ200ȱmgȱ(asȱhydrochloride)ȱwithȱ50ȱmgȱartesunateȱcanȱbeȱalternatives.ȱ

artesunateȱ+ȱmefloquineȱ Tablet: 25 mgȱ+ 55ȱmg;ȱ100 mgȱ+ȱ220ȱmg.ȱ

chloroquine*ȱ

Oralȱliquid: 50ȱmgȱ(asȱphosphateȱorȱsulfate)/5ȱmL.

Tablet:ȱ100ȱmg;ȱ150ȱmgȱ(asȱphosphateȱorȱsulfate).ȱ

*ȱForȱuseȱonlyȱforȱtheȱtreatmentȱofȱP.vivaxȱinfection.ȱ

doxycycline*ȱ

Capsule: 100ȱmgȱ(asȱhydrochlorideȱorȱhyclate).

Tabletȱ(dispersible):ȱ100ȱmgȱ(asȱmonohydrate).ȱ

*ȱForȱuseȱonlyȱinȱcombinationȱwithȱquinine.ȱ

mefloquine*ȱTablet: 250ȱmgȱ(asȱhydrochloride).ȱȱ

*ȱToȱbeȱusedȱinȱcombinationȱwithȱartesunateȱ50ȱmg.ȱ

primaquine*ȱ

Tablet: 7.5ȱmg;ȱ15 mgȱ(asȱdiphosphate).ȱ

*ȱOnlyȱforȱuseȱtoȱachieveȱradicalȱcureȱofȱP.vivaxȱandȱP.ovaleȱinfections,ȱgivenȱforȱ14ȱdays.ȱ

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quinine*ȱ

Injection: 300ȱmgȱquinineȱhydrochloride/ȱmL inȱ2ȬmLȱampoule.ȱ

Tablet:ȱ300ȱmgȱ(quinineȱsulfate)ȱorȱ300ȱmgȱ(quinineȱbisulfate).ȱ

*ȱForȱuseȱonlyȱinȱtheȱmanagementȱofȱsevereȱmalaria,ȱandȱshouldȱbeȱusedȱinȱcombinationȱwithȱdoxycycline.ȱ

sulfadoxineȱ+ȱpyrimethamine*ȱTablet: 500ȱmgȱ+ȱ25ȱmg.

*ȱOnlyȱinȱcombinationȱwithȱartesunateȱ50ȱmg.ȱ

6 .5 .3 .2 For prophylaxisȱ

chloroquine*ȱ

Oralȱliquid: 50ȱmgȱ(asȱphosphateȱorȱsulfate)/5ȱmL.

Tablet:ȱ150ȱmgȱ(asȱphosphateȱorȱsulfate).ȱ

*ȱForȱuseȱonlyȱinȱcentralȱAmericanȱregions,ȱforȱP.vivaxȱinfections.ȱ

doxycyclineȱa ȱ

Solidȱoral dosageȱform: 100ȱmgȱ(asȱhydrochloride orȱhyclate).ȱ

a > 8 years.ȱ

mefloquineȱa ȱTablet: 250ȱmgȱ(asȱhydrochloride).ȱ

a > 5 kg or > 3 m onths.ȱ

proguanil*ȱTablet: 100ȱmgȱ(asȱhydrochloride).ȱ

*ȱForȱuseȱonlyȱinȱcombinationȱwithȱchloroquine.ȱ

6 .5 .4 Ant ipneum ocystosis and ant itoxoplasm osis m edicines

pyrimethamineȱ Tablet: 25ȱmg.

sulfadiazineȱ Tablet:ȱ500ȱmg.

sulfamethoxazoleȱ+ȱtrimethoprimȱ

Injection:ȱ

80ȱmgȱ+ȱ16ȱmg/ȱmLȱinȱ5ȬȱmLȱampoule;ȱȱ80ȱmgȱ+ȱ16ȱmg/ȱmLȱinȱ10ȬȱmLȱampoule.ȱ

Oralȱliquid:ȱ200ȱmgȱ+ȱ40ȱmg/5ȱȱmLȱ[ c] .ȱ

Tablet:ȱ100ȱmgȱ+ȱ20ȱmg;ȱ400ȱmgȱ+ȱ80ȱmgȱ[ c] .ȱ

ComplementaryȱList

pentamidineȱ Tablet:ȱ200ȱmg;ȱ300ȱmgȱ(asȱisethionate).ȱ

6 .5 .5 Ant it rypanosom al m edicines

6 .5 .5 .1 African t rypanosom iasisȱ

Medicinesȱforȱtheȱtreatmentȱofȱ1stȱstageȱAfricanȱtrypanosomiasis

pentamidine*ȱPowderȱforȱinjection:ȱ200ȱmgȱ(asȱisetionate)ȱinȱvial.

*ȱToȱbeȱusedȱforȱtheȱtreatmentȱofȱTrypanosomaȱbruceiȱgambienseȱinfection.ȱ

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suraminȱsodium*ȱ

Powderȱforȱinjection: 1ȱgȱinȱvial.ȱ

*ȱToȱbeȱusedȱforȱtheȱtreatmentȱofȱtheȱinitialȱphaseȱofȱTrypanosomaȱbruceiȱrhodesienseȱinfection.ȱ

Medicinesȱforȱtheȱtreatmentȱofȱ2ndȱstageȱAfricanȱtrypanosomiasis

eflornithine*ȱ

Injection:ȱ200ȱmgȱ(hydrochloride)/ȱmLȱinȱ100ȬmL

bottle.ȱ

*ȱToȱbeȱusedȱforȱtheȱtreatmentȱofȱTrypanosomaȱbruceiȱgambienseȱinfection.ȱ

melarsoprolȱInjection: 3.6%ȱsolution,ȱ5ȬmLȱampouleȱ(180ȱmgȱofȱactiveȱȱcompound).ȱ

nifurtimox*ȱ

Tablet: 120ȱmg.

*ȱOnlyȱtoȱbeȱusedȱinȱcombinationȱwithȱeflornithine,ȱforȱȱtheȱtreatmentȱofȱTrypanosomaȱbruceiȱgambienseȱinfection.ȱ

ComplementaryȱListȱ[ c] ȱ

melarsoprolȱ Injection:ȱ3.6%ȱsolutionȱinȱ5ȬȱmLȱampouleȱ(180ȱmgȱofȱactiveȱcompound).ȱ

6 .5 .5 .2 Am erican t rypanosom iasis

benznidazoleȱTablet: 12.5ȱmg [ c] ;100ȱmg.ȱ

Tabletȱ(scored):ȱ50ȱmg.ȱ

nifurtimoxȱ Tablet: 30ȱmg;ȱ120ȱmg;ȱ250ȱmg.ȱ

7 . ANTI MI GRAI NE MEDI CI NES ȱ

7 .1 For t reatm ent of acute a t tack

acetylsalicylicȱacidȱ Tablet: 300ȱmgȱtoȱ500ȱmg.

ibuprofenȱ[ c] ȱ Tablet:ȱ200ȱmg;ȱ400ȱmg.ȱ

paracetamolȱOralȱliquid: 125ȱmg/5 mL [ c] .ȱ

Tablet:ȱ300ȱmgȱtoȱ500ȱmg.ȱ

7 .2 For prophylax is

ȱpropranololȱ Tablet: 20ȱmg;ȱ40ȱmgȱ(hydrochloride).ȱ

8 . ANTI NEOPLASTI CS AND I MMUNOSUPPRESSI VES

Medicinesȱlistedȱbelowȱshouldȱbeȱusedȱaccordingȱtoȱprotocolsȱforȱtreatmentȱofȱtheȱdiseases. ȱ8 .1 I m m unosuppressive m edicines

ComplementaryȱListȱ

azathioprine Powderȱforȱinjection:ȱ100ȱmgȱ(asȱsodiumȱsalt)ȱinȱvial.ȱ

Tabletȱ(scored):ȱ50ȱmg.ȱ

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ciclosporin

Capsule:ȱ25ȱmg.ȱ

Concentrateȱforȱinjection:ȱ50ȱmg/ȱmLȱinȱ1ȬȱmLȱampouleȱforȱorganȱtransplantation.ȱ

8 .2 Cytotox ic and adjuvant m edicines

ComplementaryȱListȱ

allȬtransȱretinoidȱacidȱ(ATRA)ȱCapsule:ȱȱ10ȱmg.ȱ

acuteȱpromyelocyticȱleukemia.ȱ

allopurinolȱ[ c] ȱ Tablet:ȱ100ȱmg;ȱ300ȱmg.ȱ

asparaginaseȱPowderȱforȱinjection:ȱ10ȱ000ȱIUȱinȱvial.ȱ

acuteȱlymphoblasticȱleukemia.ȱ

bendamustineȱ

Injection:ȱȱ45ȱmg/0.5ȱmL;ȱ180ȱmg/2ȱmL.ȱ

chronicȱlymphocyticȱleukemiaȱȱ follicularȱlymphomaȱȱ

bleomycinȱ

Powderȱforȱinjection:ȱ15ȱmgȱ(asȱsulfate)ȱinȱvial.ȱ

Hodgkinȱlymphomaȱ Kaposiȱsarcomaȱ ovarianȱgermȱcellȱtumourȱ testicularȱgermȱcellȱtumourȱ

calciumȱfolinateȱ

ȱ

Injection:ȱ3ȱmg/ȱmLȱinȱ10ȬȱmLȱampoule.ȱ

Tablet:ȱ15ȱmg.ȱ

earlyȱstageȱcolonȱcancerȱ earlyȱstageȱrectalȱcancerȱ gestationalȱtrophoblasticȱneoplasiaȱ metastaticȱcolorectalȱcancerȱ osteosarcomaȱ Burkittȱlymphomaȱ

capecitabineȱ

Tablet:ȱȱ150ȱmg;ȱ500ȱmg.ȱ

ȱearlyȱstageȱcolonȱcancerȱ ȱearlyȱstageȱrectalȱcancerȱ metastaticȱbreastȱcancerȱ ȱmetastaticȱcolorectalȱcancerȱ

carboplatinȱ

Injection:ȱ50ȱmg/5ȱȱmL;ȱ150ȱmg/15ȱȱmL;ȱ450ȱmg/45ȱȱmL;ȱ600ȱmg/60ȱȱmL.ȱ

earlyȱstageȱbreastȱcancerȱ epithelialȱovarianȱcancerȱ nasopharyngealȱcancerȱ nonȬsmallȱcellȱlungȱcancerȱ osteosarcomaȱ retinoblastomaȱ

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chlorambucilȱTablet:ȱ2ȱmg.ȱ

chronicȱlymphocyticȱleukemia.ȱ

cisplatinȱ

Injection:ȱȱ50ȱmg/50ȱmL;ȱ100ȱmg/100ȱmL.ȱ

cervicalȱcancerȱ(asȱaȱradioȬsensitizer)ȱ headȱandȱneckȱcancerȱ(asȱaȱradioȬsensitizer)ȱ nasopharyngealȱcancerȱ(asȱaȱradioȬsensitizer)ȱ nonȬsmallȱcellȱlungȱcancerȱ osteosarcomaȱ ovarianȱgermȱcellȱtumourȱ testicularȱgermȱcellȱtumourȱ

ȱ

cyclophosphamideȱ

Powderȱforȱinjection:ȱ500ȱmgȱinȱvial.ȱ

Tablet:ȱ25ȱmg.ȱ

chronicȱlymphocyticȱleukemiaȱ diffuseȱlargeȱBȬcellȱlymphomaȱ earlyȱstageȱbreastȱcancerȱ gestationalȱtrophoblasticȱneoplasiaȱ Hodgkinȱlymphomaȱ follicularȱlymphomaȱ rhabdomyosarcomaȱ Ewingȱsarcomaȱ acuteȱlymphoblasticȱleukemiaȱ Burkittȱlymphomaȱ metastaticȱbreastȱcancer.ȱ

cytarabineȱ

Powderȱforȱinjection:ȱ100ȱmgȱinȱvial.ȱ

acuteȱmyelogenousȱleukemiaȱ acuteȱlymphoblasticȱleukemiaȱ acuteȱpromyelocyticȱleukemiaȱ Burkittȱlymphoma.ȱ

dacarbazineȱPowderȱforȱinjection:ȱ100ȱmgȱinȱvial.ȱ

Hodgkinȱlymphomaȱ

dactinomycinȱ

ȱ

Powderȱforȱinjection:ȱ500ȱmicrogramsȱinȱvial.ȱ

gestationalȱtrophoblasticȱneoplasiaȱ rhabdomyosarcomaȱ Wilmsȱtumourȱ

daunorubicinȱ

Powderȱforȱinjection:ȱ50ȱmgȱ(hydrochloride)ȱinȱvial.ȱ

acuteȱmyelogenousȱleukemiaȱ acuteȱpromyelocyticȱleukemiaȱ

ȱ

docetaxelȱ

Injection:ȱ20ȱmg/ȱmL;ȱ40ȱmg/ȱmL.ȱ

earlyȱstageȱbreastȱcancerȱ metastaticȱbreastȱcancerȱ metastaticȱprostateȱcancerȱ

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doxorubicinȱ

Powderȱforȱinjection:ȱ10ȱmg;ȱ50ȱmgȱ(hydrochloride)ȱinȱvial.ȱ

diffuseȱlargeȱBȬcellȱlymphomaȱ ȱearlyȱstageȱbreastȱcancerȱ Hodgkinȱlymphomaȱ Kaposiȱsarcomaȱ follicularȱlymphomaȱ metastaticȱbreastȱcancerȱ osteosarcomaȱ Ewingȱsarcomaȱ acuteȱlymphoblasticȱleukemiaȱ Wilmsȱtumourȱ Burkittȱlymphomaȱ

etoposideȱ

Capsule:ȱ100ȱmg.ȱ

Injection:ȱ20ȱmg/ȱmLȱinȱ5ȬȱmLȱampoule.ȱ

testicularȱgermȱcellȱtumourȱ gestationalȱtrophoblasticȱneoplasiaȱ Hodgkinȱlymphomaȱ nonȬsmallȱcellȱlungȱcancerȱ ovarianȱgermȱcellȱtumourȱ retinoblastomaȱ Ewingȱsarcomaȱ acuteȱlymphoblasticȱleukemiaȱ Burkittȱlymphomaȱ

fludarabineȱ

Powderȱforȱinjection:ȱ50ȱmgȱ(phosphate)ȱinȱvial.ȱ

Tablet:ȱȱ10ȱmgȱ

chronicȱlymphocyticȱleukemia.ȱ

fluorouracilȱ

Injection:ȱ50ȱmg/ȱmLȱinȱ5ȬȱmLȱampoule.ȱ

earlyȱstageȱbreastȱcancerȱ earlyȱstageȱcolonȱcancerȱ earlyȱstageȱrectalȱcancerȱ metastaticȱcolorectalȱcancerȱ nasopharyngealȱcancer.ȱ

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filgrastimȱ

Injection:ȱȱ120ȱmicrograms/0.2ȱmL;ȱȱ300ȱmicrograms/0.5ȱmL;ȱ480ȱmicrograms/0.8ȱmLȱinȱpreȬfilledȱsyringeȱȱ300ȱmicrograms/mLȱinȱ1ȬȱmLȱvial,ȱ480ȱmg/1.6ȱmLȱinȱ1.6ȬȱmLȱvial.ȱ

Asȱprimaryȱprophylaxisȱinȱpatientsȱatȱhighȱriskȱforȱdevelopingȱfebrileȱneutropeniaȱassociatedȱwithȱmyelotoxicȱchemotherapy.ȱ

Asȱsecondaryȱprophylaxisȱforȱpatientsȱwhoȱhaveȱexperiencedȱneutropeniaȱfollowingȱpriorȱmyelotoxicȱchemotherapyȱ

toȱfacilitateȱadministrationȱofȱdoseȱdenseȱchemotherapyȱregimensȱȱȱ

gemcitabineȱ

Powderȱforȱinjection:ȱȱ200ȱmgȱinȱvial,ȱ1ȱgȱinȱvial.ȱ

epithelialȱovarianȱcancerȱ nonȬsmallȱcellȱlungȱcancerȱ

hydroxycarbamideȱ

Solidȱoralȱdosageȱform:ȱ200ȱmg;ȱ250ȱmg;ȱ300ȱmg;ȱ400ȱmg;ȱ500ȱmg;ȱ1ȱg.ȱ

chronicȱmyeloidȱleukemia.ȱ

ifosfamideȱ

Powderȱforȱinjection:ȱȱ500ȱmgȱvial;ȱ1Ȭgȱvial;ȱ2Ȭgȱvial.ȱ

testicularȱgermȱcellȱtumourȱ ovarianȱgermȱcellȱtumourȱ osteosarcomaȱ rhabdomyosarcomaȱ Ewingȱsarcomaȱ

imatinibȱ

Tablet:ȱ100ȱmg;ȱ400ȱmg.ȱ

chronicȱmyeloidȱleukemiaȱ gastrointestinalȱstromalȱtumourȱ

irinotecanȱ

Injection:ȱȱ40ȱmg/2ȱmLȱinȱ2ȬȱmLȱvial;ȱ100ȱmg/5ȱmLȱinȱ5ȬȱmLȱvial;ȱ500ȱmg/25ȱmLȱinȱ25ȬȱmLȱvial.ȱ

metastaticȱcolorectalȱcancer.ȱ

mercaptopurineȱ

Tablet:ȱ50ȱmg.ȱ

acuteȱlymphoblasticȱleukemiaȱ acuteȱpromyelocyticȱleukemia.ȱ

mesnaȱ

Injection:ȱ100ȱmg/ȱmLȱinȱ4ȬȱmLȱandȱ10ȬȱmLȱampoules.ȱ

Tablet:ȱ400ȱmg;ȱ600ȱmg.ȱ

testicularȱgermȱcellȱtumourȱ ovarianȱgermȱcellȱtumourȱ osteosarcomaȱ rhabdomyosarcomaȱ Ewingȱsarcoma.ȱ

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methotrexateȱ

Powderȱforȱinjection:ȱ50ȱmgȱ(asȱsodiumȱsalt)ȱinȱvial.ȱ

Tablet:ȱ2.5ȱmgȱ(asȱsodiumȱsalt).ȱ

earlyȱstageȱbreastȱcancerȱ gestationalȱtrophoblasticȱneoplasiaȱ osteosarcomaȱ acuteȱlymphoblasticȱleukemiaȱ acuteȱpromyelocyticȱleukemiaȱ

oxaliplatinȱ

Injection:ȱ50ȱmg/10ȱmLȱinȱ10ȬȱmLȱvial;ȱ100ȱmg/20ȱmLȱinȱ20ȬȱmLȱvial;ȱ200ȱmg/40ȱmLȱinȱ40ȬȱmLȱvial.ȱ

Powderȱforȱinjection:ȱȱ50ȱmg,ȱ100ȱmgȱinȱvial.ȱȱ

earlyȱstageȱcolonȱcancerȱ metastaticȱcolorectalȱcancerȱ

paclitaxelȱ

Powderȱforȱinjection:ȱ6ȱmg/ȱmL.ȱ

epithelialȱovarianȱcancerȱ earlyȱstageȱbreastȱcancerȱ metastaticȱbreastȱcancerȱ Kaposiȱsarcomaȱ nasopharyngealȱcancerȱ nonȬsmallȱcellȱlungȱcancerȱ ovarianȱgermȱcellȱtumourȱ

procarbazineȱ Capsule:ȱ50ȱmgȱ(asȱhydrochloride).ȱ

rituximabȱ

Injection:ȱȱ100ȱmg/10ȱmLȱinȱ10ȬȱmLȱvial;ȱ500ȱmg/50ȱmLȱinȱ50ȬȱmLȱvial.ȱ

diffuseȱlargeȱBȬcellȱlymphomaȱ chronicȱlymphocyticȱleukemiaȱ follicularȱlymphoma.ȱ

tioguanineȱ[ c] ȱSolidȱoralȱdosageȱform:ȱ40ȱmg.ȱ

acuteȱlymphoblasticȱleukemia.ȱ

trastuzumabȱ

Doseȱform:ȱ

earlyȱstageȱHER2ȱpositiveȱbreastȱcancerȱ metastaticȱHER2ȱpositiveȱbreastȱcancer.ȱ

vinblastineȱ

Powderȱforȱinjection:ȱ10ȱmgȱ(sulfate)ȱinȱvial.ȱ

Hodgkinȱlymphomaȱ Kaposiȱsarcoma.ȱ Testicularȱgermȱcellȱtumourȱ Ovarianȱgermȱcellȱtumourȱ

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vincristineȱ

Powderȱforȱinjection:ȱ1ȱmg;ȱ5ȱmgȱ(sulfate)ȱinȱvial.ȱ

diffuseȱlargeȱBȬcellȱlymphomaȱ ȱgestationalȱtrophoblasticȱneoplasiaȱ Hodgkinȱlymphomaȱ Kaposiȱsarcomaȱ follicularȱlymphomaȱ retinoblastomaȱ rhabdomyosarcomaȱ Ewingȱsarcomaȱ acuteȱlymphoblasticȱleukemiaȱ Wilmsȱtumourȱ Burkittȱlymphoma.ȱ

vinorelbineȱ

Injection:ȱȱ10ȱmg/mLȱinȱ1ȬȱmLȱvial;ȱȱ50ȱmg/5ȱmLȱinȱ5ȬȱmLȱvial.ȱ

nonȬsmallȱcellȱlungȱcancerȱ metastaticȱbreastȱcancerȱ

8 .3 Horm ones and ant ihorm ones

ComplementaryȱListȱ

anastrozoleȱ

Tablet:ȱȱ1ȱmg.ȱ

earlyȱstageȱbreastȱcancerȱ metastaticȱbreastȱcancer.ȱ

bicalutamideȱTablet:ȱ50ȱmg.ȱ

metastaticȱprostateȱcancer.ȱ

dexamethasoneȱ

Injection:ȱ4ȱmg/ȱmLȱinȱ1ȬȱmLȱampouleȱ(asȱdisodiumȱphosphateȱsalt).ȱ

Oralȱliquid:ȱ2ȱmg/5ȱȱmLȱ[ c] .ȱ

acuteȱlymphoblasticȱleukemia.ȱ

leuprorelinȱȱ

Doseȱformȱ

earlyȱstageȱbreastȱcancerȱ metastaticȱprostateȱcancerȱ

hydrocortisoneȱ

Powderȱforȱinjection:ȱ100ȱmgȱ(asȱsodiumȱsuccinate)ȱinȱvial.ȱ

acuteȱlymphoblasticȱleukemia.ȱ

methylprednisoloneȱ[ c] ȱ

Injection:ȱ40ȱmg/ȱmLȱ(asȱsodiumȱsuccinate)ȱinȱ1ȬȱmLȱsingleȬdoseȱvialȱandȱȱ5ȬȱmLȱmultiȬdoseȱvials;ȱ80ȱmg/ȱmLȱ(asȱsodiumȱsuccinate)ȱinȱ1ȬȱmLȱsingleȬdoseȱvial.ȱ

acuteȱlymphoblasticȱleukamia.ȱ

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ȱprednisoloneȱ

Oralȱliquid:ȱ5ȱmg/ȱmLȱ[ c] .ȱ

Tablet:ȱ5ȱmg;ȱ25ȱmg.ȱ

chronicȱlymphocyticȱleukemiaȱ diffuseȱlargeȱBȬcellȱlymphomaȱ Hodgkinȱlymphomaȱ follicularȱlymphomaȱ acuteȱlymphoblasticȱleukemiaȱ Burkittȱlymphomaȱ

tamoxifenȱ

Tablet:ȱ10ȱmg;ȱ20ȱmgȱ(asȱcitrate).ȱ

earlyȱstageȱbreastȱcancerȱ metastaticȱbreastȱcancerȱ

9 . ANTI PARKI NSONI SM MEDI CI NES ȱ

ȱbiperidenȱInjection: 5ȱmgȱ(lactate)ȱinȱ1ȬȱmLȱampoule.ȱ

Tablet:ȱ2ȱmgȱ(hydrochloride).ȱ

levodopaȱ+ȱȱcarbidopaȱȱTablet: ȱ100ȱmgȱ+ȱ10ȱmg;ȱ100ȱmgȱ+ȱ25ȱmg;ȱ250ȱmgȱ+ȱ25ȱmgȱȱ

1 0 . MEDI CI NES AFFECTI NG THE BLOOD

1 0 .1 Ant ianaem ia m edicines ȱ

ferrousȱsaltȱ

Oralȱliquid: equivalentȱtoȱ25ȱmgȱironȱ(asȱsulfate)/mL.ȱ

Tablet:ȱequivalentȱtoȱ60ȱmgȱiron.ȱ

ferrousȱsaltȱ+ȱfolicȱacidȱȱTablet: equivalentȱtoȱ60ȱmgȱironȱ+ȱ400ȱmicrogramsȱfolicȱacidȱ(nutritionalȱsupplementȱforȱuseȱduringȱpregnancy).ȱ

folicȱacidȱ

Tablet: 400ȱmicrograms*;ȱ1ȱmg;ȱ5ȱmg.ȱ

*periconceptualȱuseȱforȱpreventionȱofȱfirstȱoccurrenceȱofȱneuralȱtubeȱdefectsȱ

hydroxocobalaminȱInjection: 1ȱmg (asȱacetate,ȱasȱhydrochloride orȱasȱsulfate)ȱinȱ1ȬȱmLȱampoule.ȱ

1 0 .2 Medicines affect ing coagulat ion

ȱenoxaparin*ȱ

Injection:ȱȱampouleȱorȱpreȬfilledȱsyringeȱ

20ȱmg/0.2ȱmL;ȱ40ȱmg/0.4ȱmL;ȱ60ȱmg/0.6ȱmL;ȱ80ȱmg/0.8ȱmL;ȱ100ȱmg/1ȱmL;ȱ120ȱmg/0.8ȱmL;ȱ150ȱmg/1ȱmLȱ

*Alternativesȱareȱlimitedȱtoȱnadroparinȱandȱdalteparinȱȱ

heparinȱsodiumȱInjection: 1000ȱIU/ mL;ȱ5000ȱIU/ȱmL;ȱ20ȱ000ȱIU/ mL

inȱ1ȬȱmLȱampoule.ȱ

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phytomenadioneȱ

Injection: 1ȱmg/ mL [ c] ; 10ȱmg/ȱmLȱinȱ5ȬȱmL

ampoule.ȱ

Tablet:ȱ10ȱmg.ȱ

protamineȱsulfateȱ Injection: 10ȱmg/ mL inȱ5ȬmLȱampoule.ȱ

tranexamicȱacidȱ Injection: 100 mg/ mL inȱ10ȬȱmLȱampoule.ȱ

ȱwarfarinȱ Tablet: 1ȱmg;ȱ2ȱmg;ȱ5ȱmgȱ(sodiumȱsalt).ȱ

ComplementaryȱListȱ[ c] ȱ

desmopressinȱ

Injection:ȱȱ4ȱmicrograms/ȱmLȱ(asȱacetate)ȱinȱ1ȬȱmLȱampoule.ȱ

Nasalȱspray:ȱȱ10ȱmicrogramsȱ(asȱacetate)ȱperȱdoseȱ

heparinȱsodiumȱȱ Injection:ȱ1000ȱIU/ȱmL;ȱ5000ȱIU/ȱmLȱinȱ1ȬȱmLȱampoule.ȱ

protamineȱsulfateȱȱ Injection:ȱ10ȱmg/ȱmLȱinȱ5ȬȱmLȱampoule.ȱ

ȱwarfarinȱȱ Tablet:ȱ0.5ȱmg;ȱ1ȱmg;ȱ2ȱmg;ȱ5ȱmgȱ(sodiumȱsalt).ȱ

1 0 .3 Other m edicines for haem oglobinopathies

ComplementaryȱListȱ

deferoxamine*ȱPowderȱforȱinjection:ȱ500ȱmgȱ(mesilate)ȱinȱvial.ȱ*ȱDeferasiroxȱoralȱformȱmayȱbeȱanȱalternative,ȱdependingȱonȱcostȱandȱavailability.ȱ

hydroxycarbamideȱ Solidȱoralȱdosageȱform:ȱ200ȱmg;ȱ500ȱmg;ȱ1ȱg.ȱ

1 1 . BLOOD PRODUCTS OF HUMAN ORI GI N AND PLASMA SUBST I TUTESȱ

1 1 .1 Blood and blood com ponents

InȱaccordanceȱwithȱtheȱWorldȱHealthȱAssemblyȱresolutionȱWHA63.12,ȱWHOȱrecognizesȱthatȱachievingȱselfȬsufficiency,ȱunlessȱspecialȱcircumstancesȱprecludeȱit,ȱinȱtheȱsupplyȱofȱsafeȱbloodȱcomponentsȱbasedȱonȱvoluntary,ȱnonȬremuneratedȱbloodȱdonation,ȱandȱtheȱsecurityȱofȱthatȱsupplyȱareȱimportantȱnationalȱgoalsȱtoȱpreventȱbloodȱshortagesȱandȱmeetȱtheȱtransfusionȱrequirementsȱofȱtheȱpatientȱpopulation.ȱȱAllȱpreparationsȱshouldȱcomplyȱwithȱtheȱWHOȱrequirements.ȱ

fresh�frozenȱplasmaȱȱ ȱ

plateletsȱȱ ȱ

redȱbloodȱcellsȱȱ ȱ

wholeȱbloodȱȱ ȱ

1 1 .2 Plasm a- der ived m edicines ȱ

AllȱhumanȱplasmaȬderivedȱmedicinesȱshouldȱcomplyȱwithȱtheȱWHOȱrequirements.ȱȱ

1 1 .2 .1 Hum an im m unoglobulins ȱ

antiȬDȱimmunoglobulinȱȱ Injection: 250ȱmicrogramsȱinȱsingleȬdoseȱvial.

AntiȬrabiesȱimmunoglobulinȱȱ Injection: 150ȱIU/ mL inȱvial.ȱ

AntiȬtetanusȱimmunoglobulinȱ Injection: 500ȱIUȱinȱvial.

ComplementaryȱListȱ ȱ

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normalȱimmunoglobulinȱ

Intramuscularȱadministration:ȱ16%ȱproteinȱsolution.*ȱ

Intravenousȱadministration:ȱ5%;ȱ10%ȱproteinȱsolution.**ȱ

Subcutaneousȱadministration:ȱ15%;ȱ16%ȱproteinȱsolution.*ȱ

*ȱȱIndicatedȱforȱprimaryȱimmuneȱdeficiency.ȱ**IndicatedȱforȱprimaryȱimmuneȱdeficiencyȱandȱKawasakiȱdisease.ȱ

1 1 .2 .2 Blood coagulat ion factorsȱ

ComplementaryȱListȱ

ȱcoagulationȱfactorȱVIIIȱȱ Powderȱforȱinjection:ȱ500ȱIU/vial.ȱ

ȱcoagulationȱfactorȱIXȱ Powderȱforȱinjection:ȱ500ȱIU/vial,ȱ1000ȱIU/vial.

1 1 .3 Plasm a subst itutes ȱ

ȱdextranȱ70*ȱInjectableȱsolution:ȱ6%.

*ȱPolygeline,ȱinjectableȱsolution,ȱ3.5%ȱisȱconsideredȱasȱequivalent.ȱ

1 2 . CARDI OVASCULAR MEDI CI NES

1 2 .1 Ant iangina l m edicines

ȱbisoprolol*ȱ

Tablet: 1.25 mg;ȱ5ȱmg.

*ȱȱincludesȱmetoprololȱandȱcarvedilolȱasȱalternatives.ȱ

glycerylȱtrinitrate Tabletȱ(sublingual): 500ȱmicrograms.ȱ

ȱisosorbideȱdinitrateȱ Tabletȱ(sublingual): 5ȱmg.

verapamilȱ Tablet:ȱ40ȱmg;ȱ80ȱmgȱ(hydrochloride).ȱ

1 2 .2 Ant iar rhythm ic m edicines

ȱbisoprolol*ȱ

Tablet: 1.25 mg;ȱ5ȱmg.

*ȱȱincludesȱmetoprololȱandȱcarvedilolȱasȱalternatives.ȱ

digoxinȱ

Injection: 250ȱmicrograms/ mLȱinȱ2ȬȱmLȱampoule.

Oralȱliquid:ȱ50ȱmicrograms/ȱmL.ȱȱ

Tablet:ȱ62.5ȱmicrograms;ȱ250ȱmicrograms.ȱ

epinephrineȱ(adrenaline)ȱInjection:ȱ100ȱmicrograms/ mLȱ(asȱacidȱtartrate orȱhydrochloride)ȱinȱ10ȬȱmLȱampoule.ȱ

lidocaineȱInjection: 20ȱmgȱ(hydrochloride)/ȱmLȱinȱ5ȬȱmL

ampoule.ȱ

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verapamilȱ

Injection: 2.5ȱmgȱ(hydrochloride)/ȱmLȱinȱ2ȬȱmL

ampoule.ȱ

Tablet:ȱ40ȱmg;ȱ80ȱmgȱ(hydrochloride).ȱ

ComplementaryȱListȱ ȱ

amiodaroneȱInjection:ȱ50ȱmg/ȱmLȱinȱ3ȬȱmLȱampouleȱ(hydrochloride).ȱ

Tablet:ȱ100ȱmg;ȱ200ȱmg;ȱ400ȱmgȱ(hydrochloride).ȱ

1 2 .3 Ant ihypertensive m edicines

ȱamlodipineȱ Tablet: 5 mg (asȱmaleate,ȱmesylateȱorȱbesylate).

ȱbisoprolol*ȱ

Tablet:ȱ1.25 mg;ȱ5ȱmg.

*ȱȱincludesȱatenolol,ȱmetoprololȱandȱcarvedilolȱasȱalternatives.ȱȱAtenololȱshouldȱnotȱbeȱusedȱasȱaȱfirstȬlineȱagentȱinȱuncomplicatedȱhypertensionȱinȱpatientsȱ>60ȱyearsȱ

ȱenalaprilȱ Tablet: 2.5ȱmg;ȱ5ȱmg (asȱhydrogenȱmaleate).

hydralazine*ȱ

Powderȱforȱinjection: 20ȱmgȱ(hydrochloride)ȱinȱampoule.ȱ

Tablet:ȱ25ȱmg;ȱ50ȱmgȱ(hydrochloride).ȱ

*ȱHydralazineȱisȱlistedȱforȱuseȱonlyȱinȱtheȱacuteȱmanagementȱofȱsevereȱpregnancyȬinducedȱhypertension.ȱItsȱuseȱinȱtheȱtreatmentȱofȱessentialȱhypertensionȱisȱnotȱrecommendedȱinȱviewȱofȱtheȱevidenceȱofȱgreaterȱefficacyȱandȱsafetyȱofȱotherȱmedicines.ȱ

ȱhydrochlorothiazideȱOralȱliquid:ȱ50ȱmg/5ȱmL.

Solidȱoralȱdosageȱform:ȱ12.5ȱmg;ȱ25ȱmg.ȱ

methyldopa*

Tablet:ȱ250ȱmg.

*ȱMethyldopaȱisȱlistedȱforȱuseȱonlyȱinȱtheȱmanagementȱofȱpregnancyȬinducedȱhypertension.ȱItsȱuseȱinȱtheȱtreatmentȱofȱessentialȱhypertensionȱisȱnotȱrecommendedȱinȱviewȱofȱtheȱevidenceȱofȱgreaterȱefficacyȱandȱsafetyȱofȱotherȱmedicines.ȱ

ComplementaryȱListȱ

sodiumȱnitroprusside Powderȱforȱinfusion:ȱ50ȱmgȱinȱampoule.ȱ

1 2 .4 Medicines used in hear t fa ilure

ȱbisoprolol*ȱ

Tablet:ȱ1.25 mg;ȱ5ȱmg.

*ȱincludesȱmetoprololȱandȱcarvedilolȱasȱalternatives.ȱ

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digoxin

Injection: 250ȱmicrograms/ mLȱinȱ2ȬȱmLȱampoule.

Oralȱliquid:ȱ50ȱmicrograms/ȱmL.ȱ

Tablet:ȱ62.5ȱmicrograms;ȱ250ȱmicrograms.ȱ

ȱenalapril Tablet: 2.5ȱmg;ȱ5ȱmg (asȱhydrogenȱmaleate).

ȱfurosemide

Injection: 10ȱmg/ mL inȱ2ȬmLȱampoule.ȱ

Oralȱliquid:ȱ20ȱmg/5ȱȱmLȱ[ c] .ȱ

Tablet:ȱ40ȱmg.ȱ

ȱhydrochlorothiazide Oralȱliquid:ȱ50ȱmg/5ȱmL.

Solidȱoralȱdosageȱform:ȱ25ȱmg.ȱ

spironolactone Tablet: 25ȱmg.

ComplementaryȱListȱ

dopamine Injection:ȱ40ȱmg/ȱmLȱ(hydrochloride)ȱinȱ5ȬȱmLȱvial.ȱ

1 2 .5 Ant ithrom bot ic m edicines

1 2 .5 .1 Ant i- platelet m edicines

acetylsalicylicȱacidȱ Tablet: 100ȱmg.

clopidogrelȱȱ Tablet:ȱȱ75ȱmg;ȱ300ȱmg

1 2 .5 .2 Throm bolyt ic m edicines

ComplementaryȱListȱ

streptokinaseȱ Powderȱforȱinjection:ȱ1.5ȱmillionȱIUȱinȱvial.ȱ

1 2 .6 Lipid- low er ing agents

ȱsimvastatin*ȱTablet: 5ȱmg;ȱ10ȱmg;ȱ20ȱmg;ȱ40ȱmg.ȱ

*ȱForȱuseȱinȱhighȬriskȱpatients.ȱ

1 3 . DERMATOLOGI CAL MEDI CI NES ( topica l)

1 3 .1 Ant ifungal m edicines

ȱmiconazoleȱ Creamȱorȱointment:ȱ2%ȱ(nitrate).ȱ

seleniumȱsulfideȱ DetergentȬbasedȱsuspension:ȱ2%.ȱ

sodiumȱthiosulfateȱ Solution: 15%.

terbinafineȱ Cream: 1% orȱOintment: 1%ȱterbinafineȱhydrochloride.ȱ

1 3 .2 Ant i- infect ive m edicines

mupirocinȱCreamȱ(asȱmupirocinȱcalcium):ȱ2%.ȱ

Ointment:ȱ2%.ȱ

potassiumȱpermanganateȱ Aqueousȱsolution: 1:10ȱ000.ȱ

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silverȱsulfadiazineȱa ȱCream:ȱ1%.

a > 2 m onths.ȱ

1 3 .3 Ant i- inf lam m atory and ant iprur it ic m edicines

ȱbetamethasoneȱa ȱCreamȱorȱointment:ȱ0.1%ȱ(asȱvalerate).ȱ

a Hydrocort isone preferred in neonates.ȱ

ȱcalamineȱȱ Lotion.

ȱhydrocortisoneȱ Creamȱorȱointment:ȱ1%ȱ(acetate).ȱ

1 3 .4 Medicines affect ing sk in dif ferent ia t ion and p rolifera t ion

benzoylȱperoxide Creamȱorȱlotion: 5%.

coalȱtarȱ Solution: 5%.

fluorouracilȱ Ointment: 5%.

ȱpodophyllumȱresinȱ Solution: 10%ȱtoȱ25%.

salicylicȱacid Solution: 5%.

urea Creamȱorȱointment: 5%;ȱ10%.ȱ

1 3 .5 Scabicides and pediculicides

ȱbenzylȱbenzoateȱa ȱLotion: 25%.

a > 2 years.

permethrinȱCream: 5%.

Lotion:ȱ1%.ȱ

1 4 . DI AGNOSTI C AGENTS

1 4 .1 Ophtha lm ic m edicines

fluoresceinȱ Eyeȱdrops: 1%ȱ(sodiumȱsalt).ȱ

ȱtropicamideȱ Eyeȱdrops: 0.5%.

1 4 .2 Radiocont rast m edia

ȱamidotrizoate Injection: 140ȱmgȱtoȱ420ȱmgȱiodineȱ(asȱsodium orȱmeglumineȱsalt)/ȱmLȱinȱ20ȬȱmLȱampoule.ȱ

bariumȱsulfate Aqueousȱsuspension.

ȱiohexol Injection: 140ȱmgȱtoȱ350ȱmgȱiodine/ȱmLȱinȱ5ȬmL;ȱ10ȬmL;ȱ20ȬȱmLȱampoules.ȱ

ComplementaryȱListȱ

bariumȱsulfateȱ[ c] ȱ Aqueousȱsuspension.ȱ

ȱmeglumineȱiotroxate Solution:ȱ5ȱgȱtoȱ8ȱgȱiodineȱinȱ100ȱȱmLȱtoȱ250ȱȱmL.ȱ

1 5 . DI SI NFECTANTS AND ANTI SEPTI CS

1 5 .1 Ant isept ics ȱ

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ȱchlorhexidineȱ Solution:ȱ5%ȱ(digluconate).ȱ

ȱethanolȱ Solution: 70%ȱ(denatured).

ȱpovidoneȱiodineȱ Solution: 10% (equivalentȱtoȱ1%ȱavailableȱiodine).

1 5 .2 Disinfectants

alcoholȱbasedȱhandȱrub

Solutionȱcontainingȱethanolȱ80%ȱvolumeȱ/volumeȱȱ

Solutionȱcontainingȱisopropylȱalcoholȱ75%ȱvolume/volumeȱ

ȱ

ȱchlorineȱbaseȱcompound Powder: (0.1%ȱavailableȱchlorine)ȱforȱsolution.

ȱchloroxylenol Solution: 4.8%.

glutaral Solution: 2%.

1 6 . DI URETI CS

amiloride Tablet: 5ȱmgȱ(hydrochloride).ȱ

ȱfurosemide

Injection: 10ȱmg/ mL inȱ2ȬmLȱampoule.ȱ

Oralȱliquid:ȱ20ȱmg/5ȱȱmLȱ[ c] .ȱ

Tablet:ȱ10ȱmgȱ[ c] ;ȱ20ȱmgȱ[ c] ;ȱ40ȱmg.ȱ

ȱhydrochlorothiazide Solidȱoralȱdosageȱform:ȱ25ȱmg.ȱ

mannitol Injectableȱsolution: 10%;ȱ20%.ȱ

spironolactone Tablet: 25ȱmg.

ComplementaryȱListȱ[ c] ȱ

ȱhydrochlorothiazide Tabletȱ(scored):ȱ25ȱmg.ȱ

mannitolȱ Injectableȱsolution:ȱ10%;ȱ20%.

spironolactoneȱOralȱliquid:ȱ5ȱmg/5ȱȱmL;ȱ10ȱmg/5ȱȱmL;ȱ25ȱmg/5ȱȱmL.ȱ

Tablet:ȱ25ȱmg.

1 7 . GASTROI NTESTI NAL MEDI CI NES

ComplementaryȱListȱ[ c] ȱ

ȱpancreaticȱenzymes AgeȬappropriateȱformulationsȱandȱdosesȱincludingȱlipase,ȱproteaseȱandȱamylase.ȱ

1 7 .1 Ant iulcer m edicines ȱ

ȱomeprazole

Powderȱforȱinjection:ȱȱ40ȱmgȱinȱvialȱ

Powderȱforȱoralȱliquid:ȱ20ȱmg;ȱ40ȱmgȱsachets.ȱ

Solidȱoralȱdosageȱform:ȱ10ȱmg;ȱ20ȱmg;ȱ40ȱmg.ȱ

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ȱranitidineȱ

Injection: 25 mg/ mL (asȱhydrochloride)ȱinȱ2ȬmL

ampoule.ȱ

Oralȱliquid:ȱ75ȱmg/5ȱȱmLȱ(asȱhydrochloride).ȱ

Tablet:ȱ150ȱmgȱ(asȱhydrochloride).ȱ

1 7 .2 Ant iem et ic m edicines

dexamethasoneȱ

Injection: 4ȱmg/ mL inȱ1ȬmLȱampouleȱ(asȱdisodiumȱphosphateȱsalt).ȱ

Oralȱliquid:ȱ0.5ȱmg/5ȱȱmL;ȱ2ȱmg/5ȱȱmL.ȱ

Solidȱoralȱdosageȱform:ȱ0.5ȱmg;ȱ0.75ȱmg;ȱ1.5ȱmg;ȱ4ȱmg.ȱ

metoclopramideȱa ȱȱ

Injection: 5ȱmgȱ(hydrochloride)/ȱmLȱinȱ2ȬȱmL

ampoule.ȱ

Oralȱliquid:ȱ5ȱmg/5ȱȱmLȱ[ c] .ȱ

Tablet:ȱ10ȱmgȱ(hydrochloride).ȱ

a Not in neonates.ȱ

ondansetronȱa ȱ

Injection:ȱ2ȱmgȱbase/ mL inȱ2ȬȱmLȱampouleȱ(asȱhydrochloride).ȱ

Oralȱliquid:ȱ4ȱmgȱbase/5ȱȱmL.ȱ

Solidȱoralȱdosageȱform:ȱEqȱ4ȱmgȱbase;ȱEqȱ8ȱmgȱbase;ȱEqȱ24ȱmgȱbase.ȱ

a > 1 m onth.ȱ

1 7 .3 Ant i- inf lam m atory m edicines

ȱsulfasalazineȱ

Retentionȱenema.

Suppository:ȱ500ȱmg.ȱ

Tablet:ȱ500ȱmg.ȱ

ComplementaryȱListȱ

ȱhydrocortisoneȱ

Retentionȱenema.ȱ

Suppository:ȱ25ȱmgȱ(acetate).ȱ(theȱȱonlyȱappliesȱtoȱhydrocortisoneȱretentionȱenema).ȱ

1 7 .4 Laxat ives

ȱsenna Tablet: 7.5ȱmgȱ(sennosides)ȱ(orȱtraditionalȱdosageȱforms).ȱ

1 7 .5 Medicines used in diarrhoea

1 7 .5 .1 Oral rehydrat ion

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oralȱrehydrationȱsaltsȱ

Powderȱforȱdilution inȱ200ȱmL;ȱ500ȱȱmL;ȱ1ȱL.ȱglucose:ȱȱ ȱ ȱ 75ȱmEqȱȱsodium:ȱȱ ȱ ȱ 75ȱmEqȱorȱmmol/Lȱȱchloride:ȱȱ ȱ ȱ 65ȱmEqȱorȱmmol/Lȱpotassium:ȱȱ ȱ ȱ 20ȱmEqȱorȱmmol/Lȱȱcitrate:ȱȱ ȱ ȱ ȱ 10ȱmmol/Lȱȱosmolarity:ȱȱ ȱ ȱ 245ȱmOsm/Lȱȱglucose:ȱȱ ȱ ȱ 13.5ȱg/Lȱȱsodiumȱchloride:ȱ ȱ ȱȱ2.6ȱg/Lȱpotassiumȱchloride:ȱ ȱ ȱȱ1.5ȱg/Lȱȱtrisodiumȱcitrateȱdihydrate*:ȱ ȱȱ2.9ȱg/Lȱȱ

*trisodiumȱcitrateȱdihydrateȱmayȱbeȱreplacedȱbyȱsodiumȱhydrogenȱcarbonateȱ(sodiumȱbicarbonate)ȱ2.5ȱg/L.ȱHowever,ȱasȱtheȱstabilityȱofȱthisȱlatterȱformulationȱisȱveryȱpoorȱunderȱtropicalȱconditions,ȱitȱisȱrecommendedȱonlyȱwhenȱmanufacturedȱforȱimmediateȱuse.ȱȱ

1 7 .5 .2 Medicines for diarrhoea

zincȱsulfate*ȱ

Solidȱoralȱdosageȱform: 20ȱmg.ȱ

*ȱInȱacuteȱdiarrhoeaȱzincȱsulfateȱshouldȱbeȱusedȱasȱanȱadjunctȱtoȱoralȱrehydrationȱsalts.ȱ

1 8 . HORMONES, OTHER ENDOCRI NE MEDI CI NES AND CONTRACEPTI VES

1 8 .1 Adrenal horm ones and synthet ic subst itutes

fludrocortisoneȱȱ Tablet:ȱ100ȱmicrogramsȱ(acetate).ȱ

hydrocortisoneȱȱ Tablet:ȱ5ȱmg;ȱ10ȱmg;ȱ20ȱmg.ȱ

1 8 .2 Androgens

ComplementaryȱListȱ

testosteroneȱ Injection:ȱ200ȱmgȱ(enanthate)ȱinȱ1ȬȱmLȱampoule.ȱ

1 8 .3 Cont racept ives

1 8 .3 .1 Oral horm onal contracept ives

ȱethinylestradiolȱ+ȱȱlevonorgestrelȱȱ Tablet: 30ȱmicrogramsȱ+ȱ150ȱmicrograms.ȱ

ȱethinylestradiolȱ+ȱȱnorethisteroneȱȱ Tablet: 35ȱmicrogramsȱ+ȱ1ȱmg.ȱ

levonorgestrel Tablet: 30ȱmicrograms;ȱ750ȱmicrogramsȱ(packȱofȱtwo);ȱ1.5ȱmg.ȱ

1 8 .3 .2 I njectable horm onal contracept ives

estradiolȱcypionateȱ+ȱmedroxyprogesteroneȱacetateȱ Injection:ȱ5ȱmgȱ+ȱ25ȱmg.

medroxyprogesteroneȱacetateȱ Depotȱinjection: 150ȱmg/ mLȱinȱ1ȬȱmLȱvial.ȱ

norethisteroneȱenantateȱ Oilyȱsolution: 200ȱmg/ mL inȱ1ȬȱmLȱampoule.

1 8 .3 .3 I nt rauter ine devices

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copperȬcontainingȱdeviceȱ

levonorgestrelȬreleasingȱintrauterineȱsystemȱIntrauterineȱsystemȱwithȱreservoirȱcontainingȱ52ȱmgȱofȱlevonorestrelȱ

1 8 .3 .4 Barr ier m ethods

condomsȱ

diaphragmsȱ

1 8 .3 .5 I m plantable contracept ives

etonogestrelȬreleasingȱimplantȱSingleȬrodȱetonogestrelȬreleasingȱimplant,ȱcontainingȱ68ȱmgȱofȱetonogestrel.ȱ

levonorgestrelȬreleasingȱimplant TwoȬrodȱlevonorgestrelȬreleasingȱimplant,ȱeachȱrodȱcontainingȱ75ȱmgȱofȱlevonorgestrelȱ(150ȱmgȱtotal).

1 8 .3 .5 I nt ravaginal contracept ives

progesteroneȱvaginalȱring*ȱ

ProgesteroneȬreleasingȱvaginalȱringȱcontainingȱ2.074ȱgȱofȱmicronizedȱprogesterone.ȱ

*Forȱuseȱinȱwomenȱactivelyȱbreastfeedingȱatȱleastȱ4ȱtimesȱperȱdayȱȱ

1 8 .4 Est rogens

1 8 .5 I nsulins and other m edicines used for diabetes

ȱgliclazide*ȱ

Solidȱ oralȱ dosageȱ form: (controlledȬreleaseȱ tablets)ȱ30ȱmg;ȱ60ȱmg;ȱȱ

ȱ80ȱmg.ȱ

*ȱglibenclamideȱnotȱsuitableȱaboveȱ60ȱyears.ȱ

glucagonȱ Injection:ȱ1 mg/ mL.

insulinȱinjectionȱ(soluble)ȱInjection: 40ȱIU/ mL inȱ10ȬmLȱvial;ȱ100ȱIU/ȱmL inȱ10ȬȱmLȱvial.ȱȱ

intermediateȬactingȱinsulinȱȱInjection: 40ȱIU/ mL inȱ10ȬmLȱvial;ȱ100ȱIU/ȱmL inȱ10ȬȱmLȱvialȱ(asȱcompoundȱinsulinȱzincȱsuspensionȱorȱisophaneȱinsulin).ȱ

metforminȱ Tablet: 500ȱmgȱ(hydrochloride).ȱ

ComplementaryȱListȱ[ c] ȱ

metforminȱȱ Tablet:ȱ500ȱmgȱ(hydrochloride).ȱ

1 8 .6 Ovulat ion inducers ȱ

ComplementaryȱListȱ

clomifeneȱ Tablet:ȱ50ȱmgȱ(citrate).ȱ

1 8 .7 Progestogens ȱ

ȱmedroxyprogesteroneȱacetateȱ Tablet: 5ȱmg.

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1 8 .8 Thyroid horm ones and ant ithyroid m edicines

levothyroxineȱTablet: 25ȱmicrograms [ c] ;ȱ50ȱmicrograms;ȱ100ȱmicrogramsȱ(sodiumȱsalt).ȱ

potassiumȱiodideȱ Tablet: 60ȱmg.

ȱpropylthiouracilȱ Tablet: 50ȱmg.

ComplementaryȱListȱ[ c] ȱ

Lugolȇsȱsolutionȱ Oralȱliquid:ȱaboutȱ130ȱmgȱtotalȱiodine/ȱmL.ȱ

potassiumȱiodideȱ Tablet:ȱ60ȱmg.ȱ

propylthiouracilȱȱ Tablet:ȱ50ȱmg.ȱ

1 9 . I MMUNOLOGI CALS

1 9 .1 Diagnost ic agents

AllȱtuberculinsȱshouldȱcomplyȱwithȱtheȱWHOȱrequirementsȱforȱtuberculins.ȱȱ

tuberculin,ȱpurifiedȱproteinȱderivativeȱ(PPD)ȱ Injection.

1 9 .2 Sera and im m unoglobulins

AllȱplasmaȱfractionsȱshouldȱcomplyȱwithȱtheȱWHOȱrequirements.ȱ

AntiȬvenomȱimmunoglobulin*ȱInjection.

*ȱExactȱtypeȱtoȱbeȱdefinedȱlocally.ȱ

diphtheriaȱantitoxinȱ Injection: 10ȱ000ȱIU;ȱ20ȱ000ȱIUȱinȱvial.ȱ

1 9 .3 Vaccines

WHOȱ immunizationȱpolicyȱ recommendationsȱ areȱpublishedȱ inȱvaccineȱpositionȱpapersȱonȱ theȱbasisȱofȱrecommendationsȱmadeȱbyȱtheȱStrategicȱAdvisoryȱGroupȱofȱExpertsȱonȱImmunizationȱ(SAGE).ȱȱȱ

WHOȱvaccineȱpositionȱpapersȱareȱupdatedȱthreeȱtoȱfourȱtimesȱperȱyear.ȱȱTheȱlistȱbelowȱdetailsȱtheȱvaccinesȱforȱwhichȱthereȱisȱaȱrecommendationȱfromȱSAGEȱandȱaȱcorrespondingȱWHOȱȱpositionȱpaperȱasȱatȱ[DATE].ȱȱTheȱmostȱrecentȱversionsȱofȱtheȱWHOȱpositionȱpapers,ȱreflectingȱtheȱcurrentȱevidenceȱrelatedȱtoȱaȱspecificȱvaccineȱandȱtheȱrelatedȱrecommendations,ȱcanȱbeȱaccessedȱatȱanyȱtimeȱonȱtheȱWHOȱwebsiteȱat:ȱ

ȱhttp://www.who.int/immunization/documents/positionpapers/en/index.html.ȱ

Vaccineȱ recommendationsȱmayȱ beȱ universalȱ orȱ conditionalȱ (e.g.,ȱ inȱ certainȱ regions,ȱ inȱ someȱ highȬriskȱpopulationsȱorȱasȱpartȱofȱimmunizationȱprogrammesȱwithȱcertainȱcharacteristics).ȱȱDetailsȱareȱavailableȱinȱtheȱ relevantȱ positionȱ papers,ȱ andȱ inȱ theȱ Summaryȱ Tablesȱ ofȱ WHOȱ Routineȱ ImmunizationȱRecommendationsȱavailableȱonȱtheȱWHOȱwebsiteȱat:ȱ

http://www.who.int/immunization/policy/immunization_tables/en/index.html.ȱȱȱ

SelectionȱofȱvaccinesȱfromȱtheȱModelȱListȱwillȱneedȱtoȱbeȱdeterminedȱbyȱeachȱcountryȱafterȱconsiderationȱofȱinternationalȱrecommendations,ȱepidemiologyȱandȱnationalȱpriorities.ȱȱ

AllȱvaccinesȱshouldȱcomplyȱwithȱtheȱWHOȱrequirementsȱforȱbiologicalȱsubstances.ȱȱ

WHOȱnotedȱtheȱneedȱforȱvaccinesȱusedȱinȱchildrenȱtoȱbeȱpolyvalent.ȱ

Recommendationsȱforȱallȱ ȱ

BCGȱvaccineȱ

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diphtheriaȱvaccineȱ

Haemophilusȱinfluenzaeȱtypeȱbȱvaccineȱ

hepatitisȱBȱvaccineȱ

HPVȱvaccineȱ

measlesȱvaccineȱ

pertussisȱvaccineȱ

pneumococcalȱvaccineȱ

poliomyelitisȱvaccineȱȱ

rotavirusȱvaccineȱ

rubellaȱvaccineȱȱ

tetanusȱvaccineȱȱ

ȱ

Recommendationsȱforȱcertainȱregionsȱ

Japaneseȱencephalitisȱvaccineȱ

yellowȱfeverȱvaccineȱ

tickȬborneȱencephalitisȱvaccineȱ

ȱ

RecommendationsȱforȱsomeȱhighȬriskȱpopulationsȱ

choleraȱvaccineȱ

hepatitisȱAȱvaccineȱ

meningococcalȱmeningitisȱvaccineȱ

rabiesȱvaccineȱȱ

typhoidȱvaccineȱȱ

ȱ

Recommendationsȱforȱimmunizationȱprogrammesȱwithȱcertainȱcharacteristicsȱ

influenzaȱvaccineȱ(seasonal)ȱ

mumpsȱvaccineȱȱ

varicellaȱvaccineȱ

ȱ

2 0 . MUSCLE RELAXANTS ( PERI PHERA LLY- ACTI NG) AND CHOLI NESTERASE I NHI BI TORS

ȱatracuriumȱȱ Injection: 10ȱmg/ mL (besylate).ȱ

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neostigmineȱ

Injection: 500ȱmicrogramsȱinȱ1ȬȱmLȱampoule;ȱ2.5ȱmgȱ(metilsulfate)ȱinȱ1ȬȱmLȱampoule.ȱ

Tablet:ȱ15ȱmgȱ(bromide).ȱ

suxamethoniumȱInjection: 50ȱmgȱ(chloride)/ mLȱinȱ2ȬȱmLȱampoule.

Powderȱforȱinjectionȱ(chloride),ȱinȱvial.ȱ

ȱvecuroniumȱ[ c] ȱ Powderȱforȱinjection:ȱ10ȱmgȱ(bromide)ȱinȱvial.ȱ

ComplementaryȱListȱ

pyridostigmineȱInjection:ȱ1ȱmgȱinȱ1ȬȱmLȱampoule.ȱ

Tablet:ȱ60ȱmgȱ(bromide).ȱ

ȱvecuroniumȱ Powderȱforȱinjection:ȱ10ȱmgȱ(bromide)ȱinȱvial.ȱ

2 1 . OPHTHALMOLOGI CAL PREPARATI ONS

2 1 .1 Ant i- infect ive agents

aciclovirȱ Ointment: 3%ȱW/W.

azithromycin Solutionȱ(eyeȱdrops):ȱ1.5%.

ȱgentamicin Solutionȱ(eyeȱdrops):ȱ0.3%ȱ(sulfate).ȱ

ȱofloxacin Solutionȱ(eyeȱdrops): 0.3%.

ȱtetracycline Eyeȱointment: 1%ȱ(hydrochloride).ȱ

2 1 .2 Ant i- inf lam m atory agents ȱ

ȱprednisolone Solutionȱ(eyeȱdrops): 0.5%ȱ(sodiumȱphosphate).

2 1 .3 Local anaesthet ics ȱ

ȱtetracaineȱa Solutionȱ(eyeȱdrops): 0.5%ȱ(hydrochloride).

a Not in preterm neonates.ȱ

2 1 .4 Miot ics and ant iglaucom a m edicines

acetazolamideȱ Tablet: 250ȱmg.

latanoprostȱ Solutionȱ(eyeȱdrops): latanoprostȱ50ȱmicrograms/mL

ȱpilocarpineȱSolutionȱ(eyeȱdrops): 2%;ȱ4%ȱ(hydrochloride orȱnitrate).ȱ

ȱtimololȱSolutionȱ(eyeȱdrops): 0.25%;ȱ0.5%ȱ(asȱhydrogenȱmaleate).ȱ

2 1 .5 Mydr ia t ics

atropine*ȱa ȱȱ

Solutionȱ(eyeȱdrops): 0.1%;ȱ0.5%;ȱ1%ȱ(sulfate).

*ȱ[ c] ȱOrȱhomatropineȱ(hydrobromide)ȱorȱcyclopentolateȱ(hydrochloride).ȱ

a > 3 m onths.ȱ

ComplementaryȱListȱ

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epinephrineȱ(adrenaline)ȱ Solutionȱ(eyeȱdrops):ȱ2%ȱ(asȱhydrochloride).ȱ

2 1 .6 Ant i- vascular endothelia l grow th factor ( VEGF) preparat ions ȱ

ComplementaryȱListȱ

bevacizumabȱ Injection:ȱ25ȱmg/ȱmL.ȱ

2 2 . OXYTOCI CS AND ANTI OXYTOCI CS

2 2 .1 Oxytocics

ȱergometrineȱInjection: 200ȱmicrogramsȱ(hydrogenȱmaleate)ȱinȱ1ȬmLȱampoule.ȱȱ

misoprostol

Tablet: 200ȱmicrograms.

Managementȱofȱincompleteȱabortionȱandȱmiscarriage;ȱ

Preventionȱandȱtreatmentȱofȱpostpartumȱhaemorrhageȱwhereȱoxytocinȱisȱnotȱavailableȱorȱcannotȱbeȱsafelyȱusedȱ

Vaginalȱtablet:ȱ25ȱmicrograms.*ȱ

*ȱOnlyȱforȱuseȱforȱinductionȱofȱlabourȱwhereȱappropriateȱfacilitiesȱareȱavailable.ȱ

oxytocin Injection: 10ȱIUȱinȱ1ȬmL.

ComplementaryȱListȱ

mifepristone*ȱ�ȱmisoprostol*ȱ

Whereȱpermittedȱunderȱnationalȱlawȱandȱwhereȱculturallyȱacceptable.ȱ

ȱ

Tabletȱ200ȱmgȱ�ȱtabletȱ200ȱmicrograms.ȱ

*ȱRequiresȱcloseȱmedicalȱsupervision.ȱ

2 2 .2 Ant ioxytocics ( tocolyt ics)

nifedipineȱ ImmediateȬreleaseȱcapsule:ȱ10ȱmg.ȱ

2 3 . PERI TONEAL DI ALYSI S SOLUTI ON

ComplementaryȱListȱ

intraperitonealȱdialysisȱsolutionȱ(ofȱappropriateȱcomposition)ȱ Parenteralȱsolution.ȱ

2 4 . MEDI CI NES FOR MENTAL AND BEHAVI OURAL DI SORDERS

2 4 .1 Medicines used in psychot ic disorders

ȱchlorpromazineȱ

Injection: 25ȱmgȱ(hydrochloride)/ȱmLȱinȱ2ȬȱmL

ampoule.ȱ

Oralȱliquid:ȱ25ȱmgȱ(hydrochloride)/5ȱȱmL.ȱ

Tablet:ȱ100ȱmgȱ(hydrochloride).ȱ

ȱfluphenazineȱInjection: 25ȱmgȱ(decanoateȱorȱenantate)ȱinȱ1ȬmL

ampoule.ȱ

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ȱhaloperidolȱInjection: 5ȱmgȱinȱ1ȬmL ampoule.ȱ

Tablet:ȱ2ȱmg;ȱ5ȱmg.ȱ

risperidoneȱ Solidȱoralȱdosageȱform:ȱ0.25ȱmgȱtoȱ6.0ȱmg.ȱ

ComplementaryȱList

chlorpromazineȱ[ c]

Injection:ȱ25ȱmgȱ(hydrochloride)/ȱmLȱinȱ2ȬȱmLȱampoule.ȱ

Oralȱliquid:ȱ25ȱmgȱ(hydrochloride)/5ȱȱmL.ȱ

Tablet:ȱ10ȱmg;ȱ25ȱmg;ȱ50ȱmg;ȱ100ȱmgȱ(hydrochloride).ȱ

clozapineȱ Solidȱoralȱdosageȱform:ȱ25ȱtoȱ200ȱmg.ȱ

haloperidolȱ[ c]

Injection:ȱ5ȱmgȱinȱ1ȬȱmLȱampoule.ȱ

Oralȱliquid:ȱ2ȱmg/ȱmL.ȱ

Solidȱoralȱdosageȱform:ȱ0.5ȱmg;ȱ2ȱmg;ȱ5ȱmg.ȱ

ȱ ȱ

2 4 .2 Medicines used in m ood disorders ȱ

2 4 .2 .1 Medicines used in depressive disordersȱ

ȱamitriptyline Tablet: 25ȱmg;ȱ75mg. (hydrochloride).ȱȱ

fluoxetineȱ Solidȱoralȱdosageȱform: 20ȱmgȱ(asȱhydrochloride).

ComplementaryȱListȱ[ c] ȱ

fluoxetineȱa Solidȱoralȱdosageȱform:ȱ20ȱmgȱ(asȱhydrochloride).ȱ

a > 8 years.ȱ

2 4 .2 .2 Medicines used in bipolar disordersȱ

carbamazepine Tabletȱ(scored): 100ȱmg;ȱ200ȱmg.ȱ

lithiumȱcarbonate Solidȱoralȱdosageȱform:ȱ300ȱmg.ȱ

valproicȱacidȱ(sodiumȱvalproate) Tabletȱ(entericȬcoated): 200ȱmg;ȱ500ȱmgȱ(sodiumȱvalproate).ȱ

2 4 .3 Medicines for anx iety disorders ȱ

ȱdiazepam Tabletȱ(scored): 2ȱmg;ȱ5ȱmg.ȱ

2 4 .4 Medicines used for obsessive com pulsive disord ers ȱ

clomipramine Capsule: 10ȱmg;ȱ25ȱmgȱ(hydrochloride).ȱ

2 4 .5 Medicines for disorders due to psychoact ive su bstance use ȱ

nicotineȱreplacementȱtherapyȱ(NRT)ȱȱChewingȱgum:ȱ2ȱmg;ȱ4ȱmg (asȱpolacrilex).ȱ

Transdermalȱpatch:ȱ5ȱmgȱtoȱ30ȱmg/16ȱhrs;ȱ7ȱmgȱtoȱ21ȱmg/24ȱhrs.ȱ

ComplementaryȱListȱ

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ȱmethadone*ȱ

Concentrateȱforȱoralȱliquid:ȱ5ȱmg/ȱmL;ȱ10ȱmg/ȱmLȱ(hydrochloride).ȱ

Oralȱliquid:ȱ5ȱmg/5ȱȱmL;ȱ10ȱmg/5ȱȱmLȱ(hydrochloride).ȱ

*ȱTheȱsquareȱboxȱisȱaddedȱtoȱincludeȱbuprenorphine.ȱTheȱmedicinesȱshouldȱonlyȱbeȱusedȱwithinȱanȱestablishedȱsupportȱprogramme.ȱ

2 5 . MEDI CI NES ACTI NG ON THE RESPI RATORY TRACT ȱ

2 5 .1 Ant iasthm at ic and m edicines for chronic obst ru ct ive pulm onary disease ȱ

ȱbeclometasoneȱInhalationȱ(aerosol): 50 microgramsȱ(dipropionate)ȱperȱdose;ȱ100ȱmicrogramsȱ(dipropionate)ȱperȱdoseȱ(asȱCFCȱfreeȱforms).ȱ

ȱbudesonideȱ[ c] Inhalationȱ(aerosol): 100ȱmicrogramsȱperȱdose;ȱ200ȱmicrogramsȱperȱdose.ȱ

epinephrineȱ(adrenaline)ȱInjection: 1ȱmgȱ(asȱhydrochlorideȱorȱhydrogenȱtartrate)ȱinȱȱ1ȬȱmLȱampoule.ȱ

ipratropiumȱbromideȱ Inhalationȱ(aerosol):ȱ20ȱmicrograms/meteredȱdose.ȱ

ȱsalbutamolȱ

Inhalationȱ(aerosol): 100ȱmicrogramsȱ(asȱsulfate)ȱperȱdose.ȱ

Injection:ȱ 50ȱmicrogramsȱ (asȱ sulfate)/ȱmLȱ inȱ 5ȬȱmLȱampoule.ȱ

Meteredȱdoseȱinhalerȱ(aerosol):ȱ100ȱmicrogramsȱ(asȱsulfate)ȱperȱdose.ȱ

Respiratorȱsolutionȱ forȱuseȱ inȱnebulizers:ȱ5ȱmgȱ (asȱsulfate)/ȱmL.ȱ

2 6 . SOLUTI ONS CORRECTI NG W ATER, ELECTROLYTE AND ACI D– BASE DI STURBANCES ȱ

2 6 .1 Ora l ȱ

oralȱrehydrationȱsaltsȱȱ Seeȱsectionȱ17.5.1.ȱȱ

potassiumȱchlorideȱ Powderȱforȱsolution.ȱ

2 6 .2 Parentera l

glucoseȱ Injectableȱsolution: 5%ȱ(isotonic);ȱ10%ȱ(hypertonic);ȱ50%ȱ(hypertonic).ȱ

glucoseȱwithȱsodiumȱchlorideȱ

Injectableȱsolution: 4%ȱglucose,ȱ0.18%ȱsodiumȱchlorideȱȱ(equivalentȱtoȱNa+ȱ30ȱmmol/L,ȱClȬȱ30ȱmmol/L).ȱ

Injectableȱsolution:ȱ5%ȱglucose,ȱ0.9%ȱsodiumȱchlorideȱ(equivalentȱtoȱNa+ȱ150ȱmmol/LȱandȱClȬȱ150ȱmmol/L);ȱ5%ȱglucose,ȱ0.45%ȱsodiumȱchlorideȱ(equivalentȱtoȱNa+ȱ75ȱmmol/LȱandȱClȬȱ75ȱmmol/L)ȱ[ c] .ȱ

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potassiumȱchlorideȱ

Solution: 11.2%ȱinȱ20ȬmL ampouleȱ(equivalentȱtoȱK+ȱ1.5ȱmmol/ȱmL,ȱClȬȱ1.5ȱmmol/ȱmL).ȱ

Solutionȱforȱdilution:ȱ7.5%ȱ(equivalentȱtoȱKȱ1ȱmmol/ȱmLȱandȱClȱ1ȱmmol/ȱmL)ȱ[ c] ;ȱ15%ȱ(equivalentȱtoȱKȱ2ȱmmol/ȱmLȱandȱClȱ2ȱmmol/ȱmL)ȱ[ c] .ȱ

sodiumȱchlorideȱInjectableȱsolution: 0.9%ȱisotonicȱ(equivalentȱtoȱNa+ȱ154ȱmmol/L,ȱClȬȱ154ȱmmol/L).ȱ

sodiumȱhydrogenȱcarbonateȱ

Injectableȱsolution:ȱ1.4%ȱisotonicȱ(equivalentȱtoȱNa+ȱ167ȱmmol/L,ȱHCO3Ȭȱ167ȱmmol/L).ȱ

Solution:ȱ8.4%ȱinȱ10ȬȱmLȱampouleȱ(equivalentȱtoȱNa+ȱ1000ȱmmol/L,ȱHCO3Ȭ1000ȱmmol/L).ȱ

ȱsodiumȱlactate,ȱcompoundȱsolutionȱ Injectableȱsolution.

2 6 .3 Miscellaneous ȱ

waterȱforȱinjectionȱ 2ȬȱmL;ȱ5ȬȱmL;ȱ10ȬȱmLȱampoules.ȱ

2 7 . VI TAMI NS AND MI NERALS ȱ

ascorbicȱacidȱ Tablet: 50ȱmg.

calciumȱ Tablet:ȱ500ȱmgȱ(elemental).ȱ

cholecalciferol*ȱ[ c]

Oralȱliquid: 400ȱIU/ mL.

Solidȱoralȱdosageȱform:ȱ400ȱIU;ȱ1000ȱIU.ȱ

*ȱErgocalciferolȱcanȱbeȱusedȱasȱanȱalternative.ȱ

ȱergocalciferolȱOralȱliquid: 250ȱmicrograms/ȱmLȱ(10ȱ000ȱIU/ mL).

Solidȱoralȱdosageȱform:ȱ1.25ȱmgȱ(50ȱ000ȱIU).ȱ

iodineȱȱ

Capsule: 200 mg.

Iodizedȱoil:ȱ1ȱȱmLȱ(480ȱmgȱiodine);ȱ0.5ȱȱmLȱ(240ȱmgȱiodine)ȱinȱampouleȱ(oralȱorȱinjectable);ȱ0.57ȱȱmLȱ(308ȱmgȱiodine)ȱinȱdispenserȱbottle.ȱ

ȱnicotinamideȱ Tablet: 50ȱmg.

pyridoxineȱ Tablet: 25ȱmgȱ(hydrochloride).ȱ

retinolȱ

Capsule: 50ȱ000ȱIU;ȱ100 000ȱIU;ȱ200ȱ000ȱIUȱ(asȱpalmitate).ȱ

Oralȱoilyȱsolution:ȱ100ȱ000ȱIUȱ(asȱpalmitate)/ȱmLȱinȱmultidoseȱdispenser.ȱ

Tabletȱ(sugarȬcoated):ȱ10ȱ000ȱIUȱ(asȱpalmitate).ȱ

WaterȬmiscibleȱinjection:ȱ100ȱ000ȱIUȱ(asȱpalmitate)ȱinȱȱ2ȬȱmLȱampoule.ȱ

riboflavinȱ Tablet: 5ȱmg.

sodiumȱfluorideȱ Inȱanyȱappropriateȱtopicalȱformulation.ȱ

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thiamineȱ Tablet: 50ȱmgȱ(hydrochloride).ȱ

ComplementaryȱListȱ

calciumȱgluconateȱ Injection:ȱ100ȱmg/ȱmLȱinȱ10ȬȱmLȱampoule.ȱ

2 8 . EAR, NOSE AND THROAT MEDI CI NES [ c]

aceticȱacidȱ Topical:ȱ2%,ȱinȱalcohol.ȱ

budesonideȱȱ Nasalȱspray:ȱ100ȱmicrogramsȱperȱdose.ȱ

ciprofloxacinȱ Topical:ȱ0.3%ȱdropsȱ(asȱhydrochloride).ȱ

xylometazolineȱa ȱNasalȱspray: 0.05%.ȱ

a ȱNot in children less than 3 months.ȱ

2 9 . SPECI FI C MEDI CI NES FOR NEONATAL CARE ȱ

2 9 .1 Medicines adm inistered to the neonate [ c]

caffeineȱcitrate

Injection:ȱ 20 mg/ mL (equivalentȱ toȱ 10ȱmgȱ caffeineȱbase/ȱmL).ȱ

Oralȱliquid:ȱ20ȱmg/ȱmLȱ(equivalentȱtoȱ10ȱmgȱcaffeineȱbase/ȱmL).ȱ

ChlorhexidineȱȱSolutionȱ orȱ gel: 7.1%ȱ (digluconate)ȱ deliveringȱ 4%ȱchlorhexidineȱ(forȱumbilicalȱcordȱcare)ȱ[ c] .ȱȱ

ComplementaryȱListȱ

ȱibuprofenȱ Solutionȱforȱinjection:ȱ5ȱmg/ȱmL.ȱ

ȱprostaglandinȱEȱSolutionȱforȱinjection:ȱȱ

ProstaglandinȱE1:ȱ0.5ȱmg/ȱmLȱinȱalcohol.ȱProstaglandinȱEȱ2:ȱ1ȱmg/ȱmL.ȱ

surfactantȱ Suspensionȱ forȱ intratrachealȱ instillation:ȱ25ȱmg/ȱmLȱorȱ80ȱmg/ȱmL.ȱ

2 9 .2 Medicines adm inistered to the m other

dexamethasoneȱInjection:ȱ4ȱmg/ mL dexamethasoneȱphosphateȱ(asȱdisodiumȱsalt)ȱȱ

3 0 . MEDI CI NES FOR DI SEASES OF JOI NTS

3 0 .1 Medicines used to t reat gout

allopurinolȱ Tablet: 100ȱmg.

3 0 .2 Disease- m odify ing agents used in rheum atoid di sorders ( DMARDs)

chloroquineȱ Tablet: 100ȱmg;ȱ150ȱmgȱ(asȱphosphateȱorȱsulfate).

ComplementaryȱList

azathioprineȱ Tablet:ȱ50ȱmg.ȱ

hydroxychloroquineȱ[ c] ȱȱ Solidȱoralȱdosageȱform:ȱ200ȱmgȱ(asȱsulfate).ȱ

methotrexateȱ Tablet:ȱ2.5ȱmgȱ(asȱsodiumȱsalt).ȱ

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penicillamineȱ Solidȱoralȱdosageȱform:ȱ250ȱmg.ȱ

sulfasalazineȱ Tablet:ȱ500ȱmg.ȱ

3 0 .3 Juvenile joint diseases ȱ

acetylsalicylicȱacid*ȱ(acuteȱorȱchronicȱuse)ȱ

Suppository:ȱ50ȱmgȱtoȱ150ȱmg.ȱ

Tablet:ȱ100ȱmgȱtoȱ500ȱmg.ȱ

*ȱForȱuseȱforȱrheumaticȱfever,ȱjuvenileȱarthritis,ȱKawasakiȱdisease.ȱ

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Table 1 .1 : Medicines w ith age or w eight rest r ict ion s ȱ

atazanavirȱ >25ȱkgȱatropineȱ >3ȱmonthsȱbenzylȱbenzoateȱ >2ȱyearsȱbetamethasoneȱtopicalȱpreparationsȱ hydrocortisoneȱpreferredȱinȱneonatesȱcefazolinȱ >1ȱmonthȱceftriaxoneȱ >41ȱweeksȱcorrectedȱgestationalȱageȱȱdarunavirȱ >ȱ3ȱyearsȱdiloxanideȱ >25ȱkgȱȱdoxycyclineȱ >8ȱyearsȱ(exceptȱforȱseriousȱinfectionsȱe.g.ȱcholera)ȱefavirenzȱ >3ȱyearsȱorȱ>10ȱkgȱȱemtricitabineȱ >3ȱmonthsȱfluoxetineȱ >8ȱyearsȱȱibuprofenȱ >3ȱmonthsȱ(exceptȱIVȱformȱforȱpatentȱductusȱarteriosus)ȱmefloquineȱ >5ȱkgȱorȱ>3ȱmonthsȱmetoclopramideȱ Notȱinȱneonatesȱnevirapineȱ >ȱ6ȱweeksȱondansetronȱ >1ȱmonthȱsaquinavirȱ >25ȱkgȱȱsilverȱsulfadiazineȱ >2ȱmonthsȱtetracaineȱ Notȱinȱpretermȱneonatesȱtrimethoprimȱ >6ȱmonthsȱxylometazolineȱ >3ȱmonthsȱ

ȱ

ȱȱȱȱȱȱȱȱȱ

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Table 1 .2 : Explanat ion of dosage form s ȱ

A. Pr incipa l dosage form s used in EML – ora l adm inist ra t ion ȱ

ȱTermȱȱ

Definitionȱȱ

Solidȱoralȱdosageȱformȱ

RefersȱtoȱtabletsȱorȱcapsulesȱorȱotherȱsolidȱdosageȱformsȱsuchȱasȱȇmeltsȇȱthatȱareȱimmediateȬreleaseȱpreparations.ȱItȱimpliesȱthatȱthereȱisȱnoȱdifferenceȱinȱclinicalȱefficacyȱorȱsafetyȱbetweenȱtheȱavailableȱdosageȱforms,ȱandȱcountriesȱshouldȱthereforeȱchooseȱtheȱform(s)ȱtoȱbeȱlistedȱdependingȱonȱqualityȱandȱavailability.ȱȱȱȱTheȱtermȱȇsolidȱoralȱdosageȱformȇȱisȱneverȱintendedȱtoȱallowȱanyȱtypeȱofȱmodifiedȬreleaseȱtablet.ȱȱ

Tabletsȱȱ

Refersȱto:ȱȱȱ uncoatedȱorȱcoatedȱ(filmȬcoatedȱorȱsugarȬcoated)ȱtabletsȱthatȱareȱ

intendedȱtoȱbeȱswallowedȱwhole;ȱȱ unscoredȱandȱscored*;ȱȱ tabletsȱthatȱareȱintendedȱtoȱbeȱchewedȱbeforeȱbeingȱswallowed;ȱȱ tabletsȱthatȱareȱintendedȱtoȱbeȱdispersedȱorȱdissolvedȱinȱwaterȱorȱ

anotherȱsuitableȱliquidȱbeforeȱbeingȱswallowed;ȱȱ tabletsȱthatȱareȱintendedȱtoȱbeȱcrushedȱbeforeȱbeingȱswallowed.ȱȱTheȱtermȱȇtabletȇȱwithoutȱqualificationȱisȱneverȱintendedȱtoȱallowȱanyȱtypeȱofȱmodifiedȬreleaseȱtablet.ȱȱ

Tabletsȱ(qualified)ȱ

Refersȱtoȱaȱspecificȱtypeȱofȱtablet:ȱchewableȱȬȱtabletsȱthatȱareȱintendedȱtoȱbeȱchewedȱbeforeȱbeingȱswallowed;ȱȱdispersibleȱȬȱtabletsȱthatȱareȱintendedȱtoȱbeȱdispersedȱinȱwaterȱorȱanotherȱsuitableȱliquidȱbeforeȱbeingȱswallowed;ȱȱsolubleȱȬȱtabletsȱthatȱareȱintendedȱtoȱbeȱdissolvedȱinȱwaterȱorȱanotherȱsuitableȱliquidȱbeforeȱbeingȱswallowed;ȱȱcrushableȱȬȱtabletsȱthatȱareȱintendedȱtoȱbeȱcrushedȱbeforeȱbeingȱswallowed;ȱȱscoredȱȬȱtabletsȱbearingȱaȱbreakȱmarkȱorȱmarksȱwhereȱsubȬdivisionȱisȱintendedȱinȱorderȱtoȱprovideȱdosesȱofȱlessȱthanȱoneȱtablet;ȱsublingualȱȬȱtabletsȱthatȱareȱintendedȱtoȱbeȱplacedȱbeneathȱtheȱtongue.ȱȱTheȱtermȱȇtabletȇȱisȱalwaysȱqualifiedȱwithȱanȱadditionalȱtermȱ(inȱparentheses)ȱinȱentriesȱwhereȱoneȱofȱtheȱfollowingȱtypesȱofȱtabletȱisȱintended:ȱgastroȬresistantȱ(suchȱtabletsȱmayȱsometimesȱbeȱdescribedȱasȱentericȬcoatedȱorȱasȱdelayedȬrelease),ȱprolongedȬreleaseȱorȱanotherȱmodifiedȬreleaseȱform.ȱ

ȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱȱ*ȱȱ Scoredȱtabletsȱmayȱbeȱdividedȱforȱeaseȱofȱswallowing,ȱprovidedȱthatȱdoseȱisȱaȱwholeȱnumberȱofȱtablets.ȱ

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ȱTermȱȱ

Definitionȱȱ

ȱȱ

Capsulesȱȱ

Refersȱtoȱhardȱorȱsoftȱcapsules.ȱȱȱTheȱtermȱȇcapsuleȇȱwithoutȱqualificationȱisȱneverȱintendedȱtoȱallowȱanyȱtypeȱofȱmodifiedȬreleaseȱcapsule.ȱȱ

Capsulesȱ(qualified)ȱ

TheȱtermȱȇcapsuleȇȱwithȱqualificationȱrefersȱtoȱgastroȬresistantȱ(suchȱcapsulesȱmayȱsometimesȱbeȱdescribedȱasȱentericȬcoatedȱorȱasȱdelayedȬrelease),ȱprolongedȬreleaseȱȱorȱanotherȱmodifiedȬreleaseȱform.ȱȱ

Granulesȱ

Preparationsȱthatȱareȱissuedȱtoȱpatientȱasȱgranulesȱtoȱbeȱswallowedȱwithoutȱfurtherȱpreparation,ȱtoȱbeȱchewed,ȱorȱtoȱbeȱtakenȱinȱorȱwithȱwaterȱorȱanotherȱsuitableȱliquid.ȱȱTheȱtermȱȇgranulesȇȱwithoutȱfurtherȱqualificationȱisȱneverȱintendedȱtoȱallowȱanyȱtypeȱofȱmodifiedȬreleaseȱgranules.ȱȱ

OralȱpowderȱPreparationsȱthatȱareȱissuedȱtoȱpatientȱasȱpowderȱ(usuallyȱasȱsingleȬdose)ȱtoȱbeȱtakenȱinȱorȱwithȱwaterȱorȱanotherȱsuitableȱliquid.ȱȱ

Oralȱliquidȱȱ

Liquidȱpreparationsȱintendedȱtoȱbeȱswallowedȱi.e.ȱoralȱsolutions,ȱsuspensions,ȱemulsionsȱandȱoralȱdrops,ȱincludingȱthoseȱconstitutedȱfromȱpowdersȱorȱgranules,ȱbutȱnotȱthoseȱpreparationsȱintendedȱforȱoromucosalȱadministrationȱe.g.ȱgarglesȱandȱmouthwashes.ȱȱOralȱliquidsȱpresentedȱasȱpowdersȱorȱgranulesȱmayȱofferȱbenefitsȱinȱtheȱformȱofȱbetterȱstabilityȱandȱlowerȱtransportȱcosts.ȱIfȱmoreȱthanȱoneȱtypeȱofȱoralȱliquidȱisȱavailableȱonȱtheȱsameȱmarketȱ(e.g.ȱsolution,ȱsuspension,ȱgranulesȱforȱreconstitution),ȱtheyȱmayȱbeȱinterchangedȱandȱinȱsuchȱcasesȱshouldȱbeȱbioequivalent.ȱItȱisȱpreferableȱthatȱoralȱliquidsȱdoȱnotȱcontainȱsugarȱandȱthatȱsolutionsȱforȱchildrenȱdoȱnotȱcontainȱalcohol.ȱȱ

ȱB. Pr incipa l dosage form s used in EMLc – parentera l adm inist ra t ion

ȱTermȱ Definition

Injectionȱ Refersȱtoȱsolutions,ȱsuspensionsȱandȱemulsionsȱincludingȱthoseȱconstitutedȱfromȱpowdersȱorȱconcentratedȱsolutions.ȱ

Injectionȱ(qualified)ȱ Routeȱofȱadministrationȱisȱindicatedȱinȱparenthesesȱwhereȱrelevant.ȱInjectionȱ(oily)ȱ Theȱtermȱ`injection�ȱisȱqualifiedȱbyȱ`(oily)�ȱinȱrelevantȱentries.ȱIntravenousȱinfusionȱ Refersȱtoȱsolutionsȱandȱemulsionsȱincludingȱthoseȱconstitutedȱfromȱ

powdersȱorȱconcentratedȱsolutions.ȱȱ

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C. Other dosage form s ȱ

Modeȱofȱadministrationȱ

Termȱtoȱbeȱused

Toȱtheȱeyeȱ Eyeȱdrops,ȱeyeȱointments.ȱTopicalȱ Forȱliquids:ȱlotions,ȱpaints.ȱ

ForȱsemiȬsolids:ȱcream,ȱointment.ȱRectalȱȱ Suppositories,ȱgelȱorȱsolution.ȱVaginalȱ Pessariesȱorȱvaginalȱtablets.ȱInhalationȱ Powderȱforȱinhalation,ȱpressurizedȱinhalation,ȱnebulizer.ȱ

ȱ

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Indexȱabacavir (ABC) 12 abacavir + lamivudine 13 acetazolamide 38 acetic acid 42 acetylcysteine 4 acetylsalicylic acid 2, 18, 29, 43 aciclovir 12, 37 albendazole 6 alcohol based hand rub 31 allopurinol 19, 43 all-trans retinoic acid (ATRA) 19 amidotrizoate 30 amikacin 11 amiloride 31 amiodarone 28 amitriptyline 2, 39 amlodipine 28 amodiaquine 16 amoxicillin 6 amoxicillin + clavulanic acid 6 amphotericin B 11, 15 ampicillin 6 anti-D immunoglobulin 26 antitetanus immunoglobulin 27 antivenom immunoglobulin 35 artemether 16 artemether + lumefantrine 16 artesunate 16 artesunate + amodiaquine 16 artesunate + mefloquine 16 ascorbic acid 41 asparaginase 19 atazanavir 13 atracurium 37 atropine 1, 4, 38 azathioprine 19, 43 azithromycin 8, 37 barium sulfate 30 BCG vaccine 36 beclometasone 40 bedaquiline 11 bendamustine 19 benzathine benzylpenicillin 7 benznidazole 18 benzoyl peroxide 30 benzyl benzoate 30 benzylpenicillin 7 betamethasone 30 bevacizumab 38 bicalutamide 24 biperiden 25 bisoprolol 27, 28, 29 bleomycin 19 budesonide 40, 42 bupivacaine 1 caffeine citrate 42 calamine 30 calcium 42 calcium folinate 19 calcium gluconate 4, 42 capecitabine 19 capreomycin 11 carbamazepine 5, 40 carboplatin 20 cefalexin 7 cefazolin 7

cefixime 7 cefotaxime 7 ceftazidime 7 ceftriaxone 7 charcoal, activated 4 chlorambucil 20 chloramphenicol 8 chlorhexidine 31 chlorine base compound 31 chloroquine 16, 17, 43 chloroxylenol 31 chlorpromazine 39 chlorpromazine 39 cholecalciferol 42 cholera vaccine 37 ciclosporin 19 ciprofloxacin 8, 42 cisplatin 20 clarithromycin 8 clindamycin 9 clofazimine 9 clomifene 35 clomipramine 40 clopidogrel 29 clotrimazole 11 cloxacillin 7 clozapine 39 coagulation factor IX 27 coagulation factor VIII 27 coal tar 30 codeine 2 condoms 34 copper-containing device 34 cyclizine 2 cyclophosphamide 20 cycloserine 11 cytarabine 20 dacarbazine 20 daclatasvir 14 dactinomycin 20 dapsone 9 darunavir 13 dasabuvir 14 daunorubicin 21 deferoxamine 4, 26 delamanid 11 desmopressin 26 dexamethasone 2, 3, 24, 32, 43 dextran 70 27 diaphragms 34 diazepam 3, 5, 40 diethylcarbamazine 6 digoxin 27, 29 diloxanide 15 dimercaprol 4 diphtheria antitoxin 35 diphtheria vaccine 36 docetaxel 21 docusate sodium 3 dopamine 29 doxorubicin 21 doxycycline 8, 16, 17 efavirenz (EFV or EFZ) 13 efavirenz + emtricitabine + tenofovir 13 eflornithine 18 emtricitabine + tenofovir 13

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enalapril 28, 29 enoxaparin 25 entecavir 14 ephedrine 1 epinephrine (adrenaline) 3, 28, 38, 40 ergocalciferol 42 ergometrine 38 erythromycin 8 estradiol cypionate + medroxyprogesterone acetate 33 ethambutol 10 ethambutol + isoniazid 10 ethambutol + isoniazid + pyrazinamide + rifampicin 10 ethambutol + isoniazid + rifampicin 10 ethanol 31 ethinylestradiol + levonorgestrel 33 ethinylestradiol + norethisterone 33 ethionamide 11 ethosuximide 5 etonogestrel-releasing implant 34 etoposide 21 ferrous salt 25 ferrous salt + folic acid 25 filgrastim 22 fluconazole 11 flucytosine 11 fludarabine 21 fludrocortisone 33 fluorescein 30 fluorouracil 21, 30 fluoxetine 3, 39, 40 fluphenazine 39 folic acid 25 fomepizole 4 fresh frozen plasma 26 furosemide 29, 31 gemcitabine 22 gentamicin 9, 37 gliclazide 34 glucagon 34 glucose 41 glucose with sodium chloride 41 glutaral 31 glyceryl trinitrate 27 griseofulvin 11 Haemophilus influenzae type b vaccine 36 haloperidol 3, 39 halothane 1 heparin sodium 25, 26 hepatitis A vaccine 37 hepatitis B vaccine 36 HPV vaccine 36 hydralazine 28 hydrochlorothiazide 28, 29, 31 hydrocortisone 3, 24, 30, 32, 33 hydroxocobalamin 25 hydroxycarbamide 22, 26 hydroxychloroquine 43 hyoscine butylbromide 3 hyoscine hydrobromide 3 ibuprofen 2, 18, 43 ifosfamide 22 imatinib 22 imipenem + cilastatin 8 influenza vaccine 37 insulin injection (soluble) 34 intermediate-acting insulin 34 intraperitoneal dialysis solution (of appropriate composition)

39

iodine 42 iohexol 30 ipratropium bromide 40 irinotecan 22 isoflurane 1 isoniazid 10 isoniazid + pyrazinamide + rifampicin 10 isoniazid + rifampicin 10 isosorbide dinitrate 27 ivermectin 6 Japanese encephalitis vaccine 36 kanamycin 11 ketamine 1 lactulose 3 lamivudine (3TC) 12 lamivudine + nevirapine + stavudine 13 lamivudine + nevirapine + zidovudine 13 lamivudine + zidovudine 14 latanoprost) 38 ledipasvir + sofosbuvir 15 leuprorelin 24 levamisole 6 levodopa + carbidopa 25 levofloxacin 11 levonorgestrel 33 levonorgestrel-releasing implant 34 levonorgestrel-releasing intrauterine system 34 levothyroxine 35 lidocaine 1, 28 lidocaine + epinephrine (adrenaline) 1 linezolid 11 lithium carbonate 40 loperamide 3 lopinavir + ritonavir (LPV/r) 13 loratadine 4 lorazepam 5 Lugol's solution 35 magnesium sulfate 5 mannitol 31 measles vaccine 36 mebendazole 6 medroxyprogesterone acetate 34, 35 mefloquine 17 meglumine iotroxate 31 melarsoprol 18 meningococcal meningitis vaccine 37 mercaptopurine 22 mesna 22 metformin 34 methadone 40 methotrexate 23, 43 methyldopa 28 methylprednisolone 24 methylthioninium chloride (methylene blue) 4 metoclopramide 32 metronidazole 9, 15 miconazole 29 midazolam 1, 3, 5 mifepristone 39 miltefosine 15 misoprostol 38, 39 morphine 1, 2 mumps vaccine 37 mupirocin 30 naloxone 4 neostigmine 37 nevirapine (NVP) 13 niclosamide 6

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nicotinamide 42 nicotine replacement therapy (NRT) 40 nifedipine 39 nifurtimox 18 nitrofurantoin 9 nitrous oxide 1 norethisterone enantate 34 normal immunoglobulin 27 nystatin 12 ofloxacin 37 ombitasvir + paritaprevir + ritonavir 15 omeprazole 32 ondansetron 3, 32 oral rehydration salts 33, 41 oseltamivir 14 oxaliplatin 23 oxamniquine 6 oxygen 1 oxytocin 38 packed red blood cells 26 paclitaxel 23 p-aminosalicylic acid 11 pancreatic enzymes 31 paracetamol 2, 18 paromomycin 15 pegylated interferon alfa 2a 15 penicillamine 4, 43 pentamidine 17, 18 permethrin 30 pertussis vaccine 36 phenobarbital 5 phenoxymethylpenicillin 7 phenytoin 5 phytomenadione 26 pilocarpine 38 platelet concentrates 26 pneumococcal vaccine 36 podophyllum resin 30 poliomyelitis vaccine 36 potassium chloride 41 potassium ferric hexacyano-ferrate(II) -2H20 (Prussian blue) 4 potassium iodide 12, 35 potassium permanganate 30 povidone iodine 31 praziquantel 6 prednisolone 4, 25, 38 primaquine 17 procaine benzylpenicillin 7 procarbazine 23 progesterone vaginal ring 34 proguanil 17 propofol 1 propranolol 18 propylthiouracil 35 prostaglandin E 43 protamine sulfate 26 pyrantel 6 pyrazinamide 10 pyridostigmine 37 pyridoxine 42 pyrimethamine 17 quinine 17 rabies immunoglobulin 26 rabies vaccine 37 ranitidine 32 retinol 42 ribavirin 14, 15 riboflavin 42

rifabutin 10 rifampicin 9, 10 rifapentine 10 risperidone 39 ritonavir 13 rituximab 23 rotavirus vaccine 36 rubella vaccine 36 salbutamol 41 salicylic acid 30 saquinavir (SQV) 13 selenium sulfide 29 senna 3, 32 silver sulfadiazine 30 simeprevir 14 simvastatin 29 sodium calcium edetate 4 sodium chloride 41 sodium fluoride 42 sodium hydrogen carbonate 41 sodium lactate 41 sodium nitrite 4 sodium nitroprusside 28 sodium stibogluconate or meglumine antimoniate 15 sodium thiosulfate 4, 29 sofosbuvir 14 spectinomycin 9 spironolactone 29, 31 stavudine (d4T) 12 streptokinase 29 streptomycin 10, 11 succimer 4 sulfadiazine 17 sulfadoxine + pyrimethamine 17 sulfamethoxazole + trimethoprim 9, 17 sulfasalazine 32, 43 suramin sodium 18 surfactant 43 suxamethonium 37 tamoxifen 25 tenofovir disoproxil fumarate 12, 14 terbinafine 29 testosterone 33 tetanus vaccine 36 tetracaine 38 tetracycline 37 thiamine 42 thioguanine 23 tick-borne encephalitis vaccine 36 timolol 38 tranexamic acid 26 trastuzumab 23 triclabendazole 6 trimethoprim 9 tropicamide 30 tuberculin, purified protein derivative (PPD) 35 typhoid vaccine 37 urea 30 valganciclovir 14 valproic acid (sodium valproate) 5, 40 vancomycin 9 varicella vaccine 37 vecuronium 37 verapamil 27, 28 vinblastine 23 vincristine 24 vinorelbine 24 warfarin 26

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water for injection 41 whole blood 26 xylometazoline 42

yellow fever vaccine 36 zidovudine (ZDV or AZT) 12 zinc sulfate 33

ȱ