ANEXO N°% SOLICITUD DE AUTORIZAGION PARA LA UTILIZACION DE MEDICAMENTOS NO CONSIDERADOS EN EL PETITORIO NACIONAL UNICO DE MEDICMANETOS ESENCIALES (PNUME) DATOS GENERALES 1 statement BINS INSTITUGION: sito Nocona de Salad No San Bore 2 Datos de! solictante Nombre y Apolos Or. PattoM Haman Eenaccaya Ne Colegiatwra, 37682 Profesion Especalidad Yaaeo Para Sermo /Dapartamant Uni de ui inensvos Galea [IL MEDICAMENTO SoLiciTADO " cocennacen] Fama | vis de | Dosedana| costo | owaeinant| costo ge! 042.06 ym | amy wtoverosa 190801) nuevos | ras | 12628 PROSTAGLANDINA E+ 00 ugimt | ampota Jens Songun | tums | sae | Werte Ill MEDICAMENTOS ALTERNATIVOS EN EL PERIODO Extn meacarmor tres no RAE s 0 Doraminasin Comin ntaracions (061) | coneentassn Ll _ IV. MOTIVOS DE LA SOLIeIUD arcar el caso que corresponda, [Ty ® Reascitn avers que determine aust [7 © Fat trannies y eaencla de atematias en ot PRUNE, Nos obtvolarespueta clic esperada luego de... minutes) (horas) (lah) (cama) etree (0) ‘susponsn el medicament ol paciente #neistancia de ora atoms on Enfermedad o susie clinica no cables por ls medicaments del PRUME. 2 ® contanseacones stots is ateratvas de que esaponen ano Prue") (Hy Arecosrtes te econ oe psoas araceend po owns de este 1 tact mate rte es, T7 hieraccen meseamerioesCeamente leans con [Hoes epoca [1 @ Nocosioa ce un vin ati raion aera no ene Fo cia cemprobadn eno mercado tamactrice de alg medicament, concentra farm amacdics, {9} Disminucin signitenva dl costo, cone ute de una aternatva de dterenteconcentacion yo forma famactule as [J ® Stwncion de monepoio para un mesiamento del PRUNE, que sect slnicavamente xu costDW JUSTIFICACTON DE TA SOLICITUD. Indicaciino condicin eines principal ® coe: sweacnana | Corie | ' d princi oie [Cardiopatias Congénitas Ductus-Dependientes o Cantidad 2 [Indians concen Rigi: SS lsocinda(s)!" ta principal saan q ‘Atesia Pulmonar ja} 2] 25 375 4 ‘Transposicién de Grandes Vasos al 2|o] 20 300 a Coartacion de la Aorta ‘ol2] 5 35 525 3 lose encuentra dentro de alguna guia/protocolo de wso institucional ©) NO_Deserafirmativa la respuesta adjuntar copia 4. Poblacin Objetive Nevnato Nino [)doescente [—]Aduto []eronte []estante 5. FI medicamento solcitado sera de uso: mutator JAmbos usos 6 taforme tenieo: [dunia informe terion basad on la evdercia centiiea costo con referencia a bblagiatia independiente, ce recono NUM 11) Fine cas de qe ke soit sfc por ns de prof 12) She mace exquemas combinade.cosgnar fox dans solicnads para cada no de fos medicaments combina ica wt medicament considera en el PSUME, Siexperameme, considevar el range de 9) Consaderar fps de vera a pico actual pene Yeh Frees cde proceso que requeren dew Medicom gu poe momma nncrl sueren de rakoniente de largo peso eo Sse raed esqucmeas combina conuignar Tox datos slices para ca la ever incur datos de efcaca, sequidad, convenience, prestgio como ensayos clncos contlados, met-anaisis al medcamenta scliclado denro de un mismo gro AL SOLICTTANTE GT somal consi solamente ef mombre de nod eles Pi arse el cao qe wn exgnns wel hrmino “ero ratamint eric cer ext mens pos) morro) seRatodos) ne tem IV ngpmede er wsado, Bsa nformaciin noe plicable par ha aera “del os meticamenies Ca cao erecta debe reprtarse al Sstema Peruano de Farmacovigiania 100 mew de onto coma) acleras) a trary autor informa pertinent det labora de robles sobre la eeoia re) prin de emia de ks bactras acaas ene estublecitert 00 fps un ot sg ce ect eerso qu imposible ws del (os 12 Salameme pura aguelfos eae prods Ts tere rf que mpd emplearse era) ers del petuara para eos) meaner cto 4 5) mesic el prt 1) Eypecicor text staan elie para ba cal thse matamtena. De ser pertinent considrar ef grado de severadad esta time, Se refers a segunda condi fo ms) necesarta pra ofrecer et tratamietaANEXO N° 2 MODELO DE INFORME TECNICO DE MEDICAMENTOS NO CONSIDERADOS EN EL PETITORIO NACIONAL UNICO DE MEDICAMENTOS ESENCIALES |.- INFORMACION GENERAL: Medicamento Solicitado : PROSTAGLANDINA £1 Indicacion Especifica _: Mantener la permeabilidad del Conducto Arterioso en Cardiopatias Ductus-Dependientes Numero de Casos Anuales: Estimado de 150 casos por aio Il. JUSTIFICACION: Las cardiopatias congénitas que presentan sintomas en la etapa neonatal pueden ser divididas en dos grandes grupos en relacion a si dependen o no del flujo de! conducto arterioso para su supervivencia ylo estabilidad hemodinamica Dentro de este contexto mantener la persistencia ductal con Prostaglandinas del tipo E (PGE). ha cambiado profundamente el pronéstico de nitios recién nacidos con cardiopatias, en los que la persistencia ductal, es vital Esta opcion de tratamiento ha tenido un impacto importantisimo en el cuidado de Neonatos con lesiones cardiacas ductus-dependientes, ayudando a disminuir la Mortalidad y permitiendo diferir las intervenciones quirirgicas 0 de cateterismo intervencionista hasta lograr estabilizar al paciente, reemplazando asi los intentos desesperados de intervenciones paliativas de emergencia en nifios extremadamente graves e inestables Las prostaglandinas son sustancias del grupo de acidos grasos insaturados. Cuyo precursor es el acido araquidénico. Este es transformado por accion de la ciclooxigenasa en endoperoxidasas, que finalmente y de nuevo por accion enzimatica, son transformadas en prostaglandinas.Durante la vida fetal la permeabilidad de! ductus se mantiene fundamentalmente por la accion combinada de los efectos relajantes de la tension baja de 02 y de las prostaglandins, sintetizadas localmente Il. EVALUACION DE LA EFICACIA: En 1973 Coceani y Oley ,2, demostraron la eficacia de las prostaglandinas PGE1 y PGE2 en la relajacion del ductus arterioso en condiciones anaerobias. Tras la experimentacion animal , en 1975 se utilizaron por primera vez en nifios con cardiopatias cianoticas, con flujo pulmonar ductus-dependiente a. extendiéndose rapidamente sus indicaciones a pacientes con cardiopatias con flujo sistemico ductus-dependiente al demostrar que actuaban igualmente en condiciones aerobias \s.«) y posteriormente a nihos con transposicion de grandes arterias con septo integro, en los que clinicamente era evidente que la persistencia ductal favorecia su evolucién y por tanto constituia una ventaja dicho tratamiento En 1981 se publicaron los resultados de un estudio multicéntrico iniciado en 1976 y llevado a cabo para evaluar la eficacia y complicaciones del uso de PGE1 (IV) en ninos con cardiopatias ductus-dependientes (». El estudio comprendio 492 pacientes, de los cuales 385 tenian cardiopatias cianoticas con flujo pulmonar efectivo disminuido. y 107 con flujo sistémico reducido, incluyendo estenosis aortica, anomalias del arco aortico y S. de corazon izquierdo hipoplasico. £1 estudio demostré la eficacia clinica del uso de PGE1 con disminucion significativa de la morbi-mortalidad La Prostaglandina E1 segiin las agencias reguladoras de Medicamentos, Food and Drug Administration (FDA), Agencia Francesa de Seguridad Sanitaria de productos de la Salud y la Agencia Espafiola de Medicamentos 11) fue aprobado para el mantenimiento temporal de la permeabilidad del conducto arterioso, hasta la intervencion quirirgica paliativa 0 correctiva. en los recién nacidos con defectos cardiacos congenitos que dependen de la apertura del ductus para sobrevivir. Tales defectos cardiacos congénitos incluyen+ Atresia 0 estenosis pulmonar, © Atresia tricuspidea * Tetralogia de Fallot + Interrupcion del arco aértico + Coartacion de la aorta, * Estenosis 0 atresia aortica, + Atresia mitral o + Transposicion de vasos con o sin otros defectos La Sociedad Espariola de Cardiologia ,12, recomienda que tras la sospecha clinica © el diagndstico de cardiopatia ductus-dependiente, debe iniciarse Ia infusion de Prostaglandina E1. a dosis de 0.05 ug/kg/min, y reducir la fraccion inspirada de oxigeno a 0.4 salvo que exista patologia pulmonar asociada La Guia Clinica de Cardiopatias Congénitas operables en menores de 15 afios del Ministerio de Salud de Chile \:») refiere que la dosis de Prostaglandina E1 puede oscilar entre 0.01 - 0.05 ugikg/min y su maxima respuesta se obtiene entre 15 minutos a 4 horas, asimismo recomienda iniciar su infusion a dosis minima’ entre 001 -00.2 ugikg/min y aumentarla cada 30 minutos si no hay respuesta No sobrepasar 0.05 ugikg/min. Se recomienda ademas recordar que las cardiopatias, Con flujo pulmonar bajo (Ejemplo: Atresia Pulmonar) y la Transposicion de Grandes Arterias responden mas rapido que aquellas con flujo sistemico mantenido por el Ductus (Ejemplo: Interrupcion de Arco Aortic) Sino se dispone de diagnostico de certeza, el uso tentativo de PGE1 en pacientes Gianoticos es menos riesgoso que dejar al paciente sin tratamiento, la gran mayoria de las Cardiopatias Cianoticas va a responder al tratamiento. Disponer siempre de la posibilidad del uso de ventilacion mecanica cuando se inicie su infusion, ya que es capaz de provocar apneas, sobre todo si se trata de nilos de menos de 2 kgs. y se usa en dosis mayor de 0,01 ug/kg/minProstaglandina €1 esta considerada en la Lista Modelo de Medicamentos Esenciales para Nifos de la OMS vigente recomendado para mantener la permeabilidad del conducto arterioso, cuando el recién nacido presenta una lesion Clanotica interrupcion del arco aértico. El informe del comite de expertos de la OMS sefiala que no se han realizado revisiones sistematicas de la eficacia de las prostaglandinas en el manejo de permeabilidad de! conducto arterioso, pero esta terapia es recomendada en las guias Clinicas de tratamiento (14, La Guia NICE recomienda iniciar una infusion de prostaglandina inmediatamente después del nacimiento en recién nacids con enfermedad pulmonar severa y atresia pulmonar con septum ventricular intacto, para mantener el Ductus arterioso abierto y realizar una evaluacién para establecer la severidad del sindrome de hipoplasia de corazon izquierdo (1), I EVALUACION DE LA SEGURIDAD: COMPLICACIONES Y EFECTOS ADVERSOS Se han descrito efectos adversos por el uso breve de prostaglandins, como tambien por el empleo prolongado, definido como aquel con duracion mayor a 7 dias. en su mayoria de caracter reversible con la supresion del tratamiento «« ‘Sistema Nervioso Central: Episodios de APNEA han sido reportados en aproximadamente el 12% de los pacientes tratados. Es mas frecuente en los pacientes menores de 2 Kg y usualmente aparece dentro de la primera hora de iniciada la infusion. Otros efectos adversos comunes han sido fiebre en 14% y convulsiones en 4% En menos del 1% de los pacientes puede presentarse hemorragia cerebral agitacion psicomotriz, hipotermia, irrtabilidad y letargiaSistema Cardiovascular: El efecto adverso mas comin reportado ha sido enrojecimiento en aproximadamente 10% de los pacientes. bradicardia en 7%, hipotension en 4%. taquicardia en 3%, paro cardiaco en 1% y edemas en 1%. Las siguientes reacciones han sido reportadas en menos del 1% de los pacientes: ICC. hiperemia, bloqueo AV de segundo grado. shock. espasmo infundibular derecho, taquicardia SV y fibrilacién ventricular. Sistema Respiratorio: En menos del 1% de los pacientes: sibilantes. hipercapnea. depresion respiratoria, dificultad respiratoria y taquipnea Sistema Gastrointestinal: Puede producir obstruccién del vaciamiento gastrico secundaria a hiperplasia antral, Este efecto parece estar relacionado a la duracidn de la terapia y dosis acumulativa de la droga. A dosis recomendada su administracion por mas de 120 horas (5 dias), debe ser cercanamente monitorizada para descartar hiperplasia antral. Ademas puede producir diarreas en el 2% de los pacientes y en menos de 1% hiperbilitrubinemia Sistema Hematolégico: Coaguiacion intravascular diseminada en 1%, En menos del 1% anemia sangrado y trombocitopenia Sistema Excretor: Anuria y hematuria en menos del 1% de los pacientes Sistema Oseo: Proliferacion cortical (hiperostosis cortical) ha sido observada durante la administracion en periodos largos de tiempo. Evaluacion radiolégica puede ser necesaria para valorar el grado de hiperostosis cortical en pacientes contratamiento prolongado. Usualmente resuelve entre 6 a 12 meses despues de terminar el tratamiento con PGE1 V.- EVALUACION FARMACOECONOMICA: La dosis diaria establecida por la Agencia espafola de medicamentos y productos sanitarios es de 0.05-0.1 ug/kg/min por infusion endovenose a partir de una solucion que contiene una ampolla de 500 ugiml, Esta solucion tiene una duracion de 24 horas. El costo unitario de Prostaglandina E1 (500 ug/ml) ampolla es de Si 842.86 (Fuente Sistema Electrénico de Contrataciones del Estado. SEACE 2011) «16 Para Prostaglandina E 1 (500 ug/ml), existe 1 Registro Sanitario vigente en la Base de datos de DIGEMID (Febrero 2012). V.- CONCLUSIONES: + Las cardiopatias congenitas que presentan sintomas en la etapa neonatal pueden ser divididas en dos grandes grupos en relacion a si dependen 0 no del flujo del conducto arterioso para su supervivencia y/o estabilidad hemodinamica, Dentro de éste contexto mantener la persistencia ductal con Prostaglandinas del tipo E (PGE), ha cambiado profundamente el pronostico de ninos recien nacidos con cardiopatias. en los que la persistencia ductal, es vital * Existen muchos tipos de cardiopatias congénitas que requieren la permeabilidad del Conducto Arterioso para su supervivencia entre ellas tenemos’ Atresia Pulmonar, Atresia Tricuspide, Estenosis Valvular Pulmonar Severa. Transposicion de Grandes Vasos. Coartacion de Aorta, Sindrome de Corazon lzquierdo Hipoplasico + La Prostagiandina E1 esta aprobada por las Agencias Reguladoras de medicamentos de Alta Vigilancia Sanitaria de la FDA y la Agencia Espanola de medicamentos y productos Sanitarios, para el uso paliativo. en el mantenimiento temporal de la permeabilidad de! conducto arterioso hasta que‘a cirugia paliativa correctiva se puede realizar en los recién nacidos con defectos congenitos cardiacos, que dependen de la persistencia del conducto arterioso para la supervivencia Esta considerado en la Lista Modelo de Medicamentos Esenciales para nifios de la OMS vigente, recomendado para mantener la permeabilidad del Conducto arterioso, cuando el recién nacido presenta una lesién cianética interrupcién del arco aértico Se han reportado reacciones adversas del Sistema Cardiovascular, Sistema nervioso central, Gastrointestinal, Hematolgico, Neuromuscular y Esquelético, Se ha observado que la incidencia y gravedad estan relacionados con la duracion del tratamiento y acumulacion de la dosis. Aproximadamente un 10 - 12% de recien nacidos con defectos cardiacos congénitos tratados con Prostaglandina E1 presentaron apnea. siendo mas frecuente en los niflos con menos de 2 kg de peso al nacer: generalmente aparece durante la 1° hora de infusion, por ello se recomienda administrarse solamente la dosis recomendada y por personal médico especializado, en hospitales o centros donde pueda disponerse de cuidados intensivosBIBLIOGRAFIA: Adnel Olortegut. Manuel Adrianzen. Incidencia estimada de las cardiopatias congenitas en ninos menores de 1 ano en el Peru An Fac Med Lima 2007 Coceani F. Olley PM. The response of the ductus to prostaglandins Can J Physiol Pharmacol 51:220-225, 1973 Elliot RB, Starling MB, Neutze JM. Medical manipulation of the ductus arteriosus, Lancet 2: 406-407.1975 Olley PM.Coceani F,Bodach F. E-Type prostaglandins. A new emergency therapy for certain cyanotic congenital heart malformations. Circulation 53.728-731.1976 Heymann MA.Berman W Jr,Rudolph AM, Witman V. Dilation of the ductus arteriosus by prostaglandin E1 in aortic arch abnormalities. Circulation 59: 169-173.1979 Clyman RF, Heyman MA, Rudolph AM. Ductus arteriosus responses to prostaglandin E1 at high and low oxygen concentrations. Prostaglandins 13:219-222 .1977 Lang P, Freed MD, Berman FZ et al. Use of prostaglandin £1 in infants with 0-Transposition of the great arteries and intact septum. Am J Cardiol 44°77- 81, 1979 Freed MD, Heyman MA, Lewis AB et al. Prostaglandins £1 in infants with Ductus Arteriosus dependent congenital heart disease. Circulation 64:899- 905,1981% Agencia espahola de medicamentos y productos sanitarios Alprostadil Ficha técnica de aprobacién del producto.2008 10. Agence Francaise de Sécurité Sanitarie des produits de Santé Alprostadil 2008 11. Alprostadil Food and Drug Administration FDA 12 Carlos Maroto Monedero et al. Guias de practica clinica en las cardiopatias congenitas del recién nacido. Sociedad Espafiola de Cardiologia. Rev Esp Cardiol Vol. 54. Num. 1, Enero 2001; 49-66 13 MINISTERIO DE SALUD. Guia Clinica Cardiopatias Congénitas Operables enmenores de 15 afios. 1st Ed. Santiago: Minsal, 2005. 14. WHO Model List of Essential Medicines for Children. 3rd lst (March 2011) 'S.NICE. Interventional procedure overview of percutaneous fetal balloon valvuloplasty for pulmonary atresia with intact ventricular septum (PAIVS) september 2005 16 Sistema Electronico de Contrataciones del Estado. SEACE 2011WHO Model List of Essential Medicines for Children Explanatory Notes This Model List is intended for use for children up to 12 years of age. The core Hist presents a list of minimum medicine needs for a basic health-care system, listing the most efticacious, sate and cost-eltective medicines tor priority conditions. Priority conditions are selected on the bavis of current and estimated! future public health relevance, and potential for sate and cost The complementary list presents essential medicines tor priority dis ases, tar which specialized alist training are needed iagnostte or monitoring. facilities, and/or specialist medical care, and/or spe: In case of doubt medicines mae also be listed as complementary on the basis af consistent higher costs bor less attractive costetic veness ina variety of settings. The square box symbol (G) is primarily intended to indicate similar clinical pertormance within pharmacological class, Ihe listed medicine should be the example of the class tor which there is the best ex idence for effectiveness and safety. In some eases, this may be the first medicine that 1s Licensed for marketing: in other instances, subsequently licensed compounds may be sater or more etiectiv Where there is no difference in terms of efficacy and safety data, the listed medicine should be the one that is generally: wwaslable at the lowest price, based on international drug price intormattan sources Therapeutic equivalence is only indicated on the basis of reviews af efficacy and safety and when Consistent with WHO clinical guidelines, National lists should not use a similar symbol and should be spevitic thet final selection, which would dep nd on local availability and price. Ihe format and numbering ot the 17th WHO Model List of Hssenttal Medicines have been retained bit ay indicated in the text, some sections have been deleted because they contain medicines that are 6 relevant fur children, [a indicates that there is an age or weight restriction on use of the medicines: the details tor each medicine are in Table | Ih the List of Pssential Medicines tor Children, an additional symbol is used indicates that the Committee has endorsed the medicine as essential but has requested o revives ot the etfisaey and safety to confirm this decision, or to expand use to additional age groups Ihe presence of an entry on the Essential Medicines List carries no assurance ay to pharmaceutical tory authority too gjitality [ts the responsibility of the relevant national oF regional drug, rey ure that wach product is of approp! ale pharmaceutical quality (including stabubty) and that when relewant dulferent pradducts are interchangeable. Hor recommendations and advice concerning all aspects of the quality assurance of medicines see the WHO Medicines web site hip: seis eaten ant medicines areas gully aes anice Modianes and dosage forms are listed in alphabetical order within each section and there ts 0 Implicabon of preference tor one form over another. Standard treatment guidelines should be consulted for information un appropriate dosage forms,The main terms used for dosage forms in the Essential Me ‘dicines List can be tound in Annes 1 Definitions of many of these terms and pharmaceutical quality requicem itterent categories are published in the ts applicable to the Frent edition of The International Pharnempocia acticin. publications pharmaco unde tinh1. ANAESTHETICS 1.1 General anaesthetics and oxygen 1.1.1 Inhalational medicines halothane Inhalation, isotlurane Inhalation nitrous ovide Inhalation onsen Inhalation (medicinal gos) 1.1.2 Injectable medicines eta Injection: 50 my (as hydrochloride) ml in sm vial Injection; 10 mg/ml; 20 my prep” “Tiriopental may be used as an alternative depending on local swailability and cost 1.2 Local anaesthetics Injection: 0.254%; 0.5% ¢hydroctloride) in vial bupivacaine Injection for spinal anaesthesia: 1" hydrochloride in f-ml ampoule to be mised with 75%. ghurose solution Injection: 1" 2% (hydrochloride) in vial. Injection for spinal anaesthesia: 5". (hyvirochloride) 1 2ml ampoule to be mived with 7.5" glucose solution Topical forms; 2° to 4". (hydrochloride Dental cartridge: 2% (hydrochloride) + epinephrine Pst OU! hdocaine «epinephrine Injection: 1" 1-200 000 in vial «(hydrochloride or sulfate) + epinephrine 1.3 Preoperative medication and sedation for short-term procedures atropme Injection: 1 mg (sultate) in L-ml ampoule Injection: 1 mya Diiviatacots Oral liquid: 2 mg/ml Tablet: 7.5 mg 15 my, morphine Injection: 10 my (sulfate oF hydrochloride) in -ml ampoule 2. ANALGESICS, ANTIPYRETICS, NON-STEROIDAL ANTI- INFLAMMATORY MEDICINES (NSAIMs), MEDICINES USED TO TREAT GOUT AND DISEASE MODIFYING AGENTS IN RHEUMATOID DISORDERS (DMARDs) 2.1 Non-opioids and non-steroidal anti-inflammatory medicines (NSAIMs) Oral Hiquid: 200) mg/3 ml buprofen al Tablet: 200 n 1) ma | > 3 months.Oral liquid: 12 Suppository: 100) mg Parectlammal Tablet: 100 my: to 500 mg. * Not recommended for anti-inflammatory tse due to lack of proven benefit to that effect Complementary List Suppository: 50 ng 10 L avetulsalieulic acid Tablet: 100 ute to 500 my “For use for rhewmatic fever, juvenile artletis, Runesth discs 2.2 Opioid analgesics Injection: 10 mg (morphine hydrochloride oF morphine sultate in Lem ampoule (Oral liquid: 10 my (morphine hydrochloride oF morphine morphine sulfatey 5 mal Tablet: 10 my (morphine sulfate} Tablet (prolonged release: 101 my; 30 my, 60 my (morphine 2.4 Disease modifying agents used in rheumatoid disorders (DMARDs) Complementary List rude itornpun Solid oral dosage form: 2000 meg tas sulfite methotrenate Tablet: 2.5 my (as sativa sal 3. ANTIALLERGICS AND MEDICINES USED IN ANAPHYLAXIS. Injection: 10 my, (hydrogen maleate) in Lem ampoule, Oral liquid: 2 mg/S ml (hydrogen maleate) Clchiorphorsiminua] 2 Tablet: 4 mg (hydrogen maleate) a) >t year & Review of diphenhydramine to assess comparative efficacy and Safety with chlorphenamine as a possible preferable al AR0.Gthacone Injection: + mg/ml in L-ml ampoule (as disodium phosphate salt, epinspidoon romana Injection: | mg (ay hydruchloride or hydrogen tartrate) in Lem! ampoule, hydrocortisone Powder for injection: 100 my (as sodium succinate) in Vial Oral Liquid: 5 mg/ml O predans Fablet:5 mg; 25 mg.4. ANTIDOTES AND OTHER SUBSTANCES USED IN POISONINGS 4.1 Non-specific charcoal, activated 4.2 Specific acetyleysteme Complementary List Powder. Injection: 200 mg/ml in 10-ml ampoule Oral liquid: 10° Injection: | my (sulfate) in -ml ampoule Injection: 100 mg/ml in 10-ml ampoule Injection: 400 micrograms (hydrochloride) in I-ml ampoule Powder for injection: 500 my ionesilate in vial 50) eg int 2 rl uy Injection into Injection: 200 vug ma is 5 yl amon Solid oral dosage form: 100 ne 5. ANTICONVULSANTS/ANTIEPILEPTICS, Arbamavepine diacepam Dlorasepam phenobarbital phenytoin Valprove acid (sodium valproate) Complementary List Oral Liquid: 100 my/5 ml Tablet (chewable): 100) my Wns Tablet (scored): 100 my 200 my, Gel oF rectal solution: 5 mg/m! in (1.5 ml: 2-mb demi tubes Parenteral formulation: 2 mg/ml in T-mlampoule; # my/mb in L-ml ampoule Injection: 200 mg/ml soxlivrn) Oral liquid: 15 my ml Tablet: 13 mg to 100 mg Injection: 39 mg/m in Sem vial soxtium salt) Oral Higuid: 25 mg. o 3) my/3 ml” Solid oral dosage form: 25 my Hl mn) mg (uation salt Tablet (chewable): 50 my + The presence of both 25 my/S ml and 3 myg/5 ml strengths on the same market would 1use confusion in prescribing and. dispensing and should be avowed. Oral Liquid: 200 my/3 ml Tablet (crushable): 100 my, Tablet (enteric-coated): 200) my; 530) my sodium valproate: apse: 250 mg Onl guid: 250 mg 3 0h6. ANTI-INFECTIVE MEDICINES 6.1 Anthelminthics 6.1.1 Intestinal anthelminthics ulbendacol Tablet (chewable): 400) my, Tablet: 50) mp: 150) my (as hydrochloride levamisole * The Committee recommended that this medicine be reviewed tor deletion at its next meeting, Should only: be useat ny combination with other anthelminthies mebendarole Tablet (chewable): 10)) mg: 50) my, Tablet (chewable): 500) nix, iclosamide™ * Niclosamide is listed for use when praciqutantel treatment fails The Committee recommended that this medicine be reviewed lor deletion at its nest meetin prariquantel Tablet: 150 rng 0 my, . (Oral liquid: 50 my, (as embonate oF pamoateyal frame Tablet (chewable): 250 mg (as embonate or pamoate) 6.1.2 Antifilarials Mbendacove Tablet (chewable 400) my: ctiethylearamasine Tablet: 50 my 100 mn, shyctroyen cttate) svermecti Tablet (scored 3 ms. my, 6.1.3 Antischistosomals and other antitrematode medicines pravignantel Tablet: 600 my Complementary List Capsule: 250 my. eraonnegnne® Ona tiguid: 250 weg 5 * Onamriguine is listed for use 6.2 Antibacterials 6.2.1 Beta Lactam medicines Powder for oral liquid: 125 mg (as trihycieatey/5 mb, 250) ys as trihydiratey5 ml aves Solid oral dosage form: 250 nyt; 500 mye (as trihydrate) Oral tiquid: 125 mg amosicillin + 31.25 my clavulanic aciel’S mal amoxicillin © clavulanic acid AND 250 mg amoxicillin + 62.5 mg claveelante acid/S al Tablet: 500) my (as trihydrate) + 125 mye (as potassium salt snypacilin Powder for injection: 500 mg: | (as sodiuim salt) un vial onvalhinetenaeipenenna Powder for injection: 900) my bensylpemiciliin (- 1.2 million IL) nen ne Ca pane in S-ml vial: 144 g benylpenicillin (= 24 milhion IL) in Seml vialbenzylpenicillin velalewny ceftriasone’ al elosacillin phenoyvmethy penicillin procaine bens Ipenicillin® Complementary List cottacadenn smipenint® + cilastatin 6.2.2 Other antibacterials Powder for injection: 600 mg, (= 1 million IU): 34-3 mutton IU) (sodium oF potassium salt) in vial Powder for reconstitution with water: 25 my/5 ml, 250 my/5 ol (anhydrows) Solid oral dosage form: 250 my, (as monohydrate), Powder for injection: | y (as sodium salt) in vial + Vor stirgical prophylasis, >t maven Powder for injection: 250 mg; 1 4 (as soxtium salt) in vial * Do not administer with calerum and avord un antants with hyperbilirubinemia [a] >41 weeks corrected gestational age: Capsule: 500 yg 1g (as sodiury salt) Powder for injection: 51M) mg. (as sodium salt) in vial Powder for oral liquid: 125 my (as sodium salt)/3 ml Powder for oral liquid: 250 my (as potassium salty/3 ml Tablet: 0. mg (as potassiuim salt) Powder for injection: 1g 1 million 1U).3 g (-3 million IL) in nndledd as first-line * Procaine benvylpenicillin is not recom treatment for neon, tal sepsis except in settings with high neonatal mortality, when given by trained health workers 6) caves where hospital care is not achiewable. Powter jor infection: 250 ag por c4al (as sulin sai dna gemteration cephalosporin of chase forse ie hus Poteder for injection: 250 mg oF 1 6s pontaluydrate) a cv Powder for injection: 250 mg tas monoleyrated + 250 11g 1 salt): 500 mg fas monohipatey » 500 yg tas soi sale) a ex * Only listed forthe tretnnent of life tereate ng hospital based infection due’ to suspee Merop for use in childven over te age of 3 months nd ar procen maultideng yesistan & 1s indicated for the trenton of meningitis nid i Hiernsed Capsule: 2501 mg; 500 my (anhydrous) (Oral liquid: 200 myy/5 ml * Only listed for trachoma,chloramphenicol eoprotlosacin ervthromyen Dgentamicin, sultamethosacae + trimethoprim trimethyl Complementary List clondameaie Capsule: 250 my, Oily suspension for injection®; (15 2-ml ampoule, soditim suceimatey/mt in * Only for the presumptive treatment of epidemic meningitis in children older than 2 vears. Oral liquid: 150 my: (as palmitatey/5 ml. Powder for injection: I (sodium sticcinate) in vial Oral Liquid: 250 mg/5 ml (anhydrous) Solution for IV infusion: 2 mg/ml (as hyclate) Tablet 50 my (as hydrochloride) Oral liquid: nydrous) img/S ml: 50. mg/ml Solid oral dosage form: 50 my: 100) my (as hyelate) Bluse im entaren 8 years ony for ie-tveatenng nections wen no Powder for oral liquid: | ethyl succinate. Solid oral dosage for succinate) img ml (as stearate or esolale or 2250 my (as stearate OF estolate or ethyl Inject 10 mg: 40mg (as sulfate an 2m ia Injection: 500 my. in 100-m vial Oral Hiquid: 200 my (as ben oatey/5 ml Tablet: 200 my, to 300 my, Oral iquid: 25 my/5 ml Tabet: 100 my, Injection: 80 mg + 16 mg/ml in Sel ampoule 80 mg + 16 mg/ml in 10-ail ampoule Oral liquid: 200 ag + 40-m Tablet: 100 mg, + 20 mag UN my + 80 mg, Oral liquid: 50 my/3 mi Tablet: 100 mg; 200 me 3] 6 months Capsule: 150 my «as hxydrovistoride) Injection: 150 mg (as phosphates ni Oral liquid: °5 mg 5 mil ras pabnitates Poder for injection: 250 ing (as hydrochloride on»6.2.3 Antileprosy medicines Medicines used in the treatment of leprosy should never be used except in combination Combination therapy is essential to prevent the emergence of drug resistance. Colour coded blister packs (MDT blister packs) containing standard two medicine (paucibacillary leprosy) or three medi (multibacillary leprosy) combinations for adult and childhood leprosy should be used MDI blister packs can be supplied free of charge through WHO, lotavimine Capsule: 50 mg: 100 my, dapsone ‘Tablet: 25 my, 50 mg; 100 my, rilampicin Solid oral dosage form: 1511 my: 300 mg, 6.2.4 Antituberculosis medicines The Committee recommends and endorses the use of fived-dose combinations and the de lopment br appropriate new tived-dose combinations, including modified dosage forms, non-retrigerated products and paediatric dosage forms of assured pharmaceutical quality Oral liquid: 25 mgm! ethambutol ‘Tablet: 100 mg: 400 my (hydrochloride) Oral Fiquid: 50 my/ ml soni Tablet: 100 mg to 300 mg, Tablet (scored) 50 ma, Oral liquid: 30 mg/ml Tablet: $00 mg py. ‘Tablet (dispersibley: 150 my, Tablet (scored): 150 my, Oral liquid: 20 mg/m sitampicin) Solid oral dosage form: 150 mg: 310 me a Powder for injection: 1 9, (as sulfate) in vial streptomycin 2 . ‘Eereview of safety and efficacy of streptomycin in chighood TB. Complementary List resistant tuberculosis (MUR=(B) id centres adhering to WHO standards for TR control. > Reserve second-line drugs for the treatment of multidrng should be used in sp Tithe Commitee requests a eve of the medicines for MOR-TB ia chldren anh Poavier for injections: 100 mg: 500 ng: 1 ¢ as sultate inet capes Pouwder for injection: fas sate in al silos Solid oral dosage form: 250 mn thiontis Tablet: 125 mg: 250 anit Pow for injection: I gas sulfatey in eal Tablet: 200) mg: 400 on. elosanor Levofloacin may be an alternatioe hased om acutlability nat programme considerGranules: 4 ¢ in sachet Table 6.3 Antifungal medicines Capsule: 50 my, onacoke Injection: 2 mg/m! in vial Oral liquid: 50 myy5 mi Oral liquid: 125 my/3 mt srisearuabsie Solid oral dosage form: 125 mys, 250 mys Lozenge: 10 004 IL nystatin (ral fiquid: 50 mng/5 nt: 100.000 1 Tablet: 100 000 10; 500 000 TL Complementary List amphorericon Pousler for injection: 90 mg i vi 1s sana deonyehoate or liposamal imp Capsute: 250 mg foe Infusion: 2.5 i 250 mi potas ii Suturated solution. 6.4 Antiviral medicines 6.4.1 Antiherpes medicines (Oral liquid: 200) my/5 ml aciclovir Powder for injection: 250 my. (as sextiaim salt) in vial Tablet: 200 my 6.4.2 Antiretrovirals Based on current evidence nd experience of use, medicines in the following three classes of {ateuls are inchiced ay essential medicines for treatment and prevention at HIV (prevention (i mother to-child transmission and postespostre prophylavis), the Commiltew emphies th Uperbunce of using these products in accordance with global and national guidelines, the Committee appr product mmends and endorses the use of fxed-dose combinations and the development te new fixed-dose combina ons, including modified dosage forms, nun-tetrigers Hn paediatric dosage forms of assured pharmaceutical quality. Sie! tablets can be used in children and therefore can be considered for inclusion in the listing ot tiblets, provided adequate quality products are available 6.4.2.1 Nucleoside/Nucleotide reverse transcriptase inhibitors Oral Liquid: 100 my (as sullate)/3 mb sbacavie ABC) Tablet: 300 myg (as sultate),Buffered powder for oral liquid: 1(X? mp: 167 my: 250 my packets Capsule (unbuffered enteric-coated): 125 my 20) mys 250) mx didanosine (dally 4040 mg Tablet (buffered chewable, dispersible}: 25 my, 50 ng: LN! my 130. mg 200 mg. Capsule: 200 my, Oral Hiquid: 10 mg/m emtrictabine (FICHE + ELC is am acceptable alternative to 3IC, based on knowledge ot the pharmacology, the resistance patterns and clinical trials antiretroviral, 3 months Oral liquid: 50 mg/ml lamivudine BFC) a ° Tablet: 150 mg, Capsule: 15 mg 20 my 30 my, stavudine (eld Dy ” ene Powder for oral liquid: 3 oy Capsule: HN) mg: 250 my, (Oral liquid: 50 myg/3 mi Aida dine DV or AZT) “ Solution for 1V infusion injection: 10) mg/ml in 20-1 val Tablet: 00 mg. 6.4.2.2 Non-nucleoside reverse transcriptase inhibitors Capsuite: 30 mg 100 mg; 200 my, . Oral Tiquid: 150 mg/3 mt etavirens (HEV oF FEZ) " * Tablet: 600 my, [3] >3 yeors or >10 9 (Oral liquid: 30 m nevirapine ONVPY Tablet: 2100 mg. 6.4.2.3 Protease inhibitors Selection of protease inhibitor(s) trom the Model List will need to be determined by each country atter consideration oF inte wnce, Kitonavir as tional and national: treatment yuidelines and exper recommended tor use in combination as a pharmacological booster, and not as an antiretracital in its owt ight. All other protease inhibitors should be used in boosted forms (e.g. with ritonavir) Solid oral dosage form: 100 my 150. my HN) my: (as sulfate) atazanavira Baska Capsule: 1333 mg +383 mg lopinavir ritonavir PVir) Oral tiqud: 400 my, 100 my Tablet (heat stable): 1000 mg +25 mg: 20) mg, + 30 mys Oral Liquid: 4001 my/5 mt Ftonavi Solid oral dosage form: 100m Tablet (heat stable): mg: 100 mg,saquinavir QV] Solid oral dosage form: 200 my; (as mesilate), fa)>25 ka, FIXED-DOSE COMBINATIONS lamivudine «nevirapine 6.4.3 Other antivirals bas tein? Tablet: 150 mg 200 mg, +30 my, Tablet (dispersible: 30 mg + 50mg + 6 my: 60 mg + 100 my + 12 Mg Tablet: 30 my + 50 mg + 60 mg; 150 mg + 200 ry +R my Tablet: 30 any, + 60) my: 150 mye + 300 my. Capsule: 30 my: 45 mg; 75 my (as phosphate) Oral powder: 12 mg/ml * Oseltamivir should be used only in compliance with the WHO. treatment guidelines, ic, (1) for treatment af patients with severe or Progressive clinical illness with confirmed or suspected influenza pandemic (FINI) 2009, (2) tor the ti MENLO patients with confirmed or suspected but uncomplicated illness duve to pandemic influenca virus infection whe were in higher risk groups, most notably for pregnant women and children under 2 years of ave: Injection for intravenous administration: 80) my, and | in 10-ml phosphate buffer solution, Solid oral dosage form: 200 my; 400 mys; 60K! my, * For the treatment of viral haemorrhagic levers only 6.5 Antiprotozoal medicines 6.5.1 Antiamoebic and antigiardiasis medicines dilosanide metronidazole Tablet: 500 mg (furoate) 2540, Injection: 500 m,n 10-1 vial Oral Fiquid 200 mp (as henson wh Tablet: 200 mg to 500 my, 6.5.2 Antileishmaniasis medicines umphotertcan Bs miltetsine Powder for injection: 30 ng, in vial As sodium deoxycholate oF liposomal comple, Solid oral dosage form: 11) my: 50 my Solution for intramuscular injection: 7 (as the sulfate), 0 my. of paromomyciny baseInjection: 100 mg/ml, 1 vial = W) ml or 3%, equivalent to, approximately 8.1" antimony (pentavalent) in 3-ml ampoule. sodium stiboyluconate or umine intimomtate & Review of comparative offectiveness and safety of antimoniats for Feishmaniasis, and whether they should be kept on the core list or ‘moved to the complementary list meg 6.5.3 Antimalarial medicines 6.5.3.1 For curative treatment Medicines for the treatment of P. faleiparun malaria cases should be used in combination. ‘The list currently: recommends combinations according to treatment guidelines, ‘The Committee reco that mot all of these FDCs exist_and encourages their development and rigorous testing The Committee also enconrages development and testing of rectal dosage formulations, ‘Tablet: 153 mg or 208) mg (as hydrochloride) sanwodtiaguine™ * To be used in combination with artesunate 50 my 07 y injection: 80 mg/ml in Tem ampoule etler® * For use in the management of severe malaria Tablet: 20 mg + 120 mg, srtemether « ham. ‘Tablet (dispersible): 20 mg + 120 my, jantrine* * Not recommended in the first trimester of preys children below 5 ky, Injection: with a separate ampoule of 5% sodium b mpoules, containing 6 mg anhydrous artesunie ack arbonate solution For use in the management of severe malaria Rectal dosage form: 50) my; 200) my capsules (lor pre-reh je malaria only: patients should be take appropriate health facility for follow-up care) artesunate™ treatment of sew wan Tablet: 50) my, * To be used in combination with either amodiaquine, metloxuine or sulladosine + pyrimethamine. Tablet: 25 ng + 675 mgs 30 my + 135: my 10 mg + 27 my artesunate + amodiaquine * * Other combinations that deliver the target doses reyuuired such ay 153 mg oF 200 mg (as hydrochloride) with 30 my artesunate can be aernatives Oral liquid: 50 mg (as phosphate or sultatey/5 nal q phosp eboraguine? Tablet: 1000 mg: 150 mg (as phosphate or sul , + For use only forthe treatment of Pci infection, Capsule: 110) mg (2s hydrochloride oF hyctate) closyeyeline Tablet (dispersible): 1041 nig (as monohydrate). + For use only in combination with quinine Tablet: 250 my (as hydrochlorice) meitoguine™ * To be used iy combination with artesunate 30 mg,Tablet: 75 mg: 15 mg (as diphosphate) primaguie * Only for use to achieve radical cure of Prins and infections, given for 14 days. Injection: 300) my, quinine hydrochloride/ml in 2-ml ampoule roid? Tablet: 300 mg (quinine sulfate) oF 300 mg (quinine bisulfate), * For use only in the management of severe malaria, and should be ised in combination with dowyeyeline Tablet: 500) my, mg. sultadoxine + pyrimethaminet * Only in combination with artesunate 30 my 6.5.3.2 For prophylaxis Oral liquid: 50 mg (as phosphate of sultatey/5 ml chlorogtine™ Fablet: 150 mg (as phosphate or stliate) * For use only for the treatment of P.viay intection, Solid oral dosage form: 100 mg (as hydrochloride oF hvelate) fal =8 years Tablet:2 doyveveline al 0 mg (as hyctrochloride, amelie fa) >5 ko oF >3 months. . Tablet: 11 mg tas hydrochloride pressas * For use only in combination with chloroquine 6.5.4 Antipneumocystosis and antitoxoplasmosis medicines pyrimethamine Tablet: 25 my sultadiazne Tablet: 500 my, Injection: SO my + 16 mg/ml in Sem ampoule: Sultamethosazele 80 my + 16 mg/ml in Hm ampoule ametioprey Oral liquid: 200 my + 40 myy/5 ml Tabet: 100 mg + 20 mys 400 mg © SI mgs 6.5.5 Antitrypanosomal medicines 6.5.5.1 African trypanosomiasis Medicines for the treatment of 1 stage African trypanosomiasis, Powder for injection: 200 mg (a etionate) in vial pentamidine® * To be used for the treatment of [rypanasonta brucei gambivnse infection Powder for injection: 1 in vial Suramin sodiam™ * To be used for the treatment of the initial phase of Trypanosoma brucci rhodesionse infectionMedicines for the treatment of 2! stage African trypanosomiasis Injection: 200 mg (hydrochlorice)/ml in Likt-ml bottle etlomithine® * Tobe used for the treatment of Prypantosnaua brucet gains. Complementary List net sl ot Injection: 3 Hom in 5d ampoule 180 ms wf active comgrnna 6.5.5.2 American trypanosomiasis bensnidacote Tablet: 110mg nifurtimen Tablet: 30 mg; 120. mg 250 my, 7. ANTIMIGRAINE MEDICINES 7.4 For treatment of acute attack ibuprofen Tablet: 200 mg: 400) mg, Oral liquide 125 my5 ml o_o Tablet: 300) my to 5001 my 7.2 For prophylaxis Tablet: 20 my: 8. ANTINEOPLASTIC, IMMUNOSUPPRESSIVES AND MEDICINES USED IN PALLIATIVE CARE 8.1 Immunosuppressive medicines Complementary bist Powder for injection: 109 ing tas satan sal val Tablet (scored): 50 my Capsute: 2% me sicosponite Comcerttrate for ixjection: 50 mye ait in Lond ampoule tor oan 8.2 Cytotoxi Medicines listed below should be used according to protocols for treatment of the diseases. and adjuvant medicines Complementary List ACUTE LYMPHOBLAS IC LEUKAEMIA STEP Pozeder for injection: 1) 090 IL in sunetloasane (Oral tigqusats 2 mg/5 mt sues topnrin Tablet: 50 mg Powder for injection: 50 mig (us soiany salt) i val Tablet: 25 mg ‘as sedi salt,Injection: 40 mg/m eas sodium succinate) an L-nal saogle soe ota and ulprerdnisolone Sl multidose vials: $O meena as soatiunn secinoate) i Lyn singe don al, Oral liquid: 5: mg nt ans Powder for injections Lng: 5 my (alate in vial ster? rt amie Poweder for injections 500 mg ns vil tara Powder for injection: 100 mg val fatonovuicin Potwder for injection: 50) mg (rovilovide i oa tavern Powder for iyjetion: 10 nig, 30 moe andrctoride incl Inurovortisone Poreder for injections 100 my cx stun sce nate) ital senate Powvder for injections 50 mg lassi salt) on vial tiiogranin Solid onal dosage form: 40 mg WILMS’ TUMOUR (NEPHROBLASTOMA) STEP 1 & STEP 2 dae tonomnucin Powder for injection: 400) micrograms in vial faumorbicir Porwdter for injection: 5) img Cylroctlovide? on cial oneristane Powder for injection: L mg, 5 ong (oltiter in vial BURKITT'S LYMPHOMA, STEP 1 & STEP 2 Powder for injection: 500 ing in via emtarsben Poder for injections 100 men vial foortin Powider for injection: 1 mg. 30 mg sawtovchtartiet aw cial sretuisolane Orat biguid 5 myn trite Poweder for injection: Lm: my (atte iy cial ADJUVANT MEDICINES Tablet: 100 mg: 300 neg Injection: 100 mega ind ond an 10 mi anoles Table 8:3 Hormones-and-entihermenes 8.4 Medicines used in palliative care 400 mg: 600 mg amitriptyline Tablet: 10 my: 25 mg. Injection: 50) mg/ml evdiine Tablet: 50 mp, Injection: 4 mg/ml in I-ml ampoule (as disodium phosphate salt) dexamethasone Tablet: 2 mg.Injection: 5 mg/ml : Oral liquid: 2 my/3 mi shavepam Rectal solution: 2.5 my 3 my: 10 my, Tablet: 5 mg: 10 mg, , Capsule: 100 mg, dlocusate sodigin Oral liquid: 50 my/3 mh , Solid oral dosage form: 20 my, (as hydroxhloride) Hyosetine a B>8 years Injection: 400 microxrams/ml: 4) micrograms/ml hyoscine hydrobromide ‘Transdermal patches: | 1 Oral Liquid: 200 my/5 ml ibuproten et: 200 ng 40 mg 0K ng [a] Not in children less than 3 months. Lactulose Oral liquid: 31-37 y/5 mi Mn: | mg/ml 5 mpienl Granules (modified release) (to mix with water): 20 my: MW my ‘6 yg 100 mg 200 my, Injection: 10 my/mt secghte Oral liquid: 10 my/5 mi. Tablet (controlled released: 10 mgs) mg 0 my Tablet immediate release: 1m Injection: 2 mg base/nl in 2st ampoule (as hvdruchlore) slanstra Oral liquid 4 mg base ml Solid oral dosage form: Fy 4 my base: Fy mg bose S-ARFFEPARICENSONISM-MEDICINES 10. MEDICINES AFFECTING THE BLOOD. 10.1 An al liquid: 7.5 my/3 ml naemia medicines The Committee proposed a revs Toren sof the evidence for appropriate dose combinations of iron and folic acid for \ Oral Liquid: equivalent to 25 mg, iron (ay sulfateyiml ferrous salt Tablet: equivalent to 60 mg iron, tolts acid Tablet: I my; 5 ayy ee Injection: 1 my fay acetate, hydrochloride oF as sulfate) uy Lint Uroxovobalamin aan10.2 Medicines affecting coagula Injection: 1 mg/ml: 10 mg/ml in 5-ml ampoule Htomenadione Tablet: 10 m Complementary List heparin sation, Injections 1000 lait: 5000 fA Et anponk protamine su Injection: 10 mgm on 5-m ampocl Dicwtonn Tablet: 0.5 mg: mg: 2 mg: 5 ang tsadinan salty 10.3 Other medicines for haemoglobinopathies Complementary list Povedder for injection: 500) my tnesilate) in vial eter. anniw *Deterasivan ave form may bean alt natien, eprending am east and stoailabity feadronn eta Solid oral dosage form: 200 my. 500 mg: Ig 11. BLOOD PRODUCTS AND PLASMA SUBSTITUTES 11.1 Plasma substitutes > =the Commitee requested» evew to determine wether these medcines are essential or cron 11.2 Plasma fractions for specific use Mi plasma tractions should comply with the WHO Requirements for the Collection Processing and Ru Contr of Blood, Blood Components and Plasma Derivatives (Revived I), (VINO lector al Report Series, No, 840, 1994, Annes 2p, Complementary List Ghicto Vit concentrate Driead Ci acton 1X com vs VIL Dried. IX. XY convener Intramuscular administration: ts proteas solution * Intravenous administration: 3°: 10 “i solution. punnghobidie Subcutaneous aiministration: 15°: 16% protcin sotution + Indicated for primary immune deficiency “dicated for primary imme defictoneys and Kas 12. CARDIOVASCULAR MEDICINES 42-4-Antianginal medicines 12.2 Antiarrhythmic medi thi diacase es 7 3 The Comttee nated the potent importance of these medicines and requested veh of these medicines are essential for culdeen determine 12.3 Antihypertensive medicines Denalapril Tablet: 25 my: 5 mg (as hydrogen maleate)12.4 Medicines used in heart failure Injection: 250 micrograms/ml in 2-ml ampoule aigoin Oral liquid: 50 microgra Tablet: 625 micrograms; 250 micrograms Injection: 10 mg/ml in 2-ml ampoule sarenerid ral liquid: 20 mg/$ ml Tablet: 40 my Comptementary List Injection: 40 my faydvochlorade on 5m sal TF Review of safety and efficacy of dopamine in children. 42.5-Antthrembetre medicines 12.6 Lipid-lowering agents 7 The Committee noted the potential importance af these medicines in children but -equested a review of the Section before endorsing any medicine as essential 13. DERMATOLOGICAL MEDICINES (topical) 13.1 Antifungal medicines O miconacole Cream or ointment: 2% (nitrate) terbinafine Cream: 1° or Ointment: 1". terbinatine hydrochloride 13.2 Anti-infective medicines > T the Commuter requested a review of safety of al antibiotics including tetracycline ointment in neonates Cream (as mupirocin calcium): muapirocin Ointment: 2 potassium permanganate Aqueous solution: 1:11 (00) Cream: 1s 1 sultadiainw la a 13.3 Anti-inflammatory and antipruritic medicines Cream oro Lal nyarecorusone preferred in neonates. é ment: D1 4as valerate) CO betamethasone al lamin Lotion. hydrocortisone Cream or ointment Ps (acetate) 13.4 Medicines affecting skin differentiation and proliferation benzogl peroside Cream oF lotion: 5". Solution: 5 1D podophyttum resin Solution: 101%. to salicylic aciel Solution: ise (Cream or ointment: 5%; 113.5 Scabicides and pedic: les Lotion: 2 Dhensyl benvoate al Bl >2 years Cream: permettirin Lotion: 1% 14. DIAGNOSTIC AGENTS 14.1 Ophthalmic medicines Hluorescein Eye drops: 1% (sodium salt. Diropicammide Eye drops: 0. 14.2 Radiocontrast medi, "requested a review of possible alternative contrast agents for use in children Complementary List bravitan sultay Aqueons suspension 15. DISINFECTANTS AND ANTISEPTICS 15.1 Antiseptics menweteratan Solution: 5% (dighiconate}; 20% (dighuconated ineeds to be diluted prior to use for cord cate} ethanol Solution: 70% (denatured). O poly videne iodine Solution: 10% (equivatent to 1" available iodine) 15.2 Disinfectants Dehlorine base compound Powder: (0.1% available chlorine) tor solution Ochlorosstenol Solution: 4.8" lt Solution: 2" 16. DIURETICS Injection: 10) mg/ml i ml amponite rurosemid Oral liquid: 20 m/3 mi Tablet: 10 my: 20 my 40 mg Complementary List Dinubrovtelonarh Tablet (cored): 25 m it Injectable solution: 10°20" Oral liquids 5 ongi5 mnt: 10 mag5 ml: 25 1 5 el Tablets 2 17. GASTROINTESTINAL MEDICINES Complementary List opm ssyn Age aprprite formulations aad doses inching lyase, proteuse and amylase17.1 Antiulcer medicines Domepravolke Dranitidine™ 17.2 Antiemetic medicines desamethasone metoclopramide condanseteon al Powder for oral liquid: 20 mg: all mye sacs Solid oral dosage form: 10) mg; 20 mg; 10mg Injection: 25 mpm (as hytrochloride) in 2-1 ampoule Oral Liquid: 75 ang/3 ml (as hydrochloride) Tablet: 150 my (as hydrochloride) “The Committee has requested a review of the comparative ctigetiveness and satety, for possible deletion of this class ot medicine at its next meeting. Injection: 4 mg/ml in Ll ampoule (as disodium phosphate salt) Oral liquid: 0.5 mg/3 mb; 2 mg/3 mt Solid oral dosage form: (5 mg; (0.75 mye: 15 my: + mg Injection: 5 mg (hydrochloride)/ml in 2-ml ampoule Oral liquid: 5 myy5 mt Tablet: 10 mg (hydrochloride) fa) not m neonates, Injection: 2 my base/ml in 2-ml ampoule as hydrochloride Oral liquid: 4 my, base/S mb Solid oral dosage form: Fy 4 my base: Fg § mg base ft mont, 27.3 Anteintemmeten-medremes 17.4 Laxatives 7 Z the Committee noted the potential mportance of these medicines 19 chigren but requested a review sing any medicine as essential 17.5 Medicines used in diarrhoea 17.5.1 Oral rehydration coral rehydration salts glucose 5 mEq sodium 75 mky or mmolil chloride: 65 mB or mmol/l potassiune 20 mFg or mmolit citrate: 10 mmolil osmolarity 245 mOsm ghacose sodium chloride, potasstum chloride trisodium citrate dilydrates trisodium citrate dihydrate may be replaced be sodium hye corbonate (sodtnum bicarbonate} 25 g/L. However, asthe 9 Latter tormulation i very pair under tropical eondhit recommended ishen manutactured for immediate use Powder for dilution in 200 mi; 500 ml 1117.5.2 Medicines for diarrhoea in children Solid oral dosage form: 20 my gine sultatet “Inacute diarrhoea zine sulfate should be used as an adjunct te hydration salts, 39-5.3-Antidiarrhoeet {symptomatic} medicines in-adults 18. HORMONES, OTHER ENDOCRINE MEDICINES AND CONTRACEPTIVES 18.1 Adrenal hormones and synthetic substitutes Hudtrocortisen. Tablet: 100 micrograms (acetate hydracorticone Tablet: 5 my: 10 mg; 20 my 18.5 Insulins and other medicines used for diabetes hucaygor Injection: | my/mt stn anjection (soluble) Injection: 100 IU/ml in 10-m vial sevmvedioteactings iain Injection: 100 [U/ml in 10-ml vial ENS TNR (a8 compound insulin zinc suspension oF isophan instlin Complementary List ettornin Tablet: 48:6-Ovulation indueers 48:7 Progestegens 18.8 Thyroid hormones and antithyroid medicines a 100 ey: Uaedrochlovide . Tablet: 25 micrograms; 30) micrograms, 10h! micrograms Seuasy Sodium sal) Complementary List lu tin Onal liquid: shout 130 mg total iotine/nit fu Tablet: 00 Tablet: 50 my fa Z Review of use of propytthouracil in children and appropnateness of Carbimazole as an alternative19. IMMUNOLOGICALS 19.1 Diagnostic agents Mil tuberculins should comply with the WHO Requirements for Tuberculins (Revised 1945). WHO, Fpert Committee on Biological Standardization, Usiety-sixth report. (WHO Lechnical Report Serie No.745, 1987, Annes 1) luberculin, purified protein ferivative PPD) aie 19.2 Sera and immunoglobulins All plasma fractions should comply with the WHO Requirements for the Collection, Processing and {Quality Control of Blood, Blood Components and Plasma Derivatives (Revised 1992), WHO Papert ‘Commuter on Biological Standardization, Forty-third report. (WHO Technical Report Series, No SHU, 1994, Annes 2) Injection: 500 IU in vial chuman) Injection. antivenom immunoglobulis® . * Fyact type to be defined locally diphtheria antitesin Injection: 10 000 1; 20.000 IU in vial, 1U/ml in via CD rabies immunoglobelin Inject 19.3 Vaccines Selection at vaccines from the Model List will need to be determined by each country atter ndemioloyy ane national priorities. The list be consideration of international recommendations, ¢ details the vaceines for which there is either a recommendation from the Steategic Advisory Group of Paperis on Immunization (SAGE) dnttys sews immunisation sage conclusions/en indes htm!) and/or 4 WHO position paper theep yes shen antinmumcataony ppapersen inves hunt), [his site will be updated as new position papers are published and contains the most recent information and ions, All vaccines should comply with the WHO Requirements tor Biological Substances, The Committee noted the need for vaccines used in children to be polyvalent beG cholera vaccine diphtheria vaccine Huemepiiles infucnsae type by hepatitis. \ vaccine hepatitis B vaccine influensa vaccine Japanese encephalitis vaccine measles vaccine meningococcal meningitis,pertussis vaccine pheumocoecal vaccine poliomyelitis vaccine rubella vaccine letanus vaccine tephoid vaccine aricella vaccine yellow fever yaceine 20. MUSCLE RELAXANTS (PERIPHERALLY-ACTING) AND CHOLINESTERASE INHIBITORS = The Committee nas requested a review of ts section at its next macting Injection: 500 micrograms in Lom! ampoule: 2.53 ny: (metifsultate neostigmine in Tmt ampoule, Tablet: 15 my (bromide) Injection: 50 mg ichloride)/tn! in 2-ant ampoule " Powder for injection: (chloride), in Vial Oe uroniam Powder for injection: 10’ my (bromide) in vial Complementary List Injection: 1 mg J nil anspout wide Tablet: 60) mg dbrennider 21. OPHTHALMOLOGICAL PREPARATIONS ~ The Committoe requested a review of newer medicines for potential 21.1 Anti-infective agents sen lovin Ointment: 3%) W/W gentamicin Solution (eye drops): 0.3% (suliate) Dletracveline Eye ointment: 1" (hydrochloride) 21.2 Anti-inflammatory agents 1 predict Solution (eye drops) 0.5% (sodium phoaphate) 21.3 Local anaesthetics Sol ion (eye drops): 0.5". (hydrochloride Otetracanelal