FLAGYL 500MG/100ML SOLUTION FOR INFUSION
Active substance: METRONIDAZOLE
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Flagyl 500mg/100ml
SolutionforInfusion MinibagPlus Metronidazole
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INDICATIONS Flagylisindicatedintheprophylaxisandtreatmentofinfectionsinwhichanaerobic bacteriahavebeenidentifiedoraresuspectedtobethecause. Flagylisactiveagainstawiderangeofpathogenicmicro-organismsnotablyspecies ofbacteroides,fusobacteria,clostridia,eubacteria,anaerobiccocciandGardnerella vaginalis. Flagylisindicatedinadultsandchildrenforthefollowingindications: 1. Thepreventionofpost-operativeinfectionsduetoanaerobicbacteria,particularly speciesofbacteroidesandanaerobicstreptococci. 2. Thetreatmentofsepticaemia,bacteraemia,peritonitis,brainabscess,necrotising pneumonia,osteomyelitis,puerperalsepsis,pelvicabscess,pelviccellulitisandpostoperativewoundinfectionsfromwhichsusceptiblepathogenicanaerobeshavebeen isolated. Considerationsshouldbegiventoofficialguidanceontheappropriateuseofantibacterial agents. KINETICS Metronidazoleiswidelydistributedinbodytissuesafterinjection.Atleasthalfthedose isexcretedintheurineasmetronidazoleanditsmetabolitesincludinganacidoxidation product,ahydroxyderivativeandaglucoronide. Metronidazolediffusesacrosstheplacentaandisfoundinthebreastmilkofnursing mothersinconcentrationsequivalenttothoseintheserum. 10%ofthedoseisboundinplasma.Clearance:1.30.3ml/min/kg. Volumeofdistribution:1.10.4litres/kg.Half-life:8.52.9hours. Effectiveconcentration:3-6micrograms/ml. ADMINISTRATIONANDDOSAGE FlagylInfusionshouldbeinfusedintravenouslyatanapproximaterateof5ml/minute. Oraladministrationshouldbesubstitutedassoonasfeasible.Onlythosesubstances specificallylistedunderPharmaceuticalPrecautionsshouldbemixedwithFlagyl Infusion.FlagylSolutionforInfusionmaybedilutedwithappropriatevolumesofdiluents listedunderPharmaceuticalPrecautions.Onnoaccountshouldanyothersubstancesbe administeredconcurrentlybythesamei.v.routeexceptforthosespecificallylistedunder PharmaceuticalPrecautions. AnaerobicInfections Treatmentfor7daysshouldbesatisfactoryformostpatientsbut,dependingonclinical andbacteriologicalassessments,thephysicianmightdecidetoprolongtreatmente.g.for theeradicationofinfectionfromsiteswhichcannotbedrainedorareliabletoendogenous recontaminationbyanaerobicpathogensfromthegut,oropharynxorgenitaltract. A. Prophylaxisagainstanaerobicinfection,chieflyinthecontextofabdominal(especially colorectal)andgynaecologicalsurgery. Adults:500mgi.v.shortlybeforeoperation,repeated8hourly;oraldosesof200mgor 400mg8hourlyshouldbestartedassoonasfeasible. Children<12years:20-30mg/kgasasingledosegiven1-2hoursbeforesurgery Newbornswithagestationage<40weeks:10mg/kgbodyweightasasingledose beforeoperation. B. Treatmentofestablishedanaerobicinfection.Tobeusedinitiallyifpatientscondition orsymptomsprecludeoraltherapy. Adults:500mgi.v.8hourly. Children>8weeksto12yearsofage:Theusualdailydoseis20-30mg/kg/day asasingledoseordividedinto7.5mg/kgevery8hours.Thedailydosemaybe increasedto40mg/kg,dependingontheseverityoftheinfection.Durationof treatmentisusually7days. Children<8weeksofage:15mg/kgasasingledosedailyordividedinto 7.5mg/kgevery12hours.Innewbornswithagestationage<40weeks,accumulation ofmetronidazolecanoccurduringthefirstweekoflife,thereforetheconcentrationsof metronidazoleinserumshouldpreferablebemonitoredafterafewdaystherapy. Elderlypatients:Cautionisadvisedintheelderly,particularlyathighdoses,although thereislimitedinformationavailableonmodificationofdosage. Bacterialvaginosis: Adolescents:400mgtwicedailyfor5-7daysor2000mgasasingledose. Urogenitaltrichomoniasis: Adultsandadolescents:2000mgasasingledoseor200mg3timesdailyfor7days or400mgtwicedailyfor5-7days Children<10years:40mg/kgorallyasasingledoseor15-30mg/kg/daydividedin 2-3dosesfor7days;nottoexceed2000mg/dose Giardiasis: >10years:2000mgoncedailyfor3days,or400mgthreetimesdailyfor5days,or 500mgtwicedailyfor7to10days Children7to10years:1000mgoncedailyfor3days Children3to7years:600to800mgoncedailyfor3days Children1to3years:500mgoncedailyfor3days Alternatively,asexpressedinmgperkgofbodyweight:15-40mg/kg/daydividedin 2-3doses. Amoebiasis: >10years:400to800mg3timesdailyfor5-10days Children7to10years:200to400mg3timesdailyfor5-10days Children3to7years:100to200mg4timesdailyfor5-10days Children1to3years:100to200mg3timesdailyfor5-10days Alternatively,dosesmaybeexpressedbybodyweight:35to50mg/kgdailyin 3divideddosesfor5to10days,nottoexceed2400mg/day EradicationofHelicobacterpyloriinpaediatricpatients:Asapartofacombination therapy,20mg/kg/daynottoexceed500mgtwicedailyfor7-14days.Officialguidelines shouldbeconsultedbeforeinitiatingtherapy. CONTRAINDICATION Knownhypersensitivitytometronidazole,nitroimidazoles (e.g.tinidazole)oranyoftheexcipients. PRECAUTIONS CODE Useinpregnancyandlactation:Thereisinadequateevidenceof thesafetyofmetronidazoleinpregnancy.Flagylshouldnottherefore begivenduringpregnancyorduringlactationunlessthephysician considersitessential.Inthesecircumstancestheshort,highdosage regimensarenotrecommended. Thismedicinalproductcontains13.365mmol(307mg)sodiumper 100mlofsolution.Tobetakenintoconsiderationbypatientsona controlledsodiumdiet. Abilitytodriveandusemachinery:Metronidazolemayoccasionally causedrowsiness,dizziness,confusion,hallucinations,convulsions (fits)ortemporaryeffectsonyoureyesight(e.g.blurredordouble vision).Ifyouareaffected,donotdriveorusemachinery. Metronidazolehasnousefuldirectactivityagainstaerobicand facultativelyanaerobicbacteria.Thereisapossibilitythatafter Trichomonasvaginalishasbeeneliminatedagonococcalinfection mightpersist.Regularclinicalandbiologicalsurveillanceareadvised ifadministrationofFlagylformorethan10daysisconsideredtobe
necessaryandpatientsshouldbemonitoredforadversereactions suchasperipheralorcentralneuropathy. Theeliminationhalf-lifeofmetronidazoleremainsunchangedinthe presenceofrenalfailure.Thedosageofmetronidazoletherefore needsnoreduction.Suchpatientshoweverretainthemetabolitesof metronidazole.Theclinicalsignificanceofthisisnotknownatpresent. NoroutineadjustmentinthedosageofFlagylneedstobemadein patientswithrenalfailureundergoingintermittentperitonealdialysis (IPD)orcontinuousambulatoryperitonealdialysis(CAPD). Inpatientsundergoinghaemodialysis,metronidazoleandits metabolitesareefficientlyremovedduringan8-hourperiodofdialysis. Metronidazoleshouldthereforebere-administeredimmediatelyafter haemodialysis. Aspartate-amino-transferaseassaysmaygivespuriouslylowvaluesin patientsbeingtreatedwithmetronidazole,dependingonthemethod used. Metronidazoleismainlymetabolisedbyhepaticoxidation.Substantial impairmentofmetronidazoleclearancemayoccurinthepresenceof advancedhepaticinsufficiency.Significantaccumulationmayoccurin patientswithhepaticencephalopathyandtheresultinghighplasma 00000 concentrationofmetronidazolemaycontributetothesymptomsofthe encephalopathy.Flagylshould,therefore,beadministeredwithcaution topatientswithhepaticencephalopathy.Thedailydosageshouldbe reducedtoonethirdandmaybeadministeredoncedaily. FlagylshouldbeusedwithcautioninpatientswithactivediseaseoftheCNSduetothe riskofneurologicalaggravation.Clinicianswhocontemplatecontinuoustherapyforthe reliefofchronicconditionsforperiodslongerthanthoserecommendedareadvisedto considerthepossibletherapeuticbenefitagainsttheriskofperipheralneuropathy. Patientsshouldbeadvisednottotakealcoholduringmetronidazoletherapyandfor atleast48hoursafterwardsbecauseofthepossibilityofadisulfiram-like(antabuse effect)reaction.Psychoticreactionshavebeenreportedinpatientswhowereusing metronidazoleanddisulfiramconcurrently. Somepotentiationofanticoagulanttherapyhasbeenreportedwhenmetronidazolehas beenusedwiththewarfarin-typeoralanticoagulants.Dosageofthelattermayrequire adjustment.Thereisnointeractionwithheparin.However,anticoagulantactivityshouldbe routinelymonitoredwiththeseproducts. Lithiumretentionaccompaniedbyevidenceofpossiblerenaldamagehasbeenreported inpatientstreatedsimultaneouslywithlithiumandmetronidazole.Lithiumtreatment shouldthereforebetaperedorwithdrawnbeforeadministeringmetronidazole.Plasma concentrationsoflithium,creatinineandelectrolytesshouldbemonitoredinpatientsunder treatmentwithlithiumwhiletheyreceivemetronidazole. Patientsreceivingphenobarbitalorphenytoinmetabolisemetronidazoleatamuchgreater ratethannormal,reducingthehalf-lifetoapproximately3hours. Plasmalevelsofbusulfanmaybeincreasedbymetronidazolewhichmayleadtosevere busulfantoxicity. Metronidazolereducestheclearanceof5fluorouracilandcanthereforeresultinincreased toxicityof5fluorouracil. Patientsreceivingciclosporinareatriskofelevatedciclosporinserumlevels.Serum ciclosporinandserumcreatineshouldbecloselymonitoredwhenco-administrationis necessary. Patientsshouldbewarnedthatmetronidazolemaydarkenurine. ADVERSEEFFECTS Frequency,typeandseverityofadversereactionsinchildrenarethesameasinadults. Thefrequencyofadverseeventslistedbelowisdefinedusingthefollowingconvention: verycommon(1/10);common(1/100to<1/10); uncommon(1/1,000to<1/100);rare(1/10,000to<1/1,000);veryrare(<1/10,000), notknown(cannotbeestimatedfromtheavailabledata). Seriousadversereactionsoccurrarelywithstandardrecommendedregimens.Clinicians whocontemplatecontinuoustherapyforthereliefofchronicconditions,forperiodslonger thanthoserecommended,areadvisedtoconsiderthepossibletherapeuticbenefitagainst theriskofperipheralneuropathy. Bloodandlymphaticsystemdisorders: Veryrare:agranulocytosis,neutropenia,thrombocytopenia,pancytopenia Notknown:leucopenia. Immunesystemdisorders: Rare:anaphylaxis Notknown:angiodema,urticaria,fever. Metabolismandnutritiondisorders: Notknown:anorexia. Psychiatricdisorders: Veryrare:psychoticdisorders,includingconfusionandhallucinations. Notknown:depressedmood. Nervoussystemdisorders: Veryrare: encephalopathy(eg.confusion,fever,headache,hallucinations,paralysis, lightsensitivity,disturbancesinsightandmovement,stiffneck)andsubacute cerebellarsyndrome(eg.ataxia,dysathria,gaitimpairment,nystagmusand tremor)whichmayresolveondiscontinuationofthedrug. drowsiness,dizziness,convulsions,headaches. Not known: during intensive and/or prolonged metronidazole therapy, peripheral sensory neuropathy or transient epileptiform seizures have been reported. In most cases neuropathy disappeared after treatment was stopped or when dosage was reduced. Aseptic meningitis Eyedisorders: Veryrare:transientvisiondisorderssuchasdiplopiaandmyopia. Not known: optic neuropathy/neuritis Gastrointestinaldisorders: Notknown:tastedisorders,oralmucositis,furredtongue,nausea,vomiting, gastro-intestinaldisturbancessuchasepigastricpainanddiarrhoea. Hepatobiliarydisorders: Veryrare:abnormalliverfunctiontests,cholestatichepatitis,jaundiceandpancreatitis whichisreversibleondrugwithdrawal. Skinandsubcutaneoustissuedisorders: Veryrare:skinrashes,pustulareruptions,pruritis,flushing Notknown:erythemamultiforme. Musculoskeletal,connectivetissueandbonedisorders: Veryrare:myalgia,arthralgia. Renalandurinarydisorders: Veryrare:darkeningofurine(duetometronidazolemetabolite). TREATMENTOFOVERDOSAGE Singleoraldosesofmetronidazole,upto12ghavebeenreportedinsuicideattemptsand accidentaloverdoses.Symptomswerelimitedtovomiting,ataxiaandslightdisorientation. Thereisnospecificantidoteformetronidazoleoverdosage.Incasesofsuspectedmassive overdose,symptomaticandsupportivetreatmentshouldbeinstituted. PHARMACEUTICALPRECAUTIONS CefuroximesodiumisphysicallyandchemicallycompatiblewithFlagyl.Thefollowing drugshavebeenshowntobephysicallycompatibleintermsofpHandappearancewith FlagylInfusionoverthenormalperiodofadministration,althoughthereisnoevidenceof chemicalstability:-amikacinsulphate,ampicillinsodium,carbenacillinsodium,cefotaxime sodium,cephalothinsodium,cephazolinsodium,chloramphenicolsodiumsuccinate, clindamycinphosphate,gentamicinsulphate,hydrocortisonesodiumsuccinate,latamoxef disodium,netilmicinsulphateandtobramycinsulphate. Inpatientsmaintainedonintravenousfluids,FlagylInfusionmaybedilutedwith appropriatevolumesofnormalsaline,dextrose-saline,dextrose5%w/vorpotassium chlorideinfusions(20and40mmol/litre).Apartfromtheabove,Flagylshouldonno accountbemixedwithanyothersubstance. FlagylInfusionmustnotbemixedwithcefamandolenafate,cefoxitinsodium,dextrose 10%w/v,compoundlactateinjection,penicillinGpotassium. 000000
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PRESENTATION Boxesof10x100mlbottleseachcontainingmetronidazoleinjection(forintravenous infusion)500mg/100ml. Boxesof30x100mlViaflexbagseachcontainingmetronidazoleinjection(forintravenous infusion)500mg/100ml. Theaqueoussolutionalsocontainscitricacid,sodiumchlorideandsodiumphosphate. PREPARATIONFORADMINISTRATIONOFVIAFLEXBAGS Viaflexcontainershaveanoutletportdesignedforanadministrationsetwithasingle connector.Ifanadministrationsetwithacombinedairoutlet/fluidpathconnectorhastobe used,ensuretheairinlettubeisalwaysclampedoff. 1. Removetheprotectiveoverpouchbytearingdownfromnotchandremovecontainer. 2. Squeezecontainerandinspectforminuteleaksandexaminesolutionforvisible particlesorcloudinessbyviewingalongseam.Discardunitifleaks,particlesor cloudinessareevident. 3. SuspendcontainerfromD-shapedhanger. 4. Usingaseptictechniqueprepareadministrationset.
5. SuspendthecontainerusingtheD-shapedhangerandremovetheprotectorfromthe administrationportasfollows: withonehand,gripthewingsoftheblueprotectorbelowthefracturezone(a) withtheotherhand,gripthewingsabovethefracturezone(b) removetheuppersectionoftheprotectorwithonetwistingmovement(c) insertthesetconnectorwellintotheport(d) 6. Prime,setandregulateadministrationasrequired.Ifadministrationsetbecomes blockeddonotpumpcontentsbackintocontainerbutreplaceequipment. 7. Discardallcontainersandequipmentafteruse.Donotreconnectpartlyused containers. FURTHERINFORMATION FlagylInfusiondoesnotcontainapreservative. Flagylisaregisteredtrademark. ViaflexisaTradeMarkofBaxterHealthcareCorporationU.S.A. ViaflexbagscontainingFlagylInfusionaremanufacturedby: BaxterHealthcareS.A.,Castlebar,Co.Mayo,Ireland. WinthropPharmaceuticals,POBox611,Guildford,Surrey,GU14YS Textissued02/2011
Flagyl500mg/100mlSolutionforInfusion
MinibagPlus TheFlagylMinibagPlusisintendedforthereconstitutionanddeliveryofadditionalsingle dosedrugpowdersin20mmvials.
InstructionsforUse Donotremoveunitfromoverwrapuntilreadyforuse.Theoverwrapis amoisturebarrier.Theinnerbagmaintainsthesterilityoftheproduct. 1. Toopen,tearoverwrapdownsideatslitandremovesolution container.Inspectforminuteleaksbysqueezinginnerbag firmly.Checktoensuresealsareintactandbluefrangibleisnot leaking.Ifleaksarefounddiscardunitassterilityorfunction may beimpaired. Removeprotectivecoverofdrugvialandswabwithappropriate disinfectant. Observingaseptictechnique,peelbackthefoilcoverfromend ofreconstitutiondevice.Fig.1. Placethedrugvialonaflatsurface.Holdthereconstitutiondevice withyourthumbandindexfingerandpushthedeviceoverthe drugvial,puncturingthestopperandlockinginplace.Fig.2. Justpriortoadministration,breakbluefrangibleconnector.Grip topofbluefrangibleconnectorbetweenthumbandforefinger ofonehand.Gripbaseoffrangiblewiththumbandforefingerof otherhand.Breakfrangiblesealbybending90inonedirection then180intheoppositedirection.Fig.3. PositionthedrugvialbelowtheMinibagPlusandsqueezethe MinibagPlustotransfersolutiontherebypartiallyfillingthevial (1/3tofull)Fig.4. 7. Keepthereconstitutiondeviceattachedtothedrugvial.Agitate thevialgentlytodissolvethedrug inthevial. 8. InvertthedrugvialabovetheMinibagPlus.Squeezethe MinibagPlustoforceairintothevial,thenreleasethepressure ontheMinibagPlusbyrelaxingyourhandandallowingthe reconstituteddrugtoflowbackintotheMinibagPluscontainer. Repeatprocedureuntilvialisemptyofalldrug.Fig.5. 9. Immediatelypriortoadministration,examinesolutionforany visibleparticles. 10. LabeltheMinibagPlusaccordingtohospitalprocedures 11. Donotdetachdrugvialfromreconstitutiondeviceatanytime. 6.
2. 3. 4. 5.
HOSPITAL LABEL
Blue frangible connector Reconstitution device
Twist Off Protector
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PreparationforAdministration MinibagPluscontainershaveanoutletportdesignedforan administrationsetwithasingleconnector.Ifanadministrationset withacombinedairinlet/fluidpathconnectorhastobeused,ensure theairinlettubeisalwaysclampedoff. 1. SuspendcontainerfromD-shapedhanger 2. Usingaseptictechniqueprepareadministrationset. 3. Removetheprotectorfromtheadministrationportasfollows: withonehand,gripthewingsoftheblueprotectorbelowthe fracturezone(a)
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withtheotherhand,gripthewingsabovethefracturezone(b) removetheuppersectionoftheprotectorwithonetwisting movement(c) insertthesetconnectorwellintotheport(d) 4. Prime,setandregulateadministrationasrequired.If administrationsetbecomesblockeddonotpumpcontentsback intocontainerbutreplaceequipment. 5. Discardallcontainersandequipmentafteruse.Donotreconnect partlyusedcontainers.
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PATIENTINFORMATIONLEAFLET
FLAGYL500MG/100ML SOLUTIONFORINFUSION
MinibagPlus Metronidazole
Readallofthisleafletcarefullybeforeyouaregiventhis medicine Keepthisleaflet.Youmayneedtoreaditagain. Ifyouhavefurtherquestions,pleaseaskyourdoctoror pharmacist. Thismedicinehasbeenprescribedforyou.Donotpassitonto others.Itmayharmthem,eveniftheirsymptomsarethesame asyours. Ifanyofthesideeffectsgetsserious,orifyounoticeany sideeffectsnotlistedinthisleaflet,pleasetellyourdoctoror pharmacist. Inthisleaflet: 1. WhatFlagylisandwhatitisusedfor 2. BeforeyouaregivenFlagyl 3. HowyouwillbegivenFlagyl 4. Possiblesideeffects 5. HowtostoreFlagyl 6. Furtherinformation 1. WHATFLAGYLISANDWHATITISUSEDFOR ThenameofthismedicineisFlagyl500mg/100mlSolutionfor Infusion(calledFlagylinthisleaflet).Flagylcontainsamedicine calledmetronidazole.Thisbelongstoagroupofmedicinescalled antibiotics. Itworksbykillingthebacteriathatcauseinfectionsinyourbody. Itcanbeusedto: Treatinfectionsoftheblood,brain,lung,bones,genitaltract, pelvicareaandstomach Preventinfectionsaftersurgery Ifyouneedanyfurtherinformationonyourillness,speaktoyour doctor. 2. BEFOREYOUAREGIVENFLAGYL DonothaveFlagylif: Youareallergic(hypersensitive)tometronidazole,nitroimidazoles (e.g.tinidazole)oranyoftheotheringredientsinyourmedicine (listedinSection6:Furtherinformation). Signsofanallergicreactioninclude:arash,swallowingor breathingproblems,swellingofyourlips,face,throatortongue. DonothaveFlagylifanyoftheaboveapplytoyou.Ifyouare notsure,talktoyourdoctororpharmacistbeforereceivingyour medicine. TakespecialcarewithFlagylandcheckwithyourdoctorbefore havingyourmedicineif: Youhaveorhaveeverhadaliverproblem. Youarehavingkidneydialysis(seesection3:Peoplehaving kidneydialysis) Youhaveadiseaseofthenervoussystem Ifyouarenotsureifanyoftheaboveapplytoyou,talktoyour doctorbeforereceivingyourmedicine.Dothiseveniftheyhave appliedinthepast.
Takingothermedicines Pleasetellyourdoctorifyouaretakingorhaverecentlytaken anyothermedicines.Thisincludesmedicinesobtainedwithouta prescription,includingherbalmedicines.ThisisbecauseFlagyl canaffectthewaysomeothermedicineswork.Also,someother medicinescanaffectthewayFlagylworks. Inparticulartellyourdoctorifyouaretakinganyofthefollowing medicines: Medicinesusedtothinthebloodsuchaswarfarin Lithiumformentalillness Phenobarbitalorphenytoinforepilepsy 5fluorouracilforcancer Busulfanforleukaemia(cancerofthebloodcells) Ciclosporintopreventtherejectionoforgansaftertransplant Disulfiramforalcoholism Ifyouarenotsure,talktoyourdoctorbeforereceivingyour medicine. HavingFlagylwithfoodanddrink DonotdrinkanyalcoholwhileyouarehavingFlagylandfor48 hoursafterfinishingyourcourse.Drinkingalcoholwhilstyouare beingtreatedmightcauseunpleasantsideeffects,suchasfeeling sick(nausea),beingsick(vomiting),stomachpain,hotflushes,very fastorunevenheartbeat(palpitations)andheadache. Pregnancyandbreast-feeding TellyourdoctorbeforehavingFlagylif: Youarepregnant,mightbecomepregnantorthinkyoumaybe pregnant.Flagylshouldnotbetakenduringpregnancyunless consideredabsolutelynecessary. Youarebreast-feeding.ItisbetternottouseFlagylifyouare breast-feeding.Thisisbecausesmallamountsmaypassintothe mothersmilk. Drivingandusingmachines WhiletakingFlagylyoumayfeelsleepy,dizzy,confused,seeorhear thingsthatarenotthere(hallucinations),havefits(convulsions)or temporaryeyesightproblems(suchasblurredordoublevision).If thishappens,donotdriveoruseanymachineryortools. Tests Yourdoctormaywishtocarryoutsometestsifyouhavebeen havingthismedicineformorethan10days. Importantinformationaboutsomeoftheingredientsofyour FlagylInfusion Sodium:Thereis307mgofsodiumper100mlinfusionbag.This maybeharmfultopeopleonalowsodiumorlowsaltdiet. 3. HOWYOUWILLBEGIVENFLAGYL Howyourmedicinewillbegiven Yourmedicinewillbeadministeredtoyoubyadoctorornurse.The lengthofyourcourseoftreatmentwilldependonyourneedsand theillnessbeingtreated. Flagylisadministeredintoaveinusingadripatarateof 5ml/minute Otherantibioticscanbeadministeredusingthesameminibagas Flagyltohelptreatyourinfection. ThedoseofFlagylwilldependonyourneedsandtheillness beingtreated Thelengthofyourtreatmentwilldependonthetypeofinfection youhaveandhowbaditis AssoonaspossibleafterstartingyourtreatmentwithFlagyl,your doctorwillsuggestchangingtoamedicinetakenbymouth
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Theusualdoseforadultsandchildrenisgivenbelow: Totreatbacterialinfection Adults Youwillbegiven500mg(100ml)Flagylevery8hours Children Yourdoctorwillworkouthowmuchyourchildshouldbe givendependingontheirweight Thedosewillberepeatedevery8hours Ifyourchildisababyunder8weeksofage,yourdoctorwill givethemonedailydoseortwoseparatedoses12hourly Topreventinfectionsfromhappeningaftersurgery Adults Youwillbegiven500mg(100ml)Flagylshortlybeforeyour operation Thedosewillberepeatedevery8hours Children Yourdoctorwillworkouthowmuchyourchildshouldbe givendependingontheirweight Yourchildwillreceivethefirstdose1-2hoursbeforetheir operation Peoplehavingkidneydialysis KidneydialysisremovesFlagylfromyourblood.Ifyouarehaving kidneydialysisyoumusthavethismedicineafteryourdialysis treatment. Peoplewithliverproblems Yourdoctormayloweryourdoseorusethemedicinelessoften. IfyouaregivenmoreFlagylthanyoushould Itisunlikelythatyourdoctorornursewillgiveyoutoomuch medicine.Yourdoctorornursewillmonitoryourprogressandcheck howmuchmedicineyouaregiven.Alwaysaskifyouarenotsure whyyouarebeinggivenamedicine. IfyouarenotgivenFlagylattherighttime Ifyoudonotreceiveyourdoseattherighttimetellyourdoctoror nurseassoonaspossibletoarrangeforanotherinjection. 4. POSSIBLESIDEEFFECTS Likeallmedicines,Flagylcancausesideeffects,althoughnot everybodygetsthem. Telladoctorstraightawayif: Yougetswellingofthehands,feet,ankles,face,lipsorthroat whichmaycausedifficultyinswallowingorbreathing.Youcould alsonoticeanitchy,lumpyrash(hives)ornettlerash(urticaria) ThismaymeanyouarehavinganallergicreactiontoFlagyl. Yougetahighfever,headache,seeorhearthingsthatare notthere,feelclumsyorhavedifficultyincontrollingyour movements,areconfused,moresensitivetolightthanusual, noticeastiffneck,unusualbehaviouroreyemovementsorhave problemswithspeaking.Thiscouldbeaseriousbutveryrare conditioncalledencephalopathy Talktoyourdoctorstraightawayifyounoticethefollowingside effects. Yellowingoftheskinandeyes.Thiscouldbeduetoaliver problem(jaundice). Unexpectedinfections,mouthulcers,bruising,bleedinggums,or severetiredness.Thiscouldbecausedbyabloodproblem. Severestomachpainwhichmayreachthroughtoyourback (pancreatitis)
Tellyourdoctorornurseifyounoticeanyofthefollowingside effects: Veryrare(affectslessthan1in10000people) Fits(convulsions) Mentalproblemssuchasfeelingconfusedandseeingorhearing thingsthatarenotthere(hallucinations) Problemswithyoureyesightsuchasblurredordoublevision Skinrashorflushing Headache Darkeningoftheurine Feelingsleepyordizzy Painsinthemusclesorjoints Notknown(frequencycannotbeestimatedfromtheavailable data) Numbness,tingling,pain,orafeelingofweakness,inthearmsor legs Unpleasanttasteinthemouth Furredtongue Feelingsick(nausea),beingsick(vomiting),upsetstomach, stomachpains,ordiarrhoea Lossofappetite Fever Feelingdepressed Pain in your eyes (optic neuritis) A group of symptoms together including: fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. This may be caused by an inflammation of the membranes that cover the brain and spinal cord (meningitis). Ifanyofthesideeffectsgetsserious,lastslongerthanafewdays oryounoticeanysideeffectsnotlistedinthisleaflet,pleasetell yourdoctorornurse. 5. HOWTOSTOREFLAGYL Thedoctorandhospitalpharmacistareusuallyresponsiblefor storing,usinganddisposingofFlagylcorrectly. Keepthismedicineinasafeplaceoutofthereachandsightof children. Donotusethismedicineaftertheexpirydateshownonthebag label. Storethismedicinebelow25Cinadarkplacetoprotectfrom light. Donotdisposeofmedicines,whicharenolongerneeded,by flushingdownatoiletorsinkorbythrowingoutwithyournormal householdrubbish.Thiswillhelpprotecttheenvironment. 6. FURTHERINFORMATION WhatFlagylSolutionforInfusioncontains Each100mlofsolutioncontains500mgmetronidazoleastheactive substance. Theotheringredientsare:Sodiumphosphate,citricacidanhydrous, sodiumchlorideandwaterforinjections. WhatFlagylSolutionforInfusionlookslike FlagylSolutionforInfusionisabright,paleyellowsolution. FlagylSolutionforInfusionisavailableinminibagscontaining100ml ofsolution. TheMarketingAuthorisationHolderis: WinthropPharmaceuticals,POBox611,Guildford,Surrey,GU14YS TheManufactureris: BaxterHealthcareS.A.,Castlebar,Co.Mayo,RepublicofIreland
ThisleafletwaslastupdatedinFebruary 2011
FlagylandWinthropareregisteredtrademarks.2011Winthrop Pharmaceuticals. 4
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SolutionforInfusion MinibagPlus Metronidazole
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INDICATIONS Flagylisindicatedintheprophylaxisandtreatmentofinfectionsinwhichanaerobic bacteriahavebeenidentifiedoraresuspectedtobethecause. Flagylisactiveagainstawiderangeofpathogenicmicro-organismsnotablyspecies ofbacteroides,fusobacteria,clostridia,eubacteria,anaerobiccocciandGardnerella vaginalis. Flagylisindicatedinadultsandchildrenforthefollowingindications: 1. Thepreventionofpost-operativeinfectionsduetoanaerobicbacteria,particularly speciesofbacteroidesandanaerobicstreptococci. 2. Thetreatmentofsepticaemia,bacteraemia,peritonitis,brainabscess,necrotising pneumonia,osteomyelitis,puerperalsepsis,pelvicabscess,pelviccellulitisandpostoperativewoundinfectionsfromwhichsusceptiblepathogenicanaerobeshavebeen isolated. Considerationsshouldbegiventoofficialguidanceontheappropriateuseofantibacterial agents. KINETICS Metronidazoleiswidelydistributedinbodytissuesafterinjection.Atleasthalfthedose isexcretedintheurineasmetronidazoleanditsmetabolitesincludinganacidoxidation product,ahydroxyderivativeandaglucoronide. Metronidazolediffusesacrosstheplacentaandisfoundinthebreastmilkofnursing mothersinconcentrationsequivalenttothoseintheserum. 10%ofthedoseisboundinplasma.Clearance:1.30.3ml/min/kg. Volumeofdistribution:1.10.4litres/kg.Half-life:8.52.9hours. Effectiveconcentration:3-6micrograms/ml. ADMINISTRATIONANDDOSAGE FlagylInfusionshouldbeinfusedintravenouslyatanapproximaterateof5ml/minute. Oraladministrationshouldbesubstitutedassoonasfeasible.Onlythosesubstances specificallylistedunderPharmaceuticalPrecautionsshouldbemixedwithFlagyl Infusion.FlagylSolutionforInfusionmaybedilutedwithappropriatevolumesofdiluents listedunderPharmaceuticalPrecautions.Onnoaccountshouldanyothersubstancesbe administeredconcurrentlybythesamei.v.routeexceptforthosespecificallylistedunder PharmaceuticalPrecautions. AnaerobicInfections Treatmentfor7daysshouldbesatisfactoryformostpatientsbut,dependingonclinical andbacteriologicalassessments,thephysicianmightdecidetoprolongtreatmente.g.for theeradicationofinfectionfromsiteswhichcannotbedrainedorareliabletoendogenous recontaminationbyanaerobicpathogensfromthegut,oropharynxorgenitaltract. A. Prophylaxisagainstanaerobicinfection,chieflyinthecontextofabdominal(especially colorectal)andgynaecologicalsurgery. Adults:500mgi.v.shortlybeforeoperation,repeated8hourly;oraldosesof200mgor 400mg8hourlyshouldbestartedassoonasfeasible. Children<12years:20-30mg/kgasasingledosegiven1-2hoursbeforesurgery Newbornswithagestationage<40weeks:10mg/kgbodyweightasasingledose beforeoperation. B. Treatmentofestablishedanaerobicinfection.Tobeusedinitiallyifpatientscondition orsymptomsprecludeoraltherapy. Adults:500mgi.v.8hourly. Children>8weeksto12yearsofage:Theusualdailydoseis20-30mg/kg/day asasingledoseordividedinto7.5mg/kgevery8hours.Thedailydosemaybe increasedto40mg/kg,dependingontheseverityoftheinfection.Durationof treatmentisusually7days. Children<8weeksofage:15mg/kgasasingledosedailyordividedinto 7.5mg/kgevery12hours.Innewbornswithagestationage<40weeks,accumulation ofmetronidazolecanoccurduringthefirstweekoflife,thereforetheconcentrationsof metronidazoleinserumshouldpreferablebemonitoredafterafewdaystherapy. Elderlypatients:Cautionisadvisedintheelderly,particularlyathighdoses,although thereislimitedinformationavailableonmodificationofdosage. Bacterialvaginosis: Adolescents:400mgtwicedailyfor5-7daysor2000mgasasingledose. Urogenitaltrichomoniasis: Adultsandadolescents:2000mgasasingledoseor200mg3timesdailyfor7days or400mgtwicedailyfor5-7days Children<10years:40mg/kgorallyasasingledoseor15-30mg/kg/daydividedin 2-3dosesfor7days;nottoexceed2000mg/dose Giardiasis: >10years:2000mgoncedailyfor3days,or400mgthreetimesdailyfor5days,or 500mgtwicedailyfor7to10days Children7to10years:1000mgoncedailyfor3days Children3to7years:600to800mgoncedailyfor3days Children1to3years:500mgoncedailyfor3days Alternatively,asexpressedinmgperkgofbodyweight:15-40mg/kg/daydividedin 2-3doses. Amoebiasis: >10years:400to800mg3timesdailyfor5-10days Children7to10years:200to400mg3timesdailyfor5-10days Children3to7years:100to200mg4timesdailyfor5-10days Children1to3years:100to200mg3timesdailyfor5-10days Alternatively,dosesmaybeexpressedbybodyweight:35to50mg/kgdailyin 3divideddosesfor5to10days,nottoexceed2400mg/day EradicationofHelicobacterpyloriinpaediatricpatients:Asapartofacombination therapy,20mg/kg/daynottoexceed500mgtwicedailyfor7-14days.Officialguidelines shouldbeconsultedbeforeinitiatingtherapy. CONTRAINDICATION Knownhypersensitivitytometronidazole,nitroimidazoles (e.g.tinidazole)oranyoftheexcipients. PRECAUTIONS CODE Useinpregnancyandlactation:Thereisinadequateevidenceof thesafetyofmetronidazoleinpregnancy.Flagylshouldnottherefore begivenduringpregnancyorduringlactationunlessthephysician considersitessential.Inthesecircumstancestheshort,highdosage regimensarenotrecommended. Thismedicinalproductcontains13.365mmol(307mg)sodiumper 100mlofsolution.Tobetakenintoconsiderationbypatientsona controlledsodiumdiet. Abilitytodriveandusemachinery:Metronidazolemayoccasionally causedrowsiness,dizziness,confusion,hallucinations,convulsions (fits)ortemporaryeffectsonyoureyesight(e.g.blurredordouble vision).Ifyouareaffected,donotdriveorusemachinery. Metronidazolehasnousefuldirectactivityagainstaerobicand facultativelyanaerobicbacteria.Thereisapossibilitythatafter Trichomonasvaginalishasbeeneliminatedagonococcalinfection mightpersist.Regularclinicalandbiologicalsurveillanceareadvised ifadministrationofFlagylformorethan10daysisconsideredtobe
necessaryandpatientsshouldbemonitoredforadversereactions suchasperipheralorcentralneuropathy. Theeliminationhalf-lifeofmetronidazoleremainsunchangedinthe presenceofrenalfailure.Thedosageofmetronidazoletherefore needsnoreduction.Suchpatientshoweverretainthemetabolitesof metronidazole.Theclinicalsignificanceofthisisnotknownatpresent. NoroutineadjustmentinthedosageofFlagylneedstobemadein patientswithrenalfailureundergoingintermittentperitonealdialysis (IPD)orcontinuousambulatoryperitonealdialysis(CAPD). Inpatientsundergoinghaemodialysis,metronidazoleandits metabolitesareefficientlyremovedduringan8-hourperiodofdialysis. Metronidazoleshouldthereforebere-administeredimmediatelyafter haemodialysis. Aspartate-amino-transferaseassaysmaygivespuriouslylowvaluesin patientsbeingtreatedwithmetronidazole,dependingonthemethod used. Metronidazoleismainlymetabolisedbyhepaticoxidation.Substantial impairmentofmetronidazoleclearancemayoccurinthepresenceof advancedhepaticinsufficiency.Significantaccumulationmayoccurin patientswithhepaticencephalopathyandtheresultinghighplasma 00000 concentrationofmetronidazolemaycontributetothesymptomsofthe encephalopathy.Flagylshould,therefore,beadministeredwithcaution topatientswithhepaticencephalopathy.Thedailydosageshouldbe reducedtoonethirdandmaybeadministeredoncedaily. FlagylshouldbeusedwithcautioninpatientswithactivediseaseoftheCNSduetothe riskofneurologicalaggravation.Clinicianswhocontemplatecontinuoustherapyforthe reliefofchronicconditionsforperiodslongerthanthoserecommendedareadvisedto considerthepossibletherapeuticbenefitagainsttheriskofperipheralneuropathy. Patientsshouldbeadvisednottotakealcoholduringmetronidazoletherapyandfor atleast48hoursafterwardsbecauseofthepossibilityofadisulfiram-like(antabuse effect)reaction.Psychoticreactionshavebeenreportedinpatientswhowereusing metronidazoleanddisulfiramconcurrently. Somepotentiationofanticoagulanttherapyhasbeenreportedwhenmetronidazolehas beenusedwiththewarfarin-typeoralanticoagulants.Dosageofthelattermayrequire adjustment.Thereisnointeractionwithheparin.However,anticoagulantactivityshouldbe routinelymonitoredwiththeseproducts. Lithiumretentionaccompaniedbyevidenceofpossiblerenaldamagehasbeenreported inpatientstreatedsimultaneouslywithlithiumandmetronidazole.Lithiumtreatment shouldthereforebetaperedorwithdrawnbeforeadministeringmetronidazole.Plasma concentrationsoflithium,creatinineandelectrolytesshouldbemonitoredinpatientsunder treatmentwithlithiumwhiletheyreceivemetronidazole. Patientsreceivingphenobarbitalorphenytoinmetabolisemetronidazoleatamuchgreater ratethannormal,reducingthehalf-lifetoapproximately3hours. Plasmalevelsofbusulfanmaybeincreasedbymetronidazolewhichmayleadtosevere busulfantoxicity. Metronidazolereducestheclearanceof5fluorouracilandcanthereforeresultinincreased toxicityof5fluorouracil. Patientsreceivingciclosporinareatriskofelevatedciclosporinserumlevels.Serum ciclosporinandserumcreatineshouldbecloselymonitoredwhenco-administrationis necessary. Patientsshouldbewarnedthatmetronidazolemaydarkenurine. ADVERSEEFFECTS Frequency,typeandseverityofadversereactionsinchildrenarethesameasinadults. Thefrequencyofadverseeventslistedbelowisdefinedusingthefollowingconvention: verycommon(1/10);common(1/100to<1/10); uncommon(1/1,000to<1/100);rare(1/10,000to<1/1,000);veryrare(<1/10,000), notknown(cannotbeestimatedfromtheavailabledata). Seriousadversereactionsoccurrarelywithstandardrecommendedregimens.Clinicians whocontemplatecontinuoustherapyforthereliefofchronicconditions,forperiodslonger thanthoserecommended,areadvisedtoconsiderthepossibletherapeuticbenefitagainst theriskofperipheralneuropathy. Bloodandlymphaticsystemdisorders: Veryrare:agranulocytosis,neutropenia,thrombocytopenia,pancytopenia Notknown:leucopenia. Immunesystemdisorders: Rare:anaphylaxis Notknown:angiodema,urticaria,fever. Metabolismandnutritiondisorders: Notknown:anorexia. Psychiatricdisorders: Veryrare:psychoticdisorders,includingconfusionandhallucinations. Notknown:depressedmood. Nervoussystemdisorders: Veryrare: encephalopathy(eg.confusion,fever,headache,hallucinations,paralysis, lightsensitivity,disturbancesinsightandmovement,stiffneck)andsubacute cerebellarsyndrome(eg.ataxia,dysathria,gaitimpairment,nystagmusand tremor)whichmayresolveondiscontinuationofthedrug. drowsiness,dizziness,convulsions,headaches. Not known: during intensive and/or prolonged metronidazole therapy, peripheral sensory neuropathy or transient epileptiform seizures have been reported. In most cases neuropathy disappeared after treatment was stopped or when dosage was reduced. Aseptic meningitis Eyedisorders: Veryrare:transientvisiondisorderssuchasdiplopiaandmyopia. Not known: optic neuropathy/neuritis Gastrointestinaldisorders: Notknown:tastedisorders,oralmucositis,furredtongue,nausea,vomiting, gastro-intestinaldisturbancessuchasepigastricpainanddiarrhoea. Hepatobiliarydisorders: Veryrare:abnormalliverfunctiontests,cholestatichepatitis,jaundiceandpancreatitis whichisreversibleondrugwithdrawal. Skinandsubcutaneoustissuedisorders: Veryrare:skinrashes,pustulareruptions,pruritis,flushing Notknown:erythemamultiforme. Musculoskeletal,connectivetissueandbonedisorders: Veryrare:myalgia,arthralgia. Renalandurinarydisorders: Veryrare:darkeningofurine(duetometronidazolemetabolite). TREATMENTOFOVERDOSAGE Singleoraldosesofmetronidazole,upto12ghavebeenreportedinsuicideattemptsand accidentaloverdoses.Symptomswerelimitedtovomiting,ataxiaandslightdisorientation. Thereisnospecificantidoteformetronidazoleoverdosage.Incasesofsuspectedmassive overdose,symptomaticandsupportivetreatmentshouldbeinstituted. PHARMACEUTICALPRECAUTIONS CefuroximesodiumisphysicallyandchemicallycompatiblewithFlagyl.Thefollowing drugshavebeenshowntobephysicallycompatibleintermsofpHandappearancewith FlagylInfusionoverthenormalperiodofadministration,althoughthereisnoevidenceof chemicalstability:-amikacinsulphate,ampicillinsodium,carbenacillinsodium,cefotaxime sodium,cephalothinsodium,cephazolinsodium,chloramphenicolsodiumsuccinate, clindamycinphosphate,gentamicinsulphate,hydrocortisonesodiumsuccinate,latamoxef disodium,netilmicinsulphateandtobramycinsulphate. Inpatientsmaintainedonintravenousfluids,FlagylInfusionmaybedilutedwith appropriatevolumesofnormalsaline,dextrose-saline,dextrose5%w/vorpotassium chlorideinfusions(20and40mmol/litre).Apartfromtheabove,Flagylshouldonno accountbemixedwithanyothersubstance. FlagylInfusionmustnotbemixedwithcefamandolenafate,cefoxitinsodium,dextrose 10%w/v,compoundlactateinjection,penicillinGpotassium. 000000
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PRESENTATION Boxesof10x100mlbottleseachcontainingmetronidazoleinjection(forintravenous infusion)500mg/100ml. Boxesof30x100mlViaflexbagseachcontainingmetronidazoleinjection(forintravenous infusion)500mg/100ml. Theaqueoussolutionalsocontainscitricacid,sodiumchlorideandsodiumphosphate. PREPARATIONFORADMINISTRATIONOFVIAFLEXBAGS Viaflexcontainershaveanoutletportdesignedforanadministrationsetwithasingle connector.Ifanadministrationsetwithacombinedairoutlet/fluidpathconnectorhastobe used,ensuretheairinlettubeisalwaysclampedoff. 1. Removetheprotectiveoverpouchbytearingdownfromnotchandremovecontainer. 2. Squeezecontainerandinspectforminuteleaksandexaminesolutionforvisible particlesorcloudinessbyviewingalongseam.Discardunitifleaks,particlesor cloudinessareevident. 3. SuspendcontainerfromD-shapedhanger. 4. Usingaseptictechniqueprepareadministrationset.
5. SuspendthecontainerusingtheD-shapedhangerandremovetheprotectorfromthe administrationportasfollows: withonehand,gripthewingsoftheblueprotectorbelowthefracturezone(a) withtheotherhand,gripthewingsabovethefracturezone(b) removetheuppersectionoftheprotectorwithonetwistingmovement(c) insertthesetconnectorwellintotheport(d) 6. Prime,setandregulateadministrationasrequired.Ifadministrationsetbecomes blockeddonotpumpcontentsbackintocontainerbutreplaceequipment. 7. Discardallcontainersandequipmentafteruse.Donotreconnectpartlyused containers. FURTHERINFORMATION FlagylInfusiondoesnotcontainapreservative. Flagylisaregisteredtrademark. ViaflexisaTradeMarkofBaxterHealthcareCorporationU.S.A. ViaflexbagscontainingFlagylInfusionaremanufacturedby: BaxterHealthcareS.A.,Castlebar,Co.Mayo,Ireland. WinthropPharmaceuticals,POBox611,Guildford,Surrey,GU14YS Textissued02/2011
Flagyl500mg/100mlSolutionforInfusion
MinibagPlus TheFlagylMinibagPlusisintendedforthereconstitutionanddeliveryofadditionalsingle dosedrugpowdersin20mmvials.
InstructionsforUse Donotremoveunitfromoverwrapuntilreadyforuse.Theoverwrapis amoisturebarrier.Theinnerbagmaintainsthesterilityoftheproduct. 1. Toopen,tearoverwrapdownsideatslitandremovesolution container.Inspectforminuteleaksbysqueezinginnerbag firmly.Checktoensuresealsareintactandbluefrangibleisnot leaking.Ifleaksarefounddiscardunitassterilityorfunction may beimpaired. Removeprotectivecoverofdrugvialandswabwithappropriate disinfectant. Observingaseptictechnique,peelbackthefoilcoverfromend ofreconstitutiondevice.Fig.1. Placethedrugvialonaflatsurface.Holdthereconstitutiondevice withyourthumbandindexfingerandpushthedeviceoverthe drugvial,puncturingthestopperandlockinginplace.Fig.2. Justpriortoadministration,breakbluefrangibleconnector.Grip topofbluefrangibleconnectorbetweenthumbandforefinger ofonehand.Gripbaseoffrangiblewiththumbandforefingerof otherhand.Breakfrangiblesealbybending90inonedirection then180intheoppositedirection.Fig.3. PositionthedrugvialbelowtheMinibagPlusandsqueezethe MinibagPlustotransfersolutiontherebypartiallyfillingthevial (1/3tofull)Fig.4. 7. Keepthereconstitutiondeviceattachedtothedrugvial.Agitate thevialgentlytodissolvethedrug inthevial. 8. InvertthedrugvialabovetheMinibagPlus.Squeezethe MinibagPlustoforceairintothevial,thenreleasethepressure ontheMinibagPlusbyrelaxingyourhandandallowingthe reconstituteddrugtoflowbackintotheMinibagPluscontainer. Repeatprocedureuntilvialisemptyofalldrug.Fig.5. 9. Immediatelypriortoadministration,examinesolutionforany visibleparticles. 10. LabeltheMinibagPlusaccordingtohospitalprocedures 11. Donotdetachdrugvialfromreconstitutiondeviceatanytime. 6.
2. 3. 4. 5.
HOSPITAL LABEL
Blue frangible connector Reconstitution device
Twist Off Protector
Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
PreparationforAdministration MinibagPluscontainershaveanoutletportdesignedforan administrationsetwithasingleconnector.Ifanadministrationset withacombinedairinlet/fluidpathconnectorhastobeused,ensure theairinlettubeisalwaysclampedoff. 1. SuspendcontainerfromD-shapedhanger 2. Usingaseptictechniqueprepareadministrationset. 3. Removetheprotectorfromtheadministrationportasfollows: withonehand,gripthewingsoftheblueprotectorbelowthe fracturezone(a)
Fig. 6
withtheotherhand,gripthewingsabovethefracturezone(b) removetheuppersectionoftheprotectorwithonetwisting movement(c) insertthesetconnectorwellintotheport(d) 4. Prime,setandregulateadministrationasrequired.If administrationsetbecomesblockeddonotpumpcontentsback intocontainerbutreplaceequipment. 5. Discardallcontainersandequipmentafteruse.Donotreconnect partlyusedcontainers.
(a) (b) (c) 2
(d)
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PATIENTINFORMATIONLEAFLET
FLAGYL500MG/100ML SOLUTIONFORINFUSION
MinibagPlus Metronidazole
Readallofthisleafletcarefullybeforeyouaregiventhis medicine Keepthisleaflet.Youmayneedtoreaditagain. Ifyouhavefurtherquestions,pleaseaskyourdoctoror pharmacist. Thismedicinehasbeenprescribedforyou.Donotpassitonto others.Itmayharmthem,eveniftheirsymptomsarethesame asyours. Ifanyofthesideeffectsgetsserious,orifyounoticeany sideeffectsnotlistedinthisleaflet,pleasetellyourdoctoror pharmacist. Inthisleaflet: 1. WhatFlagylisandwhatitisusedfor 2. BeforeyouaregivenFlagyl 3. HowyouwillbegivenFlagyl 4. Possiblesideeffects 5. HowtostoreFlagyl 6. Furtherinformation 1. WHATFLAGYLISANDWHATITISUSEDFOR ThenameofthismedicineisFlagyl500mg/100mlSolutionfor Infusion(calledFlagylinthisleaflet).Flagylcontainsamedicine calledmetronidazole.Thisbelongstoagroupofmedicinescalled antibiotics. Itworksbykillingthebacteriathatcauseinfectionsinyourbody. Itcanbeusedto: Treatinfectionsoftheblood,brain,lung,bones,genitaltract, pelvicareaandstomach Preventinfectionsaftersurgery Ifyouneedanyfurtherinformationonyourillness,speaktoyour doctor. 2. BEFOREYOUAREGIVENFLAGYL DonothaveFlagylif: Youareallergic(hypersensitive)tometronidazole,nitroimidazoles (e.g.tinidazole)oranyoftheotheringredientsinyourmedicine (listedinSection6:Furtherinformation). Signsofanallergicreactioninclude:arash,swallowingor breathingproblems,swellingofyourlips,face,throatortongue. DonothaveFlagylifanyoftheaboveapplytoyou.Ifyouare notsure,talktoyourdoctororpharmacistbeforereceivingyour medicine. TakespecialcarewithFlagylandcheckwithyourdoctorbefore havingyourmedicineif: Youhaveorhaveeverhadaliverproblem. Youarehavingkidneydialysis(seesection3:Peoplehaving kidneydialysis) Youhaveadiseaseofthenervoussystem Ifyouarenotsureifanyoftheaboveapplytoyou,talktoyour doctorbeforereceivingyourmedicine.Dothiseveniftheyhave appliedinthepast.
Takingothermedicines Pleasetellyourdoctorifyouaretakingorhaverecentlytaken anyothermedicines.Thisincludesmedicinesobtainedwithouta prescription,includingherbalmedicines.ThisisbecauseFlagyl canaffectthewaysomeothermedicineswork.Also,someother medicinescanaffectthewayFlagylworks. Inparticulartellyourdoctorifyouaretakinganyofthefollowing medicines: Medicinesusedtothinthebloodsuchaswarfarin Lithiumformentalillness Phenobarbitalorphenytoinforepilepsy 5fluorouracilforcancer Busulfanforleukaemia(cancerofthebloodcells) Ciclosporintopreventtherejectionoforgansaftertransplant Disulfiramforalcoholism Ifyouarenotsure,talktoyourdoctorbeforereceivingyour medicine. HavingFlagylwithfoodanddrink DonotdrinkanyalcoholwhileyouarehavingFlagylandfor48 hoursafterfinishingyourcourse.Drinkingalcoholwhilstyouare beingtreatedmightcauseunpleasantsideeffects,suchasfeeling sick(nausea),beingsick(vomiting),stomachpain,hotflushes,very fastorunevenheartbeat(palpitations)andheadache. Pregnancyandbreast-feeding TellyourdoctorbeforehavingFlagylif: Youarepregnant,mightbecomepregnantorthinkyoumaybe pregnant.Flagylshouldnotbetakenduringpregnancyunless consideredabsolutelynecessary. Youarebreast-feeding.ItisbetternottouseFlagylifyouare breast-feeding.Thisisbecausesmallamountsmaypassintothe mothersmilk. Drivingandusingmachines WhiletakingFlagylyoumayfeelsleepy,dizzy,confused,seeorhear thingsthatarenotthere(hallucinations),havefits(convulsions)or temporaryeyesightproblems(suchasblurredordoublevision).If thishappens,donotdriveoruseanymachineryortools. Tests Yourdoctormaywishtocarryoutsometestsifyouhavebeen havingthismedicineformorethan10days. Importantinformationaboutsomeoftheingredientsofyour FlagylInfusion Sodium:Thereis307mgofsodiumper100mlinfusionbag.This maybeharmfultopeopleonalowsodiumorlowsaltdiet. 3. HOWYOUWILLBEGIVENFLAGYL Howyourmedicinewillbegiven Yourmedicinewillbeadministeredtoyoubyadoctorornurse.The lengthofyourcourseoftreatmentwilldependonyourneedsand theillnessbeingtreated. Flagylisadministeredintoaveinusingadripatarateof 5ml/minute Otherantibioticscanbeadministeredusingthesameminibagas Flagyltohelptreatyourinfection. ThedoseofFlagylwilldependonyourneedsandtheillness beingtreated Thelengthofyourtreatmentwilldependonthetypeofinfection youhaveandhowbaditis AssoonaspossibleafterstartingyourtreatmentwithFlagyl,your doctorwillsuggestchangingtoamedicinetakenbymouth
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Theusualdoseforadultsandchildrenisgivenbelow: Totreatbacterialinfection Adults Youwillbegiven500mg(100ml)Flagylevery8hours Children Yourdoctorwillworkouthowmuchyourchildshouldbe givendependingontheirweight Thedosewillberepeatedevery8hours Ifyourchildisababyunder8weeksofage,yourdoctorwill givethemonedailydoseortwoseparatedoses12hourly Topreventinfectionsfromhappeningaftersurgery Adults Youwillbegiven500mg(100ml)Flagylshortlybeforeyour operation Thedosewillberepeatedevery8hours Children Yourdoctorwillworkouthowmuchyourchildshouldbe givendependingontheirweight Yourchildwillreceivethefirstdose1-2hoursbeforetheir operation Peoplehavingkidneydialysis KidneydialysisremovesFlagylfromyourblood.Ifyouarehaving kidneydialysisyoumusthavethismedicineafteryourdialysis treatment. Peoplewithliverproblems Yourdoctormayloweryourdoseorusethemedicinelessoften. IfyouaregivenmoreFlagylthanyoushould Itisunlikelythatyourdoctorornursewillgiveyoutoomuch medicine.Yourdoctorornursewillmonitoryourprogressandcheck howmuchmedicineyouaregiven.Alwaysaskifyouarenotsure whyyouarebeinggivenamedicine. IfyouarenotgivenFlagylattherighttime Ifyoudonotreceiveyourdoseattherighttimetellyourdoctoror nurseassoonaspossibletoarrangeforanotherinjection. 4. POSSIBLESIDEEFFECTS Likeallmedicines,Flagylcancausesideeffects,althoughnot everybodygetsthem. Telladoctorstraightawayif: Yougetswellingofthehands,feet,ankles,face,lipsorthroat whichmaycausedifficultyinswallowingorbreathing.Youcould alsonoticeanitchy,lumpyrash(hives)ornettlerash(urticaria) ThismaymeanyouarehavinganallergicreactiontoFlagyl. Yougetahighfever,headache,seeorhearthingsthatare notthere,feelclumsyorhavedifficultyincontrollingyour movements,areconfused,moresensitivetolightthanusual, noticeastiffneck,unusualbehaviouroreyemovementsorhave problemswithspeaking.Thiscouldbeaseriousbutveryrare conditioncalledencephalopathy Talktoyourdoctorstraightawayifyounoticethefollowingside effects. Yellowingoftheskinandeyes.Thiscouldbeduetoaliver problem(jaundice). Unexpectedinfections,mouthulcers,bruising,bleedinggums,or severetiredness.Thiscouldbecausedbyabloodproblem. Severestomachpainwhichmayreachthroughtoyourback (pancreatitis)
Tellyourdoctorornurseifyounoticeanyofthefollowingside effects: Veryrare(affectslessthan1in10000people) Fits(convulsions) Mentalproblemssuchasfeelingconfusedandseeingorhearing thingsthatarenotthere(hallucinations) Problemswithyoureyesightsuchasblurredordoublevision Skinrashorflushing Headache Darkeningoftheurine Feelingsleepyordizzy Painsinthemusclesorjoints Notknown(frequencycannotbeestimatedfromtheavailable data) Numbness,tingling,pain,orafeelingofweakness,inthearmsor legs Unpleasanttasteinthemouth Furredtongue Feelingsick(nausea),beingsick(vomiting),upsetstomach, stomachpains,ordiarrhoea Lossofappetite Fever Feelingdepressed Pain in your eyes (optic neuritis) A group of symptoms together including: fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. This may be caused by an inflammation of the membranes that cover the brain and spinal cord (meningitis). Ifanyofthesideeffectsgetsserious,lastslongerthanafewdays oryounoticeanysideeffectsnotlistedinthisleaflet,pleasetell yourdoctorornurse. 5. HOWTOSTOREFLAGYL Thedoctorandhospitalpharmacistareusuallyresponsiblefor storing,usinganddisposingofFlagylcorrectly. Keepthismedicineinasafeplaceoutofthereachandsightof children. Donotusethismedicineaftertheexpirydateshownonthebag label. Storethismedicinebelow25Cinadarkplacetoprotectfrom light. Donotdisposeofmedicines,whicharenolongerneeded,by flushingdownatoiletorsinkorbythrowingoutwithyournormal householdrubbish.Thiswillhelpprotecttheenvironment. 6. FURTHERINFORMATION WhatFlagylSolutionforInfusioncontains Each100mlofsolutioncontains500mgmetronidazoleastheactive substance. Theotheringredientsare:Sodiumphosphate,citricacidanhydrous, sodiumchlorideandwaterforinjections. WhatFlagylSolutionforInfusionlookslike FlagylSolutionforInfusionisabright,paleyellowsolution. FlagylSolutionforInfusionisavailableinminibagscontaining100ml ofsolution. TheMarketingAuthorisationHolderis: WinthropPharmaceuticals,POBox611,Guildford,Surrey,GU14YS TheManufactureris: BaxterHealthcareS.A.,Castlebar,Co.Mayo,RepublicofIreland
ThisleafletwaslastupdatedinFebruary 2011
FlagylandWinthropareregisteredtrademarks.2011Winthrop Pharmaceuticals. 4
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Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
