CEFUROXIME MARTINDALE PHARMA

Main information

  • Trade name:
  • CEFUROXIME MARTINDALE PHARMA
  • Dosage:
  • 1.5 Grams
  • Pharmaceutical form:
  • Pdr for Soln for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEFUROXIME MARTINDALE PHARMA
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0361/030/002
  • Authorization date:
  • 18-06-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995,asamended

MedicinalProducts(ControlofPlacingontheMarket)Regulations,2007,asamended

PA0361/030/002

CaseNo:2042214

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

MartindalePharmaceuticalsLtd

BamptonRoad,HaroldHill,Romford,RM38UG,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CefuroximeMartindalePharma1.5gpowderforsolutionforInjection

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom18/06/2010until17/06/2015.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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Date Printed 15/07/2010 CRN 2042214 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CefuroximeMartindalePharma1.5gpowderforsolutionforInjection

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachvialcontains1500mgCefuroxime(as1578mgcefuroximeSodium).

Forafulllistofexcipientsseesection6.1

3PHARMACEUTICALFORM

PowderforSolutionforInjection.

Whitetoalmostwhitepowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Cefuroximeisindicatedintheparenteraltreatmentofthefollowinginfectionscausedbyorganismsthataresensitiveto

cefuroxime:

Lowerrespiratorytractinfections:acuteexacerbationofchronicbronchitisandbacterialpneumonia

Upperurinarytractinfections:pyelonephritis.

Considerationshouldbegiventoofficialguidanceontheappropriateuseofantibacterialagents.

4.2Posologyandmethodofadministration

Usualdosage:

Adolescents(age12to17years),adultsandelderly

Mostinfectionswillrespondtocefuroxime750mgthreetimesaday.

Formoresevereinfections,thedosemaybeincreasedto1.5gthreetimesadaybyintravenousinjection.

Ifnecessary,thefrequencyofadministrationofcefuroximecanbeincreasedtofourtimesaday750mguptototal

dailydosesof3gorfourtimesaday1500mguptototaldailydosesof6g.

Dosageinimpairedrenalfunctionforadolescents,adultsandelderly:

Itisnotnecessarytoreducethedoseifcreatinineclearanceismorethan20ml/min.

Inpatientswithmarkedlyimpairedrenalfunctionthedosageofcefuroximeshouldbereducedasfollows:

Creatinineclearance

(ml/min) Recommendeddosageofcefuroxime

(mg) Frequencyofdosage

(hours)

>20 normaldosage

10-20 750 12

<10 750 24

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Specialprecautionsarerequiredifcreatinineclearanceis<10ml/minuteandtreatmentshouldtakeplaceunder

appropriateexpertsupervision(seesection4.4).

Serumconcentrationofcefuroximeshouldbemonitoredinpatientswithsevererenalimpairment.

Forpatientsonhaemodialysisafurther750mgdose,byintravenousorintramuscularinjection,shouldbegivenatthe

endofeachsession.

Forlow-fluxhaemofiltrationfollowthedosagerecommendedunderimpairedrenalfunction.

Paediatricpatients

Preterm(bornat<36weeksofgestation)andtermnewborninfants(age0-27days):

Cefuroximeisnotrecommendedfortheuseintheseagegroupsduetoinsufficientdataonsafetyandefficacy.Inthe

firstweeksoflifetheserumhalf-lifeofcefuroximecanbethreetofivetimesthatinadults(seesection5.2).

Infants,toddlers(age28daysto23months)andChildren(2yearsto11years):

Therecommendeddosagerangeis30to100mg/kg/daygivenasthreeorfourdivideddoses.Mostinfectionswill

respondtoadoseof60mg/kg/day.

Infants,toddlers(28daysto23months)andchildren(2to11years)withimpairedrenalfunction:

Thereareinsufficientdataregardinguseofcefuroximeinpaediatricrenalinsufficiencyandthereforesuchuseisnot

recommended.

Incaseofpaediatricdosewhereuseof1.5gvialisnotappropriate,considerationshouldbegiventotheuseofa750or

250mgvial.

RouteofAdministration:

Cefuroximemaybeadministeredbyintravenousinjection(within3–5minutes)(seesection6.6).

Dosesabove750mgofcefuroximeshouldnotbeadministeredintramuscularly.

4.3Contraindications

Hypersensitivitytocefuroximeortoanyothercephalosporinantibiotics.

Previousimmediateand/orseverehypersensitivityreactiontopenicillinoranybeta-lactamdrug.

4.4Specialwarningsandprecautionsforuse

Specialcareisindicatedinpatientswhohaveexperiencedanallergicreactiontopenicillinsoranyotherbeta-lactam

antibioticsascross-reactionsmayoccur(forcontraindicationsduetoknownhypersensitivityreactionsseesection4.3).

Ifseverehypersensitivityreactionsoranaphylacticreactionsoccurafteradministrationofcefuroximesodium,theuse

ofCefuroximeshouldbediscontinuedimmediatelyandappropriateemergencymeasuresshouldbeinitiated.

Inpatientswhodevelopseverediarrhoeaduringorafteruseofcefuroximesodium,theriskoflifethreateningpseudo-

membranouscolitisshouldbetakenintoaccount.Theuseofcefuroximesodiumshouldbediscontinuedand

appropriatetreatmentmeasuresshouldbeestablished.Theuseofpreparationsinhibitingtheintestinalperistalticis

arteriovenous

haemofiltration/haemo-

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Aswithotherbroadspectrumantibiotics,prolongeduseofCefuroximesodiummayresultintheovergrowthofnon-

susceptibleorganisms(e.g.,candida,enterococciandclostridiumdifficile),whichmayrequireinterruptionof

treatment.

Cefuroximeisexcretedviathekidneys.Thereforeadoseadjustmentisrequiredinpatientswithimpairedrenal

function(seesection4.2).

Duetoanincreasedriskofcefuroximeaccumulationinserumaccompaniedbyanincreasedriskforundesirableeffects

patientswithacreatinineclearance<10ml/minshouldbetreatedunderexpertsupervision.

Asaprecaution,renalfunctionshouldbemonitoredifrenalfunctionisalreadyimpaired.

Theremaybesomevariationontheresultsofbiochemicaltestsofrenalfunction,butthesedonotappeartobeof

clinicalimportance.

Specialcareshouldbetakeninpatientswithhepaticdysfunction.

Thereareinsufficientdataregardinguseofcefuroximeinpaediatricrenalinsufficiencyandthereforetheuseinthis

patientgroupisnotrecommended.

Cefuroximesolutionsareincompatiblewithaminoglycosideantibiotics(seesection6.2).

Emesisanddiarrhoeaduetotreatmentwithcefuroxime(seesection4.8)mightaffecttheefficacyofmedicinalproducts

whicharesimultaneouslyused,e.g.oralcontraceptives.Incaseofemesisanddiarrhoeaoralcontraceptivesshould,be

supplementedwithnon-hormonalcontraceptivemeasures.

CefuroximesodiumusemayresultinafalsepositiveCoombstest.Thismayinterferewiththeperformanceofcross

matchingtestswithblood(seesection4.8).

Eithertheglucoseoxidaseorthehexokinasemethodsarerecommendedtodeterminethebloodandplasmaglucose

levelsinpatientsreceivingCefuroximesodium.Cefuroximedoesnotinterfereinthealkalinepicrateassayfor

creatinine(seesection4.5).

Urinesugartestsusingreductionmethodsmayshowfalsepositivereactions;thereforeenzymaticmethodsshouldbe

used.

Thismedicineproductcontains3.6mmol(or78mg)ofsodiumper1500mgdosewhichshouldbetakeninto

considerationforpatientsonacontrolledsodiumdiet.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Potentialnephrotoxicmedicinalproductsandloopdiuretics

Cephalosporinantibioticsathighdosageshouldbegivenwithcautiontopatientsreceivingconcurrenttreatmentwith

potentdiureticssuchasfurosemide,aminoglycosidesandamphotericinasconcomitantuseincreasestheriskof

nephrotoxicity.

Bacteriostaticantibiotics

Sincebacteriostaticdrugsmayinterferewiththebactericidalactionofcephalosporins,itisadvisabletoavoidgiving

tetracyclines,macrolides,orchloramphenicolconcomitantlywithcefuroxime.Synergismmayexistwith

aminoglycosidesandmetronidazole.

Probenecid

Concomitanttherapywithprobenecidcanreducetherenalexcretionofcephalosporinsaccompaniedbyhigherand

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4.6Pregnancyandlactation

Pregnancy

DataonalimitednumberofexposedpregnanciesindicatenoadverseeffectsofCefuroxime forinjectiononthe

pregnancyoronthehealthofthefetus/newbornchild.Todatenootherrelevantepidemiologicaldataareavailable.

Animalstudiesdonotshowanyharmfuleffectsonembryonalandfetaldevelopment(seesection5.3).Cefuroxime

reachestheembryo/fetusviatheplacenta.Duetothelimitedclinicalexperience,CefuroximeMartindalePharma ®

750mgforInjectionshouldonlybeusedduringpregnancyaftercarefulrisk/benefitassessment,especiallyduringthe

firsttrimester.

Lactation

Cefuroximeisexcretedinhumanmilk.Cefuroximeshouldonlybeusedduringlactationaftercarefulrisk/benefit

assessment.Diarrhoeaandfungusinfectionofthemucousmembranescouldoccurinthebreast-fedinfant,sothat

nursingmighthavetobediscontinued.Thepossibilityofsensitisationshouldbeborneinmind.

4.7Effectsonabilitytodriveandusemachines

Cefuroximemaysometimesbeassociatedwithsideeffects,suchastheveryrarelyoccurringneurologicalundesirable

effects(vertigo,restlessness,nervousness,confusion),thatmayimpairtheabilitytodriveavehicle,tooperate

machineryortoworksafely(seesection4.8).

4.8Undesirableeffects

Dependentonthedoseanddurationofthetreatmentapproximately3%ofalltreatedpatientsareexpectedto

experienceoneorseveraloftheadversereactionsmentionedbelow.

Frequency

Organgroup VeryCommon

(>1/100and

<1/10) Common

(>1/1.000and

<1/100) Rare

(>1/10.000and

<1/1000) Veryrare

(<1/10.000),

includingisolated

reports Notknown

Infectionsand

infestations Pseudomembranous

colitis.

Aswithother

antibiotics

prolongedusemay

leadtosecondary

superinfections

causedby

insusceptible

organisms,e.g.

Candida,

Enterococciand

Clostridium

difficile(see

section4.4).

Bloodand

lymphaticsystem

disorders Thrombocytopenia,

eosinophilic

disorder,

neutropeniaand

leukopenia Decreased

haemoglobin

concentration,

agranulocytosis Haemolytic

anaemia

Immunesystem

disorders Serumsickness Anaphylaxis

Seesection4.4 Angioedema

Nervoussystem

disorders Headache,

dizziness Vertigo,

restlessness,

Nervousness,

confusion

Gastrointestinal

disorders Gastrointestinal

disturbances,

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4.9Overdose

Acutesymptomsandsignsofanoverdoseiscerebralirritation,whichmayleadtoconvulsions.Therecanbesequelae

informofbraindamage.

Thelevelofcefuroximeinserumcanbereducedbyincreasingthediuresisorbyhaemodialysisorperitonealdialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCclassification

Pharmacotherapeuticgroup:Second-generationcephalosporins

andvomiting

Hepato-biliary

disorders Transientrisein

serumliver

enzymesALT,

ASTandLDHand

bilirubin Jaundice

Skinand

subcutaneous

tissuedisorders Skinrashes,

urticaria,

Pruritus, Erythema

multiforme

Stevens-Johnson

syndrome,

Toxicepidermal

necrolysis

Renalandurinary

disorders Increasedlevelsof

creatinineandurea

inserum,

especiallyin

patientswith

impairedrenal

function.

Seesections4.2&

Acuteinterstitial

nephritis.

Nephrotoxicity.

Acuterenaltubular

necrosishas

followedexcessive

dosageandhas

alsobeen

associatedwithits

useinolder

patientsorthose

withpre-existing

renalimpairment

Seesections4.2&

Generaldisorders

andadministration

siteconditions Thrombophlebitis

andpainfollowing

i.v.injection.

Afterrapidi.v.

administrationheat

sensationsor

nauseamayoccur. Drugfever

Investigations Theuseof

cefuroximemaybe

accompaniedbya

falsepositive

Coombstest.This

mayinterferewith

theperformanceof

crossmatching

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Modeofaction

Allcephalosporins(-lactamantibiotics)inhibitcellwallproductionandareselectiveinhibitorsofpeptidoglycan

synthesis.Theinitialstepindrugactionconsistsofbindingofthedrugtocellreceptors,calledPenicillin-Binding

Proteins.Aftera -lactamantibiotichasboundtothesereceptors,thetranspeptidationreactionisinhibitedand

peptidoglycansynthesisisblocked.Bacteriallysisistheendresult.

PD/PKrelationship

Theefficacyismainlydeterminedbythelengthoftime,duringwhichthedruglevelisabovetheminimalinhibitory

concentrationofthepathogen.

Mechanismofresistance

Bacterialresistancetocefuroximemaybeduetooneormoreofthefollowingmechanisms:

hydrolysisbybeta-lactamases.Cefuroximemaybeefficientlyhydrolysedbycertainoftheextended-

spectrumbeta-lactamases(ESBLs)andbythechromosomally-encoded(AmpC)enzymethatmaybeinducedor

stablyderepressedincertainaerobicgram-negativebacterialspecies

reducedaffinityofpenicillin-bindingproteinsforcefuroxime

outermembraneimpermeability,whichrestrictsaccessofcefuroximetopenicillinbindingproteinsingram-

negativeorganisms

drugeffluxpumps

Methicillin-resistantstaphylococci(MRS)areresistanttoallcurrentlyavailable-lactamantibioticsincluding

cefuroxime.

Penicillin-resistantStreptococcuspneumoniaearecross-resistanttocephalosporinssuchascefuroximethrough

alterationofpenicillinbindingproteins.

Beta-lactamasenegative,ampicillinresistant(BLNAR)strainsofH.influenzaeshouldbeconsideredresistantto

cefuroximedespiteapparentinvitrosusceptibility.

StrainsofEnterobacteriaceae,inparticularKlebsiellaspp.andEscherichiacolithatproduceESBLs(extended

spectrum-lactamase)maybeclinicallyresistanttotherapywithcephalosporinsdespiteapparentinvitrosusceptibility

andshouldbeconsideredasresistant.

Breakpoints:

Theclinicalminimuminhibitoryconcentration(MIC)breakpoints(EUCAST,May2009)areasfollows

Susceptibilityofstaphylococcitocefuroximeisinferredfromthemethicillinsusceptibility.

ThesusceptibilityofstreptococcusgroupsA,B,CandGcanbeinferredfromtheirsusceptibilitytobenzylpenicillin.

Non-speciesrelatedbreakpoints:insufficientdata

Susceptibility:

Theprevalenceofresistancemayvarygeographicallyandwithtimeforselectedspeciesandlocalinformationis

desirable,particularlywhentreatingsevereinfections.Asnecessary,expertadviceshouldbesoughtwhenthelocal

prevalenceofresistanceissuchthattheutilityoftheagentinatleastsometypesofinfectionsisquestionable.Thishas

Sensitive Resistant

Enterobacteriaceae ≤8

>8

S.pneumoniae ≤0.5

>1

Streptococciotherthan

S.pneumoniaeand

streptococcusgroupsA,B,C

andG ≤0.5 >0.5

H.influenzae ≤1 >2

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Commonlysusceptiblespecies

Grampositiveaerobes

Staphylococcusaureus(methicillin-susceptible)

Streptococcusagalactiae

Streptococcuspyogenes

Gramnegativeaerobes

Proteusmirabilis

Speciesforwhichacquiredresistancemaybeaproblem

Grampositiveaerobes

Staphylococcusepidermidis

Staphylococcushaemolyticus

Staphylococcushominis

Streptococcuspneumoniae 1

Gramnegativeaerobes

Citrobacterfreundii

Citrobacterkoseri

Enterobacteraerogenes

Enterobactercloacae

Escherichiacoli

Haemophilusinfluenzae

Klebsiellaoxytoca

Klebsiellapneumoniae

Moraxellacatarrhalis

Inherentlyresistantorganisms

Grampositiveaerobes

Enterococcusspp.

Listeriamonocytogenes

Staphylococcusaureus(methicillin-resistant) 2

Staphylococcusepidermidis(methicillin-resistant)

Gramnegativeaerobes

Acinetobacterbaumannii

Burkholderiacepacia

Campylobacterspp.

Morganellamorganii

Proteusvulgaris

Pseudomonasaeruginosa

Serratiaspp.

Stenotrophomonasmaltophilia

Anaerobes

Bacteroidesspp.

Clostridiumdifficile

Others

Chlamydiaspp.

Chlamydophilaspp.

Legionellaspp.

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1.Streptococciresistanttopenicillinarealwaysresistanttocefuroxime

2.Staphylococciresistanttomethicillinareresistanttootherbeta-lactams

5.2Pharmacokineticproperties

Absorption

Cefuroximeispoorlyabsorbedfromthegastro-intestinaltractandisgivenbyintramuscularorintravenousinjectionor

infusionasthesodiumsalt.Followingintravenousdosesof750mgand1,500mg,serumpeakconcentrations(C

wereapproximately50µg/mland100µg/ml,respectively,after15minutes(t

Peakplasmaconcentrationsof27 µ

gpermlhavebeenachievedabout45minutesafteranintramusculardoseof750

mgwithmeasurableamountspresent8hoursafteradose.

Distribution

Cefuroximeiswidelydistributedinthebodyandlevels,thatexceedtheMIC-valuesofmostpathogens,areachieved

pleuralfluid,sputum,bone,synovialfluid,andaqueoushumour,butonlyachievestherapeuticconcentrationsinthe

CSFwhenthemeningesareinflamed.Thevolumeofdistributionrangesbetween9.3and15.8l/1.73m 2

inhealthy

adults.About33%to50%ofcefuroximeinthecirculationisboundtoplasmaproteins.Itdiffusesacrosstheplacenta

andhasbeendetectedinbreastmilk.

Biotransformation

Cefuroximeismetabolizedonlytoaminorextent(<5%).

Elimination

Theeliminationhalf-liferangesbetweenabout70and80minafterintramuscularorintravenousadministrationin

healthyadults.Mostofthedoseofcefuroximeisexcretedunchangedinactiveform.About50%isexcretedby

glomerularfiltrationandabout50%throughrenaltubularsecretionwithin24hours,withthemajoritybeingeliminated

within6hours;highconcentrationsareachievedintheurine.Smallamountsofcefuroximeareexcretedinbile.The

renalclearanceis136.0and169.6ml/min/1.73m 2

after0.5and1gcefuroximeintravenousand137.9and

146.3ml/min/1.73m 2

after0.750and1gcefuroximeintramuscular,respectively.Theeliminationisimpairedin

patientswithimpairedrenalfunction.

Concomitantadministrationoforalprobenecidslowstubularsecretionofcefuroximeanddecreasesrenalclearanceby

approximately40%.

Oralprobenecid(1g)prolongedthehalf-lifeby63%andincreasedtheareaundertheconcentration-timecurveof

intravenouscefuroxime(750mg)byupto50%.

Cefuroximeisdialysableandsmallamountsareremovedbyperitonealdialysis.

Linearity/non-linearity

Thepeakplasmaconcentrationandtheareaundertheconcentrationcurveincreasewithincreasingdose.

Pharmacokineticsinspecialpatientgroups

Thehalf-lifeofcefuroximeisprolongedinpatientswithrenalimpairmentassociatedwiththeriskofaccumulation.

Theserumhalf-lifeis4.2hoursatacreatinineclearanceof23ml/minand22.3hoursatacreatinineclearanceof5

ml/min.Thereforedoseadjustmentisrequiredinpatientswithimpairedrenalfunction(seesection4.2).

Theserumhalf-lifeisprolongedinpretermandtermnewborninfantsduringthefirstweeksoflife(3to5timesthe

valueinadults).

5.3Preclinicalsafetydata

Effectsinnon-clinicalstudieswereobservedonlyatexposuresconsideredsufficientlyinexcessofthemaximum

Mycoplasmaspp. Irish Medicines Board

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Preclinicalnephrotoxicitystudiesshowedtheproductcancauserenaldamageinsomespecieswhenadministeredin

veryhighdoses.Itsnephrotoxicityincreaseswhenadministeredincombinationwithglycerolandfurosemide.

Themostprominenttreatment-relatedeffectwastissuedamageattheinjectionsites.

Investigationsinrabbitsandmicedidnotdemonstratereproductivetoxicityorteratogenic-effects.Cefuroximehas

beenshowntopasstheplacenta.

Gamma-glutamyltranspeptidaseactivityinraturineisinhibitedbyvariouscephalosporins,however,thelevelof

inhibitionislesswithcefuroxime.Thismayhavesignificanceintheinterferenceinclinicallaboratorytestsinhumans.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

None.

6.2Incompatibilities

Thismedicinalproductmustnotbemixedwithothermedicinalproductsandothersolutionsforinjectionexcept

thosementionedinsection6.6.

Cefuroximeshouldnotbemixedinthesyringewithaminoglycosideantibiotics.

Mixingofcefuroximewithsodiumbicarbonatesolutionssignificantlyaffectsthe

colourofthesolution.Therefore,thissolutionisnotrecommendedforthedilutionof

cefuroxime.Ifrequired,thecefuroximesolutioninwaterforinjectionscanbe

introducedintothetubingofthegivingsetinpatientsreceivingsodiumbicarbonate

solutionbyinfusion.

6.3ShelfLife

1year

Fromamicrobiologicalpointofview,theproductshouldbeusedimmediatelyafterreconstitution.Ifnotused

immediately,in-usestoragetimesandconditionspriortouseareresponsibilityoftheuser.

6.4Specialprecautionsforstorage

Unopened:Storebelow25ºCintheoriginalcartoninordertoprotectfromlight.

Forstorageconditionsafterreconstitution,seesection6.3

6.5Natureandcontentsofcontainer

Packedsinglywith20mlclearglassvial(Type-III)stopperedwithbromo-butylrubberplug,andsealedwithRed

Colouredflip-offaluminumseals.

6.6Specialprecautionsfordisposalandotherhandling

Intravenousinjection

Addwaterforinjectionimmediatelybeforeuse:

Dissolvethecontentsofthevialin15mlofwaterforinjections

Shakeuntilaclearsolutionisobtained.

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Differencesincolourandintensitydonothaveanyinfluenceonthesafetyandefficacy.Followingreconstitutionthe

totalvolumeofvialis16ml.

AnaqueoussolutionofcefuroximehasapHvalueof6.0-8.5.

Cefuroximecanbemixedwiththefollowingsolutionsforinjection:

-Waterforinjection

-sodiumchloride9mg/ml(0,9%)solution

-glucose50mg/ml(5%)solution

Asforallparenteralmedicinalproducts,inspectthereconstitutedsolutionvisuallyforparticulatematterand

discolorationpriortoadministration.Thesolutionshouldonlybeusedifthesolutionisclearandpracticallyfreefrom

particles.

Forsingleuseonly.Anyremainingsolutionshouldbediscarded.

Emptyvialsandanyunusedmedicalproductsshouldbereturnedtopharmacy/supplierortothelocalwastedisposal

site.

7MARKETINGAUTHORISATIONHOLDER

MartindalePharmaceuticalsLtd

BamptonRoad,HaroldHill

Romford

RM38UG

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA361/30/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:18thJune2010

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