CEFTAZIDIME

Main information

  • Trade name:
  • CEFTAZIDIME Pdr for Soln for Injection 250 Milligram
  • Dosage:
  • 250 Milligram
  • Pharmaceutical form:
  • Pdr for Soln for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEFTAZIDIME Pdr for Soln for Injection 250 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0361/033/004
  • Authorization date:
  • 03-06-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Ceftazidime250mgPowderforsolutionforinjection

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachvialcontains291mgofceftazidimepentahydrate,equivalentto250mgofceftazidime

Excipient:each250mgvialofpowdercontains30mgofsodiumcarbonate

Thismedicinalproductcontains0.57mmol(or13mg)ofsodiumpervial

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Powderforsolutionforinjection

Thepowderiswhiteoroff-white

4CLINICALPARTICULARS

4.1TherapeuticIndications

Ceftazidimeisindicatedfortreatmentofthefollowingbacterialinfectionswhentheyarecausedbyceftazidime-

sensitivebacteria,andonlyifbeta-lactam-antibioticswithanarrowerspectrumcannotbeused:

Nosocomialpneumonia

BronchopulmonaryinfectionsincysticfibrosiscausedbyPseudomonasaeruginosa

Meningitiscausedbyaerobicgram-negativemicroorganisms

Considerationshouldbegiventoofficialguidanceontheappropriateuseofantibacterialagents.

4.2Posologyandmethodofadministration

Posology

Thedosedependsonthedegreeofseverityoftheinfection,sensitivityandtypeofinfection,andontheage,weight

andrenalfunctionofthepatient.

Withnormalrenalfunction

Agegroup Infection Normaldose

Adults Mostindications 1gevery8hours(3g/day)

or2gevery12hours(4

g/day)

Nosocomialpneumoniaand

infectionsinpatientswith

neutropaenia 2gevery8hours(6g/day)

Bronchopulmonary

infectionsincysticfibrosis

causedbyPseudomonas

aeruginosa 100-150mg/kg/day,divided

into3doses;9g/daymust

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Theplasmahalf-lifeofceftazidimemaybe3-4timesthehalflifeinadults

Elderly:InviewofthereducedclearanceofCeftazidimeinacutelyillelderlypatients,thedailydosageshouldnot

normallyexceed3g,especiallyinthoseover80yearsofage.

Thedurationoftreatmentdependsonpatientresponse.Generallytreatmentmustcontinueforatleast48hoursafter

clinicalconvalescence.

Impairedrenalfunction

Ceftazidimeisnotmetabolisedandonlyeliminatedbyglomerularfiltration.Inpatientswithimpairedrenalfunction

(i.e.creatinineclearance<50ml/min)thedoseshouldbereducedaccordingtothefollowingtabletocompensatefor

theextendedelimination.Aloadingdoseof1000mgofceftazidimemaybegiven,followedbyasuitablemaintenance

doseasindicatedinthetable.

*Thesevaluesareforguidanceonlyandcannotaccuratelypredicttherenalfunctionofallthepatients,particularlyin

elderlypatientswheretheserumcreatinineconcentrationmaybeduetoanoverestimatedrenalfunction

Inpatientwithacombinationofrenalinsufficiencyandseriousinfections,particularlyinpatientswithneutropaenia,a

singledose,asindicatedintheabovetable,canbeincreasedby50%orthedosingfrequencycanbesuitablyincreased.

Inthesepatientstheplasmaconcentrationofceftazidimeshouldbemonitored,ifpossible,andtheminimum

concentration(bloodsampletakenimmediatelybeforethenextdose)shouldnotexceed40mg/l.

Inchildrenwithrenalinsufficiencythecreatinineclearanceshouldbeadjustedonthebasisofbodyareaormeanbody

weight(withoutfat)andthedosingfrequencyshouldbereducedasforadults.

Patientsinhaemodialysis

Theplasmahalf-lifeofceftazidimeunderhaemodialysisvariesfrom3-5hours.Theappropriatemaintenancedoseof

ceftazidimeshouldberepeatedaftereachhaemodialysisperiod.Inpatientswithkidneyfailure,whoareundergoing

continuousatrio-venoushaemodialysisorhigh-fluxhaemofiltrationintheintensivecaredepartment,adoseof1gper

dayisrecommended,dividedintoseveraldoses.Inthecaseoflow-fluxhaemofiltrationadosespecifiedforimpaired

functionisrecommended.

Inpatientswhoareundergoingvenoushaemofiltrationandvenoushaemodialysisthedosingrecommendationsinthe

Infantsandchildrenaged

overtwomonths Mostindications 30-100mg/kg/day,divided

into2or3doses

Infectedneutropenic

paediatricpatients,paediatric

patientswithcysticfibrosis

orpaediatricpatientswith

meningitis Upto150mg/kg/day(a

maximumof6gtotalper

day)dividedinto3doses

Neonatesandchildrenupto

2monthsofage Mostindications 25-60mg/kg/daydivided

into2doses *

Creatinineclearance

ml/min Approximateserum

creatinine*µmol/l

(mg/dl) Recommended

singledoseof

ceftazidime(g) Dosingfrequency,

indicatedinhours

50-31 150-200(1.7-2.3) 1 12

30-16 200-350(2.3-4.0) 1 24

15-6 350-500(4.0-5.6) 0.5 24

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Ceftazidimedosingguidelineduringcontinuousvenoushaemofiltration:

Themaintenancedoseisadministeredevery12hours

Ceftazidimedosingguidelineduringcontinuousvenoushaemodialysis:

Themaintenancedoseisadministeredevery12hours

Posologyinthecaseofhepaticinsufficiency

Nodoseadjustmentisrequiredunlessrenalfunctionisalsoimpaired.

Routesofadministration

Ceftazidimeshouldbeadministeredintravenously(bybolusinjection)orbydeepintramuscularinjectionintoalarge

musclemass,suchastheupperouterquadrantofthegluteusmaximusorlateralpartofthethigh.

Forpreparationofsolutionforinjection(seesection6.6).

4.3Contraindications

HypersensitivitytoCeftazidimeortoanyothercephalosporinantibiotics.

Previous,immediateand/orseverehypersensitivityreactiontopenicillinoranybeta-lactamantibiotic.

4.4Specialwarningsandprecautionsforuse

Itisrecommendedthatresultsfrombacteriaculturesandsensitivitytestsareobtainedbeforetreatmentisinitiated.This

Residual

renalfunction

(creatinine

clearance

ml/min) Maintenancedose(mg)atanultrafiltrationrate(ml/min)of a

16.7 33.3 50

Residual

renalfunction

(creatinine

clearance

ml/min) Maintenancedose(mg)atadialysatein-flowrate

of a

1.0litre/hour 2.0litres/hour

Ultrafiltrationrate

(litres/hour) Ultrafiltrationrate

(litres/hour)

500500 750

500500 750

500750 1000

750750 1000

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Ceftazidimeshouldbeusedincombinationwithanotherantibioticwhentreatinginfectionsthatareprobablyduetoa

mixtureofsensitiveandresistantstrainsofbacteria.Forexample,combinationtreatmentwithanantibacterial

substancethatisactiveagainstanaerobicbacteriashouldbeconsiderediftheinfectionisassumedtobeduetoaerobic

andanaerobicbacteria.

Specialcareisindicatedinpatientswhohaveexperiencedanyallergicreactiontopenicillinsoranyotherbeta-lactam-

antibioticsascross-reactionsmayoccur(forcontraindicationsduetoknownhypersensitivityreactionsseesection4.3).

SensitivebacterialstrainsofEnterobacterspp.andSerratiaspp.maydeveloparesistanceduringceftazidime

treatment.Ifitisclinicallyappropriateduringthetreatmentofsuchinfections,aperiodicsensitivitytestshouldbe

considered.

Antibiotic-associateddiarrhoea,colitisandpseudomembranouscolitisassociatedwithClostridiumdifficilehavebeen

reportedduringtheuseofceftazidime.Thesediagnosesshouldbeconsideredinanypatientwhodevelopsdiarrhoea

duringorimmediatelyaftertreatment.Ceftazidimeshouldbediscontinuedifsevereand/orbloodydiarrhoeaoccurs

duringtreatment,orasuitabletreatmentshouldbeinitiated.Peristalticinhibitorsarecontraindicated.

Ceftazidimeshouldbeusedwithcautioninpatientswithgastrointestinaldiseases,particularlycolitis.

Ceftazidimehasnotbeenshowntobenephrotoxic.However,thetotaldailydoseshouldbereducedwhenceftazidime

isadministeredtopatientswithacuteorchronicrenalinsufficiencytoavoidpossibleclinicalconsequencessuchas

convulsiveattacks(seepoint4.2).

Cephalosporinantibioticsshouldbegivenwithcautiontopatientsbeingtreatedconcomitantlywithnephrotoxicdrugs,

e.g.aminoglycosideantibioticsorstrongdiuretics(e.g.furosemide),sincethesecombinationsmayhaveanegative

influenceonrenalfunctionandhavebeenassociatedwithototoxicity(seepoints4.5and4.8).

Ceftazidimeandaminoglycosidesshouldnotbemixedinthesolutionforinjectionbecauseoftheriskforprecipitation

(seesection6.2).

TheuseofceftazidimemayresultintheproliferationofresistantmicroorganismssuchasEnterococciandCandida

spp.

Duringlong-termtreatmentwithceftazidimeitisrecommendedthatthebloodcompositionofthepatientberegularly

monitoredandthatregularbloodsamplesaretakentomonitorhepaticandrenalfunction.

Ifcopperreductionmethodsareemployed(Benedict’stest,Fehling’stest,Clinitest),minorinterferencemaybeseen

whenceftazidimeisadministered.Enzyme-basedtestsforglucosuriaarenotinfluenced,noristhealkalinepicrate

assayofcreatinine.

ThedevelopmentofapositiveCoombs’testin5%ofpatientswhenusingceftazidimemayinterferewithbloodcross-

matching.

Sodiumcontent

Thisproductcontainssodium(seesection2).

Patientsonacontrolledsodiumdietmustallowforthesodiumcontent.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Chloramphenicol,macrolidesandtetracyclineshavebeenshown,invitro¸tohaveanantagonisticeffectonceftazidime

andothercephalosporins.Theclinicalrelevanceofthisisnotknown,butifconcomitantadministrationofceftazidime

andchloramphenicol(orotherbacteriostaticsubstances:e.g.tetracycline,macrolidesorsulphonamides)isproposed,

thepossibilityofantagonismshouldbeconsidered.

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4.6Fertility,pregnancyandlactation

Pregnancy

Therearelimitedamountsofdatafromtheuseofceftazidimeinpregnantwomen.Animalstudiesdonotindicatedirect

orindirectharmfuleffectswithrespecttopregnancy,embryonal/foetaldevelopment,parturitionorpostnatal

development(seesection5.3).

Cautionshouldbeexercisedwhenprescribingtopregnantwomen.

Lactation

Ceftazidimeisexcretedinhumanmilkinsmallquantitiesbutattherapeuticdosesofceftazidimenoeffectsonthe

breast-fedinfantareanticipated.Ceftazidimecanbeusedduringbreast-feeding.

4.7Effectsonabilitytodriveandusemachines

Nostudiesontheeffectsontheabilitytodriveandusemachineshavebeenperformed.

Considerationshouldbegiventothefactthatdizzinessandconvulsionsmayoccurwhendrivingorusemachines.

4.8Undesirableeffects

Withineachfrequencygrouping,undesirableeffectsarepresentedinorderofdecreasingseriousness.

Approx.5%ofthepatientstreatedsufferfromundesirableeffects.

Organsystem

class Common(>1/100

to<1/10) Uncommon(>

1/1,000to<1/100) Rare(>1/10,000to

<1/1,000) Veryrare

(<1/10,000)

Bloodand

lymphaticsystem

disorders Eosinophilia,

thrombocytosis Thrombocytopaenia,

leucopaenia,

neutropaenia,

lymphocytosis.

PositiveCoomb’stest Agranulocytosis,

haemolyticanaemia

Immunesystem

disorders Angioneurotic

oedema,

anaphylactic

reactions

Nervoussystem

disorders Headache,dizziness,

consciousness

disorders,

paraesthesiasand

dysgeusia,

convulsions

Hepatobiliary

disorders Increasedserum

activityofliver

derivedenzymes,

e.g.gammaglutamyl

transferase,lactate

dehydrogenase,

alkalinephosphatase,

alaninetransminase,

aspartate

Jaundice

Gastrointestinal

disorders Nausea,vomiting,

diarrhoea,stomach

pains Thrush,

pseudomembranous

colitis

Skinand

subcutaneous Urticariarash,

pruritus,redness, Erythema

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Therehavebeenreportsofneurologicalafter-effects,includingtremor,myoclonus,convulsions,encephalopathyand

comainpatientswithimpairedrenalfunctionwhoseceftazidimedosehasnotbeensuitablyreduced.

ThereisariskofsuperinfectionswithEnterococcusandCandidastrains,forexample.

Nephrotoxicityhasbeenreportedafterconcomitantadministrationofcephalosporinsandaminoglycosideantibioticsor

strongdiuretics,e.g.furosemide.Renalfunctionshouldbecloselymonitored,particularlyifhigherdosesof

aminoglycosidearegivenorifthetreatmentisextendedbecauseofthepotentialnephro-andototoxicityof

aminoglycosideantibiotics(seepoints4.4and4.5).

4.9Overdose

Anoverdoseofceftazidimemaybeassociatedwithpain,inflammationandphlebitisatthepointofinjection.

Overdoseoradministrationofunsuitablyhighdosescombinedwithrenalinsufficiencymayresultinneurological

after-effects,includingdizziness,paraesthesias,headache,encephalopathy,convulsionsandcoma.

Abnormallaboratoryvalueswhichmayoccurafteranoverdoseincludeanincreaseinserumconcentrationsof

bilirubin,creatinine,urea,increaseintheserumactivityofliver-derivedenzymes,e.g.ASATandALAT,positive

Coombs’test,thrombocytosis,thrombocytopaenia,eosinophilia,leucopaeniaandanextensionofprothrombintime.

Generalsymptomaticandsupportiveproceduresshouldbeinstitutedtogetherwithspecificproceduresaimedat

monitoringconvulsiveattacks.Incaseofaseriousoverdose,particularlyinpatientswithrenalfailure,combined

haemodialysisandhaemoperfusionmaybeconsideredifthereisnoresponsetomoreconservativetreatment.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:OTHERBETA-LACTAMANTIBACTERIALS,thirdgenerationcephalosporins

ATCcode:J01DD02

Mechanismofaction

tissuedisorders maculopapulous

rash(exanthema) Johnsonsyndrome,

toxicepidermal

necrolysis

Renaland

urinarydisorders Reductionof

glomerularfiltration

rateandincreasein

serumconcentration

ofureaand

creatinine

Pregnancy,

puerperiumand

perinatal

conditions Vaginalcandidiasis,

vaginitis

General

disordersand

administration

siteconditions Phlebitisor

thrombophlebitis,

pains,

inflammationof

thepointof

injectionor

intravenous

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beta-lactamdrugs,ceftazidimedisplaysantibacterialactivitybybindingitselftoandinhibitingtheactionofcertain

synthesisenzymes(transpeptidases)inthecellwallofthebacteria.Inhibitionofoneormoreoftheseessential

penicillin-bindingproteinsresultsinaninterruptionincellwallbiosynthesisinthefinalstageofpeptidoglycane

production,whichgivesrisetodissolutionofthecellofthebacteriumanditsdeath.

PK/PDrelationship

Theantibacterialisdependentonthetimethefreeconcentrationinserum/urineexceedstheirMIC-value.

Resistancemechanism

Bacterialresistancetoceftazidimemaybeduetooneormoreofthefollowingmechanisms:

hydrolysisbymeansofbetalactamases.Ceftazidimecanbeeffectivelyhydrolysedbysomeofthebroad

spectrumbeta-lactamases(ESBLs)andbychromosomedecoded(AmpC)enzymeswhichcanbe

inducedorundergostablede-repressionincertainaerobicgram-negativestrainsofbacteria

reducedaffinityofpenicillin-bindingproteinstoceftazidime

exteriormembraneimpermeabilitywhichlimitstheaccessofceftazidimetopenicillin-bindingproteinsin

gram-negativebacteria

drugeffluxpumps

Morethanoneoftheseresistancemechanismsmayoccursimultaneouslyinonesinglebacterialcell.Dependingonthe

existingmechanism(s)bacteriamaydisplaycross-resistancetoseveralorallotherbeta-lactamsand/orantibacterial

substancesbelongingtoanotherclass.

Breakpoints(accordingtoEUCAST)

ClinicalMICbreakpointsforseparatingsensitive(S)pathogensfromresistant(R)pathogensaccordingtoEUCAST

(27.04.2010)are:

Enterobacteriaceae:S<1.0mg/l;R>4mg/l

Pseudomonasspp.:S<8*mg/l;R>8mg/l

Non-speciesrelatedbreakpoints:S<4mg/l;R>8mg/l

*Thebreakpointsrelatetohighdosetherapy(2gx3)

Sensitivity

Theprevalenceofacquiredresistancemayverygeographicallyandwithtimeforselectedspeciesandlocalinformation

onresistanceisdesirable,particularlywhentreatingsevereinfections.Asnecessary,expertadviceshouldbesought

whenthelocalprevalenceofresistanceissuchthattheutilityoftheagentinatleastsometypesofinfectionsis

questionable.

Commonlysusceptiblespecies

Gram-positivemicroorganisms

Streptococcusagalactiae(groupB)

Streptococcuspyogenes

Gram-negativemicroorganisms:

Haemophilusinfluenzae

Moraxellacatarrhalis

Proteusmirabilis ++

Proteusvulgaris

Serratialiquefaciens

Speciesforwhichacquiredresistancemaybeaproblem

Gram-positivemicroorganisms:

StaphylococcusaureusMSSA

Streptococcuspneumoniae#

Gram-negativemicroorganisms:

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++ESBLproducingstrainsarealwaysresistant

+++Inatleastoneregiontheresistanceisover50%

#Exhibitssomein-vitroactivitytopenicillin-sensitivestrains,butthisshouldnotbereliedoninthetreatment

ofpneumococcalinfections

5.2Pharmacokineticproperties

Meanmaximumserumconcentrationsafterdifferentdoseswereasfollowsinpersonswithnormalrenalfunction.

*measuredinpatientswithcysticfibrosiswhosedistributionvolumemaybeincreased

Generallytheplasmaconcentrationofceftazidimeexceeds2mg/l8hoursafterintramuscularadministrationof500mg

ormore.

Afterrepeatedintravenousdosesof1and2gevery8hoursfor10days,nosignsofaccumulationofceftazidimewere

seenintheseruminpersonswithnormalrenalfunction.

Distribution

Acinetobacterspp.

Burkholderiacepacia

Citrobacterfreundii

EnterobacteraerogenesandEnterobactercloacae

Klebsiellapneumoniae ++

Klebsiellaoxytoca ++

Morganellamorganii

Pseudomonasaeruginosa

Serratiamarcescens

Stenotrophomonasmaltophilia +++

Inherentlyresistantorganisms

Gram-positivemicroorganisms:

Enterococcusspp.

Staphylococcusaureus,methicillinresistant(MRSA)

Staphylococcus–coagulasenegative,methicillinresistant.

Anaerobes:

Bacteroidesfragilis

Clostridiumdifficile

Other:

Chlamydiaspp.

Chlamydophilaspp.

Legionellaspp.

Mycoplasmaspp.

Treponemapallidum

Intramuscular

injection(after1

hour) Intravenousbolus

injection

(after5minutes)

250mg --- 26mg/l

500mg 18mg/l 45mg/l

1g 39mg/l 90mg/l

2g --- 170mg/l

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Ceftazidimeconcentrationswhicharehigherthantheminimuminhibitionconcentrationforgeneralpathogenscanbe

obtainedintissuessuchasbones,heartandgallbladder,sputum,chamberwall,synovial,pleuralandperitonealfluids.

Ceftazidimequicklypassesthroughtheplacenta.

Ceftazidimeonlypassesthroughtheblood-brainbarriertoasmallextentandlowconcentrationsareobtainedinthe

cerebrospinalfluidintheabsenceofinflammation.Therapeuticlevelsof4-20mg/mlormoreareobtainedinthe

cerebrospinalfluidinthecaseofmeningealinflammation.

Elimination

Approx.80-90%ofaceftazidimedoseiseliminatedunconvertedviathekidneysoveraperiodof24hours,which

givestohighconcentrationsintheurine.

Inpersonswithnormalrenalfunctionthehalflifeofceftazidimeisapprox.2hoursafterintramuscularadministration.

Impairedliverfunctionhadnoeffectonthepharmacokineticsofceftazidimeinpersonswhoreceived2gintravenously

every8hoursfor5days.Doseadjustmentisnotthereforenecessaryinpatientswithimpairedhepaticfunctionunless

therenalfunctionisalsoimpaired.

5.3Preclinicalsafetydata

Non-clinicaldatarevealnospecialhazardforhumansbasedonconventionalstudiesofsafetypharmacology,repeat

dosetoxicity,genotoxicity,toxicitytoreproduction.Carcinogenicitystudieshavenotbeenperformedwithceftazidime.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

AnhydrousSodiumCarbonate

6.2Incompatibilities

Ceftazidimeandaminoglycosidesmustnotbemixedinthesameinfusionsolutionduetotheriskofprecipitation.

Cannulaeandcathetersforintravenousapplicationmustberinsedwithisotonicsaltwaterbetweentheadministration

ofceftazidimeandvancomycintoavoidprecipitation.

Thismedicinalproductmustnotbemixedwithothermedicinalproductsexceptthosementionedinsection6.6.

6.3Shelflife

Vialbeforebreakingopen:

1year

Vialafterbreakingopen:

Theproductshouldbeusedimmediately

Afterreconstitution:

Theproductshouldbeusedimmediately

Fromthemicrobiologicalpointofview,theproductmustbeusedimmediately.Ifnotusedimmediately,in-usestorage

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Chemicalandphysicalin-usestabilityhasbeendemonstratedfor:

6hoursat2ºC-8 o

CwhenpreparedinSterileWaterforInjection

12hoursat2ºC-8 o

Cwhenpreparedin1%LidocaineHydrochlorideInjection

6.4Specialprecautionsforstorage

Unopened:

Storebelow25°C

Keepthevialintheoutercartoninordertoprotectfromlight

Forstorageconditionsofthereconstitutedmedicinalproduct,seesection6.3.

6.5Natureandcontentsofcontainer

250mgpowderforinjection

Clear,colourlesstypeIglassvial(10ml)withbromobutylrubberstopperandpolypropyleneflip-offaluminiumseal,

20mmorangecoloured,bothsideslacquered.Thevialsareplacedincartons.Packsizes:boxesofone,fiveorten

vials.Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

Disposal

Forsingleuseonly.Discardanyunusedsolution.

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

Thedilutionistobemadeunderasepticconditions.Thesolutionistobeinspectedvisuallyforparticulatematterand

discolorationpriortoadministration.Thesolutionshouldonlybeusedifthesolutionisclearandfreefromparticles.

Instructionsforreconstitution:

CeftazidimeshouldbereconstitutedwithSterileWaterforInjectionor1%LidocaineHydrochlorideInjection

(intramuscularuseonly)(seethefollowingtable).

PreparationofsolutionsofCeftazidime

Allvialsassuppliedareunderreducedpressure.

Whenceftazidimeisdissolved,carbondioxideisreleasedandapositivepressuredevelops.Foreaseofuse,followthe

recommendedtechniquesofreconstitutiondescribedbelow.

Preparationfordirectadministrationfor250mg

Thefollowingreconstitutionguidelinesshouldbefollowed:

1.Insertthesyringeneedlethroughtheoriginalvialclosureandinjecttherecommendedvolumeofdiluent.The

vacuummayassistentryofthediluent.

Amountofdiluenttobe

added(ml) Approximateceftazidime

concentration(mg/ml)

Intramuscular

250mg 1.0 210

Intravenous-Injection

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3.Shaketheoriginalvialtodissolvethecontent.Carbondioxideisreleasedandaclearsolutionwillbeobtainedin

about1to2minutes.

4.Inverttheoriginalvial.Withthesyringeplungerfullydepressed,inserttheneedlethroughthevialclosureand

withdrawthetotalvolumeofsolutionintothesyringe(thepressureinthevialmayaidwithdrawal).Ensurethatthe

needleremainswithinthesolutionanddoesnotentertheheadspace.

5.Thewithdrawnsolutionmaycontainsmallbubblesofcarbondioxide;theymaybedisregarded.

Forintravenousinjection,thesolutionmustbeadministereddirectlyintothevein.

Pleaserefertosection6.3forinusestabilityofthereconstitutedproduct.

Extemporaneoussolutionsforpaediatricsingledosesaretobereconstitutedwiththemostadequatestrengthinorderto

reduceasfaraspossiblevolumestobediscarded.Multipleuseofthesingledosecontainersisnotappropriate.The

reconstitutedproductshouldbeusedimmediately(seesection6.3).

Solutionsrangefromlightyellowtoamberdependingonconcentration,diluentandstorageconditionsused.Within

thestatedrecommendations,productpotencyisnotadverselyaffectedbysuchcolourvariations.

Beforeadministration,thereconstitutedanddilutedsolutionsshouldbeinspectedvisuallyforparticulatematterand

discoloration.Onlyclear,andcolourlesssolutionfreefromparticlesshouldbeused.

7MARKETINGAUTHORISATIONHOLDER

MartindalePharmaceuticalsLtd

BamptonRoad

HaroldHill

Romford

RM38UG

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA361/33/4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:3rdJune2011

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