CEFOTAXIME 1 Grams Pdr for Soln for Injection

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
CEFOTAXIME SODIUM
Available from:
Teva Pharma B.V.
ATC code:
J01DD01
INN (International Name):
CEFOTAXIME SODIUM
Dosage:
1 Grams
Pharmaceutical form:
Pdr for Soln for Injection
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Third-generation cephalosporins
Authorization status:
Authorised
Authorization number:
PA0749/012/002
Authorization date:
2006-11-10

Package Leaflet:Informationforthe patient

Cefotaxime 500 mgPowderfor Solutionfor Injection

Cefotaxime1000 mgPowderfor Solutionfor Injection

Cefotaxime

Read allofthis leafletcarefully before youstarttakingthismedicinebecauseitcontainsimportant

informationforyou.

Keep thisleaflet. You mayneedto readitagain.

Ifyou haveanyfurtherquestions,askyourdoctor, nurseorpharmacist.

This medicine hasbeen prescribedforyouonly.Donotpass itonto others. Itmay harmthem, evenif

theirsigns ofillnessarethesame as yours.

Ifyou getanyside effects,talkto yourdoctor, nurseorpharmacist.Thisincludesanypossibleside

effectsnotlistedinthis leaflet.Seesection 4.

Whatisin thisleaflet:

1. WhatCefotaxime is and whatitis usedfor

2. Whatyou needto knowbefore youtakeCefotaxime

3. HowtotakeCefotaxime

4. Possibleside effects

5. Howto store Cefotaxime

6. Contents ofthe packand otherinformation

1. WHATCEFOTAXIMEIS ANDWHATIT IS USEDFOR

Cefotaxime 500 mgPowderfor Solutionfor InjectionandCefotaxime1000mgPowderfor Solution

for Injection containcefotaxime.

Cefotaxime belongs to a group ofdrugs called antibiotics, whichareused totreatbacterialinfections.

Cefotaxime isusedtotreatinfectionsofthefollowing:

Chest(respiratorytract)

Kidneys, bladderandurethra (the tubethatcarries urine fromthebladder)

Skin andsofttissues

Abdomen, such asperitonitis

Cefotaxime isalso used to treatatype ofsexuallytransmitted diseasecalled gonorrhoea.

Cefotaxime canalso be used totreatotherinfections, such as meningitis.

2.WHATYOUNEEDTOKNOWBEFOREYOUTAKECEFOTAXIME

Do notuseCefotaxime:

Ifyou are allergicto cefotaxime oranyofthe otheringredients ofthis medicine(listedinsection 6)

Ifyou are allergicto certainotherantibiotics(e.g. penicillins,cephalosporins)

Ifyou are allergicto lidocaine and you areto be givencefotaxime as aninjectioninto a muscle

Warnings and precautions

Talkto yourdoctorornurse beforeusingthis medicine.

Ifyou are allergic to cefotaxime oranyotherantibiotic

Seriousskinrasheshavebeenreportedwiththeuseofcefotaxime.Therashmayprogressto

widespreadblisteringandpeelingoftheskin(Seesection4).Ifyoudeveloparashortheseskin

symptoms,contactyourdoctorimmediately.

Ifyou have aprevioushistoryofallergiesorasthma

Ifyou have everhad colitis(inflammation ofthebowels)

Ifyou have kidneyproblems

High doses ofcefotaxime, especiallyinpatients with kidneyproblems, mayresultinencephalopathy

(e.g. impairmentofconsciousness, abnormalmovements and convulsions)(Seesection 4).You should

contactyourdoctorimmediatelypriorto continuingtreatmentifsuch reactions occur.

Ifyou are on asodiumcontrolled diet

Ifyourtreatmentlastslongerthan 7days, yourdoctorwillneedtocarryoutbloodtests

OthermedicinesandCefotaxime

Tellyourdoctorornurse ifyou are taking, have recentlytakenormighttakeanyothermedicines.

Antibiotics (e.g. tetracycline, erythromycin, chloramphenicol)orsulfonamides(e.g. co-trimoxazole)as

theymayaffectthe action ofcefotaxime

An aminoglycoside antibiotic (e.g. neomycin orstreptomycin), asthe medicine mustbetaken separately

ora doseadjustmentmaybe required

Cephalosporins (e.g. cefaclor)as adoseadjustmentmaybe required

Probenecid asthis mayleadto higherlevels ofcefotaxime in the body

Diuretics“watertablets”(e.g. bumetanide),asyourdoctormayneed to monitoryourkidneyfunction or

adjustyourdose.

Cefotaxime canaffectthe results ofsome blood andurinetests. Make surethatthe doctorknows you are

takingCefotaxime before you have suchtests. Yourdoctorwillarrange regularblood, liverand kidneytests

duringlongtermtreatment.

Pregnancy,breast-feedingandfertility:

Pregnancy

Yourdoctorwilldecide ifyou should receive Cefotaxime duringpregnancy.

Breast-feeding

Yourdoctorwilldecide ifyou should receive Cefotaxime duringbreast-feeding.

Ifyou are pregnantorbreast-feeding, thinkyoumaybepregnantorare planningtohave ababy, askyour

doctorforadvicebefore takingthismedicine.

Driving andusingmachines:

In individualcases, whenadministeredin high doses,cramp, muscle spasms and giddiness have occurred. If

affected donotdrive oroperate machinery.

Importantinformation about some ofthe ingredients ofCefotaxime:

Thesodiumcontent(2.2 mmol/g)should be taken intoconsiderationifyou are ona sodiumcontrolled diet.

3.HOW TOTAKECEFOTAXIME

Adoctorornursewilladministeryourmedicinebyinjection. Yourdose,the durationandtheroute of

administration willdependon theseverityandtype ofinfection you have as wellas yourweight.

Therecommendeddoseis:

Adults andadolescents above12 years ofage:

1000-6000 mgdaily, divided into 2 dosesat12 hourintervals. In severe cases the dosemaybe increased to

12000 mg, divided into3 or4 dosesand given at6or8 hourintervals.

Infants,toddlersand children (1 month-12 years):

50-100mgperkilogramofbodyweightperday(6 to12 hourintervals).

Pre termnew borninfantsand term newborn infants (0-27 days):

50 mgcefotaxime perkilogramofbodyweightperday(in 2-4 divided doses).

Gonorrhoea

Theusualdoseis500to1000 mgasa singledose, although1000 mgis preferable.

Impaired kidneyfunction

Yourdoctorwilldecide whatdoseis bestforyou.

Ifyou are anadultwitha creatinineclearance(a measure ofkidneyfunction)of20ml/minute orless, your

doctorwillgive you halfofthe usualdose ofCefotaxime.Ifyourcreatinineclearanceis 5 ml/minute orless,

yourdoctorwillgive you1000 mgofCefotaxime atfirstand afterthatyourdailydosewillbe halved

withoutachange in the frequencyofdosing(forexample,ifyou shouldreceive1000 mgofCefotaxime 2

timesa day, you willreceive500 mgofCefotaxime 2 timesa day).

In patients on haemodialysis, 500 mg-2000mgis given byi.v. injectionattheend ofeverydialysis.This

doseis repeated every24 hours.

Elderly

No dosage adjustments areneededin patients with normalrenalfunction

Ifyoutakemore Cefotaxime thanyoushould:

As adoctorornurse willbegivingyou yourmedicine,itis unlikelythatyou willreceive anoverdose.

However, ifyou have anyconcerns you shouldletyourdoctorornurseknowimmediately.

With accidentaloverdose,you canfeel:

impairmentofconsciousness, abnormalmovements and convulsions(encephalopathy)

twitching(spasm)ofmuscles

muscle cramps (painfulmusclecontractions).

4.POSSIBLESIDEEFFECTS

Like allmedicines,this medicinecancauseside effects,although noteverybodygetsthem.

Afew people(mayaffectup to 1in 1000 people)maydevelop asevereallergicreaction.Thisisa rare but

veryseriousside effect.Ifyou experienceanyofthefollowingsideeffectstellyourdoctorornursestraight

away:

Swellingofthe face,hands,feet, lips,tongue orthroat

Difficultyswallowingorbreathing.

Afew people(mayaffectup to 1in 10000 people)maydevelop a life-threateningskin disease (Stevens-

Johnsonsyndrome).This isa veryrare butveryserioussideeffect. Ifyou experienceanyofthefollowing

sideeffectstellyourdoctorornursestraightaway:

skin peeling

sores onthe mucousmembranes

skin rash.

Thefollowingsideeffectshave beenreported atthe approximate frequenciesshown:

Very common(mayaffectmore than 1in 10people)

For intramuscularinjections:pain wheretheinjectionwasgiven (withorwithoutthe hardeningofthe

skin).

Common(mayaffectupto1 in 10people)

Pain ora burningfeelingalongthe vein where Cefotaxime has beengiven.

Loss ofappetite, nausea

Sickness

Stomachache

Diarrhoea.

Uncommon(mayaffectupto 1in 100people)

Lownumbers ofalltypesofwhite bloodcells.The signs include increasednumberofinfections, for

example in yourmouth, gums, throatandlungs.

Lownumbers ofplatelets in yourblood.Thesigns include bruisingeasilyand nosebleeds

Increaseineosinophils

Increasedjointormuscle pain, headaches, chills,fever(usuallylowgrade),dropin bloodpressure,

hivesandrash (Jarisch-Herxheimerreaction).

Epilepticfits(especiallyifyou have kidneyproblems)

Changesin certain liverfunction testresults(ALAT,ASAT,gammaGT, AP, LDH)

Changesin certain kidneyfunctiontestresults (creatinin, urea)

Skin reactions.Theseinclude anettlerash which maycovera lotofyourbodyanditching

Fever(a high temperature)

Rare(mayaffectupto 1in1000 people)

Some side effectsare onlyseen when a bloodtestistaken. Theseinclude:

decreasesin the numberofcertain typesofbloodcellse.g. lowred bloodcellcountdueto destruction

(haemolyticanaemia)causingunusualtirednessorweakness, lownumberofspecificwhite blood cells,

leadingtoincreased susceptibilitytoinfections.

Inflammation ofthe large bowel(colon).The signs include diarrhoea, usuallywithbloodand mucus,

stomach pain andfever.

Allergic skin reactions,itchingand drug-fevers

Very rare(mayaffectupto 1 in 10 000 people)

Irregularheartbeat

Kidneyproblems includinginflammation

Notknown(frequencycannotbeestimatedfromtheavailable data)

Superinfections

Swollen face,tongue orpharynx, difficultyin swallowing, hivesand difficultiesin breathing

(angioedema)

Headache, dizziness, encephalopathy(e.g. impairmentofconsciousness,abnormalmovements)

Vomiting

Inflammation ofthe liver(hepatitis,sometimeswithjaundice)

For intramuscularinjection,containinganaestheticlidocaine, systemicreactionstolidocaine are

possible

Reporting ofside effects

Ifyou getanyside effects, talkto yourdoctor, pharmacistornurse.This includesanypossible sideeffects

notlistedinthis leaflet. You can alsoreportside effects directlyvia HPRAPharmacovigilance, Earlsfort

Terrace, IRL-Dublin 2;Tel:+353 1 6764971;Fax:+353 1 6762517.Website: www.hpra.ie ;E-mail:

medsafety@hpra.ie . Byreportingsideeffects you canhelp provide moreinformation onthesafetyofthis

medicine.

5.HOW TOSTORECEFOTAXIME

Keepthis medicineoutofthesightandreachofchildren.

Do notstore above 25°C.The vialshould be keptinthe outercartonin ordertoprotectfromlight.

Do notusethis medicineaftertheexpirydatewhich isstatedon thecarton afterEXP. The expirydate refers

to the lastdayofthatmonth.

Do notthrowawayanymedicinesvia wastewaterorhousehold waste. Askyourpharmacisthowtothrow

awaymedicinesyounolongeruse.Thesemeasureswillhelpto protectthe environment.

6.CONTENTS OF THEPACKANDOTHERINFORMATION

What Cefotaxime contains

Theactivesubstanceiscefotaxime (ascefotaxime sodium). Each vialcontains 500 mgor1000 mg

ofcefotaxime as thesodiumsalt.

What Cefotaximelookslike andcontents ofthe pack

TransparenttypeIIglassvialwith bromobutylrubberstopperand aluminiumsealwitha flipoffcap,

containingcefotaxime sodium, equivalentto 500 mgor1000 mgcefotaxime.

Thevialsare packed in acartonbox containing1, 5 or10 vials.

Notallpacksizesmaybe marketed.

MarketingAuthorisationHolderandManufacturer

MarketingAuthorisation Holder

Teva PharmaB.V.,Swensweg5,2031GAHaarlem,The Netherlands.

Manufacturer

Pharmachemie B.V.,Swensweg5,P.O.Box 552,2003 RNHaarlem,The Netherlands

or

Laboratorio ReigJofré, S.A.,C/Jarama 111 Polígono Industrial,Toledo,45007Toledo,Spain

This medicinalproductis authorised in the MemberStatesunderthe followingnames:

Belgium

Cefotaxime TEVA500 mgpoedervooroplossingvoorinjectie

Cefotaxime TEVA1000 mgpoedervooroplossingvoorinjectie

Ireland

Cefotaxime 500 mgPowderforSolutionforInjection

Cefotaxime1000 mgPowderforSolutionforInjection

TheNetherlands

Cefotaxim500 PCH,poedervooroplossingvoori.v./i.m. injectie 500 mg

Cefotaxim1000 PCH, poedervooroplossingvoori.v./i.m. injectie 1000 mg

Sweden CefotaximTeva

Thisleafletwaslastrevised in09/2015.

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cefotaxime1000mgPowderforSolutionforInjection

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachvialcontainscefotaximesodiumequivalentto1000mgcefotaxime.

3PHARMACEUTICALFORM

Powderforsolutionforinjection.

Whiteorslightlyyellowpowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofthefollowingsevereinfectionswhenknownorthoughtverylikelytobeduetoorganismsthatare

susceptibletocefotaxime(seesection5.1)

Infectionsofthelowerrespiratorytract

Infectionsofthekidneysandotherupperurinarytractinfections

Infectionsoftheskinandsofttissue

Genitalinfectionscausedbygonococci,particularlywhenpenicillinhasfailedorisunsuitable

Intra-abdominalinfections(includingperitonitis)(cefotaximeshouldbeusedincombinationwithanother

antibioticthatcanprovideanaerobiccoverinthetreatmentofintra-abdominalinfections)

AcuteMeningitis

Considerationshouldbegiventoofficiallocalguidanceontheappropriateuseofantibioticswhenusingcefotaxime.

4.2Posologyandmethodofadministration

Cefotaximesodiummaybeadministeredintravenouslybybolusinjectionorintramuscularly.

Cefotaxime500mgand1000mgaresuitablefori.v.andi.m.injection.

Theintramuscularmethodofadministrationisreservedtoexceptionalclinicalsituationsandshouldundergoarisk-

benefitassessment!Itisrecommendedthatnomorethan4mlisinjectedunilaterally.Ifthedailydoseexceeds2000

mgcefotaximeorifcefotaximeisinjectedmorefrequentlythantwiceperday,thei.v.routeisrecommended.

Intramuscularadministrationofcefotaximereconstitutedwithlidocaineshouldnotbeadministratedtochildreninthe

firstyearofage.

Dosagewithindividualanddailyadministration

Dosageandtypeofadministrationdependsontheseverityoftheinfection,thesensitivityofthebacteriumandthe

conditionofthepatient.

Forthedosagesandroutesofadministrationwhicharenotpossiblewiththisstrength,otherstrengthsareavailable.

Thedurationofthetreatmentdependsonthecourseofdisease.Asageneralrulecefotaximeisadministratedfora

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Adultsandadolescents(12to16-18years)

ingeneralreceive1000mgcefotaximeevery12hours.Inseverecases,thedailydosecanbeincreasedupto12000mg.

Dailydosesupto6000mgcanbedividedintoatleasttwoindividualadministrationsat12hourintervals.Higherdaily

dosesmustbedividedintoatleast3to4individualadministrationsat8or6-hourintervalsrespectively.Thefollowing

tablemayserveasaguidetodosages:

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

receive50mgto100mgcefotaximeaccordingtotheseverityoftheinfection(upto150mg)perkilogramofbody

weightperdayin2to4divideddoses(every12-6hours).Thefollowingtablemayserveasaguidetodosages:

Inindividualcases-particularlyinlife-threateningsituations-itmaybenecessarytoincreasethedaily

doseto200mgcefotaximeperkilogramofbodyweightwithoutexceedingthemaximumdailydosage

of12000mg.

Pretermnewborninfantsandtermnewborninfants(0-27days)

receiveingeneraldosesof50mgcefotaximeperkilogramofbodyweightperdayin2to4divideddoses(every12-6

hours).Incaseoflife-threateningsituationsitmaybenecessarytoincreasethedailydose.Forsevereinfections150

Typeofinfection Singledose

cefotaxime Dose

interval Dailydose

cefotaxime

Typicalinfections,inwhicha

sensitivebacteriumisproven

orsuspected 1000mg 12h 2000mg

Infections,inwhichvarious

bacteriawithhightomedium

sensitivityaredemonstratedor

suspected 2000mg 12h 4000mg

Unclearbacterialillnesses

whichcannotbelocalisedand

wherethepatientiscritically

2000-3000mg 8h

6h 6000-9000mg

8000-12000mg

Typeofinfection Dose

interval Dailydose

cefotaxime

Typicalinfections,inwhicha

sensitivebacteriumisprovenor

suspected 6-12h 50mg/kg

Infections,inwhichvariousbacteria

withhightomediumsensitivityare

demonstratedorsuspected 6-12h 100mg/kg

Unclearbacterialillnesseswhich

cannotbelocalisedandwherethe

patientiscriticallyill 6-8h 150mg/kg*

Typeofinfection Age Dose

interval Dailydose

cefotaxime

Typicalinfectionsduetosensitive

bacteriaorincaseswithhighto

mediumsensitivitydemonstratedor

suspected 0-7days

8days–1

month 6-12h 50mg/kg

Unclearbacterialillnesseswhich

cannotbelocalisedandwherethe

patientiscriticallyill 0-7days

8days–1

month 6-12h 100mg/kg*

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Inindividualcases-particularlyinlife-threateningsituations-itmaybenecessarytoincreasethedaily

doseto200mgcefotaximeperkilogramofbodyweight.Thisdosageshouldnotbeexceededinviewof

notfullymaturedkidneyclearance.

Gonorrhoea

Uncomplicatedgonorrhoea:asingleintramuscularinjectionof500mgto1000mgcefotaxime,although1000mgis

recommendedaspreferable.Incaseofdisseminatedgonococcalinfection,localofficialguidelinesshouldbefollowed.

Thepossibilityofsyphilisneedstoberuledout,beforestartingcefotaximetherapy.

Specialdosagerecommendations

Dosageinthecaseofimpairedrenalfunction

Foradultpatientswithacreatininclearanceof20ml/minuteorless,themaintenancedoseistobereducedtohalfthe

normaldose(seesection4.4).

Foradultpatientswithacreatininclearanceof5ml/minuteorless,afteraninitialloadingdoseof1000mg,dailydose

shouldbehalvedwithoutchangeinthefrequencyofdosing,i.e.1000mgin12hourlybecomes500mg12hourly,

1000mg8hourlybecomes500mg8hourly,2000mg8hourlybecomes1000mg8hourlyetc.Asinallotherpatients,

dosagemayrequirefurtheradjustmentaccordingtothecourseoftheinfectionandthegeneralconditionofthepatient.

Haemodialysis

Inpatientsonhaemodialysis,500-2000mgisgivenbyi.v.injectionattheendofeverydialysis.Thisdoseisrepeated

every24hours.

Elderly

Nodosageadjustmentsareneededinpatientswithnormalrenalfunction.

Methodofadministration

Seealsosection6.6.“Instructionsforuseandhandling”.

Intravenousinjection

Fori.v.injection,Cefotaxime500mgpowderforsolutionforinjectionisdissolvedinatleast2mlwaterforinjection

andCefotaxime1000mgpowderforsolutionforinjectioninatleast4mlandsubsequentlyinjecteddirectlyintothe

veinover3to5minutesorafterclampingoftheinfusiontubeintothedistalendofthetube.Duringpost-marketing

surveillance,potentiallylife-threateningarrhythmiahasbeenreportedinaveryfewpatientswhoreceivedrapid

intravenousadministrationofcefotaximetroughacentralvenouscatheter.

Intramuscularinjection

Forintramuscularinjection,500mgCefotaxime500mgpowderforsolutionforinjectionand1000mgCefotaxime

1000mgpowderforsolutionforinjectionisdissolvedin2and4mlwaterforinjectionrespectively.Afterwardsthe

injectionshouldtakeplacedeepintotheglutealmuscle.Painwiththei.m.injectioncanbeavoidedbydissolving

Cefotaxime500mgpowderforsolutionforinjectionin2mlorCefotaxime1000mgpowderforsolutionforinjection

in4mlof1%lidocainesolution.Anintravascularinjectionistobeavoidedinthiscasebecauseofpossibleadverse

effects.IfCefotaximeisintramuscularlyadministeredafterreconstitutionwithlidocaine,theSmPCoflidocaineshould

becheckedforthenecessaryproductinformation.

Combinationtherapy

Acombinationtherapyofcefotaximewithaminoglycosidesisindicatedwithoutavailabilityofanantibiograminthe

caseofsevere,life-threateninginfections.Thekidneyfunctionmustbewatchedinusingthecombinationwith

aminoglycosides.

Cefotaximeandaminoglycosidesshouldnotbemixedinthesamesyringeorperfusionfluid.

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4.3Contraindications

Hypersensitivitytocephalosporins

Inpatientswithahistoryofhypersensitivitytocefotaximeand/ortoanycomponentofthisproduct,apenicillinorto

anyothertypeofbeta-lactamdrug.

Allergiccrossreactionscanexistbetweenpenicillinsandcephalosporins(seesection4.4“Specialwarningsand

precautionsforuse”).

Contraindicationstolidocainemustbeexcludedbeforeintramuscularinjectionofcefotaximewhenlidocainesolution

isusedasasolvent(seesection4.4.)SeeinformationintheSummaryofProductCharacteristicsoflidocaine,

especiallycontraindications.

4.4Specialwarningsandprecautionsforuse

Aswithotherantibiotics,theuseofcefotaxime,especiallyifprolonged,mayresultinovergrowthofnon-susceptible

organisms,suchasEnterococcusspp,candida,Pseudomonasaeruginosa.Repeatedevaluationofthepatient's

conditionisessential.Ifsuper-infectionoccursduringtreatmentwithcefotaxime,appropriatemeasuresshouldbetaken

andspecificanti-microbialtherapyshouldbeinstitutedifconsideredclinicallynecessary.

Anaphylacticreactions:

Serious,includingfatalhypersensitivityreactionshavebeenreportedinpatientsreceivingcefotaxime(seesections4.3

“Contraindications”and4.8“Undesirableeffects”).

Ifahypersensitivityreactionoccurs,treatmentmustbestopped.

Theuseofcefotaximeisstrictlycontra-indicatedinsubjectswithaprevioushistoryofimmediatetypehypersensitivity

tocephalosporins.

Sincecrossallergyexistsbetweenpenicillinsandcephalosporins,cefotaximeshouldbegivenwithextremecautionto

patientswhohavehadanyothertypeofhypersensitivityreactiontoapenicillinoranyotherbeta-lactamdrug.Before

therapywithcefotaximeisinstituted,carefulinquiryshouldbemadetodeterminewhetherthepatienthadanyprevious

hypersensitivityreactionstocefotaxime,anyothercephalosporin,ortoanypenicillinorotherbeta-lactamdrug.

Seriousbullousreactions

CasesofseriousbullousskinreactionslikeStevens-Johnsonsyndromeortoxicepidermalnecrolysishavebeen

reportedwithcefotaxime(seesection4.8).Patientsshouldbeadvisedtocontacttheirdoctorimmediatelypriorto

continuingtreatmentifskinand/ormucosalreactionsoccur.

Cefotaximeshouldbeusedwithcautioninpatientswithallergicdiathesesandasthma.

Clostridiumdifficileassociateddisease(e.g.pseudomembranouscolitis)

Antibiotic-associateddiarrhoea,colitisandpseudomembranouscolitishaveallbeenreportedwiththeuseof

cefotaxime.Diarrhoea,particularlyifsevereand/orpersistent,occurringduringtreatmentorintheinitialweeks

followingtreatment,maybesymptomaticofClostridiumdifficileassociateddisease(CDAD).CDADmayrangein

severityfrommildtolifethreatening,themostsevereformofwhichispseudo-membranouscolitis.Thediagnosisof

thisrarebutpossiblyfatalconditioncanbeconfirmedbyendoscopyand/orhistology.

Thesediagnosesshouldbeconsideredinanypatientwhodevelopssevereand/orbloodydiarrhoeaduringorshortly

aftertreatment.

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suspected,cefotaximeshouldbediscontinuedimmediately.Appropriatetreatmentmeasuresshouldbeinitiatedand

specificantibiotictherapyshouldbestartedwithoutdelayifconsiderednecessary.

Clostridiumdifficileassociateddiseasecanbefavouredbyfaecalstasis.

Medicinalproductsthatinhibitperistalsisshouldnotbegiven.

Cefotaximeshouldbeusedwithcautioninindividualswithaprevioushistoryofgastro-intestinaldisease,particularly

colitis.

Aswithothercephalosporins,prolongeduseofcefotaximemayresultintheovergrowthofnon-susceptibleorganisms,

suchasenterococciandCandidaspp.

Haematologicalreactions

Sincehaematologicalabnormalitiessuchasleukopenia,neutropeniaand,morerarely,agranulocytosismaydevelop

duringtreatmentwithcefotaxime,particularlyifgivenoverlongperiodsbloodcountshouldbemonitorediftreatment

lastsforlongerthan7-10days.Incaseofneutropenia(<1400neutrophils/mm 3

),treatmentshouldbeinterrupted.

Somecasesofeosinophiliaandthrombocytopenia,rapidlyreversibleonstoppingtreatment,havebeenreported.Cases

ofhaemolyticanaemiahavealsobeenreported(seesection4.8).

Fastinfusionintoacentralveincancausearrhythmia.

Renalinsufficiency

Thedosageshouldbemodifiedaccordingtothecreatinineclearancecalculated(seesection4.2).

Cautionshouldbeexercisedifcefotaximeisadministeredtogetherwithaminoglycosides;probenecidorother

nephrotoxicdrugs(seesection4.5).Renalfunctionmustbemonitoredinthesepatients,theelderly,andthosewithpre-

existingrenalimpairment.

Cautionshouldbeexercisedifcefotaximeisadministeredtogetherwithaminoglycosides;probenecidorother

nephrotoxicdrugs(seesection4.5).Renalfunctionmustbemonitoredinthesepatients,theelderly,andthosewithpre-

existingrenalimpairment.

Ifcefotaximeisintramuscularlyadministeredafterreconstitutionwithlidocaine,theSmPCoflidocaineshouldbe

checkedforthenecessaryproductinformation.

Seesection4.3forcontraindicationsforformulationscontaininglidocaine.

Neurotoxicity

Highdosesofbeta-lactamantibiotics,includingcefotaxime,particularlyinpatientswithrenalinsufficiency,mayresult

inencephalopathy(e.g.impairmentofconsciousness,abnormalmovementsandconvulsions)(seesection4.8).

Patientsshouldbeadvisedtocontacttheirdoctorimmediatelypriortocontinuingtreatmentifsuchreactionsoccur.

Precautionsforadministration

Duringpost-marketingsurveillance,potentiallylife-threateningarrhythmiahasbeenreportedinaveryfewpatients

whoreceivedrapidintravenousadministrationofcefotaximethroughacentralvenouscatheter.Therecommendedtime

forinjectionorinfusionshouldbefollowed(seesection“Posologyandmethodofadministration”).

EffectsonLaboratoryTests

AswithothercephalosporinsapositiveCoombs'testhasbeenfoundinsomepatientstreatedwithcefotaxime.This

phenomenoncaninterferewiththecross-matchingofblood.Urinaryglucosetestingwithnon-specificreducingagents

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Sodiumintake

Thisproductcontainssodium,whichshouldbetakenintoaccountwhenprescribingtopatientsrequiringsodium

restriction.Cefotaxime1000mgpowderforsolutionforinjectioncontains1048mgcefotaximesodiumwhichis

equivalentto2.2mmolsodium(50.6mgsodium).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Cefotaxime/otherantibiotics

Asfaraspossible,cefotaximeshouldnotbecombinedwithsubstanceshavingabacteriostaticaction(e.g.tetracycline,

erythromycin,chloramphenicolorsulfonamides),sinceanantagonisticeffecthasbeenobservedregardingtheanti-

bacterialeffectinvitro.Asynergisticeffectcanresultwiththecombinationwithaminoglycosides.

Anincreasedriskofoto-andnephrotoxicityhavebeenreportedwhenhighdosesofcephalosporinshavebeenused

concomitantlytoaminoglycosides.Adoseadjustmentmaybenecessary,andthekidneyfunctionmustbewatched(see

section4.2“Posologyandmethodofadministration”).

Uricosurics:Probenecidinterfereswiththerenaltubulartransferofcefotaxime,therebyincreasingcefotaximeexposure

about2-foldandreducingrenalclearancetoabouthalfattherapeuticdoses.Duetothelargetherapeuticindexof

cefotaxime,nodosageadjustmentisneededinpatientswithnormalrenalfunction.Dosageadjustmentmaybeneeded

inpatientswithrenalimpairment(seesections4.4and4.2).

Aminoglycosideantibioticsanddiuretics:Aswithothercephalosporins,cefotaximemaypotentiatethenephrotoxic

effectsofnephrotoxicdrugssuchasaminoglycosidesorpotentdiuretics(e.g.furosemide).Renalfunctionmustbe

monitoredinthesepatients(seesection4.4).

4.6Fertility,pregnancyandlactation

Pregnancy

Thesafetyofcefotaximehasnotbeenestablishedinhumanpregnancy.

Animalstudiesdonotindicatedirectorindirectharmfuleffectswithrespecttoreproductivetoxicity.

Thereare,however,noadequateandwellcontrolledstudiesinpregnantwomen.

Cefotaximecrossestheplacentalbarrier.Therefore,cefotaximeshouldnotbeusedduringpregnancyunlessthe

anticipatedbenefitoutweighsanypotentialrisks.

Breast-feeding

Cefotaximepassesintohumanbreastmilk.

Effectsonthephysiologicalintestinalfloraofthebreast-fedinfantleadingtodiarrhoea,tocolonisationbyyeast-like

fungi,andsensitisationoftheinfantcannotbeexcluded.

Therefore,adecisionshouldbemadewhethertodiscontinuebreast-feedingortodiscontinuetherapytakinginto

accountthebenefitofbreast-feedingforthechildandthebenefitofthetherapyforthewomen.

4.7Effectsonabilitytodriveandusemachines

Nostudiesontheeffectontheabilitytodriveandusemachineshavebeenperformed.

Thereisnoevidencethatcefotaximedirectlyimpairstheabilitytodriveortooperatemachines.

Inindividualcases,inadministrationofhighdosesofcefotaximeandparticularlyinthepatientswithsimultaneous

kidneyfunctionimpairment,encephalopathymayoccur(e.g.impairmentofconsciousness,abnormalmovementsand

convulsions),andgiddinesshavebeenreported(seesection4.8).Patientsshouldbeadvisednottodriveoroperate

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4.8Undesirableeffects

Adversereactionstocefotaximehaveoccurredrelativelyinfrequentlyandhavegenerallybeenmildandtransientand

occurinabout5%ofpatientstreatedwithcefotaxime.

Thesideeffects,describedbelow,areclassifiedaccordingtofollowingfrequencies:

Verycommon:1/10;Common:1/100to <

1/10;Uncommon:1/1,000to <

1/100;Rare:1/10,000to <

1/1,000;Very

rare <

1/10,000,Notknown(cannotbeestimatedfromtheavailabledata)*

Infectionsandinfestations

Notknown: Superinfection(seesection4.4)

Bloodandlymphaticsystemdisorders

Uncommon: Leukopenia,eosinophilia,thrombocytopenia

Rare Neutropenia,haemolyticanaemia,granulocytopenia.

Agranulocytosismaydevelop,particularlyafterprolongedtherapy(seesection4.4).These

occurrencesarereversible.Iftherapylastsformorethan7daysbloodpicturechecksshouldbe

instituted.

Immunesystemdisorders

Uncommon: Jarisch-Herxheimerreaction

Rare Severeacutehypersensitivityreaction(anaphylaxia).Ananaphylacticshockislifethreatening

andnecessitatescorrespondingemergencymeasures.

Allergicskin-reactions(e.g.urticaria,exanthema),itchinganddrug-fevers.

Veryrare,includingisolatedcases

Erythemamultiforme(mildtosevereformsi.e.Stevens-Johnsonsyndrome)andtoxic-epidermal

necrolysis.

Inpatientswithaninclinationtoallergiesanallergicreactionismorelikely.

Notknown Angioedema,bronchospasm.

Nervoussystemdisorders

Uncommon: Convulsionshavebeenreported,especiallywithhighdosesandinpatientswithrenalfunction

impairment(seesection4.4)

Notknown: Headache,dizziness,encephalopathy(e.g.impairmentofconsciousness,abnormalmovements)

(seesection4.4)

Cardiacdisorders

Veryrare Averysmallnumberofcasesofarrhythmiashaveoccurredfollowingrapidbolusinfusion

throughacentralvenouscatheter.

Gastrointestinaldisorders

Common Gastrointestinaldisturbances,likelossofappetite,nausea,sickness,stomachacheordiarrhoea,

whichareusuallymildinnatureandfrequentlyfadeawayduringorotherwiseaftertermination

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Rare Pseudomembranouscolitis.Seealsosection4.4“Specialwarningsandprecautionsforuse”.

Notknown: Vomiting

Renalandurinarydisorders

Uncommon: Decreaseinrenalfunction/increasedserumcreatinine(particularlywhenco-prescribedwith

aminoglycosides)andureaconcentrations

Veryrare,includingisolatedcases

Acuteinterstitialnephritis

Hepato-biliarydisorders

Uncommon Slight,transientincreasesinserumbilirubinand/orliverenzymes(ALAT,ASAT,GammaGT,

alkalinephosphatase,LDH)

Notknown: Hepatitis*(sometimeswithjaundice)

Skinandsubcutaneoustissuedisorders

Uncommon: Rash,pruritus,urticaria

Notknown: Erythemamultiforme,Stevens-Johnsonsyndrome,toxicepidermalnecrolysis(seesection4.4)

Generaldisordersandadministrationsiteconditions

Verycommon: ForIMformulations:Transientpainmaybeexperiencedatthesiteofinjection.Thisismore

likelytooccurwithhigherdoses.

Common Occasionally,phlebitishasbeenreportedinpatientsreceivingintravenouscefotaxime.However,

thishasrarelybeenacausefordiscontinuationoftreatment.

Painandhardeningofthetissue(induration)occasionallyariseattheinjectionsiteafter

intramuscularinjection.

Uncommon: Fever

Notknown: ForIMformulations(sincethesolventcontainslidocaine):Systemicreactionstolidocaine

*postmarketingexperience

Descriptionofselectedadversereactions

Jarisch-Herxheimerreaction

Forthetreatmentofborreliosis,aJarisch-Herxheimerreactionmaydevelopduringthefirstdaysoftreatment.

Theoccurrenceofoneormoreofthefollowingsymptomshasbeenreportedafterseveralweeks’treatmentof

borreliosis:skinrash,itching,fever,leukopenia,increaseinliverenzymes,difficultyofbreathing,jointdiscomfort.

Hepatobiliarydisorders

Increaseinliverenzymes(ALAT,ASAT,LDH,gamma-GTand/oralkalinephosphatase)and/orbilirubinhavebeen

observed.Theselaboratoryabnormalitiesmayrarelyexceedtwicetheupperlimitofthenormalrangeandelicita

patternofliverinjury,usuallycholestaticandmostoftenasymptomatic.

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Liverandkidneyfunctionshouldbemonitoredintheeventofprolongeduse.

Reportingofsuspectedadversereactions

Reportingsuspectedadversereactionsafterauthorisationofthemedicinalproductisimportant.Itallowscontinued

monitoringofthebenefit/riskbalanceofthemedicinalproduct.Healthcareprofessionalsareaskedtoreportany

suspectedadversereactionsviaHPRAPharmacovigilance,EarlsfortTerrace,IRL-Dublin2;Tel:+35316764971;

Fax:+35316762517.Website: www.hpra.ie ;E-mail: medsafety@hpra.ie .

4.9Overdose

Symptomsofoverdosemaylargelycorrespondtotheprofileofsideeffects.

Thereisariskofreversibleencephalopathyincasesofadministrationofhighdosesofbeta-lactamantibiotics

includingcefotaxime.

Intheeventofoverdosing,cefotaximemustbediscontinued,andsupportivetreatmentinitiatedwhichincludes

measurestoaccelerateeliminationandsymptomatictreatmentofadversereactions(e.g.convulsions).

Nospecificantidoteexists.Serumlevelsofcefotaximecanbereducedbyhaemodialysisorperitonealdialysis.

a)symptomsofoverdosing

Intoxication,sensustrictu,isnotknowninman.Withcertainriskpatternsandwiththeadministrationofveryhigh

doses,centralnervoussystemexcitationconditions,myocloniaandcrampcanoccur,ashavealsobeendescribedfor

otherbetalactams.Theriskoftheappearanceoftheseundesirableeffectsisincreasedinpatientswithseverely

restrictedkidneyfunction,epilepsyandmeningitis.

b)emergencymeasures

Centrallyinitiatedcrampscanbetreatedwithdiazepamorphenobarbital,butnotwithphenytoin.Withanaphylactic

reactionstheusualemergencymeasuresmustbecommenced,preferablywiththefirstindicationsoftheshock.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticalgroup:Thirdgenerationcephalosporins.

ATCclassification:J01DD01

Mechanismofaction

Cefotaximeinhibitstheactionofcertainbacterialcellwallsyntheticenzymesandsointerruptscellwallbiosynthesis.

Bacterialcelllysisresults.

Mechanismsofresistance

Bacterialresistancetocefotaximemaybeduetooneormoreofthefollowingmechanisms:

Hydrolysisby-lactamases.Cefotaximemaybeefficientlyhydrolysedbytheproductionofcertainextended-

spectrum-lactamases.Also,theinductionand/orconstitutiveexpressionofchromosomally-encoded(AmpC)

enzymescanefficientlyhydrolysethedrug.

Animpermeability-basedmechanismofresistance.

Effluxpumpmechanisms.

Morethanoneofthesepossiblemechanismsmayco-existinasinglebacterium.

Cefotaxime-resistantbacteriamayexhibitvaryingdegreesofcross-resistancewithother-lactams.Cefotaxime-

resistantgram-negativebacteriashowcompletecross-resistancetootherbroad-spectrumthirdgeneration

cephalosporins(e.g.ceftazidime,ceftriaxone).

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AmpC-like-lactamaseslikeEnterobactercloacae,Enterobacterspp.,Serratiaspp.,andCitrobacterspp.shouldbe

discourageddespiteapparentinvitrosusceptibility,asmutantswithstablydepressed(hyperproduced)-lactamasemay

beselectedduringtherapy.

Breakpoints

NationalCommitteeforClinicalLaboratoryStandards(NCCLS):

Enterobacteriaceae*,PseudomonasaeruginosaandotherNon-Fermenters,Staphylococcusspp.:susceptible 8mg/l;

intermediate16-32mg/l;resistant 64mg/l.

Haemophilusinfluenzae:susceptible 2mg/l.

Neisseriagonorrhoeae:susceptible 0.5mg/l.

Streptococcuspneumoniae(non-meningitis):susceptible 1mg/l;intermediate2mg/l;resistant 4mg/l.

Streptococcuspneumoniae(meningitis):susceptible 0.5mg/l;intermediate1mg/l;resistant 2mg/l.

Streptococcusspp.(beta-haemolyticgroup):susceptible 0.5mg/l.

Streptococcusspp.(viridansgroup):susceptible 1mg/l;intermediate2mg/l;resistant 4mg/l.

*StrainsofEscherichiacoliandKlebsiellaspp.thatproduceESBLsmaybeclinicallyresistanttotherapywith

cefotaximedespiteinvitrosusceptibility.

In-vitroantibacterialspectrum

Ageneraloverviewoftheantibacterialspectrumofcefotaximeisgivenbelow.Itshouldbeconsideredthatthe

prevalenceofacquiredresistancemayvarygeographicallywithintheEuropeanUnionandwithtimeforselected

species,sothatlocalinformationonresistanceisdesirable,particularlywhentreatingsevereinfections.The

informationgiveninthetablebelowprovidesanapproximateguidanceontheprobabilitieswhethermicroorganisms

willbesusceptibletocefotaxime.

Commonlysusceptiblespecies

Grampositiveaerobes

Staphylococcusaureus(MSSA)

Streptococcusagalactiae

Streptococcuspneumoniae(includingpenicillin-resistant

strains)

Streptococcuspyogenes

Gram-negativeaerobes

Haemophilusinfluenzae

Moraxellacatarrhalis°

Morganellamorganii

Neisseriagonorrhoeae°

Neisseriameningitidis°

Proteusmirabilis %

Speciesforwhichacquiredresistancemaybea

problem

Gram-positiveaerobes

Staphylococcusaureus

Staphylococcusepidermidis +

Staphylococcushaemolyticus +

Staphylococcushominis +

Gram-negativeaerobes

Citrobacterfreundii

Enterobacteraerogenes

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°Nocurrentsurveillancedataavailable.Susceptibilityisanticipatedaccordingtothecurrentscientificknowledge.

+Inatleastoneregionresistancerateisabove50%.

%ExtendedSpectrumbeta-lactamase(ESBL)producingstrainsarealwaysresistant.

resistancerates<10%incommunityacquiredinfections

5.2Pharmacokineticproperties

Cefotaximeisappliedparenterally.

Absorption

Afterintravenousinjectionof1000mgcefotaximetheserumconcentrationsafter5minamountedtoabout81-102

mg/landafter15minto46mg/l.8minafterintravenousinjectionof2000mgcefotaxime,serumconcentrationsof

167-214mg/lwererecorded.Afterintramuscularadministration,themaximumserumconcentrations(approximately

20mg/lafter1000mg)werereachedwithin30min.

Distribution

Theapparentdistributionvolumeis21-37l.

Withinfectedmeninges,cefotaximeanddesacetyl-cefotaximepenetrateintothefluidspaceandthenreach

therapeuticallyeffectiveconcentrationsthere(e.g.withinfectionswhicharecausedbygram-negativebacteriaand

pneumococci).

Escherichiacoli %

Klebsiellaoxytoca %

Klebsiellapneumoniae %

Proteusvulgaris

Serratiamarcescens

Anaerobes

Bacteroidesfragilis

Inherentlyresistantspecies

Gram-positiveaerobes

Enterococcusspp.

Listeriamonocytogenes

Staphylococcusaureus(MRSA)

Gram-negativeaerobes

Acinetobacterbaumannii

Pseudomonasaeruginosa

Stenotrophomonasmaltophilia

Anaerobes

Clostridiumdifficile

Others

Chlamydiaspp.

Chlamydophilaspp.

Legionellapneumophilia

Mycoplasmaspp.

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Cefotaximepervadestissuerapidly,passestheplacentabarrierandreacheshighconcentrationsinfoetaltissues(upto6

mg/kg).Itisonlyexpressedatalowpercentageinthemother'smilk(concentrationsinthemother'smilk:0.4mg/lafter

2000mg).

Biotransformation

Cefotaximeismetabolizedtoaconsiderableextentinman.Approximately15-25%ofaparenteraldoseisexcretedas

O-desacetyl-cefotaxime.Themetabolitepossessesanti-bacterialactivity.

Inadditiontodesacetyl-cefotaxime,therearetwootherinactivelactones.Fromdesacetyl-cefotaxime,alactoneis

producedasanephemeralintermediate,whichstillcannotbeproveneitherintheurineorintheplasma,becauseitis

subjecttoarapidconversiontostereoisomersoftheringopening(betalactamring)lactone.Thesearelikewise

eliminatedintheurine.

Elimination

Theexcretionofcefotaximeanddesacetyl-cefotaximetakesplacemainlybytherenalroute.Asmallpercentage

(approximately2%)iseliminatedwithbile.Intheurinecollectedover6-hours,40-60%ofadosewasrecoveredin

unchangedformandapproximately20%asdesacetyl-cefotaxime.Afterintravenousadministrationofradioactively

markedcefotaximesomewhatmorethan80%wasrecoveredintheurine,fromit,50-60%appearedasunchanged

mothersubstanceandtheremainderas3metabolites.

Thetotalclearanceofthecefotaximeamountsto240-390ml/minandtherenalclearanceto130-150ml/min.

Theserumhalf-livesofcefotaximeanditsactivemetaboliteamounttobe50-80minutesand125minutes,respectively.

Ingeriatricpatients(>80years)thehalf-liveswerefoundtobe120-150minutesand5hoursfortheactivemetabolite.

Withseverekidneymalfunctions(creatininclearance3-10mi/min)thehalf-lifeofthecefotaximecanbeextendedto

2.5-10hours.Cefotaximeonlyaccumulatesundertheseconditionstoasmallextent,incontrasttotheactiveand

inactivemetabolites.

Bothcefotaximeanddesacetyl-cefotaximeareremovedbyhaemodialysistoalargeextentfromtheblood.

5.3Preclinicalsafetydata

Thetoxicityofcefotaximeaftersingledosesisverylow.Cefotaximehasnomutagenicpotential,asindicatedbya

negativemicronucleustest.Studiesinratsandmicegavenoindicationofcefotaximehavingteratogenicproperties.

Fertilitywasnotimpaired.Inperinatalandpostnatalstudiesinrats,pupsborntothehighdoseanimalshad

significantlylowerweightsatbirthandremainedsmallerthancontrolpupsduringthe21daysofnursing.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Notapplicable.

6.2Incompatibilities

Cefotaximeshouldnotbemixedinalkalinesolutionssuchassodiumbicarbonateinjection.

Cefotaximeshouldalsonotbeadmixedwithaminoglycosides.However,theymaybeadministeredseparatelytothe

samepatient.

6.3Shelflife

Unopened

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Openedandreconstitutedproduct

Fromamicrobiologicalpointofview,theproductshouldbeusedimmediately.Discardanyunusedsolution.Ifnot

usedimmediately,in-usestoragetimesandconditionspriortousearetheresponsibilityoftheuser.

Chemicalandphysicalin-usestabilityhasbeendemonstratedfor6hoursat2-8ºC,whendissolvedinwaterfor

injectionand1%lidocaineHClsolution.Whenreconstitutedwithothercompatiblesolutions(seesection6.6),the

productshouldbeusedimmediately.

Thecolourofthesolutionmaychangetolightyellow,however,theefficacyandsafetyoftheantibioticarenot

influenced.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Keepthevialintheoutercartoninordertoprotectfromlight.

6.5Natureandcontentsofcontainer

TransparenttypeIIglassvialwithbromobutylrubberstopperandaluminiumsealwithaflipoffcap,containing

cefotaximesodium,equivalentto1000mgcefotaxime.

Thevialsarepackedinacartonboxcontaining1,5or10vials.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposal

Theproductiscompatiblewiththefollowingsolutions:

WaterforInjections,

Sodiumchloride9mg/ml(0.9%w/v),solutionforinfusion

Glucose50mg/ml(5%w/v),solutionforinfusion

LidocaineHCl10mg/ml(1%w/v),solutionforinjection(seealsosection4.4“Specialwarningsandprecautions

foruse”).

Thecompatibilitywithotherinfusionfluidsshouldbecheckedbeforeuse.

Reconstitutethepowderwiththesolventbyshakingvigorouslyforatleast30secondstoensurecompletedissolution.

Seealsosection4.2“Posologyandmethodofadministration”forfurtherinstructions.Onlyclearsolutions,practically

freefromparticles,shouldbeused.

Forsingleuseonly.Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocal

requirements.

7MARKETINGAUTHORISATIONHOLDER

TevaPharmaB.V.,

Swensweg5,

2031GAHaarlem,

TheNetherlands.

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:10thNovember2006

Dateoflastrenewal:12thJuly2010

10DATEOFREVISIONOFTHETEXT

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