CHIROCAINE

Main information

  • Trade name:
  • CHIROCAINE Solution injection or concentrate for solution infusion 7.5mg Mg/Ml
  • Dosage:
  • 7.5mg Mg/Ml
  • Pharmaceutical form:
  • Solution injection or concentrate for solution infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CHIROCAINE Solution injection or concentrate for solution infusion 7.5mg Mg/Ml
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0038/071/003
  • Authorization date:
  • 04-02-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Chirocaine7.5mg/mlsolutionforinjection/concentrateforsolutionforinfusion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onemlcontains7.5mglevobupivacaineaslevobupivacainehydrochloride.

Eachampoulecontains75mgin10ml.Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionforinjection/concentrateforsolutionforinfusion.

Clearcolourlesssolution,practicallyfreeofparticles.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Adults

Surgicalanaesthesia

Major,e.g.epidural(includingforcaesareansection),intrathecal,peripheralnerveblock.

Minor,e.g.localinfiltration,peribulbarblockinophthalmicsurgery.

Painmanagement

Continuousepiduralinfusion,singleormultiplebolusepiduraladministrationforthemanagementofpain

especiallypost-operativepainorlabouranalgesia.

Children

Analgesia(ilioinguinal/iliohypogastricblocks).

4.2Posologyandmethodofadministration

Levobupivacaineshouldbeadministeredonlyby,orunderthesupervisionof,aclinicianhavingthenecessarytraining

andexperience.

Thetablebelowisaguidetodosageforthemorecommonlyusedblocks.Foranalgesia(e.g.epiduraladministration

forpainmanagement),thelowerconcentrationsanddosesarerecommended.Whereprofoundorprolongedanaesthesia

isrequiredwithdensemotorblock(e.g.epiduralorperibulbarblock),thehigherconcentrationsmaybeused.Careful

aspirationbeforeandduringinjectionisrecommendedtopreventintravascularinjection.

Aspirationshouldberepeatedbeforeandduringadministrationofabolusdose,whichshouldbeinjectedslowlyandin

incrementaldoses,atarateof7.5–30mg/min,whilecloselyobservingthepatient’svitalfunctionsandmaintaining

verbalcontact.

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Maximumdose

Themaximumdosagemustbedeterminedbyevaluatingthesizeandphysicalstatusofthepatient,togetherwiththe

concentrationoftheagentandtheareaandrouteofadministration.Individualvariationinonsetanddurationofblock

doesoccur.Experiencefromclinicalstudiesshowsonsetofsensoryblockadequateforsurgeryin10-15minutes

followingepiduraladministration,withatimetoregressionintherangeof6-9hours.

Therecommendedmaximumsingledoseis150mg.Wheresustainedmotorandsensoryblockarerequiredfora

prolongedprocedure,additionaldosesmayberequired.Themaximumrecommendeddoseduringa24hourperiodis

400mg.Forpost-operativepainmanagement,thedoseshouldnotexceed18.75mg/hour.

Obstetrics

Forcaesareansection,higherconcentrationsthanthe5.0mg/mlsolutionshouldnotbeused(Seesection4.3,

Contraindications).Themaximumrecommendeddoseis150mg.

Forlabouranalgesiabyepiduralinfusion,thedoseshouldnotexceed12.5mg/hour.

Children

Inchildren,themaximumrecommendeddoseforanalgesia(ilioinguinal/iliohypogastricblocks)is1.25mg/kg/side.

Thesafetyandefficacyoflevobupivacaineinchildrenforotherindicationshavenotbeenestablished.

Specialpopulations

Debilitated,elderlyoracutelyillpatientsshouldbegivenreduceddosesoflevobupivacainecommensuratewiththeir

physicalstatus.

Inthemanagementofpost-operativepain,thedosegivenduringsurgerymustbetakenintoaccount.

Therearenorelevantdatainpatientswithhepaticimpairment(seesections4.4,Specialwarningsandprecautionsfor

useand5.2,Pharmacokineticproperties).

TableofDoses

Concentration

(mg/ml) 1 Dose MotorBlock

SurgicalAnaesthesia

Epidural(slow)

bolus 2

forsurgery

-Adults 5.0-7.5 10-20ml(50-150mg) Moderateto

complete

Epiduralslow

injection 3

for

CaesareanSection 5.0 15-30ml(75-150mg) Moderateto

complete

Intrathecal 5.0 3ml(15mg) Moderateto

complete

PeripheralNerve

Ilioinguinal/

Iliohypogastricblocks

inchildren<12years 2.5-5.0

2.5-5.0 1-40ml(2.5-150mgmax.)

0.25-0.5ml/kg(0.625-

2.5mg/kg) Moderateto

complete

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Levobupivacainesolutionforinjection/concentrationforsolutionforinfusionisavailablein2.5,5.0and7.5mg/ml

solutions.

Spreadover5minutes(seealsotext).

Givenover15-20minutes.

Incaseswherelevobupivacaineiscombinedwithotheragentse.g.opioidsinpainmanagement,thelevobupivacaine

doseshouldbereducedanduseofalowerconcentration(e.g.1.25mg/ml)ispreferable.

Theminimumrecommendedintervalbetweenintermittentinjectionsis15minutes.

Forinformationondilution,seesection6.6,Specialprecautionsfordisposalofausedmedicinalproductorwaste

materialsderivedfromsuchmedicinalproductandotherhandlingoftheproduct.

4.3Contraindications

Generalcontra-indicationsrelatedtoregionalanaesthesia,regardlessofthelocalanaestheticused,shouldbetakeninto

account.

Levobupivacainesolutionsarecontra-indicatedinpatientswithaknownhypersensitivitytolevobupivacaine,local

anaestheticsoftheamidetypeoranyoftheexcipients.(seesection4.8,Undesirableeffects).

Levobupivacainesolutionsarecontra-indicatedforintravenousregionalanaesthesia(Bier'sblock).

Levobupivacainesolutionsarecontra-indicatedinpatientswithseverehypotensionsuchascardiogenicor

hypovolaemicshock.

Levobupivacainesolutionsarecontra-indicatedforuseinparacervicalblockinobstetrics(seesection4.6,Pregnancy

andlactation).

4.4Specialwarningsandprecautionsforuse

Allformsoflocalandregionalanaesthesiawithlevobupivacaineshouldbeperformedinwell-equippedfacilitiesand

administeredbystafftrainedandexperiencedintherequiredanaesthetictechniquesandabletodiagnoseandtreatany

unwantedadverseeffectsthatmayoccur.

Levobupivacaineshouldbeusedwithcautionforregionalanaesthesiainpatientswithimpairedcardiovascularfunction

e.g.seriouscardiacarrhythmias.

Theintroductionoflocalanestheticsviaeitherintrathecalorepiduraladministrationintothecentralnervoussystemin

patientswithpreexistingCNSdiseasesmaypotentiallyexacerbatesomeofthesediseasestates.Therefore,clinical

Ophthalmic

(peribulbarblock) 7.5 5–15ml(37.5-112.5mg) Moderateto

complete

LocalInfiltration

-Adults 2.5 1-60ml(2.5-150mgmax.) Notapplicable

PainManagement 4

LabourAnalgesia

(epiduralbolus 5

) 2.5 6-10ml(15-25mg) Minimalto

moderate

LabourAnalgesia

(epiduralinfusion) 1.25 6 4-10ml/h(5-12.5mg/h) Minimalto

moderate

Post-operativepain

1.25 6

10-15ml/h(12.5-

18.75mg/h)

5-7.5ml/h(12.5–

18.75mg/h) Minimalto

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EpiduralAnesthesia

Duringepiduraladministrationoflevobupivacaine,concentratedsolutions(0.5-0.75%)shouldbeadministeredin

incrementaldosesof3to5mlwithsufficienttimebetweendosestodetecttoxicmanifestationsofunintentional

intravascularorintrathecalinjection.Whenalargedoseistobeinjected,e.g.inepiduralblock,atestdoseof3-5ml

lidocainewithadrenalineisrecommended.Aninadvertentintravascularinjectionmaythenberecognisedbya

temporaryincreaseinheartrateandaccidentalintrathecalinjectionbysignsofaspinalblock.

Syringeaspirationsshouldalsobeperformedbeforeandduringeachsupplementalinjectionincontinuous

(intermittent)cathetertechniques.Anintravascularinjectionisstillpossibleevenifaspirationsforbloodarenegative.

Duringtheadministrationofepiduralanaesthesia,itisrecommendedthatatestdosebeadministeredinitiallyandthe

effectsmonitoredbeforethefulldoseisgiven.

Epiduralanaesthesiawithanylocalanaestheticmaycausehypotensionandbradycardia.Allpatientsmusthave

intravenousaccessestablished.Theavailabilityofappropriatefluids,vasopressors,anaestheticswithanticonvulsant

properties,myorelaxants,andatropine,resuscitationequipmentandexpertisemustbeensured(seesection4.9,

Overdose).

Majorregionalnerveblocks

ThepatientshouldhaveI.V.fluidsrunningviaanindwellingcathetertoassureafunctioningintravenouspathway.

Thelowestdosageoflocalanaestheticthatresultsineffectiveanaesthesiashouldbeusedtoavoidhighplasmalevels

andseriousadverseeffects.Therapidinjectionofalargevolumeoflocalanaestheticsolutionshouldbeavoidedand

fractional(incremental)dosesshouldbeusedwhenfeasible.

UseinHeadandNeckArea

Smalldosesoflocalanaestheticsinjectedintotheheadandneckarea,includingretrobulbar,dentalandstellate

ganglionblocks,mayproduceadversereactionssimilartosystemictoxicityseenwithunintentionalintravascular

injectionsoflargerdoses.Theinjectionproceduresrequiretheutmostcare.Reactionsmaybeduetointra-arterial

injectionofthelocalanaestheticwithretrogradeflowtothecerebralcirculation.Theymayalsobeduetopunctureof

theduralsheathoftheopticnerveduringretrobulbarblockwithdiffusionofanylocalanaestheticalongthesubdural

spacetothemidbrain.Patientsreceivingtheseblocksshouldhavetheircirculationandrespirationmonitoredandbe

constantlyobserved.Resuscitativeequipmentandpersonnelfortreatingadversereactionsshouldbeimmediately

available.

UseinOphthalmicSurgery

Clinicianswhoperformretrobulbarblocksshouldbeawarethattherehavebeenreportsofrespiratoryarrestfollowing

localanaestheticinjection.Priortoretrobulbarblock,aswithallotherregionalprocedures,theimmediateavailability

ofequipment,drugs,andpersonneltomanagerespiratoryarrestordepression,convulsions,andcardiacstimulationor

depressionshouldbeassured.Aswithotheranaestheticprocedures,patientsshouldbeconstantlymonitoredfollowing

ophthalmicblocksforsignsoftheseadversereactions.

Specialpopulations

Debilitated,elderlyoracutelyillpatients:levobupivacaineshouldbeusedwithcautionindebilitated,elderlyor

acutelyillpatients(seesection4.2,Posologyandmethodofadministration).

Hepaticimpairment:sincelevobupivacaineismetabolisedintheliver,itshouldbeusedcautiouslyinpatientswith

liverdiseaseorwithreducedliverbloodflowe.g.alcoholicsorcirrhotics(seesection5.2,Pharmacokineticproperties).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

InvitrostudiesindicatethattheCYP3A4isoformandCYP1A2isoformmediatethemetabolismoflevobupivacaine.

Althoughnoclinicalstudieshavebeenconducted,metabolismoflevobupivacainemaybeaffectedbyCYP3A4

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Levobupivacaineshouldbeusedwithcautioninpatientsreceivinganti-arrhythmicagentswithlocalanaesthetic

activity,e.g.,mexiletine,orclassIIIanti-arrhythmicagentssincetheirtoxiceffectsmaybeadditive.

Noclinicalstudieshavebeencompletedtoassesslevobupivacaineincombinationwithadrenaline.

4.6Pregnancyandlactation

Pregnancy

Levobupivacainesolutionsarecontraindicatedforuseinparacervicalblockinobstetrics.Basedonexperiencewith

bupivacainefoetalbradycardiamayoccurfollowingparacervicalblock(seesection4.3,Contraindications).

Forlevobupivacaine,therearenoclinicaldataonfirsttrimester-exposedpregnancies.Animalstudiesdonotindicate

teratogeniceffectsbuthaveshownembryo-foetaltoxicityatsystemicexposurelevelsinthesamerangeasthose

obtainedinclinicaluse(seesection5.3,Preclinicalsafetydata).Thepotentialriskforhumanisunknown.

Levobupivacaineshouldthereforenotbegivenduringearlypregnancyunlessclearlynecessary.

Nevertheless,todate,theclinicalexperienceofbupivacaineforobstetricalsurgery(atthetermofpregnancyorfor

delivery)isextensiveandhasnotshownafoetotoxiceffect.

Lactation

Levobupivacaineexcretioninbreastmilkisunknown.However,levobupivacaineislikelytobepoorlytransmittedin

thebreastmilk,asforbupivacaine.Thusbreastfeedingispossibleafterlocalanaesthesia.

4.7Effectsonabilitytodriveandusemachines

Levobupivacainecanhaveamajorinfluenceontheabilitytodriveorusemachines.Patientsshouldbewarnednotto

driveoroperatemachineryuntilalltheeffectsoftheanaesthesiaandtheimmediateeffectsofsurgeryarepassed.

4.8Undesirableeffects

Adversereactionswithlocalanaestheticsoftheamidetypearerare,buttheymayoccurasaresultofoverdosageor

unintentionalintravascularinjectionandmaybeserious.

Allergic-typereactionsarerareandmayoccurasaresultofsensitivitytothelocalanesthetic.Thesereactionsare

characterisedbysignssuchasurticaria,pruritus,erythema,angioneuroticoedema(includinglaryngealoedema).

Tachycardia,sneezing,nausea,vomiting,dizziness,syncope,excessivesweating,elevatedtemperature,and,possibly,

anaphylactic-likesymptomatology(includingseverehypotension).Crosssensitivityamongmembersoftheamide-type

localanaestheticgrouphavebeenreported(seesection4.3,Contraindications).

Accidentalintrathecalinjectionoflocalanaestheticscanleadtoveryhighspinalanaesthesiapossiblywithapnoea,

severehypotensionandlossofconsciousness.

Centralnervoussystemeffects:Numbnessofthetongue,lightheadedness,dizziness,blurredvisionandmuscletwitch

followedbydrowsiness,convulsions,unconsciousnessandpossiblerespiratoryarrest.

Cardiovasculareffectsarerelatedtodepressionoftheconductionsystemoftheheartandareductioninmyocardial

excitabilityandcontractility.Thisresultsindecreasedcardiacoutput,hypotensionandECGchangesindicativeof

eitherheartblock,bradycardiaorventriculartachyarrythmiasthatmayleadtocardiacarrest.Usuallythesewillbe

precededbymajorCNStoxicity,i.e.convulsions,butinrarecases,cardiacarrestmayoccurwithoutprodromalCNS

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Themostfrequentadverseeventsreportedinclinicaltrialsirrespectiveofcausalityarelistedinthetableabove.

Neurologicaldamageisararebutwellrecognisedconsequenceofregionalandparticularlyepiduralandspinal

anaesthesia.Itmaybeduetodirectinjurytothespinalcordorspinalnerves,anteriorspinalarterysyndrome,injection

ofanirritantsubstanceoraninjectionofanon-sterilesolution.Thesemayresultinlocalisedareasofparaesthesiaor

anaesthesia,motorweakness,lossofsphinctercontrolandparaplegia.Rarely,thesemaybepermanent.

Postmarketingreports

Anaphylaxishasbeenreported.Veryrarereportsofconvulsionshaveoccurredfollowingaccidentalintravenous

administration.

4.9Overdose

Accidentalintravascularinjectionoflocalanaestheticsmaycauseimmediatetoxicreactions.Intheeventofoverdose,

peakplasmaconcentrationsmaynotbereacheduntil2hoursafteradministrationdependingupontheinjectionsite

and,therefore,signsoftoxicitymaybedelayed.Theeffectsofthedrugmaybeprolonged.

Systemicadversereactionsfollowingoverdoseoraccidentalintravascularinjectionreportedwithlongactinglocal

anaestheticagentsinvolvebothCNSandcardiovasculareffects.

CNSEffects

Convulsionsshouldbetreatedimmediatelywithintravenousthiopentoneordiazepamtitratedasnecessary.

Thiopentoneanddiazepamalsodepresscentralnervoussystem,respiratoryandcardiacfunction.Thereforetheiruse

mayresultinapnoea.Neuro-muscularblockersmaybeusedonlyiftheclinicianisconfidentofmaintainingapatent

airwayandmanagingafullyparalysedpatient.

Ifnottreatedpromptly,convulsionswithsubsequenthypoxiaandhypercarbiaplusmyocardialdepressionfromthe

effectsofthelocalanaestheticontheheart,mayresultincardiacarrhythmias,ventricularfibrillationorcardiacarrest.

CardiovascularEffects

Hypotensionmaybepreventedorattenuatedbypre-treatmentwithafluidloadand/ortheuseofvasopressors.If

hypotensionoccursitshouldbetreatedwithintravenouscrystalloidsorcolloidsand/orincrementaldosesofa

vasopressorsuchasephedrine5-10mg.Anycoexistingcausesofhypotensionshouldberapidlytreated.

Ifseverebradycardiaoccurs,treatmentwithatropine0.3-1.0mgwillnormallyrestoretheheartratetoanacceptable

level.

FREQUENCY ADVERSEEVENT

Bloodandthelymphatic

systemdisorders VeryCommon Anaemia

Nervoussystemdisorders Common Dizziness

Headache

Cardiacdisorders VeryCommon Hypotension

Gastrointestinaldisorders VeryCommon

Common Nausea

Vomiting

Pregnancy,puerperiumand

perinatalconditions Common Foetaldistress

Generaldisordersand

administrationsite

conditions Common

Common

Common Backpain

Fever

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Localanaesthetics,amide

ATCCode N01BB10

Levobupivacaineisalongactinglocalanaestheticandanalgesic.Itblocksnerveconductioninsensoryandmotor

nerveslargelybyinteractingwithvoltagesensitivesodiumchannelsonthecellmembrane,butalsopotassiumand

calciumchannelsareblocked.Inaddition,levobupivacaineinterfereswithimpulsetransmissionandconductionin

othertissueswhereeffectsonthecardiovascularandcentralnervoussystemsaremostimportantfortheoccurrenceof

clinicaladversereactions.

Thedoseoflevobupivacaineisexpressedasbase,whereas,intheracematebupivacainethedoseisexpressedas

hydrochloridesalt.Thisgivesrisetoapproximately13%moreactivesubstanceinlevobupivacainesolutionscompared

tobupivacaine.Inclinicalstudiesatthesamenominalconcentrationslevobupivacaineshowedsimilarclinicaleffectto

bupivacaine.

Inaclinicalpharmacologystudyusingtheulnarnerveblockmodel,levobupivacainewasequipotentwithbupivacaine.

5.2Pharmacokineticproperties

Inhumanstudies,thedistributionkineticsoflevobupivacainefollowingi.v.administrationisessentiallythesameas

bupivacaine.Theplasmaconcentrationoflevobupivacainefollowingtherapeuticadministrationdependsondoseand,

asabsorptionfromthesiteofadministrationisaffectedbythevascularityofthetissue,onrouteofadministration.

Therearenorelevantdatainpatientswithhepaticimpairment(seesection4.4,Specialwarningandprecautionsfor

use).

Therearenodatainpatientswithrenalimpairment.Levobupivacaineisextensivelymetabolisedandunchanged

levobupivacaineisnotexcretedinurine.

Plasmaproteinbindingoflevobupivacaineinmanwasevaluatedinvitroandwasfoundtobe>97%atconcentrations

between0.1and1.0µg/ml.

Inaclinicalpharmacologystudywhere40mglevobupivacainewasgivenbyintravenousadministration,themean

half-lifewasapproximately80+22minutes,C

1.4+0.2µg/mlandAUC70+27µgmin/ml.

ThemeanC

andAUC(0-24h)oflevobupivacainewereapproximatelydose-proportionalfollowingepidural

administrationof75mg(0.5%)and112.5mg(0.75%)andfollowingdosesof1mg/kg(0.25%)and2mg/kg(0.5%)

usedforbrachialplexusblock.Followingepiduraladministrationof112.5mg(0.75%)themeanC

andAUC

valueswere0.58µg/mland3.56µgh/mlrespectively.

Themeantotalplasmaclearanceandterminalhalf-lifeoflevobupivacaineafterintravenousinfusionwere39

litres/hourand1.3hours,respectively.Thevolumeofdistributionafterintravenousadministrationwas67litres.

Levobupivacaineisextensivelymetabolisedwithnounchangedlevobupivacainedetectedinurineorfaeces.3-

hydroxylevobupivacaine,amajormetaboliteoflevobupivacaine,isexcretedintheurineasglucuronicacidand

sulphateesterconjugates.InvitrostudiesshowedthatCYP3A4isoformandCYP1A2isoformmediatethe

metabolismoflevobupivacainetodesbutyl-levobupivacaineand3-hydroxylevobupivacainerespectively.These

studiesindicatethatthemetabolismoflevobupivacaineandbupivacainearesimilar.

Followingintravenousadministration,recoveryoflevobupivacainewasquantitativewithameantotalofabout95%

beingrecoveredinurine(71%)andfaeces(24%)in48hours.

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5.3Preclinicalsafetydata

Inanembryo-foetaltoxicitystudyinrats,anincreasedincidenceofdilatedrenalpelvis,dilatedureters,olfactory

ventricledilatationandextrathoraco-lumbarribswasobservedatsystemicexposurelevelsinthesamerangeasthose

obtainedatclinicaluse.Therewerenotreatment-relatedmalformations.

Levobupivacainewasnotgenotoxicinastandardbatteryofassaysformutagenicityandclastogenicity.No

carcinogenicitytestinghasbeenconducted.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

SodiumChloride

SodiumHydroxide

Hydrochloricacid

WaterforInjections

6.2Incompatibilities

Levobupivacainemayprecipitateifdilutedwithalkalinesolutionsandshouldnotbedilutedorco-administeredwith

sodiumbicarbonateinjections.Thismedicinalproductmustnotbemixedwithothermedicinalproductsexceptthose

mentionedinsection6.3,Shelflife.

6.3ShelfLife

Shelflifeaspackagedforsale:3years

Shelflifeafterfirstopening:Theproductshouldbeusedimmediately.

Shelflifeafterdilutioninsodiumchloridesolution0.9%:Chemicalandphysicalin-usestabilityhasbeendemonstrated

for7daysat20-22°C.Chemicalandphysicalin-usestabilitywithclonidine,morphineorfentanylhasbeen

demonstratedfor40hoursat20-22°C.

Fromamicrobiologicalpointofview,theproductshouldbeusedimmediately.Ifnotusedimmediately,in-usestorage

timesandconditionspriortousearetheresponsibilityoftheuser.

6.4Specialprecautionsforstorage

Glassampoules:storeintheoriginalpackageinordertoprotectfromlight.

Polypropyleneampoules:polypropyleneampoulesdonotrequireanyspecialstorageconditions.

6.5Natureandcontentsofcontainer

Chirocaineisavailableintwopresentations;

10mlpolypropyleneampouleinpacksof5,10&20

10mlpolypropyleneampoule,insterileblisterpacksof5,10&20

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Forsingleuseonly.Discardanyunusedsolution.

Thesolution/dilutionshouldbeinspectedvisuallypriortouse.Onlyclearsolutionswithoutvisibleparticlesshouldbe

used.

Asterileblistercontainershouldbechosenwhenasterileampoulesurfaceisrequired.Ampoulesurfaceisnotsterile

ifsterileblisterispierced.

Dilutionsoflevobupivacainestandardsolutionsshouldbemadewithsodiumchloride9mg/ml(0.9%)solutionfor

injectionusingaseptictechniques.

Clonidine8.4µg/ml,morphine0.05mg/mlandfentanyl4µg/mlhavebeenshowntobecompatiblewith

levobupivacaineinsodiumchloride9mg/ml(0.9%)solutionforinjection.

7MARKETINGAUTHORISATIONHOLDER

AbbottLaboratoriesIrelandLtd

4051KingswoodDrive

CitywestBusinessCampus

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA0038/071/003

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:04February2000

Dateoflastrenewal:18December2003

10DATEOFREVISIONOFTHETEXT

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