DYSPORT, POWDER FOR SOLUTION FOR INJECTION.

Main information

  • Trade name:
  • DYSPORT, POWDER FOR SOLUTION FOR INJECTION.
  • Dosage:
  • 500 Units/ml
  • Pharmaceutical form:
  • Pdr for Soln for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DYSPORT, POWDER FOR SOLUTION FOR INJECTION.
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0583/001/001
  • Authorization date:
  • 20-07-1994
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dysport500UnitsPowderforsolutionforinjection

2QUALITATIVEANDQUANTITATIVECOMPOSITION

ClostridiumbotulinumtypeAtoxin-haemagglutinincomplex500units*

*Oneunit(U)isdefinedasthemedianlethalintraperitonealdoseinmice.

DuringthedevelopmentofbotulinumtypeAtoxinhaemagglutinincomplex,theactivitywascommonlyexpressedin

termsofanominalweight,baseduponastandardspecificactivityof4x10 7

units/mg

Anyreferencetothisproductexpressedinnanograms,whetherintheliteratureorelsewhere,maythereforebereadily

convertedintounitsusingtheformula1ng=40U.

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

PowderforSolutionforInjection

UncolouredTypeIglassvialcontainingasterilewhitelyophilisedpowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Dysportisindicatedforthetreatmentof:

Spasticityofthearminpatientsfollowingastroke.

Dynamicequinusfootdeformityduetospasticityinambulantpaediatriccerebralpalsypatients,twoyearsofage

orolder

Spasmodictorticollis

Blepharospasm

Hemifacialspasm

Persistentsevereprimaryhyperhidrosisoftheaxillae,whichinterfereswiththeactivitiesofdailylivingandis

resistanttotopicaltreatment.

4.2Posologyandmethodofadministration

Dysportshouldonlybeadministeredbyphysicianswhohaveexperienceinthediagnosisandtreatmentofthe

conditionsindicatedandwhohavereceivedappropriatetrainingintheadministrationofDysport.

TheunitsofDysportarespecifictothepreparationandarenotinterchangeablewithotherpreparationsofbotulinum

toxin.

Axillaryhyperhidrosis

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Adultsandelderly:Therecommendedinitialdosageis100unitsperaxilla.Ifthedesiredeffectisnotattained,upto

200unitsperaxillacanbeadministeredforsubsequentinjections.

Themaximumeffectshouldbeseenbyweektwoafterinjection.Inthemajorityofcases,therecommendeddosewill

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Thetimepointforfurtherapplicationsshouldbedeterminedonanindividualbasis,whenthepatient'ssweatsecretion

hasreturnedtonormal,butnotmoreoftenthanevery16weeks.Thereissomeevidenceforacumulativeeffectof

repeateddosessothetimeofeachtreatmentforagivenpatientshouldbeassessedindividually.

Children:ThesafetyandeffectivenessofDysportinthetreatmentofprimaryaxillaryhyperhidrosishasnotbeen

investigatedinchildrenandadolescentsunder18years.

Methodofadministration

Theexposedcentralportionoftherubberstoppershouldbecleanedwithalcoholimmediatelypriortopiercingthe

septum.Asterile23or25gaugeneedleshouldbeused.

Dysportisreconstitutedwith2.5mlofsodiumchloridesolution(0.9%)toyieldasolutioncontaining200unitsperml

ofDysport.Dysportisadministeredbyintradermalinjectionattensiteswhentreatingaxillaryhyperhidrosis.

Theareatobeinjectedshouldbedeterminedbeforehandusingtheiodine-starchtest.Bothaxillaeshouldbecleaned

anddisinfected.Intradermalinjectionsattensites,eachsitereceiving10units(0.05ml)i.e.100units(0.5ml)peraxilla,

arethenadministered.Theinjectionshouldbeadministeredinanevendistributionwithinthehyperhidroticarea

(delineatedwiththeiodine-starchtestandusingteninjectionpoints).

TheuseofDysportinspasmodictorticollisandadultpost-strokespasticityisrestrictedtohospital-basedspecialist

units.Forthetreatmentofspasmodictorticollis,paediatriccerebralpalsyspasticityandadultpost-strokespasticity,

Dysportshouldonlybeinjectedbyspecialistexperiencedinthediagnosisandmanagementofthisconditionandwho

havereceivedtrainingontheadministrationofDysport.

Theexposedcentralportionoftherubberstoppershouldbecleanedwithalcoholimmediatelypriortopiercingthe

septum.Asterile23or25gaugeneedleshouldbeused.

Adultspasticityofthearmpost-stroke:

Posology

Therecommendeddoseis1000units,distributedamongstthefollowingfivemuscles:flexordigitorumprofundus

(FDP),flexordigitorumsuperficialis(FDS),flexorcarpiulnaris(FCU),flexorcarpiradialis(FCR)andbicepsbrachii

(BB).Thesitesofinjectionshouldbeguidedbystandardlocationsusedforelectromyography,althoughactual

locationoftheinjectionsitewillbedeterminedbypalpation.Itisrecommendedthattheadministrationoftheinjection

shouldalsobeunderelectromyographyguidance.Allmusclesexceptthebicepsbrachiiwillbeinjectedatonesite,

whilstthebicepswillbeinjectedattwosites.Therecommendeddistributionofdoseisgivenbelow:

Thestartingdoseshouldbeloweredifthereisevidencetosuggestthatthisdosemayresultinexcessiveweaknessof

thetargetmuscles,suchasforpatientswhosetargetmusclesaresmall,wheretheBBmuscleisnottobeinjectedor

patientswhoaretobeadministeredmulti-levelinjections.Clinicalimprovementmaybeexpectedwithintwoweeks

afterinjection.Injectionsmayberepeatedapproximatelyevery16weeks,orasrequiredtomaintainresponse,butnot

morefrequentlythaneverytwelveweeks.

Children:ThesafetyandeffectivenessofDysportinthetreatmentofarmspasticityinchildrenhasnotbeen

demonstrated.

Methodofadministration

Dysportisreconstitutedwith1.0mlofsodiumchlorideinjectionB.P.(0.9%)toyieldasolutioncontaining500units

permlofDysport.Dysportisadministeredbyintramuscularinjectionintothefivemusclesdetailedabovewhen

(units) FDP

(units) FDS

(units) FCU

(units) FCR

(units) TotalDose

(units)

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Paediatriccerebralpalsyspasticity:

Posology

Theinitialrecommendeddoseis20units/kgbodyweightgivenasadivideddosebetweenbothcalfmuscles.Ifonly

onecalfisaffected,adoseof10units/kgbodyweightshouldbeused.Considerationshouldbegiventoloweringthis

startingdoseifthereisevidencetosuggestthatthisdosemayresultinexcessiveweaknessofthetargetmuscles,such

asforpatientswhosetargetmusclesaresmallorpatientswhorequireconcomitantinjectionstoothermusclegroups.

Followingevaluationofresponsetothestartingdosesubsequenttreatmentmaybetitratedwithintherange10units/kg

and30units/kgdividedbetweenbothlegs.Themaximumdoseadministeredmustnotexceed1000units/patient.

Administrationshouldprimarilybetargetedtothegastrocnemius,althoughinjectionsofthesoleusandinjectionofthe

tibialisposteriorshouldalsobeconsidered.

Theuseofelectromyography(EMG)isnotroutineclinicalpracticebutmayassistinidentifyingthemostactive

muscles.

Clinicalimprovementmaybeexpectedwithintwoweeksafterinjection.Injectionsmayberepeatedapproximately

every16weeksorasrequiredtomaintainresponse,butnotmorefrequentlythaneverytwelveweeks.

Methodofadministration

Whentreatingpaediatriccerebralpalsyspasticity,Dysportisreconstitutedwith1.0mlofsodiumchlorideinjectionB.P.

(0.9%)toyieldasolutioncontaining500unitspermlofDysport.Dysportisadministeredbyintramuscularinjection

intothecalfmuscleswhentreatingspasticity.

Spasmodictorticollis:

Posology

Adultsandelderly:Thedosesrecommendedfortorticollisareapplicabletoadultsofallagesprovidingtheadultsare

ofnormalweightwithnoevidenceoflowneckmusclemass.Areduceddoseisappropriateifthepatientismarkedly

underweightandintheelderlywherereducedmusclemassmayexist.

Theinitialrecommendeddoseforthetreatmentofspasmodictorticollisis500units(1ml)perpatientgivenasa

divideddoseandadministeredtothetwoorthreemostactiveneckmuscles.

Forrotationaltorticollisdistributethe500unitsbyadministering350unitsintothespleniuscapitismuscle,ipsilateral

tothedirectionofthechin/headrotationand150unitsintothesternomastoidmuscle,contralateraltotherotation.

Forlaterocollis,distributethe500unitsbyadministering350unitsintotheipsilateralspleniuscapitismuscleand150

unitsintotheipsilateralsternomastoidmuscle.Incasesassociatedwithshoulderelevationtheipsilateraltrapezoidor

levatorscapulaemusclesmayalsorequiretreatment,accordingtovisiblehypertrophyofthemuscleor

electromyographic(EMG)findings.Whereinjectionsofthreemusclesarerequired,distributethe500unitsasfollows,

300unitsspleniuscapitis,100unitssternomastoidand100unitstothethirdmuscle.

Forretrocollisdistributethe500unitsbyadministering250unitsintoeachofthespleniuscapitismuscles.Thismaybe

followedbybilateraltrapeziusinjections(upto250unitspermuscle)after6weeks,ifthereisinsufficientresponse.

Bilateralspleniiinjectionsmayincreasetheriskofneckmuscleweakness.

AllotherformsoftorticollisarehighlydependentonspecialistknowledgeandEMGtoidentifyandtreatthemost

activemuscles.EMGshouldbeuseddiagnosticallyforallcomplexformsoftorticollis,forreassessmentafter

unsuccessfulinjectionsinnoncomplexcases,andforguidinginjectionsintodeepmusclesorinoverweightpatients

withpoorlypalpableneckmuscles.

Onsubsequentadministration,thedosesmaybeadjustedaccordingtotheclinicalresponseandsideeffectsobserved.

Doserangesfrom250-1000unitsarerecommended,althoughthehigherdosesmaybeaccompaniedbyincreaseinside

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Thereliefofsymptomsoftorticollismaybeexpectedwithinaweekaftertheinjection.Injectionsshouldberepeated

approximatelyeverytwelveweeksorasrequiredtopreventrecurrenceofsymptoms.

Children:ThesafetyandeffectivenessofDysportinthetreatmentofspasmodictorticollisinchildrenhasnotbeen

demonstrated.

Methodofadministration

WhentreatingspasmodictorticollisDysportisreconstitutedwith1mlSodiumChlorideInjectionBP(0.9%)toyielda

clearsolutioncontaining500unitspermlofDysport.Dysportisadministeredbyintramuscularinjectionasabove

whentreatingspasmodictorticollis.

Blepharospasmandhemifacialspasm:

Posology

Adultsandelderly:Inthetreatmentofbilateralblepharospasmtherecommendedinitialdoseis120unitspereye.After

theskinaroundeacheyehasbeencleaned,injectionsof0.1ml(20units)shouldbemademediallyandof0.2ml(40

units)shouldbemadelaterallyintothejunctionbetweenthepreseptalandorbitalpartsofboththeupperandlower

orbicularisoculimusclesofeacheye.

Forinjectionsintotheupperlid,theneedleshouldbedirectedawayfromitscentretoavoidthelevatormuscle.A

diagramtoaidplacementoftheseinjectionsisprovided.Thereliefofsymptomsmaybeexpectedtobeginwithintwo

tofourdayswithmaximaleffectwithintwoweeks.

Injectionsshouldberepeatedapproximatelyeverytwelveweeksorasrequiredtopreventrecurrenceofsymptoms.On

suchsubsequentadministrationthedosemayneedtobereducedto80unitspereye-viz-:0.1ml(20units)medially

and0.1ml(20units)laterallyaboveandbeloweacheyeinthemannerpreviouslydescribed.

Thedosemaybefurtherreducedto60unitspereyebyomittingthemediallowerlidinjection.

0.1ml 0.2ml

0.1ml 0.2ml

Incasesofunilateralblepharospasmtheinjectionsshouldbeconfinedtotheaffectedeye.Patientswithhemifacial

spasmshouldbetreatedasforunilateralblepharospasm.Thedosesrecommendedareapplicabletoadultsofallages

includingtheelderly.

Children:ThesafetyandeffectivenessofDysportinthetreatmentofblepharospasmandhemifacialspasminchildren

hasnotbeendemonstrated.

Methodofadministration

WhentreatingblepharospasmandhemifacialspasmDysportisreconstitutedwith2.5mlSodiumChlorideInjectionBP

(0.9%)toyieldaclearsolutioncontaining200unitspermlofDysport.Dysportisadministeredbysubcutaneous

injectionmediallyandlaterallyintothejunctionbetweenthepreseptalandorbitalpartsofboththeupperandlower

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4.3Contraindications

DysportiscontraindicatedinindividualswithknownhypersensitivitytoanycomponentsofDysport.Dysportis

contraindicatedinpregnancyandlactation.

4.4Specialwarningsandprecautionsforuse

Dysportshouldbeadministeredwithcautiontopatientswithexistingproblemsinswallowingorbreathingasthese

problemscanworsenfollowingthedistributionoftheeffectoftoxinintotherelevantmuscles.Aspirationhasoccurred

inrarecases,andisariskwhentreatingpatientswithspasmodictorticolliswhohaveachronicrespiratorydisorder.

Carefulconsiderationshouldbegivenbeforethereinjectionofpatientswhohaveexperiencedapreviousallergic

reactiontoaproductcontainingbotulinumtoxintypeA.Theriskofafurtherallergicreactionmustbeconsideredin

relationtothebenefitoftreatment.

Dysportshouldonlybeusedwithcautionunderclosesupervisioninpatientswithsubclinicalorclinicalevidenceof

markeddefectiveneuro-musculartransmission(e.g.myastheniagravis).Suchpatientsmayhaveanincreased

sensitivitytoagentssuchasDysportwhichmayresultinexcessivemuscleweakness.

TherearenoreportsofanyimmuneresponseafterthelocaladministrationofClostridiumbotulinumTypeAtoxin-

haemagglutinincomplexinaccordancewiththedosesrecommendedwhentreatingblepharospasmandhemifacial

spasm.Antibodyformationtobotulinumtoxinhasbeennotedrarelyinasmallnumberoftorticollispatientsreceiving

Dysport.Clinicallyneutralizingantibodieshave,beendetectedbysubstantialdeteriorationinresponsetotherapyora

needforconsistentlyincreasingdoses.

Forthetreatmentofcerebralpalsyinchildren,dysportshouldonlybeusedinchildrenover2yearsofage.

Aswithanyintramuscularinjection,Dysportshouldbeusedonlywherestrictlynecessaryinpatientswithprolonged

bleedingtimes,infectionorinflammationattheproposedinjectionsite.

Thisproductcontainsasmallamountofhumanalbumin.Theriskofsomeviralinfectionscannotbeexcludedwith

absolutecertaintyfollowingtheuseofhumanbloodorbloodproduct.

Primaryaxillaryhyperhidrosis

Medicalhistoryandphysicalexamination,alongwithspecificadditionalinvestigationsasrequired,shouldbe

performedtoexcludepotentialcausesofsecondaryhyperhidrosis(e.g.hyperthyroidism,phaeochromocytoma).This

willavoidsymptomatictreatmentofhyperhidrosiswithoutthediagnosisand/ortreatmentofunderlyingdisease.

Adverseeffectsresultingfromthedistributionoftheeffectsofthetoxintositesremotefromthesiteofadministration

havebeenreported(seesection4.8).Patientstreatedwiththerapeuticdosesmaypresentexcessivemuscleweakness.

Theriskofoccurrenceofsuchundesirableeffectsmaybereducedbyusingthelowesteffectivedoseandbynot

exceedingtherecommendeddose.

Veryrarecasesofdeath,occasionallyinacontextofdysphagia,pneumopathyand/orinpatientswithsignificant

astheniahavebeenreportedaftertreatmentwithbotulinumtoxinAorB.

Patientswithdisordersresultingindefectiveneuro-musculartransmission,difficultyinswallowingorbreathingare

moreatriskofexperiencingtheseeffects.Inthesepatients,treatmentmustbeadministeredunderthecontrolofa

specialistandonlyifthebenefitoftreatmentoutweighstherisk.

Patientsandtheircare-giversmustbewarnedofthenecessityofimmediatemedicaltreatmentincaseofproblemswith

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theeffectofbotulinumtoxinmaybepotentiatedbyaminoglycosideantibioticsoranyotherdrugsthatinterferewith

neuromusculartransmission,eg.tubocurarine-typemusclerelaxants.Thesedrugsshouldbeusedwithcaution.

Polymyxins,tetracyclinesandlincomycinshouldbeusedwithcautioninthebotulinumtoxintreatedpatient.Muscle

relaxantsshouldalsobeusedwithcaution,perhapsreducingthestartingdoseofrelaxantorusinganintermediate-

actiondrug,suchasvecuroniumoratracurium,ratherthanthosewithlongerlastingeffects.

4.6Fertility,pregnancyandlactation

TeratologicalandotherreproductivestudieshavenotbeenperformedwithDysport.Thesafetyofitsuseinpregnantor

lactatingwomenhasnotbeendemonstrated.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Verycommon>1/10:

Common>1/100,<1/10:

Uncommon>1/1000,<1/100:

Rare>1/10000,<1/1000,

Veryrare<1/10000

Adverseeffectsresultingfromdistributionoftheeffectsofthetoxintositesremotefromthesiteofinjectionhavebeen

veryrarelyreported(excessivemuscleweakness,dysphagia,aspirationpneumoniathatmaybefatal)(seesection4.4).

General

Atotalofapproximately7800patientsweretreatedwithDysportduringaseriesofclinicaltrialsinpatientssuffering

blepharospasm,hemifacialspasm,torticollisorspasticityassociatedwitheithercerebralpalsyorstrokeoraxillary

hyperhidrosis.Approximately2200patientsincludedinthesetrialsexperiencedanadverseevent.

Nervoussystemdisorders

Rare:Neuralgicamyotrophy

Skinandsubcutaneoustissuedisorders

Uncommon:Itching

Rare:Skinrashes

Generaldisordersandadministrationsiteconditions

Common:Generalisedweakness,fatigue,flulikesyndromeandpain/bruisingatinjectionsite

AxillaryHyperhidrosis

In4clinicaltrialsinvolvingapproximately217patientstreatedwithDysportthefollowingadversereactionswere

reported:

Skinandsubcutaneoustissuedisorders

Common:Compensatorysweating

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Adultspasticityofthearmpost-stroke

In14clinicaltrialsinvolving141patientstreatedwithDysportthefollowingadversereactionswerereported:

Gastrointestinaldisorders

Common:Dysphagia

Musculoskeletalandconnectivetissuedisorders

Common:Armmuscleweakness

Injury,poisingandproceduralcomplications

Common:Accidentalinjury/Falls

Dysphagiawasreportedwhendosesinexcessof2700unitswereusedeitherasasingleordivideddose.

Paediatriccerebalpalsyspasticity

In14clinicaltrialsinvolvingapproximately900patientstreatedwithDysport,thefollowingadversereactionswere

reported.

Gastrointestinaldisorders

Common:Diarrhoea

Musculoskeletalandconnectivetissuedisorders

Common:legmuscleweakness

Renalandurinarydisorders

Common:Urinaryincontinence

Generaldisordersandadministrationsiteconditions

Common:abnormalgait

Injury,poisingandproceduralcomplications

Common:Accidentalinjuryduetofalling.

Accidentalinjuryduetofallingandabnormalgaitmayhavebeenduetotheover-weakeningofthetargetmuscleand/

orthelocalspreadofDysporttoothermusclesinvolvedinambulationandbalance.

Spasmodictorticollis

In21clinicaltrialsinvolvingapproximately4100patientsthefollowingadversereactionswerereported:

Nervoussystemdisorders

Common:Dysphonia

Uncommon:Headache

Eyedisorders

Uncommon:Diplopia,blurredvision

Respiratory,thoracicandmediastinaldisorders

Rare:Respiratorydisorders

Gastrointestinaldisorders

Verycommon:Dysphagia

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Musculoskeletalandconnectivetissuedisorders

Common:Neckmuscleweakness

Dysphagiaappearedtobedoserelatedandoccurredmostfrequentlyfollowinginjectionintothesternomastoidmuscle.

Asoftdietmayberequireduntilsymptomsresolve.

Blepharospasmandhemifacialspasm

In13clinicaltrialsinvolvingapproximately1400patientsthefollowingadversereactionswerereported:

Nervoussystemdisorders

Common:Facialmuscleweakness

Uncommon:Facialnerveparesis

EyeDisorders

Verycommon:Ptosis

Common:Diplopia,Dryeyes,Tearing

Rare:Ophthalmoplegia

Skinandsubcutaneoustissuedisorders

Common:Eyelidoedema

Rare:Entropion

SideeffectsmayoccurduetodeepormisplacedinjectionsofDysporttemporarilyparalyzingothernearbymuscle

groups

Theprofileofadversereactionsreportedtothecompanyduringpost-marketingusereflectsthepharmacologyofthe

productandthoseseenduringclinicaltrials.

4.9Overdose

Excessivelocaldosesmayproducedistantandprofoundneuromuscularparalysis.Respiratorysupportmayberequired

whereexcessivedosescauseparalysisofrespiratorymuscles.Thereisnospecificantidote;antitoxinshouldnotbe

expectedtobebeneficial.Overdosecouldleadtoanincreasedriskoftheneurotoxinenteringthebloodstream,which

maycausecomplicationsassociatedwiththeeffectsoforalbotulinumpoising.(e.g.:deglutitionandphonation).

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:OtherDermatologicalPreparation

ATCcode:MO3AX01

ClostridiumbotulinumtypeAtoxin-haemagglutinincomplexblocksperipheralcholinergictransmissionatthe

neuromuscularjunctionbyapresynapticactionatasiteproximaltothereleaseofacetylcholine.Thetoxinactsonorin

thenerveendingtoantagonisethoseeventsthataretriggeredbycalciumandthatculminateintransmitterrelease.It

doesnotaffectcholinergictransmissionorpostganglionicsympathetictransmission.

Theactionoftoxininvolvesaninitialbindingstepwherebythetoxinattachesrapidlyandavidlytothepresynaptic

nervemembrane.Secondlythereisaninternalisationstepinwhichtoxincrossesthepresynapticmembrane,without

causingonsetofparalysis.FinallythetoxininhibitsthereleaseofacetylcholinebydisruptingtheCa2 +

mediated

acetylcholinereleasemechanism,therebydiminishingtheendplatepotentialandcausingparalysis.

Recoveryofimpulsetransmissionoccursgraduallyasnewnerveterminalssproutandcontactismadewiththepost

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5.2Pharmacokineticproperties

Pharmacokineticstudieswithbotlinumtoxinposeproblemsinanimalsbecauseofthehighpotency,theminutedoses

involved,thelargemolecularweightofthecompoundandthedifficultyoflabellingtoproducesufficientlyhigh

specificactivity.StudiesusingI 125

labelledtoxinhaveshownthatthereceptorbindingisspecificandsaturable,and

thehighdensityoftoxinreceptorsisacontributoryfactorinthehighpotency.Doseandtimeresponsesinmonkeys

showedthatatlowdoses,therewasadelayof2-3dayswithpeekeffectseen5-6daysafterinjection.Thedurationof

action,measuredbychangesofouteralignmentandmuscleparalysisvariedbetween2weeksand8months.This

patternisalsoseeninmanandisattributedtotheprocessofbinding,internalisationandchangesattheneuromuscular

junction.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Humanalbuminsolution200g/l

Composedof:

Humanplasmaprotein(ofwhichatleast95%ishumanalbumin)

Sodiumcaprylate

N-Acetyltryptophan/sodiumacetyltryptophanate

Sodiumchloride

6.2Incompatibilities

Thismedicinalproductshouldnotbemixedwithothermedicinalproductsexceptthoselistedinsection6.6.

6.3Shelflife

Unopenedproduct:2yearswhenstoredat2–8 o

Reconstitutedproduct:Chemicalandphysicalin–usestabilityhasbeendemonstratedfor8hoursat2-8°C.

Fromamicrobiologicalpointofview,unlessthemethodofopening/reconstitutionprecludestheriskof

microbiologicalcontamination,theproductshouldbeusedimmediately.

Ifnotusedimmediately,in–usestoragetimesandconditionspriortousearetheresponsibilityoftheuserandshould

notbelongerthan8hoursat2-8°C,theopening/reconstitutionoftheproducthavingtakenplaceincontrolledand

validatedasepticconditions.

6.4Specialprecautionsforstorage

Storeunopenedvialsinarefrigeratorat2°Cand8°C.Donotfreeze.

6.5Natureandcontentsofcontainer

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Dysportiscontainedin3mlwhiteneutralglassvials(Ph.Eur./BPTypeI),injectionsulphatetreatedtoreducethe

surfacealkalinity,with13mmneck.

Thevialissealedwitha13mmbutylfreezedryingstopperand13mmTypeIaluminiumoverseal.

Contentsofcontainer:

Boxesof1or2vialsofDysportareavailable.EachvialofDysportcontains500unitsofthetoxincomplex.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

DysportisreconstitutedwithsodiumchlorideinjectionB.P.(0.9%).Forinstructionsondilutionoftheproductbefore

administration,seesection4.2.

ReconstitutedDysportshouldbeclear,colourless,andfreeofparticulatematter,otherwiseitmustnotbeinjected.

Immediatelyaftertreatmentofthepatient,anyresidualDysportwhichmaybepresentineithervialorsyringeshould

beinactivatedwithdilutehypochloritesolution(1%availablechlorine).Thereafter,allitemsshouldbedisposedofin

accordancewithstandardhospitalpractice.

SpillagesofDysportshouldbewipedupwithanabsorbentclothsoakedindilutehypochloritesolution.

7MARKETINGAUTHORISATIONHOLDER

IpsenLimited,

190BathRoad,

Slough,

Berkshire,

SL13XE,

8MARKETINGAUTHORISATIONNUMBER

PA0583/001/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 20April1994

Dateoflastrenewal: 20April2010

10DATEOFREVISIONOFTHETEXT

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