Furexel Combi

Main information

  • Trade name:
  • Furexel Combi
  • Pharmaceutical form:
  • Oral paste
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Furexel Combi
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ivermectin, combinations
  • Therapeutic area:
  • Horses

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0213/001
  • Authorization date:
  • 28-09-2011
  • EU code:
  • UK/V/0213/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:October2011

AN:01898/2010

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FurexelCombiOralPaste

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachsyringecontains7.74gofpasteanddelivers:

ActiveSubstances:

Ivermectin 0.120g(15.5mg/g)

Praziquantel 0.600g(77.5mg/g)

Excipients:

Buthylhydroxyanisole(E320): 0.002g

SunsetYellow(E110): 0.003g

Ttitaniumdioxide(E171)): 0.155g

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralpaste

Smooth,homogeneousorangepaste

4. CLINICALPARTICULARS

4.1Targetspecies

Horses

4.2Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofmixedcestodeandnematodeorarthropodinfestations

inhorses.Thefollowingparasitesofhorsesaresensitivetothe

antiparasiticeffectsoftheproduct:

AdultTapeworms:

Anoplocephalaperfoliata

Anoplocephalamagna

Largestrongyles:

Strongylusvulgaris(adultsandarteriallarvalstages)

Strongylusedentatus(adultsandtissuelarvalstages)

Strongylusequinus(adults)

Triodontophorusspp(adults)

Triodontophorusbrevicauda

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Triodontophorusserratus

Craterostomumacuticaudatum(adults)

Adultandimmature(intraluminalfourth-stagelarvae)ofsmallstrongylesor

cyathostomes,includingbenzimidazole-resistantstrains:

Coronocyclusspp

Coronocycluscoronatus

Coronocycluslabiatus

Coronocycluslabratus

Cyathostomumspp

Cyathostomumcatinatum

Cyathostomumpateratum

Cylicocyclusspp

Cylicocyclusashworthi

Cylicocycluselongatus

Cylicocyclusinsigne

Cylicocyclusleptostomum

Cylicocyclusnassatus

Cylicodontophorusspp

Cylicodontophorusbicornatus

Cylicostephanusspp

Cylicostephanuscalicatus

Cylicostephanusgoldi

Cylicostephanuslongibursatus

Cylicostephanusminutus

Parapoteriostomumspp

Parapoteriostomummettami

Petrovinemaspp

Petrovinemapoculatum

Poteriostomumspp

Adulthairworms:Trichostrongylusaxei

Adultandimmature(fourthstageLarvae)pinworms:Oxyurisequi

Adult,third-andfourth-stagelarvaeofroundworms(ascarids):

Parascarisequorum

Microfilariaeofneckthreadworms:Onchocercaspp

Adultintestinalthreadworms:Strongyloideswesteri

Adultlarge-mouthstomachworms:Habronemamuscae

Oraland,gastricstagesofbots:Gasterophilusspp

Adultandimmature(inihibitedfourthstagelarvae)lungworms:

Dictyocaulusarnfieldi

4.3Contraindications

Theproducthasbeenformulatedforuseinhorsesonly.Cats,dogs,

especiallycollies,OldEnglishSheepdogsandrelatedbreedsorcrosses.

Alsoturtlesandtortoisesmaybeadverselyaffectedbytheconcentration

ofivermectininthisproductiftheyareallowedtoingestspilledpasteor

haveaccesstousedsyringes.

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4.4Specialwarningsfortargetspecies

Careshouldbetakentoavoidthefollowingpracticesbecausethey

increasetheriskofdevelopmentofresistanceandcouldultimatelyresult

inineffectivetherapy:

- Toofrequentandrepeateduseofanthelminticsfromthesameclass,

overanextendedperiodoftime.

- Underdosing,whichmaybeduetounderestimationofbodyweight,

misadministrationoftheproduct,orlackofcalibrationofthedosing

device(ifany).

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurther

investigatedusingappropriatetests(e.g.FaecalEggCountReduction

Test).Wheretheresultsofthetest(s)stronglysuggestresistancetoa

particularanthelmintic,ananthelminticbelongingtoanother

pharmacologicalclassandhavingadifferentmodeofactionshouldbe

used.

Resistancetomacrocycliclactones(whichincludesivermectin)hasbeen

reportedinParascarisequoruminhorsesinanumberofcountries,

includingtheEU.Thereforetheuseofthisproductshouldbebasedon

local(regional,farm)epidemiologicalinformationaboutsusceptibilityof

nematodesandrecommendationsonhowtolimitfurtherselectionfor

resistancetoanthelmintics.

4.5Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Safetystudieswerenotconductedinfoalsyoungerthan2monthsof

age,orinstallions,theuseoftheproductisnotrecommendedin

thesecategoriesofanimals.

ii.Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Washhandsafteruse.

Donotsmoke,drinkoreatwhilehandlingtheproduct.

Thisproductmaycauseskinandeyeirritation.Therefore,theuser

shouldavoidcontactoftheproductwiththeskinandtheeyes.Inthe

caseofcontact,rinseimmediatelywithplentyofwater.

Inthecaseofaccidentalingestionoreyeirritationaftercontactseek

medicaladviceimmediatelyandshowthepackageinsertorthelabel

tothephysician.

4.6Adversereactions(frequencyandseriousness)

SomehorseswithheavyinfestationsofOnchocercaspp.microfilariae

haveexperiencedoedemaandpruritisfollowingtreatment;suchreactions

wereassumedtobetheresultofthedeathoflargenumbersof

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microfilariae.Thesesignsresolvewithinafewdaysbutsymptomatic

treatmentmaybeadvisable.

Incasesofheavyinfestationswithtapeworms,signsofmild,transient

colicandloosestoolmaybeobserved.

Followingadministrationoftheproducttherehavebeenrarereportsof

inflammationofthemouth,lipandtongue,whichresultsinvariousclinical

signssuchasoedema,hypersalivation,erythema,tonguedisorderand

stomatitis.Thesereactionshavebeentransitoryinnature,appearing

within1hourandabatingwithin24to48hoursfollowingadministration.In

caseofsevereoralreactionssymptomatictreatmentisrequired.

4.7Useduringpregnancy,lactationorlay

Studiesperformedinlaboratoryanimalsshowednoteratogenicor

embryotoxiceffectofeitherivermectinorpraziquantelatthe

recommendeddosesduringtherapy.

Ivermectin-Praziquantelcombinationcanbeusedafterthefirstthree

monthsofgestationandduringlactation.Intheabsenceofclinicaldatain

earlypregnancytheproductcanonlybeusedinthefirstthreemonthsof

gestationaccordingtoariskbenefitanalysisbytheveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsof

interaction

Nodataavailable.

4.9Amountstobeadministeredandadministrationroute

Therecommendeddosageis200mcgivermectinperkilogramof

bodyweightand1mgpraziquantelperkilogramofbodyweight

correspondingto1.29gofpasteper100kgbodyweightinasingle

administration.

,Bodyweightanddosageshouldbeaccuratelydeterminedpriorto

treatment.Thecontentsofonesyringewilltreathorsesupto600kg.

Calibratedmarkingsareprovidedat100kgbodyweightintervals.The

syringeshouldbeadjustedtothecalculateddosagebysettingtheringon

theappropriateplaceontheplunger.

Directionsforuse

theproductisfororaladministrationonly.Whileholdingtheplunger,turn

theknurledringontheplunger¼turntotheleftandslideitsothestop

ringisattheprescribedweightmarking.Locktheringinplacebyturningit

¼turntotherightinordertobringthetwoarrows,theonevisibleonthe

ringandtheoneontheplungerrod,intoalignment.Makesurethehorse’s

mouthcontainsnofeed.Removethecoverfromthetipofthesyringe.

Insertthesyringetipintothehorse’smouthattheinterdentalspaceand

depositthepasteonthebaseofthetongue.Immediatelyraisethehorse’s

headforafewsecondsafterdosingandensurethatthepasteis

consumed.

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ParasitecontrolProgramme

Veterinaryadviceshouldbegivenonappropriatedosingprogramsand

stockmanagementtoachieveadequateparasitecontrolforboth

tapewormandroundworminfestations.

4.10Overdose (symptoms, emergency procedures,antidotes),if

necessary

Noundesirableeffectsrelatedtotreatmentwereobservedin2monthold

horsestreatedwiththeproductatuptothreetimestherecommended

doseandinadulthorsestreatedattentimestherecommendeddose.

Transientdecreasedfoodconsumption,increasedbodytemperature,

salivationandimpairmentofvisionwerenoticedinhorsestreatedtwice

withanivermectinoralpasteoroncewiththeproductattentimesthe

recommendeddose(i.e.,2mg/kgb.w.).Allchangesdisappearedwithin

fivedays.

Noantidotehasbeenidentified;however,symptomatictherapymaybe

beneficial.

4.11Withdrawalperiod(s)

Meat:30days.

Donotuseinmaresproducingmilkforhumanconsumption

5. PHARMACOLOGICALPROPERTIES

Summarypresentationoftheactivesubstance

Pharmacotherapeuticgroup:Anthelmintics

ATCvetcode:QP54AA51ivermectin,combinations.

Theproductisanendectocidecontaininganassociationofan

anthelminticactiveingredient,ivermectin,andacestocideactive

ingredient,praziquantel.

5.1Pharmacodynamicproperties

Ivermectinisamemberofthemacrocycliclactoneclassofendectocides.

Compoundsoftheclassbindselectivelyandwithhighaffinityto

glutamate-gatedchlorideionchannelswhichoccurininvertebratenerve

andmusclecells.Thisleadstoanincreaseinthepermeabilityofthecell

membranetochlorideionswithhyperpolarizationofthenerveormuscle

cell,whichresultsinparalysisanddeathoftheparasite.Compoundsof

thisclassmayalsointeractwithotherligand-gatedchloridechannels,

suchasthosegatedbytheneurotransmittergamma-aminobutyricacid

(GABA).

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Themarginofsafetyforcompoundsofthisclassisattributabletothefact

thatmammalsdonothaveglutamate-gatedchloridechannels,the

macrocycliclactoneshavealowaffinityforothermammalianligand-gated

chloridechannels,andmacrocycliclactonesdonotreadilycrosstheblood-

brainbarrier.

Praziquantelisasyntheticisoquinoline-pyrazinederivativewithactivity

againstseveraltrematodeandcestodeparasites.Invitroandinvivo

studieshavefoundthattrematodesandcestodesrapidlytakeup

praziquantelwithinminutes;praziquantelcausestetaniccontractionofthe

parasites'musculatureandarapidvacuolisationoftheirtegument.The

neteffectisthattheparasitedetachesfromthehost.Praziquantelaffects

membranepermeabilityintrematodesandcestodes,andinfluences

divalentcationfluxes,particularlycalciumionhomeostasis,whichis

thoughttocontributetotherapidmusclecontractionandvacuolisation.

Themarginofsafetyforthepraziquantelisduetoitsrapidmetabolism

andexcretionaswellasitsselectiveeffectonsusceptibleparasites.

5.2Pharmacokineticparticulars

Afteroraladministrationtohorsesoftherecommendeddoseofthe

product,,praziquantelisrapidlyabsorbedandexcreted,whereas

ivermectinismoreslowlyabsorbedandpersistduringalongerperiodin

thebody.

Praziquantelmaximumplasmaconcentrations(oftheorderof1μg/ml)are

reachedrapidly(approximatelyinthehourfollowingtreatment).The

praziquantelplasmaresiduedepletesrapidlytonon-quantifiablelevelsby

7.5hourspostdose.Praziquantelisexcretedasmetabolitesintheurine

andfaecesandthetotalamountexcretedaccountsfor31%and24%,

respectivelyoftheadministereddosewithin24hours.

Ivermectinmaximumplasmaconcentrations(Cmax:37.9ng/ml)are

reachedinalongerperiod(tmax:approximately9hoursaftertreatment)

andlevelsfelltonondetectable/noquantifiablevaluesonorbefore28

daysafteradministration.

Faecalexcretionisthemajorpathwayofivermectineliminationinall

speciesstudied.

Nopharmacologicalinterferencebetweenivermectinandpraziquantel

werenoted.

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6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

SunsetyellowFCF(E110)

Titaniumdioxide(E171)

Butylhydroxyanisole(E320)

Hydroxypropylcellulose

Hydrogenatedcastoroil

Glycerolformal

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelflifeoftheveterinarymedicine:3years.

Shelflifeafterfirstopeningtheimmediatepackaging:2years.

6.4Specialprecautionsforstorage

Storeintheoriginalcontainer.

Replacethecapafteruse.

6.5Natureandcompositionofimmediatepackaging

Immediatepackage

theproductisavailableinsyringescontaining7.74gofpaste:

WhitepolypropylenesyringesbarrelwithawhiteLDPEcap,arubberrod

tipandawhitepolypropyleneplungerrod,withdosedivisionscalibrated

bybodyweight.

Outerpackageandsalespresentations

Cartonboxof1individualsyringe.Eachsyringeissealedinatransparent

polypropylenebag.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

EXTREMELYDANGEROUSFORFISHANDAQUATICLIFE.Donot

contaminatesurfacewatersorditcheswithproductorusedsyringes.Any

unusedproductorwastematerialshouldbedisposedofinaccordancewith

nationalrequirements.

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7. MARKETINGAUTHORISATIONHOLDER

Janssen-CilagLtd

50-100HolmersFarmWay

HighWycombe

Buckinghamshire

HP124EG

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm 00242/4057

9. DATEOFFIRSTAUTHORISATION

Date:28 th

October2004

10 DATEOFREVISIONOFTHETEXT

Date:October2011