Molemec Plus Paste for Horses 15.5 mg/ g 77.5 mg/ g Oral Paste

Main information

  • Trade name:
  • Molemec Plus Paste for Horses 15.5 mg/ g 77.5 mg/ g Oral Paste
  • Pharmaceutical form:
  • Oral paste
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Molemec Plus Paste for Horses 15.5 mg/g 77.5 mg/g Oral Paste
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0455/001
  • Authorization date:
  • 27-06-2012
  • EU code:
  • UK/V/0455/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:January2013

AN:01575/2011

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

MolemecPlusPasteforHorses15.5mg/g/77.5mg/gOralPaste(UK)

EQVALANDUOEQUIPACK(France)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachsyringecontains7.74gofpasteanddelivers:

Activesubstances:

Ivermectin 0.120g(15.5mg/g)

Praziquantel 0.600g(77.5mg/g)

Excipients:

Butylhydroxyanisole(E320): 0.002g

SunsetYellow(E110): 0.003g

Titaniumdioxide(E171): 0.155g

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralpaste.

Smooth,homogeneousorangepaste.

4. CLINICALPARTICULARS

4.1Targetspecies

Horses

4.2Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofmixedcestodeandnematodeorarthropodinfestationsinhorses.The

followingparasitesofhorsesaresensitivetotheantiparasiticeffectsofMolemecPlus

Paste:

AdultTapeworms:

Anoplocephalaperfoliata

Anoplocephalamagna

Largestrongyles:

Strongylusvulgaris(adultsandarteriallarvalstages)

Strongylusedentatus(adultsandtissuelarvalstages)

Strongylusequinus(adults)

Triodontophorusspp(adults)

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Triodontophorusbrevicauda

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(inhibitedfourthstagelarvae)lungworms:Dictyocaulusarnfieldi

4.3 Contraindications

Donotuseinmaresproducingmilkforhumanconsumption.

Theproducthasbeenformulatedforuseinhorsesonly.Cats,Dogs,especiallyCollies,

OldEnglishSheepdogsandrelatedbreedsorcrosses,andalsoturtlesandtortoisesmay

beadverselyaffectedbytheconcentrationofivermectininthisproductiftheyareallowed

toingestspilledpasteorhaveaccesstousedsyringes

4.4 Specialwarnings

Revised:January2013

AN:01575/2011

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetheriskof

developmentofresistanceandcouldultimatelyresultinineffectivetherapy:

-Toofrequentandrepeateduseofanthelminticsfromthesameclass,overan

extendedperiodoftime.

-Underdosing,whichmaybeduetounderestimationofbodyweight,

misadministrationoftheproduct,orlackofcalibrationofthedosingdevice(if

any).

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigatedusing

appropriatetests(e.g.FaecalEggCountReductionTest).Wheretheresultsofthetest(s)

stronglysuggestresistancetoaparticularanthelmintic,ananthelminticbelongingto

anotherpharmacologicalclassandhavingadifferentmodeofactionshouldbeused.

Resistancetomacrocycliclactones(whichincludesivermectin)hasbeenreportedin

ParascarisequoruminhorsesintheEU.Thereforetheuseofthisproductshouldbe

basedonlocal(regional,farm)epidemiologicalinformationaboutsusceptibilityofgastro-

intestinalnematodesandrecommendationsonhowtolimitfurtherselectionforresistance

toanthelmintics

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Safetystudieswerenotconductedinfoalsyoungerthan2monthsofage,orinstallions,

theuseofMolemecPlusPasteisnotrecommendedinthesecategoriesofanimals.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandsafteruse.

Donotsmoke,drinkoreatwhilehandlingtheproduct.

Thisproductmaycauseskinandeyeirritation.Therefore,theusershouldavoidcontactof

theproductwiththeskinandtheeyes.Incaseofcontact,rinseimmediatelywithplentyof

water.

Inthecaseofaccidentalingestionoreyeirritationaftercontactseekmedicaladvice

immediatelyandshowthepackageinsertorthelabeltothephysician.

4.6 Adversereactions(frequencyandseriousness)

SomehorseswithheavyinfectionsofOnchocercaspp.microfilariaehaveexperienced

oedemaandpruritisfollowingtreatment;suchreactionswereassumedtobetheresultof

thedeathoflargenumbersofmicrofilariae.Thesesignsresolvewithinafewdaysbut

symptomatictreatmentmaybeadvisable.

Incasesofheavyinfestationswithtapeworms,signsofmild,transientcolicandloosestool

maybeobserved.

FollowingadministrationofMolemecPlusPaste,therehavebeenrarereportsof

inflammationofthemouth,lipandtongue,whichresultsinvariousclinicalsignssuchas

Revised:January2013

AN:01575/2011

oedema,hypersalivation,erythema,tonguedisorderandstomatitis.Thesereactionshave

beentransitoryinnature,appearingwithin1hourandabatingwithin24to48hours

followingadministration.Incaseofsevereoralreactionssymptomatictreatmentis

recommended

4.7Useduringpregnancy,lactationorlay

Studiesperformedinlaboratoryanimalsshowednoteratogenicorembryotoxiceffectof

eitherivermectinorpraziquantelattherecommendeddosesduringtherapy.

Ivermectin-Praziquantelcombinationcanbeusedafterthefirstthreemonthsofgestation

andduringlactation.IntheabsenceofclinicaldatainearlypregnancyMolemecPlus

Pastecanonlybeusedinthefirstthreemonthsofgestationaccordingtoariskbenefit

analysisbytheveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Nodataavailable.

4.9 Amountstobeadministeredandadministrationroute

Therecommendeddosageis200mcgivermectinperkilogramofbodyweightand1mg

praziquantelperkilogramofbodyweightcorrespondingto1.29gofpasteper100kg

bodyweightinasingleadministration.

Bodyweightanddosageshouldbeaccuratelydeterminedpriortotreatment.Thecontents

ofonesyringewilltreathorsesupto600kg.Calibratedmarkingsareprovidedat100kg

bodyweightintervals.Thesyringeshouldbeadjustedtothecalculateddosagebysetting

theringontheappropriateplaceontheplunger.

Directionsforuse

MolemecPlusPasteisfororaladministrationonly.Whileholdingtheplunger,turnthe

knurledringontheplunger¼turntotheleftandslideitsothestopringisatthe

prescribedweightmarking.Locktheringinplacebyturningit¼turntotherightinorderto

bringthetwoarrows,theonevisibleontheringandtheoneontheplungerrod,into

alignment.Makesurethehorse’smouthcontainsnofeed.Removethecoverfromthetip

ofthesyringe.Insertthesyringetipintothehorse’smouthattheinterdentalspaceand

depositthepaste onthebaseofthetongue.Immediatelyraisethehorse’sheadforafew

secondsafterdosingandensurethatthepasteisconsumed.

ParasitecontrolProgram

Veterinaryadviceshouldbegivenonappropriatedosingprogramsandstockmanagement

toachieveadequateparasitecontrolforbothtapewormandroundworminfestations.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noundesirableeffectsrelatedtotreatmentwereobservedin2montholdhorsestreated

withtheproductatuptothreetimestherecommendeddoseandinadulthorsestreatedat

tentimestherecommendeddose.

Transientdecreasedfoodconsumption,increasedbodytemperature,salivationand

impairmentofvisionwerenoticedinhorsestreatedtwicewithanivermectinoralpasteor

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AN:01575/2011

oncewithMolemecPlusPasteattentimestherecommendeddose(i.e.,2mg/kgb.w.).All

changesdisappearedwithinfivedays.

Noantidotehasbeenidentified;however,symptomatictherapymaybebeneficial.

4.11Withdrawalperiod(s)

Meat:30days.

Donotuseinmaresproducingmilkforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup: Anthelmintics

ATCvetcode: QP54AA51ivermectin,combinations.

MolemecPlusPasteisanendectocidecontaininganassociationofananthelminticactive

ingredient,ivermectin,andacestocideactiveingredient,praziquantel.

5.1Pharmacodynamicproperties

Ivermectinisamemberofthemacrocycliclactoneclassofendectocides.Compoundsof

theclassbindselectivelyandwithhighaffinitytoglutamate-gatedchlorideionchannels

whichoccurininvertebratenerveandmusclecells.Thisleadstoanincreaseinthe

permeabilityofthecellmembranetochlorideionswithhyperpolarizationofthenerveor

musclecell,whichresultsinparalysisanddeathoftheparasite.Compoundsofthisclass

mayalsointeractwithotherligand-gatedchloridechannels,suchasthosegatedbythe

neurotransmittergamma-aminobutyricacid(GABA).

Themarginofsafetyforcompoundsofthisclassisattributabletothefactthatmammals

donothaveglutamate-gatedchloridechannels,themacrocycliclactoneshavealow

affinityforothermammalianligand-gatedchloridechannels,andmacrocycliclactonesdo

notreadilycrosstheblood-brainbarrier.

Praziquantelisasyntheticisoquinoline-pyrazinederivativewithactivityagainstseveral

trematodeandcestodeparasites.Invitroandinvivostudieshavefoundthattrematodes

andcestodesrapidlytakeuppraziquantelwithinminutes;praziquantelcausestetanic

contractionoftheparasites'musculatureandarapidvacuolisationoftheirtegument.The

neteffectisthattheparasitedetachesfromthehost.Praziquantelaffectsmembrane

permeabilityintrematodesandcestodes,andinfluencesdivalentcationfluxes,particularly

calciumionhomeostasis,whichisthoughttocontributetotherapidmusclecontraction

andvacuolisation.Themarginofsafetyforthepraziquantelisduetoitsrapidmetabolism

andexcretionaswellasitsselectiveeffectonsusceptibleparasites.

5.2 Pharmacokineticparticulars

AfteroraladministrationtohorsesoftherecommendeddoseofMolemecPlusPaste,

praziquantelisrapidlyabsorbedandexcreted,whereasivermectinismoreslowly

absorbedandpersistsduringalongerperiodinthebody.Praziquantelmaximumplasma

concentrations(oftheorderof1µg/ml)arereachedrapidly(approximatelyinthehour

followingtreatment).Thepraziquantelplasmaresiduedepletesrapidlytonon-quantifiable

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levelsby7.5hourspostdose.Praziquantelisexcretedasmetabolitesintheurineand

faecesandthetotalamountexcretedaccountsfor31%and24%,respectivelyofthe

administereddosewithin24hours.

Ivermectinmaximumplasmaconcentrations(Cmax:37.9ng/ml)arereachedinalonger

period(tmax:approximately9hoursaftertreatment)andlevelsfelltonondetectable/no

quantifiablevaluesonorbefore28daysafteradministration.

Faecalexcretionisthemajorpathwayofivermectineliminationinallspeciesstudied.

Nopharmacologicalinterferencebetweenivermectinandpraziquantelwasnoted.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

SunsetyellowFCF(E110)

Titaniumoxide(E171),

Butylhydroxyanisole(E320)

Hydroxypropylcellulose

Hydrogenatedcastoroil

Glycerolformal

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelflifeafterfirstopeningtheimmediatepackaging:2years

6.4.Specialprecautionsforstorage

Storeintheoriginalcontainer.Replacethecapafteruse.

6.5Natureandcompositionofimmediatepackaging

Immediatepackage

MolemecPlusPasteisavailableinsyringescontaining7.74gofpaste:

WhitepolypropylenesyringesbarrelwithawhiteLDPEcap,arubberrodtipandawhite

polypropyleneplungerrod,withdosedivisionscalibratedbybodyweight.

Outerpackageandsalespresentations

Eachsyringeissealedinatransparentpolypropylenebag.

Cartonboxof1individualsyringe.

Cartonboxof50individualsyringes.

Notallpacksizesmaybemarketed.

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6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

EXTREMELYDANGEROUSFORFISHANDAQUATICLIFE.Donotcontaminatesurface

watersorditcheswithproductorusedsyringes.Anyunusedproductorwastematerial

shouldbedisposedofinaccordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

MerialAnimalHealthLimited

POBox327

SandringhamHouse

HarlowBusinessPark

Harlow

Essex

CM195TG

UnitedKingdom

8. MARKETINGAUTHORISATIONNUMBER

Vm08327/4252

9. DATEOFFIRSTAUTHORISATION

05July2011

10. DATEOFREVISIONOFTHETEXT

January2013

Approved: 31/01/2013