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
    France
  • Language:
  • English

Therapeutic information

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

Other information

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)

Revised:January2013

AN:01575/2011

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

Revised:January2013

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

Revised:January2013

AN:01575/2011

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.

Revised:January2013

AN:01575/2011

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

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

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