MILBEMAX CHEWABLE TABLETS FOR SMALL DOGS AND PUPPIES

Main information

  • Trade name:
  • MILBEMAX CHEWABLE TABLETS FOR SMALL DOGS AND PUPPIES
  • Pharmaceutical form:
  • Chewable tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MILBEMAX CHEWABLE TABLETS FOR SMALL DOGS AND PUPPIES
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Milbemycin, combinations
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0135/005
  • Authorization date:
  • 09-07-2011
  • EU code:
  • FR/V/0135/005
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

SUMMARYOFPRODUCTCHARACTERISTICS

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1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

MILBEMAXchewabletabletsforsmalldogsandpuppies

SE:Milbemaxvet.chewabletabletsforsmalldogsandpuppies

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Onechewabletabletcontains:

Activesubstances:

Milbemycinoxime 2.5mg

Praziquantel 25.0mg

Excipients:

Glycerol(E422) 92.12mg

Propyleneglycol(E1520) 0.91mg

Ironoxide,brown(E172) 0.66mg

Butylhydroxyanisole(E320) 0.26mg

Propylgallate(E310) 0.09mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Chewabletablet

Ovalshaped,darkbrown.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies

Indogs:treatmentofmixedinfectionsbyadultcestodesandnematodesofthefollowingspecies:

-Cestodes:

Dipylidiumcaninum

Taeniaspp.

Echinococcusspp.

Mesocestoidesspp.

-Nematodes:

Ancylostomacaninum

Toxocaracanis

Toxascarisleonina

Trichurisvulpis

Crenosomavulpis(Reductionofthelevelofinfection)

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Angiostrongylusvasorum(Reductionofthelevelofinfection)(seespecifictreatmentscheduleunder

section4.9“Amountstobeadministeredandadministrationroute”)

Theproductcanalsobeusedinthepreventionofheartwormdisease(Dirofilariaimmitis),if

concomitanttreatmentagainstcestodesisindicated.

4.3 Contraindications

Donotuseindogsweighinglessthan1kg.

Donotuseincaseofhypersensitivitytotheactivesubstancesortoanyofexcipients.

Seealsosection4.5"Specialprecautionsforuse".

4.4 Specialwarnings

StudieswithmilbemycinoximeindicatethatthemarginofsafetyincertaindogsofCollieorrelated

breedsislessthaninotherbreeds.Inthesedogs,therecommendeddoseshouldbestrictlyobserved.

Thetoleranceoftheproductinyoungpuppiesfromthesebreedshasnotbeeninvestigated.Clinical

signsinColliesaresimilartothoseseeninthegeneraldogpopulationwhenoverdosed(seesection

4.10“Overdose”).

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Treatmentofdogswithahighnumberofcirculatingmicrofilariaecansometimesleadtothe

appearanceofhypersensitivityreactions,suchaspalemucousmembranes,vomiting,trembling,

labouredbreathingorexcessivesalivation.Thesereactionsareassociatedwiththereleaseofproteins

fromdeadordyingmicrofilariaeandarenotadirecttoxiceffectoftheproduct.Theuseindogs

sufferingfrommicrofilaremiaisthusnotrecommended.

Inheartwormrisk-areas,orinthecaseitisknownthatadoghasbeentravellingtoandfrom

heartwormriskregions,beforeusingtheproduct,aveterinaryconsultationisadvisedtoexcludethe

presenceofanyconcurrentinfestationofDirofilariaimmitis.Inthecaseofapositivediagnosis,

adulticidaltherapyisindicatedbeforeadministeringtheproduct.

Echinococcosisrepresentsahazardforhumans.IncaseofEchinococcosis,specificguidelinesonthe

treatmentandfollowupandonthesafeguardofpersonshavetobefollowed.Expertsorinstitutesof

parasitologyshouldbeconsulted.

Nostudieshavebeenperformedwithseverelydebilitateddogsorindividualswithseriously

compromisedkidneyorliverfunction.Theproductisnotrecommendedforsuchanimalsoronly

accordingtoabenefit/riskassessmentbytheresponsibleveterinarian.

Indogslessthan4weeksold,tapeworminfectionisunusual.Treatmentofanimalslessthan4weeks

oldwithacombinationproductmaythereforenotbenecessary.

Parasiteresistancetoanyparticularclassofanthelminticmaydevelopfollowingfrequent,repeateduse

ofananthelminticofthatclass.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Washhandsafteruse.

Intheeventofaccidentalingestionofthetablets,particularlybyachild,seekmedicaladvice

immediatelyandshowthepackageleafletorthelabeltothedoctor.

4.6 Adversereactions(frequencyandseriousness)

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Inveryrareoccasions,systemicsigns(suchaslethargy),neurologicalsigns(suchasmuscletremors

andataxia)and/orgastrointestinalsigns(suchasemesis,drooling,diarrhoeaandanorexia)havebeen

observedindogsafteradministrationoftheveterinarymedicinalproduct.

4.7 Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasbeenestablishedduringpregnancyandlactation.

Canbeusedinpregnantandlactatingbitches.

Canbeusedinbreedinganimals.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Theconcurrentuseoftheproductwithselamectiniswelltolerated.Nointeractionswereobserved

whentherecommendeddoseofthemacrocycliclactoneselamectinwasadministeredduringtreatment

withtheproductattherecommendeddose.Intheabsenceoffurtherstudies,cautionshouldbetaken

inthecaseofconcurrentuseoftheproductandothermacrocycliclactones.Also,nosuchstudieshave

beenperformedwithreproducinganimals.

4.9 Amountstobeadministeredandadministrationroute

Minimumrecommendeddoserate:0.5mgofmilbemycinoximeand5mgofpraziquantelperkgare

givenonceorally.Theproductshouldbeadministeredwithoraftersomefood.

Dependingonthebodyweightofthedog,thepracticaldosingisasfollows:

Weight NumberofTablet

1–5kg 1tablet

Incaseswhenheartwormdiseasepreventionisusedandatthesametimetreatmentagainsttapeworm

isrequired,theproductcanreplacethemonovalentproductforthepreventionofheartwormdisease.

ForAngiostrongylusvasoruminfections,milbemycinoximeshouldbegivenfourtimesatweekly

intervals.Itisrecommended,whereconcomitanttreatmentagainstcestodesisindicated,totreatonce

withtheproductandcontinuewiththemonovalentproductcontainingmilbemycinoximealone,forthe

remainingthreeweeklytreatments.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theadversereactionsobservedarethesameasthoseobservedattherecommendeddose(seesection

4.6“Adversereactions(frequencyandseriousness)”)butmorepronounced.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiparasiticproducts,insecticidesandrepellants-endectocides

ATCvetCode: QP54AB51(Milbemycincombinations)

5.1 Pharmacodynamicproperties

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Milbemycinoximebelongstothegroupofmacrocycliclactones,isolatedfromthefermentationof

Streptomyceshygroscopicusvar.aureolacrimosus.Itisactiveagainstmites,againstlarvalandadult

stagesofnematodesaswellasagainstlarvaeofDirofilariaimmitis.

Theactivityofmilbemycinisrelatedtoitsactiononinvertebrateneurotransmission:Milbemycinoxime,

likeavermectinsandothermilbemycins,increasesnematodeandinsectmembranepermeabilityto

chlorideionsviaglutamate-gatedchlorideionchannels(relatedtovertebrateGABA

andglycine

receptors).Thisleadstohyperpolarisationoftheneuromuscularmembraneandflaccidparalysisand

deathoftheparasite.

Praziquantelisanacylatedpyrazino-isoquinolinederivative.Praziquantelisactiveagainstcestodesand

trematodes.Itmodifiesthepermeabilityforcalcium(influxofCa 2+ )inthemembranesoftheparasite

inducinganimbalanceinthemembranestructures,leadingtomembranedepolarisationandalmost

instantaneouscontractionofthemusculature(tetany),rapidvacuolizationofthesyncytialtegumentand

subsequenttegumentaldisintegration(blebbing),resultingineasierexpulsionfromthegastrointestinal

tractordeathoftheparasite.

5.2 Pharmacokineticparticulars

Afteroraladministrationofpraziquantelinthedog,peakserumlevelsofparentarerapidlyattained

(Tmaxapproximately0.5-4hours)anddeclinequickly(t

approximately1.5hours).Thereisa

substantialhepaticfirst-passeffect,withveryrapidandalmostcompletehepaticbiotransformation,

principallytomonohydroxylated(alsosomedi-andtri-hydroxylated)derivatives,whicharemostly

glucuronideand/orsulfateconjugatedbeforeexcretion.Plasmabindingisabout80%.Excretionisfast

andcomplete(about90%in2days);theprincipalrouteofeliminationisrenal.

Afteroraladministrationofmilbemycinoximeindogs,peakplasmalevelsoccuratabout2-4hours,and

declinewithahalf-lifeoftheunmetabolisedmilbemycinoximeof1-4days.Bioavailabilityisabout

80%.

Intherat,metabolismappearstobecompletealthoughslow,sinceunchangedmilbemycinoximehas

notbeenfoundinurineorfaeces.Mainmetabolitesintherataremonohydroxylatedderivatives,

attributabletohepaticbiotransformation.Inadditiontorelativelyhighliverconcentrations,thereissome

concentrationinfat,reflectingitslipophilicity.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Glycerol(E422)

Propyleneglycol(E1520)

Ironoxide,brown(E172)

Butylhydroxyanisole(E320)

Propylgallate(E310)

Starch,pregelatinised

Naturalchickenflavour

Confectioner’ssugarNF

Water,purified

Sodiumchloride

Citricacidmonohydrate

6.2 Incompatibilities

Notapplicable.

6.3 Shelflife

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Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

6.4.Specialprecautionsforstorage

Donotstoreabove25°C.

6.5 Natureandcompositionofimmediatepackaging

Aluminum/aluminumblister(OPA/Al/PE//Al/PE)oraluminumstrip(polyester/Al/PE)

Availablepacksizes:

1boxwith1blisterof2chewabletablets

1boxwith1blisterof4chewabletablets

1boxwith12blisters,eachblistercontains4chewabletablets

1boxwith1stripof2chewabletablets

1boxwith1stripof4chewabletablets

1boxwith12strips,eachstripcontains4chewabletablets

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

MILBEMAXchewabletabletsshouldnotenterwatercoursesasthismaybedangerousforfishand

otheraquaticorganisms.

7. MARKETINGAUTHORISATIONHOLDER

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8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateofthefirstauthorisation:{nationallyapprovedonDD/MM/YYYYorDDmonthYYYY}

10 DATEOFREVISIONOFTHETEXT

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{MM/YYYY}or<monthYYYY>