MILBEMAX

Main information

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

Documents

Localization

  • Available in:
  • MILBEMAX CHEWABLE TABLETS FOR DOGS
    Ireland
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0135/006
  • Authorization date:
  • 09-07-2011
  • EU code:
  • FR/V/0135/006
  • 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

MILBEMAXchewabletabletsfordogs

SE:Milbemaxvet.chewabletabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Onechewabletabletcontains:

Activesubstances:

Milbemycinoxime 12.5mg

Praziquantel 125.0mg

Excipients:

Glycerol(E422) 460.46mg

Propyleneglycol(E1520) 4.54mg

Ironoxide,brown(E172) 3.29mg

Butylhydroxyanisole(E320) 1.32mg

Propylgallate(E310) 0.46mg

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

Donotuseindogsweighinglessthan5kg.

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

5–25kg 1tablet

>25-50kg 2tablets

>50-75kg 3tablets

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

approximately0.5 - 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.

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6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale: 3 2 years.

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

{Name}

{Address}

<{tel}>

<{fax}>

<{e-mail}>

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateofthefirstauthorisation:{nationallyapprovedonDD/MM/YYYYorDDmonthYYYY}

10 DATEOFREVISIONOFTHETEXT

{MM/YYYY}or<monthYYYY>

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

22-10-2018

NEXGARD SPECTRA (Merial)

NEXGARD SPECTRA (Merial)

NEXGARD SPECTRA (Active substance: Afoxolaner / milbemycin oxime) - Centralised - 2-Monthly update - Commission Decision (2018)6977 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003842/WS1338/0015/G

Europe -DG Health and Food Safety