Milbemax tablets for small dogs and puppies

Main information

  • Trade name:
  • Milbemax tablets for small dogs and puppies
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Milbemax tablets for small dogs and puppies
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0135/001
  • Authorization date:
  • 17-04-2011
  • EU code:
  • FR/V/0135/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

MILBEMAXpuppyFinalRENEWALSPCJuly2007

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

MILBEMAX ®

Tabletsforsmalldogsandpuppies

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstances:

Milbemycinoxime 2.5mg

Praziquantel 25.0mg

Excipients:

QSPonedivisibletabletof125mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Oblongshaped,white,withascoreonbothsides.Onesidebearstheimprint“AA”,the

otherside“NA”.

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs

4.2Indicationsforuse,specifyingthetargetspecies

Indogs:treatmentofmixedinfectionsbyadultcestodesandnematodesofthe

followingspecies:

-Cestodes:

Dipylidiumcaninum

Taeniaspp.

Echinococcusspp.

Mesocestoidesspp.

-Nematodes:

Ancylostomacaninum

MILBEMAXpuppyFinalRENEWALSPCJuly2007

Toxocaracanis

Toxascarisleonina

Trichurisvulpis

Crenosomavulpis(Reductionofthelevelofinfection)

Angiostrongylusvasorum(Reductionofthelevelofinfection;seespecifictreatment

scheduleunderSPCpoint“4.9Amountstobeadministeredandadministrationroute”)

Theproductcanalsobeusedinthepreventionofheartwormdisease(Dirofilaria

immitis),ifconcomitanttreatmentagainstcestodesisindicated.

4.3Contraindications

Donotuseinpuppiesoflessthan2weeksofageand/orweighinglessthan0.5kg

Seealsopoint"Specialprecautionsforuse".

4.4Specialwarnings

Studieswithmilbemycinoximeindicatethatthemarginofsafetyincertaindogsof

Collieorrelatedbreedsislessthaninotherbreeds.Inthesedogs,therecommended

doseshouldbestrictlyobserved.

ThetoleranceofMILBEMAXinyoungpuppiesfromthesebreedshasnotbeen

investigated.

ClinicalsignsinColliesaresimilartothoseseeninthegeneraldogpopulationwhen

overdosed(seeinpoint4.10).

4.5Specialprecautionsforuse,includingspecialprecautionstobetakenbythe

personadministeringthemedicinalproducttoanimals

Specialprecautionsforuseinanimals

Aspergoodveterinarypractice,animalsshouldbeweighedtoensureaccurate

dosing

.

Treatmentofdogswithahighnumberofcirculatingmicrofilariaecansometimeslead

totheappearanceofhypersensitivityreactions,suchaspalemucousmembranes,

vomiting,trembling,labouredbreathingorexcessivesalivation.Thesereactionsare

associatedwiththereleaseofproteinsfromdeadordyingmicrofilariaeandarenota

directtoxiceffectoftheproduct.Theuseindogssufferingfrommicrofilaremiaisthus

notrecommended.

Inheartwormrisk-areas,orinthecaseitisknownthatadoghasbeentravellingtoand

fromheartwormriskregions,beforeusingMILBEMAX,aveterinaryconsultationis

advisedtoexcludethepresenceofanyconcurrentinfestationofDirofilariaimmitis.In

thecaseofapositivediagnosis,adulticidaltherapyisindicatedbeforeadministering

MILBEMAX.

Echinococcosisrepresentsahazardforhumans.IncaseofEchinococcosis,specific

guidelinesonthetreatmentandfollowupandonthesafeguardofpersonshavetobe

followed.Expertsorinstitutesofparasitologyshouldbeconsulted.

MILBEMAXpuppyFinalRENEWALSPCJuly2007

Nostudieshavebeenperformedwithseverelydebilitateddogsorindividualswith

seriouslycompromisedkidneyorliverfunction.Theproductisnotrecommendedfor

suchanimalsoronlyaccordingtoabenefit/riskassessmentbytheresponsible

veterinarian.

Indogslessthan4weeksold,tapeworminfectionisunusual.Treatmentofanimals

lessthan4weeksoldwithacombinationproductmaythereforenotbenecessary.

Parasiteresistancetoanyparticularclassofanthelminticmaydevelopfollowing

frequent,repeateduseofananthelminticofthatclass

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandsafteruse.

Intheeventofaccidentalingestionofthetablets,particularlybyachild,seekmedical

adviceimmediatelyandshowthepackageleafletorthelabeltothedoctor.

4.6Adversereactions(frequencyandseriousness)

“Inveryrareoccasions,systemicsigns(suchaslethargy),neurologicalsigns(suchas

muscletremorsandataxia)and/orgastrointestinalsigns(suchasemesis,diarrhea,

anorexiaanddrooling)havebeenobservedindogsafteradministrationofthe

veterinarymedicinalproduct”.

4.7Useduringpregnancy,lactationorlay

Theproductmaybeusedinbreedingdogsincludingpregnantandlactatingbitches.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

TheconcurrentuseofMILBEMAXwithselamectiniswelltolerated.Nointeractions

wereobservedwhentherecommendeddoseofthemacrocycliclactoneselamectin

wasadministeredduringtreatmentwithMILBEMAXattherecommendeddose.Inthe

absenceoffurtherstudies,cautionshouldbetakeninthecaseofconcurrentuseof

MILBEMAXandothermacrocycliclactones.Also,nosuchstudieshavebeen

performedwithreproducinganimals.

4.9Amountstobeadministeredandadministrationroute

Minimumrecommendeddoserate:0.5mgofmilbemycinoximeand5mgof

praziquantelperkgaregivenonceorally.

Theproductshouldbeadministeredwithoraftersomefood.

Dependingonthebodyweightofthedog,thepracticaldosingisasfollows:

Weight Tablets

MILBEMAXpuppyFinalRENEWALSPCJuly2007

0.5-1kg ½tablet

>1 –5kg 1tablet

>5 –10kg 2tablets

Incaseswhenheartwormdiseasepreventionisusedandatthesametimetreatment

againsttapewormisrequired,MILBEMAXcanreplacethemonovalentproductforthe

preventionofheartwormdisease.

ForAngiostrongylusvasoruminfections,milbemycinoximeshouldbegivenfourtimes

atweeklyintervals.Itisrecommended,whereconcomitanttreatmentagainstcestodes

isindicated,totreatoncewithMILBEMAXandcontinuewiththemonovalentproduct

containingmilbemycinoximealone,fortheremainingthreeweeklytreatments.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noothersignsthanthoseobservedattherecommendeddosehavebenneobserved

(see4.6)

4.11Withdrawalperiod(s)

Notapplicable

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiparasiticproducts,insecticidesandrepellants-

Endectocides

ATCvetCode:QP54AB51(Milbemycincombinations)

5.1Pharmacodynamicproperties

Milbemycinoximebelongstothegroupofmacrocycliclactones,isolatedfromthe

fermentationofStreptomyceshygroscopicusvar.aureolacrimosus.Itisactiveagainst

mites,againstlarvalandadultstagesofnematodesaswellasagainstlarvaeof

Dirofilariaimmitis.

Theactivityofmilbemycinisrelatedtoitsactiononinvertebrateneurotransmission:

Milbemycinoxime,likeavermectinsandothermilbemycins,increasesnematodeand

insectmembranepermeabilitytochlorideionsviaglutamate-gatedchlorideion

channels(relatedtovertebrateGABA

andglycinereceptors).Thisleadsto

hyperpolarisationoftheneuromuscularmembraneandflaccidparalysisanddeathof

theparasite.

Praziquantelisanacylatedpyrazino-isoquinolinederivative.Praziquantelisactive

againstcestodesandtrematodes.Itmodifiesthepermeabilityforcalcium(influxof

Ca2+)inthemembranesoftheparasiteinducinganimbalanceinthemembrane

structures,leadingtomembranedepolarisationandalmostinstantaneouscontraction

ofthemusculature(tetany),rapidvacuolizationofthesyncytialtegumentand

MILBEMAXpuppyFinalRENEWALSPCJuly2007

subsequenttegumentaldisintegration(blebbing),resultingineasierexpulsionfromthe

gastrointestinaltractordeathoftheparasite

5.2Pharmacokineticparticulars

Afteroraladministrationofpraziquantelinthedog,peakserumlevelsofparentare

rapidlyattained(T

approximately0.5-4hours)anddeclinequickly(t

approximately

1.5hours);thereisasubstantialhepaticfirst-passeffect,withveryrapidandalmost

completehepaticbiotransformation,principallytomonohydroxylated(alsosomedi-and

tri-hydroxylated)derivatives,whicharemostlyglucuronideand/orsulfateconjugated

beforeexcretion.Plasmabindingisabout80%.Excretionisfastandcomplete(about

90%in2days);theprincipalrouteofeliminationisrenal.

Afteroraladministrationofmilbemycinoximeindogs,peakplasmalevelsoccurat

about2-4hours,anddeclinewithahalf-lifeoftheunmetabolisedmilbemycinoximeof

1-4days.Bioavailabilityisabout80%.

Intherat,metabolismappearstobecompletealthoughslow,sinceunchanged

milbemycinoximehasnotbeenfoundinurineorfeces.Mainmetabolitesintheratare

monohydroxylatedderivatives,attributabletohepaticbiotransformation.Inadditionto

relativelyhighliverconcentrations,thereissomeconcentrationinfat,reflectingits

lipophilicity

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Cellulose,microcristalline

Croscarmellosesodium

Povidone

Lactosemonohydrate

Silica,colloidalanhydrous

Magnesiumstearate

6.2Incompatibilities

Notapplicable

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

2years

Shelf-lifeafterfirstopeningoftheimmediatepackaging:

1month

6.4.Specialprecautionsforstorage

Donotstoreabove30°C

Keepblisterintheoutercartontoprotectfromlight

MILBEMAXpuppyFinalRENEWALSPCJuly2007

6.5Natureandcompositionofimmediatepackaging

PVC/PE/PVdC/aluminiumblister

Availablepacksizes:

Boxwith2tabletsinblister

Boxwith4tabletsinblister

Boxwith10tabletsinblister

Boxwith20tabletsinblister

Boxwith50tabletsinblister

Boxwith100tabletsinblister

Notallpacksizesmaybemarketed

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnational

requirements.

Theproductshouldnotcomeintocontactwith(IE'sproposal)watercoursesasthismay

bedangerousforfishandotheraquaticorganisms

7. MARKETINGAUTHORISATIONHOLDER

NovartisAnimalHealthInc.

8. MARKETINGAUTHORISATIONNUMBER(S)

{NationalMANumber(s)}

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

{DDMMMYYYY}

10.DATEOFREVISIONOFTHETEXT

{MMMYYYY}

PROHIBITIONOFSALE,SUPPLYAND/ORUSE