Milbemax tablets for Cats

Main information

  • Trade name:
  • Milbemax tablets for Cats
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Milbemax tablets for Cats
    Portugal
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0135/004
  • Authorization date:
  • 17-04-2011
  • EU code:
  • FR/V/0135/004
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

MILBEMAXCatsFinalSPCRENEWALJuly2007

SummaryofProductCharacteristics

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

MILBEMAX ®

Film-coatedtabletsforcats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstances:

Milbemycinoxime

Praziquantel

16mg

40mg

Excipients:

Titaniumdioxide(E171)

Ironoxide(E172) 0.312mg

0.312mg

ExcipientsQSPonedivisabletabletof130mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Film-coatedtablet

Oblong shaped,darkred,withascoreononeside.Onesidebearstheimprint“KK”,

theotherside“NA”.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cats

4.2 Indicationsforuse

Incats:treatmentofmixedinfectionsbyimmatureandadultcestodesand

nematodesofthefollowingspecies:

MILBEMAXCatsFinalSPCRENEWALJuly2007

-Cestodes:

Dipylidiumcaninum

Taeniaspp.

Echinococcusmultilocularis

-Nematodes:

Ancylostomatubaeforme

Toxocaracati

Preventionofheartwormdisease(Dirofilariaimmitis)ifconcomitanttreatmentagainst

cestodesisindicated

4.3 Contra-indications

Donotuseincatsweighinglessthan2kg

4.4 Specialwarnings

None

4.5 Specialprecautionsforuse,includingspecialprecautionstobetakenby

thepersonadministeringthemedicinalproducttoanimals

Specialprecautionsforuseinanimals

Aspergoodveterinarypractice,animalsshouldbeweighedtoensureaccurate

dosing

Echinococcosisrepresentsahazardforhumans.IncaseofEchinococcosis,specific

guidelinesonthetreatmentandfollowupandonthesafeguardofpersonshavetobe

followed.Expertsorinstitutesofparasitologyshouldbeconsulted.

Nostudieshavebeenperformedwithseverelydebilitatedcatsorindividualswith

seriouslycompromisedkidneyorliverfunction.Theproductisnotrecommendedfor

suchanimalsoronlyaccordingtoabenefit/riskassessmentbytheresponsible

veterinarian.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

producttoanimals

Washhandsafteruse.

Intheeventofaccidentalingestionofthetablets,particularlybyachild,seekmedical

adviceimmediatelyandshowthepackageleafletorthelabeltothedoctor.

4.6 Adversereactions(frequencyandseriousness)

Inveryrareoccasions,especiallyinyoungcats,systemicsigns(suchaslethargy),

neurologicalsigns(suchasataxiaandmuscletremors)and/orgastrointestinalsigns

MILBEMAXCatsFinalSPCRENEWALJuly2007

(suchasemesisanddiarrhoea.)havebeenobservedafteradministrationofthe

veterinarymedicinalproduct.

4.7 Useduringpregnancyandlactation

MILBEMAXcanbeusedinbreedingcatsincludingpregnantandlactatingqueens.

4.8 Interactionwithothermedicamentsandotherformsofinteraction

TheconcurrentuseofMILBEMAXwithselamectiniswelltolerated.Nointeractions

wereobservedwhentherecommendeddoseofthemacrocycliclactoneselamectin

wasadministeredduringtreatmentwithMILBEMAXattherecommendeddose.Inthe

absenceoffurtherstudies,cautionshouldbetakeninthecaseofconcurrentuseof

MILBEMAXandothermacrocycliclactones.Also,nosuchstudieshavebeen

performedwithreproducinganimals.

4.9 Amountstobeadministeredandadministrationroute

Minimumrecommendeddoserate:2mgofmilbemycinoximeand5mgof

praziquantelperkgaregivenonceorally.

Theproductshouldbeadministeredwithoraftersomefood.Doingsoensures

optimumprotectionagainstheartwormdisease.

Dependingonthebodyweightofthecat,thepracticaldosingisasfollows:

Weight Tablets

2-4kg ½tablet

>4 –8kg 1tablet

>8-12kg 1½tablets

MILBEMAXcanbeinsertedintoaprogrammeforpreventionofheartwormdiseaseif

atthesametimetreatmentagainsttapewormsisindicated.MILBEMAXhasa

durationofheartwormpreventionofonemonth.Forregularpreventionofheartworm

diseasetheuseofamonosubstanceispreferred.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Incaseofoverdose,inadditiontosignsobservedattherecommendeddose(see

4.6),droolingwasobserved.Thissignwillusuallydisappearspontaneouslywithina

day.

4.11Withdrawalperiod(s)

Notapplicable.

MILBEMAXCatsFinalSPCRENEWALJuly2007

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiparasiticproducts,insecticidesandrepellants-

Endectocides

ATCvetCode:QP54AB51(Milbemycincombinations)

5.1. Pharmacodynamicproperties

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

subsequenttegumentaldisintegration(blebbing),resultingineasierexpulsionfrom

thegastrointestinaltractordeathoftheparasite.

5.2. Pharmacokineticproperties

Inthecat,praziquantelreachespeakplasmaconcentrationswithinanhourafteroral

administration.Thehalflifeofeliminationisaround3hours.

Inthedog,thereisrapidhepaticbiotransformation,prinicipallytomonohydroxylated

derivatives.Theprincipalrouteofeliminationinthedogisrenal.

Afteroraladministrationinthecat,milbemycinoximereachespeakplasma

concentrationswithin2hours.Thehalflifeofeliminationisaround13hours(

9

hours).

Intherat,metabolismappearstobecompletealthoughslow,sinceunchanged

milbemycinoximehasnotbeenfoundinurineorfeces.Mainmetabolitesintherat

aremonohydroxylatedderivatives,attributabletohepaticbiotransformation.In

additiontorelativelyhighliverconcentrations,thereissomeconcentrationinfat,

reflectingitslipophilicity.

6. PHARMACEUTICALPARTICULARS

6.1. Listofexcipients

Core:

Cellulose,microcristalline

MILBEMAXCatsFinalSPCRENEWALJuly2007

Croscarmellosesodium

Povidone

Lactosemonohydrate

Silica,colloidalanhydrous

Magnesiumstearate

Coat:

Hypromellose

Macrogol

Talc

Titaniumdioxide

Ironoxidered

6.2. Incompatibilities

Notapplicable

6.3. Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

3years

Shelf-lifeafterfirstopeningoftheimmediatepackaging:

6months

6.4. Specialprecautionsforstorage

Donotstoreabove30°C

Keepblisterintheoutercartontoprotectfromlight

6.5. Natureandcompositionofimmediatepackaging

PVC/PE/PVdC/aluminiumblister

Availablepacksizes:

Boxwith2tabletsinblister

Boxwith4tabletsinblister

Boxwith10tabletsinblister

Boxwith20tabletsinblister

Boxwith50tabletsinblister

Boxwith100tabletsinblister

Notallpacksizesmaybemarketed

6.6. Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnational

requirements.

MILBEMAXCatsFinalSPCRENEWALJuly2007

Theproductshouldnotcomeintocontactwith(IE'sproposal)watercoursesasthismay

bedangerousforfishandotheraquaticorganisms

7. MARKETINGAUTHORISATIONHOLDER

NovartisAnimalHealthInc.

8. MARKETINGAUTHORISATIONNUMBER(S)

{NationalMANumber(s)}

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHE AUTHORISATION

{DDMMMYYYY}

10. DATEOFREVISIONOFTHETEXT

{MMMYYYY}

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