Endoguard plus F Tablets for Dogs

Main information

  • Trade name:
  • Endoguard plus F Tablets for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Endoguard plus F Tablets for Dogs
    Hungary
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Combinations of quinoline derivatives and related substances
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0339/001
  • Authorization date:
  • 01-06-2012
  • EU code:
  • UK/V/0339/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:June2011

AN:02515/2008

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

DehinelPlusFlavourTabletsfordogs(CzechRepublic,Hungary,Estonia,Latvia,

Lithuania,Poland,Romania,Slovenia,Slovakia)

EndogardPlusFlavourTabletsfordogs(UnitedKingdom,Austria,Belgium,

Germany,Denmark,Greece,Ireland,Netherlands,Portugal)

EndogardSaborTabletsfordogs(Spain)

EndogardFlavourTabletsfordogs(Italy)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstances:

Praziquantel 50mg

Pyrantelembonate 144mg

Febantel 150mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablets.

Round,yellow,uncoatedtabletswithvisibledarkerspotsandbevellededgeswith

crosslineononesideandplainonotherside.

Thetabletscanbedividedintoequalhalvesorequalquarters.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs(smallandmediumsize)

4.2 Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofmixedinfestationswiththefollowingroundwormsand

tapewormsinadultdogsandpuppies:

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Nematodes

Ascarids: Toxocaracanis,Toxascarisleonina(lateimmatureformsandmature

forms)

Hookworms:Uncinariastenocephala,Ancylostomacaninum(adults)

Cestodes

Tapeworms:Taeniaspp.,Dipylidiumcaninum

4.3 Contraindications

Donotusesimultaneouslywithpiperazinecompounds.

Donotexceedthestateddosagewhentreatingpregnantbitches.

Donotuseinanimalswithaknownhypersensitivitytotheactivesubstanceortoany

ofexcipients.

Notforuseindogsyoungerthan2weeksofageand/orweighinglessthan2kg.

4.4 Specialwarningsforeachtargetspecies

Fleasserveasintermediatehostsforonecommontypeoftapeworm –Dipylidium

caninum.Tapeworminfestationiscertaintore-occurunlesscontrolofintermediate

hostsasfleas,miceetcisundertaken.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Anypart-usedtabletsshouldbediscarded.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Intheinterestsofgoodhygiene,personsadministeringthetabletdirectlytoadogor

byaddingittothedog'sfoodshouldwashtheirhandsafterwards.

Incaseofaccidentalingestion,seekmedicaladviceandshowthepackageleafletto

thephysician.

4.6 Adversereactions(frequencyandseriousness)

Inrarecasestransientloosefeaces,diarrhoeaand/orvomitingmayoccurinsome

puppies.

4.7 Useduringpregnancy,lactationorlay

Consultaveterinarysurgeonbeforetreatingpregnantanimalsforroundworms.

Theproductmaybeusedduringlactation(seeSections4.3and4.9).

Donotuseinbitchesduringthefirsttwo-thirdsofpregnancy.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Donotusesimultaneouslywithpiperazineastheanthelminticeffectsofpyranteland

piperazine(usedinmanywormingproductsfordogs)maybeantagonized.

Concurrentusewithothercholinergiccompoundscanleadtotoxicity.

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4.9 Amountstobeadministeredandadministrationroute

Fororaladministration.

Dosage

Therecommendeddoseratesare:15mg/kgbodyweightfebantel,14.4mg/kg

pyranteland5mg/kgpraziquantel.Thisisequivalentto1tabletper10kg

bodyweight.

Tabletsmaybehalved/quarteredtoallowaccuracyofdosing.

AdministrationandDurationofTreatment

Thetablet(s)canbegivendirectlytothedogordisguisedinfood.Norestrictionof

accesstofoodisrequiredeitherbeforeorafteradministrationoftheproduct.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedas

accuratelyaspossible.

Puppiesmaybewormedwiththisproductfrom2weeksofageandevery2weeks

until12weeksofage.Thereaftertheyshouldbetreatedat3monthlyintervals.Itis

advisabletotreatthebitchatthesametimeasthepuppies.

ForthecontrolofToxocara,nursingbitchesshouldbedosed2weeksaftergiving

birthandevery2weeksuntilweaning.

Forroutinecontrolasingledoseisrecommendedat3monthlyintervals.

Intheeventofaheavyroundworminfestation,arepeatdoseshouldbegivenafter

14days.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Benzimidazolespossesswidesafetymargin.Pyrantelisnotabsorbedsystematically

toanyextent.Praziquantelalsohasawidesafetymargin,ofuptofivetimesthe

recommendeddose.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Anthelmintics,ATCvetcode:QP52AC55

5.1 Pharmacodynamicproperties

Theproductcontainsanthelminticsactiveagainstroundwormsandtapeworms.The

productcontainsthreeactivesubstances:febantel,pyrantelembonate(pamoate)

andpraziquantel,apartiallyhydrogenatedpyrazino-isoquinolinederivativeused

widelyasananthelminticforbothhumanandveterinaryuse.Pyrantelactsasa

cholinergicagonist.Itsmodeofactionistostimulatenicotiniccholinergicreceptorsof

theparasite,inducespasticparalysisandtherebyallowremovalfromthegastro-

intestinal(GI)systembyperistalsis.

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AN:02515/2008

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Withthemammaliansystemfebantelundergoesringclosureformingfenbendazole

andoxfendazole.Itisthesechemicalentitieswhichexerttheanthelminticeffectby

inhibitionoftubulinpolymerization.Formationofmicrotubulesistherebyprevented,

resultingindisruptiontostructuresvitaltothenormalfunctioningofthehelminth.

Glucoseuptake,inparticular,isaffected,leadingtodepletionincellATP.The

parasitediesuponexhaustionofitsenergyreserves,whichoccurs2 –3dayslater.

Praziquantelisveryrapidlyabsorbedanddistributedthroughouttheparasite.Bothin

vitroandinvivostudieshaveshownthatpraziquantelcausesseveredamagetothe

parasiteintegument,resultingincontractionandparalysis.Thereisanalmost

instantaneoustetaniccontractionoftheparasitemusculatureandarapid

vacuolisationofthesyncytialtegument.Thisrapidcontractionhasbeenexplainedby

changesindivalentcationfluxes,especiallycalcium.

Inthisfixedcombinationproductpyrantelandfebantelactsynergisticallyagainstall

relevantnematodes(ascaridsandhookworms)indogs.Inparticular,theactivity

spectrumcoversToxocaracanis,Toxascarisleonina,Uncinariastenocephalaand

Ancylostomacaninum.Thespectrumofactivityofpraziquntelcoversalsocestode

speciesindogs,inparticularallTaeniaspp.andDipylidiumcaninum,.Praziquantel

actsagainstadultandimmatureformsoftheseparasites.

5.2 Pharmacokineticparticulars

Perorallyadministeredpraziquantelisabsorbedalmostcompletelyfromtheintestinal

tract.Afterabsorption,thedrugisdistributedtoallorgans.Praziquantelis

metabolizedintoinactiveformsintheliverandsecretedinbile.Itisexcretedwithin

24hourstomorethan95%oftheadministereddosage.Onlytracesofnon-

metabolisedpraziquantelareexcreted.

Thepamoatesaltofpyrantelhaslowaqueoussolubility,anattributethatreduces

absorptionfromthegutandallowsthedrugtoreachandbeeffectiveagainst

parasitesinthelargeintestine.Becauseofthelowsystemicabsorptionofpyrantel

pamoate,thereisverylittledangerofadversereactions/toxicityinthehost.Following

absorption,pyrantelpamoateisquicklyandalmostcompletelymetabolizedinto

inactivemetabolitesthatareexcretedrapidlyintheurine.

Febantelisabsorbedrelativelyrapidlyandmetabolizedtoanumberofmetabolites

includingfenbendazoleandoxfendazole,whichhaveanthelminticactivity.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

LactoseMonohydrate

MaizeStarch

PovidoneK-30

SodiumLaurylSulfate

MicrocrystallineCellulose

ColloidalAnhydrousSilica

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MagnesiumStearate

MeatFlavour

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

6.4 Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

Natureofcontainer:PrintandperforatedAlu-Alublister:2tablets(1blisterwith2

tablets),inabox.

PrintandperforatedAlu-Alublister:4tablets(2blisterswith2tablets),inabox.

PrintandperforatedAlu-Alublister:10tablets(1blisterwith10tablets),inabox.

PrintandperforatedAlu-Alublister:30tablets(3blisterswith10tablets),inabox.

PrintandperforatedAlu-Alublister:50tablets(5blisterswith10tablets),inabox.

PrintandperforatedAlu-Alublister:100tablets(10blisterswith10tablets),inabox.

PrintandperforatedAlu-Alublister:300tablets(30blisterswith10tablets),inabox.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7.MARKETINGAUTHORISATIONHOLDER

KRKA,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

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AN:02515/2008

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8.MARKETINGAUTHORISATIONNUMBER

Vm01656/4017

9.DATEOFFIRSTAUTHORISATION

June2011

10.DATEOFREVISIONOFTHETEXT

June2011

4-12-2018

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FDA Approves Pexion for Treating Noise Aversion in Dogs

The U.S. Food and Drug Administration announced today that its Center for Veterinary Medicine has approved Pexion (imepitoin tablets) to treat noise aversion in dogs. Dogs with noise aversion are sensitive to loud noises such as fireworks, street/traffic noises, and gun shots.

FDA - U.S. Food and Drug Administration

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