Endoguard

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
    Ireland
  • 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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AN:02515/2008

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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

Issued:June2011

AN:02515/2008

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8.MARKETINGAUTHORISATIONNUMBER

Vm01656/4017

9.DATEOFFIRSTAUTHORISATION

June2011

10.DATEOFREVISIONOFTHETEXT

June2011

There are no safety alerts related to this product.

29-6-2018

BROADLINE (Merial)

BROADLINE (Merial)

BROADLINE (Active substance: Fipronil/ S-methoprene/ Eprinomectin/ Praziquantel) - Centralised - Yearly update - Commission Decision (2018) 4164 of Fri, 29 Jun 2018

Europe -DG Health and Food Safety

29-5-2018

Profender (Bayer Animal Health GmbH)

Profender (Bayer Animal Health GmbH)

Profender (Active substance: Emodepside / Praziquantel) - Centralised - Yearly update - Commission Decision (2018)3405 of Tue, 29 May 2018

Europe -DG Health and Food Safety