Endro Plus XL Tablets for Dogs

Main information

  • Trade name:
  • Endro Plus XL Tablets for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Endro Plus XL Tablets for Dogs
    Netherlands
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0340/002
  • Authorization date:
  • 01-06-2012
  • EU code:
  • UK/V/0340/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:March2011

AN:02517/2008

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

EndroPlusXLTabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstances:

Praziquantel 175mg

Pyrantelembonate504mg

Febantel 525mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablets

Oval,biconvextabletswithbevellededgesandscoredonbothsides.Slightly

greenish-yellow.

Thetabletscanbedividedintoequalhalves

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs(largeandextralargesize)

4.2 Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofmixedinfestationswiththefollowingroundwormsand

tapewormsinadultdogs:

Nematodes:

Ascarids:Toxocaracanis,Toxascarisleonina(lateimmatureformsandmature

forms)

Hookworms:Uncinariastenocephala,Ancylostomacaninum(adults)

Cestodes:

Tapeworms:Taeniaspp.,Dipylidiumcaninum

4.3 Contraindications

Donotusesimultaneouslywithpiperazinecompounds.

Donotuseinanimalswithaknownhypersensitivitytotheactivesubstanceorto

anyofexcipients.

Donotexceedthestateddosewhentreatingpregnantbitches.

Issued:March2011

AN:02517/2008

4.4 Specialwarningsforeachtargetspecies

Fleasserveasintermediatehostsforonecommontypeoftapeworm –Dipylidium

caninum.Tapeworminfestationiscertaintore-occurunlesscontrolofintermediate

hostssuchasfleas,miceetcisundertaken.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Thisproductisnotrecommendedforuseindogsunder17.5kgbodyweight.

Anypart-usedtabletsshouldbediscarded.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Intheinterestsofgoodhygiene,personsadministeringthetabletdirectlytoadog

orbyaddingittothedog'sfood,shouldwashtheirhandsafterwards.

Incaseofaccidentalingestion,seekmedicaladviceandshowthepackageleaflet

tothephysician.

4.6Adversereactions(frequencyandseriousness)

Noneknown.

4.7Useduringpregnancy,lactationorlay

Consultaveterinarysurgeonbeforetreatingpregnantanimalsforroundworms.

Theproductmaybeusedduringlactation(seeSection4,3and4.9).

Donotuseinbitchesduringthefirsttwo-thirdsofpregnancy.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Donotusesimultaneouslywithpiperazineastheanthelminticeffectsofpyrantel

andpiperazine(usedinmanywormingproductsfordogs)maybeantagonized.

Concurrentusewithothercholinergiccompoundscanleadtotoxicity.

Issued:March2011

AN:02517/2008

4.9 Amountstobeadministeredandadministrationroute

Fororaladministration.

Dosage

Therecommendeddoseratesare:15mg/kgbodyweightfebantel,14.4mg/kg

pyranteland5mg/kgpraziquantel.Thisisequivalentto1tabletper35kg

bodyweight.

Tabletsmaybehalvedtoallowaccuracyofdosing.

AdministrationandDurationofTreatment

Norestrictionofaccesstofoodisrequiredeitherbeforeorafteradministrationof

theproduct.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedas

accuratelyaspossible.

ForthecontrolofToxocara,nursingbitchesshouldbedosed2weeksaftergiving

birthandevery2weeksuntilweaning.

Intheeventofaheavyroundworminfestation,arepeatdoseshouldbegivenafter

14days.Forroutinecontroladultdogsshouldbetreatedwitha3monthlyintervals.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Veterinarymedicinalproductiswelltoleratedindogs.Insafetystudiesofuptofive

timestherecommendeddosegaverisetooccasionalvomiting.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Anthelmintics,ATCvetcode:QP52AC55

Issued:March2011

AN:02517/2008

5.1 Pharmacodynamicproperties

Theproductcontainsanthelminticsactiveagainstroundwormsandtapeworms.The

productcontainsthreeactivesubstances:febantel,pyrantelembonate(pamoate)

andpraziquantel,apartiallyhydrogenatedpyrazino-isoquinolinederivativeused

widelyasananthelminticforbothhumanandveterinaryuse.

Pyrantelactsasacholinergicagonist.Itsmodeofactionistostimulatenicotinic

cholinergicreceptorsoftheparasite,inducespasticparalysisandtherebyallow

removalfromthegastro-intestinal(GI)systembyperistalsis.

Withthemammaliansystemfebantelundergoesringclosureformingfenbendazole

andoxfendazole.Itisthesechemicalentitieswhichexerttheanthelminticeffectby

inhibitionoftubulinpolymerization.Formationofmicrotubulesistherebyprevented,

resultingindisruptiontostructuresvitaltothenormalfunctioningofthehelminth.

Glucoseuptake,inparticular,isaffected,leadingtodepletionincellATP.The

parasitediesuponexhaustionofitsenergyreserves,whichoccurs2 –3dayslater.

Praziquantelisveryrapidlyabsorbedanddistributedthroughouttheparasite.Both

invitroandinvivostudieshaveshownthatpraziquantelcausesseveredamageto

theparasiteintegument,resultingincontractionandparalysis.Thereisanalmost

instantaneoustetaniccontractionoftheparasitemusculatureandarapid

vacuolisationofthesyncytialtegument.Thisrapidcontractionhasbeenexplained

bychangesindivalentcationfluxes,especiallycalcium.

Inthisfixedcombinationproductpyrantelandfebantelactsynergisticallyagainstall

relevantnematodesindogs.Inparticular,theactivityspectrumcoversToxocara

canis,Toxascarisleonina,UncinariastenocephalaandAncylostomacaninum.The

spectrumofactivityofpraziquntelcoversalsocestodespeciesindogs,inparticular

Taeniaspp.andDipylidiumcaninum.Praziquantelactsagainstadultandimmature

formsoftheseparasites.

5.2 Pharmacokineticparticulars

Perorallyadministeredpraziquantelisabsorbedalmostcompletelyfromthe

intestinaltract.Afterabsorption,thedrugisdistributedtoallorgans.Praziquantelis

metabolizedintoinactiveformsintheliverandsecretedinbile.Itisexcretedwithin

24hourstomorethan95%oftheadministereddosage.Onlytracesofnon-

metabolisedpraziquantelareexcreted.

Thepamoatesaltofpyrantelhaslowaqueoussolubility,anattributethatreduces

absorptionfromthegutandallowsthedrugtoreachandbeeffectiveagainst

parasitesinthelargeintestine.Becauseofthelowsystemicabsorptionofpyrantel

pamoate,thereisverylittledangerofadversereactions/toxicityinthehost.

Followingabsorption,pyrantelpamoateisquicklyandalmostcompletely

metabolizedintoinactivemetabolitesthatareexcretedrapidlyintheurine.

Febantelisabsorbedrelativelyrapidlyandmetabolizedtoanumberofmetabolites

includingfenbendazoleandoxfendazole,whichhaveanthelminticactivity.

Issued:March2011

AN:02517/2008

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

LactoseMonohydrate

MaizeStarch

PovidoneK-30

SodiumLaurylSulfate

MicrocrystallineCellulose

ColloidalAnhydrousSilica

MagnesiumStearate

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

6.4.Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcompositionofimmediatepackaging

Natureofcontainer:PrintandperforatedAlu-Alublister.Foldingboxasanouter

package.

Contentofcontainer:2tbl.,4tbl.,10tbl.,12tbl,24tbl.,30tbl.,50tbl.,60tbl,100

tbl.and102tbl.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

Issued:March2011

AN:02517/2008

7. MARKETINGAUTHORISATIONHOLDER

KRKAd.d,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

8. MARKETINGAUTHORISATIONNUMBER

Vm01656/4016

9. DATEOFFIRSTAUTHORISATION

4March2011

10. DATEOFREVISIONOFTHETEXT

March2011

4-12-2018

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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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