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
    United Kingdom
  • Language:
  • English

Therapeutic information

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

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