Endoguard

Main information

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

Documents

Localization

  • Available in:
  • Endoguard plus XL Tablets for Dogs
    Ireland
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0339/002
  • Authorization date:
  • 01-06-2012
  • EU code:
  • UK/V/0339/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:June2011

AN:02514/2008

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

DehinelPlusXLTabletsfordogs(CzechRepublic,Hungary,Estonia,Latvia,

Lithuania,Poland,Romania,Slovenia,Slovakia)

EndogardPlusXLTabletsfordogs(UnitedKingdom,Austria,Belgium,

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

Endogardparaperrosgrandes(Spain)

Endogardpercanigrandi(Italy)

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(lateimmatureformsand

matureforms)

Issued:June2011

AN:02514/2008

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Hookworms:Uncinariastenocephala,Ancylostomacaninum(adults)

Cestodes:

Tapeworms:Taeniaspp.,Dipylidiumcaninum

4.3 Contraindications

Donotusesimultaneouslywithpiperazinecompounds.

Donotuseinanimalswithaknownhypersensitivitytotheactivesubstanceor

toanyofexcipients.

Donotexceedthestateddosagewhentreatingpregnantbitches.

4.4 Specialwarningsforeachtargetspecies

Fleasserveasintermediatehostsforonecommontypeoftapeworm –

Dipylidiumcaninum.Tapeworminfestationiscertaintore-occurunlesscontrol

ofintermediatehostssuchasfleas,miceetcisundertaken.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Thisproductisnotrecommendedforuseindogsunder17.5kgbodyweight.

Anypart-usedtabletsshouldbediscarded.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Intheinterestsofgoodhygiene,personsadministeringthetabletdirectlytoa

dogorbyaddingittothedog'sfood,shouldwashtheirhandsafterwards.

Incaseofaccidentalingestion,seekmedicaladviceandshowthepackage

leaflettothephysician.

4.6Adversereactions(frequencyandseriousness)

Noneknown.

4.7Useduringpregnancy,lactationorlay

Consultaveterinarysurgeonbeforetreatingpregnantanimalsfor

roundworms.

Theproductmaybeusedduringlactation(seealsoSections4.3and4.9).

Donotuseinbitchesduringthefirsttwo-thirdsofpregnancy.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Donotusesimultaneouslywithpiperazineastheanthelminticeffectsof

pyrantelandpiperazine(usedinmanywormingproductsfordogs)maybe

antagonized.

Concurrentusewithothercholinergiccompoundscanleadtotoxicity.

Issued:June2011

AN:02514/2008

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4.9 Amountstobeadministeredandadministrationroute

Fororaladministration.

Dosage

Therecommendeddoseratesare:15mg/kgbodyweightfebantel,14.4mg/kg

pyranteland5mg/kgpraziquantel.Thisisequivalentto1tabletper35kg

bodyweight.

Tabletsmaybehalvedtoallowaccuracyofdosing.

AdministrationandDurationofTreatment

Norestrictionofaccesstofoodisrequiredeitherbeforeorafteradministration

oftheproduct.Thetablet(s)canbegivendirectlytothedogordisguisedin

food.

Toensureadministrationofacorrectdose,bodyweightshouldbedetermined

asaccuratelyaspossible.

ForthecontrolofToxocara,nursingbitchesshouldbedosed2weeksafter

givingbirthandevery2weeksuntilweaning.

Intheeventofaheavyroundworminfestation,arepeatdoseshouldbegiven

after14days.

Forroutinecontroladultdogsshouldbetreatedevery3months.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theproductiswelltoleratedindogs.Insafetystudies,dosesofuptofive

timestherecommendeddosegaverisetooccasionalvomiting.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Anthelmintics,ATCvetcode:QP52AC55

5.1 Pharmacodynamicproperties

Theproductcontainsanthelminticsactiveagainstroundwormsand

tapeworms.Theproductcontainsthreeactivesubstances:febantel,pyrantel

embonate(pamoate)andpraziquantel,apartiallyhydrogenatedpyrazino-

isoquinolinederivativeusedwidelyasananthelminticforbothhumanand

veterinaryuse.

Issued:June2011

AN:02514/2008

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Pyrantelactsasacholinergicagonist.Itsmodeofactionistostimulate

nicotiniccholinergicreceptorsoftheparasite,inducespasticparalysisand

therebyallowremovalfromthegastro-intestinal(GI)systembyperistalsis.

Withthemammaliansystemfebantelundergoesringclosureforming

fenbendazoleandoxfendazole.Itisthesechemicalentitieswhichexertthe

anthelminticeffectbyinhibitionoftubulinpolymerization.Formationof

microtubulesistherebyprevented,resultingindisruptiontostructuresvitalto

thenormalfunctioningofthehelminth.Glucoseuptake,inparticular,is

affected,leadingtodepletionincellATP.Theparasitediesuponexhaustion

ofitsenergyreserves,whichoccurs2 –3dayslater.

Praziquantelisveryrapidlyabsorbedanddistributedthroughouttheparasite.

Bothinvitroandinvivostudieshaveshownthatpraziquantelcausessevere

damagetotheparasiteintegument,resultingincontractionandparalysis.

Thereisanalmostinstantaneoustetaniccontractionoftheparasite

musculatureandarapidvacuolisationofthesyncytialtegument.Thisrapid

contractionhasbeenexplainedbychangesindivalentcationfluxes,

especiallycalcium.

Inthisfixedcombinationproductpyrantelandfebantelactsynergistically

againstallrelevantnematodesindogs.Inparticular,theactivityspectrum

coversToxocaracanis,Toxascarisleonina,Uncinariastenocephalaand

Ancylostomacaninum.Thespectrumofactivityofpraziquntelcoversalso

cestodespeciesindogs,inparticularallTaeniaspp.andDipylidiumcaninum.

Praziquantelactsagainstadultandimmatureformsoftheseparasites.

5.2 Pharmacokineticparticulars

Perorallyadministeredpraziquantelisabsorbedalmostcompletelyfromthe

intestinaltract.Afterabsorption,thedrugisdistributedtoallorgans.

Praziquantelismetabolizedintoinactiveformsintheliverandsecretedinbile.

Itisexcretedwithin24hourstomorethan95%oftheadministereddosage.

Onlytracesofnon-metabolisedpraziquantelisexcreted.

Thepamoatesaltofpyrantelhaslowaqueoussolubility,anattributethat

reducesabsorptionfromthegutandallowsthedrugtoreachandbeeffective

againstparasitesinthelargeintestine.Becauseofthelowsystemic

absorptionofpyrantelpamoate,thereisverylittledangerofadverse

reactions/toxicityinthehost.Followingabsorption,pyrantelpamoateisquickly

andalmostcompletelymetabolizedintoinactivemetabolitesthatareexcreted

rapidlyintheurine.

Febantelisabsorbedrelativelyrapidlyandmetabolizedtoanumberof

metabolitesincludingfenbendazoleandoxfendazole,whichhaveanthelmintic

activity.

Issued:June2011

AN:02514/2008

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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

PrintandperforatedAlu-Alublister:2tablets(1blisterwith2tablets),inabox.

PrintandperforatedAlu-Alublister:4tablets(2blisterswith2tablets),ina

box.

PrintandperforatedAlu-Alublister:10tablets(1blisterwith10tablets),ina

box.

PrintandperforatedAlu-Alublister:12tablets(2blisterswith6tablets),ina

box.

PrintandperforatedAlu-Alublister:24tablets(4blisterswith6tablets),ina

box.

PrintandperforatedAlu-Alublister:30tablets(3blisterswith10tabletsor5

blisterswith6tablets),inabox.

PrintandperforatedAlu-Alublister:50tablets(5blisterswith10tablets),ina

box.

PrintandperforatedAlu-Alublister:60tablets(10blisterswith6tabletsor6

blisterswith10tablets),inabox.

PrintandperforatedAlu-Alublister:100tablets(10blisterswith10tablets),in

abox.

PrintandperforatedAlu-Alublister:102tablets(17blisterswith6tablets),ina

box.

Notallpacksizesmaybemarketed.

Issued:June2011

AN:02514/2008

Page6of6

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

KRKA,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

8. MARKETINGAUTHORISATIONNUMBER

Vm01656/4018

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