Endoguard plus XL Tablets for Dogs

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
    Greece
  • 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)

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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

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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.

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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.

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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

4-12-2018

FDA Approves Pexion for Treating Noise Aversion in Dogs

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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