Prowormer

Main information

  • Trade name:
  • Prowormer flavoured tablets for medium & small dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Prowormer flavoured tablets for medium & small dogs
    Ireland
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0412/001
  • Authorization date:
  • 23-11-2011
  • EU code:
  • UK/V/0412/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:December2011

AN:00111/2011

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PROWORMERFlavouredtabletsformediumandsmalldogs[UK,IE]

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Onetabletcontains:

Activesubstances:

Febantel.............................................................................................150mg

Pyrantel(asembonate)......................................................................50mg

Praziquantel........................................................................................50mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet.

Yellowbrown,ovaltabletwithascorelineonbothsides.

Thetabletscanbedividedintoequalhalves.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs(adultsandpuppies).

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofmixedinfectionsbyadultcestodesandnematodesofthefollowing

species:

Nematodes:

Ascarids: Toxocaracanis,Toxascarisleonina(adultandlateimmatureforms).

Hookworms:Uncinariastenocephala,Ancylostomacaninum(adults).

Whipworms:Trichurisvulpis(adults).

Cestodes:

Tapeworms:Echinococcusspp.,Taeniaspp.,Dipylidiumcaninum(adultand

immatureforms).

4.3 Contraindications

Revised:December2011

AN:00111/2011

Donotuseinanimalswithaknownsensitivitytotheactiveingredientsortoanyofthe

excipients.

4.4Specialwarningsforeachtargetspecies

AsaprecautionarymeasuretopreventtheestablishmentofEchinococcus

multilocularis,itisrecommendedthatalldogsenteringthecountrybetreatedwith

praziquantel.

Dogskepttogetherorinkennelsshouldbetreatedatthesametime.

Parasiteresistancetoanyparticularclassofanthelminticmaydevelopfollowing

frequent,repeateduseofananthelminticofthatclass.

Fleasserveasintermediatehostsforonecommontypeoftapeworm –Dipylidium

caninum.Tapeworminfestationmayreoccurunlesscontrolofintermediatehostssuch

asfleas,miceetcisundertaken.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Theproductisnotrecommendedforuseinpuppies oflessthan3kgbodyweight.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandsafteradministrationtotheanimal.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.

Peoplewithknownhypersensitivitytoanyoftheingredientsshouldavoidcontactwith

theveterinarymedicinalproduct.

4.6Adversereactions(frequencyandseriousness)

Noneknown.

4.7Useduringpregnancy,lactationorlay

Pregnancy:

Donotuseinpregnantbitchesduringthefirst4weeksofpregnancy.

Lactation:

Theproductmaybeusedduringlactation(seeSection4.9below).

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Donotusesimultaneouslywithpiperazine,astheanthelminticeffectsofpyranteland

piperazinemaybeantagonized.

Plasmaconcentrationsofpraziquantelmaybedecreasedbyconcomitant

administrationwithdrugsthatincreasetheactivityofcytochromeP-450enzymes(e.g.

dexamethasone,phenobarbital).

Concurrentusewithothercholinergiccompoundscanleadtotoxicity.

Revised:December2011

AN:00111/2011

4.9 Amountstobeadministeredandadministrationroute

Oraluse.

Therecommendeddoseratesare:15mg/kgbodyweightfebantel,5mg/kgpyrantel(as

embonate)and5mg/kgpraziquantel.Thisisequivalentto1tabletper10kg

bodyweight,inoneadministration.

Dosagesareasfollows:

Bodyweight(kg) Tabletquantity

3-5 ½

>5-10 1

>10-15 1½

>15-20 2

Thetabletsareflavouredandconsequentlytakenbymostdogsvoluntarily.

Thetabletscanbegiventothedogwithorwithoutfood.Nostarvationisneededbefore

oraftertreatment.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedas

accuratelyaspossible.

Thedosingprogramshouldbeestablishedbytheveterinarysurgeon.

Puppiesshouldbetreatedat2weeksofageandevery2weeksuntil12weeksofage.

Thereaftertheyshouldbetreatedat3monthintervals.Itisadvisabletotreatthebitchat

thesametimeasthepuppies.

ForthecontrolofToxocaracanis,nursingbitchesshouldbedosed2weeksaftergiving

birthandeverytwoweeksuntilweaning.

Forroutinewormcontroladultdogsshouldbetreatedevery3months.

Incaseofconfirmedsingleinfestationbycestodeorbynematode,amonovalent

productcontainingacestocideoranematocidealoneshouldbeused.

Forroutinetreatmentasingledoseisrecommended.

Intheeventofheavyroundworminfestationarepeatdoseshouldbegivenafter14days.

IfaninfestationcausedbyEchinococcus(E.granulosus)isdetectedindogs,arepetition

ofthetreatmentisrecommendedforsafetypurposes.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Insafetystudies,singledosesof5times(4timesinveryyoungpuppies)the

recommendeddoseorgreatergaverisetooccasionalvomiting.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

ATCvetcode:QP52AA51.

Revised:December2011

AN:00111/2011

Pharmacotherapeuticgroup:anthelmintics.

5.1 Pharmacodynamicproperties

Inthisfixedcombinationpyrantelandfebantelactagainstallrelevantnematodes

(ascarids,hookworms,andwhipworms)indogs.Inparticulartheactivityspectrum

coversToxocaracanis,Toxascarisleonina,Uncinariastenocephala,Ancylostoma

caninumandTrichurisvulpis.Thiscombinationshowssynergisticactivityinthecaseof

hookwormsandfebanteliseffectiveagainstT.vulpis.

Thespectrumofactivityofpraziquantelcoversallimportantcestodespeciesindogs,in

particularTaeniasppandDipylidiumcaninum,Echinococcusgranulosusand

Echinococcusmultilocularis.Praziquantelactsagainstalladultandimmatureformsof

theseparasites.

Praziquantelisveryrapidlyabsorbedthroughtheparasite’ssurfaceanddistributed

throughouttheparasite.Bothinvitroandinvivostudieshaveshownthatpraziquantel

causesseveredamagetotheparasiteintegument,resultinginthecontractionand

paralysisoftheparasites.Thereisanalmostinstantaneoustetaniccontractionofthe

parasitemusculatureandarapidvacuolisationofthesyncytialtegument.Thisrapid

contractionhasbeenexplainedbychangesindivalentcationfluxes,especiallycalcium.

Pyrantelactsasacholinergicagonist.Itsmodeofactionistostimulatenicotinic

cholinergicreceptorsoftheparasite,inducespasticparalysisofthenematodesand

therebyallowremovalfromthegastro-intestinal(GI)systembyperistalsis.

Withinthemammaliansystemfebantelundergoesringclosureformingfenbendazole

andoxfendazole.Itisthesechemicalentitieswhichexerttheanthelminticeffectby

inhibitionoftubulinpolymerisation.Formationofmicrotubulesistherebyprevented,

resultingindisruptionofstructuresvitaltothenormalfunctioningofthehelminth.Glucose

uptake,inparticularisaffected,leadingtoadepletionincellATP.Theparasitedies

uponexhaustionofitsenergyreserves,whichoccurs2-3dayslater.

5.2Pharmacokineticparticulars

Afteroraladministrationtodogs,praziquantelisextensivelyandquicklyabsorbedfrom

thegastro-intestinaltract.Maximumplasmaconcentrationof752µg/Lisobtainedin

lessthan2hours.Itisrapidlyandextensivelymetabolisedintheliverintohydroxylated

derivativesoftheparentcompound,thenrapidlyeliminated,mainlyinurine.

Afteroraladministrationtodogs,febantelismoderatelyabsorbedfromthegastro-

intestinaltract.Febantelisrapidlymetabolisedintheliverintofenbendazoleandits

hydroxyandoxidativederivativeslikeoxfendazole.Maximumplasmaconcentrationof

fenbendazole(173µg/L)isobtainedafterabout5hours.Maximumplasma

concentrationofoxfendazole(147µg/L)isobtainedafterabout7hours.Theexcretion

occursmainlyinthefaeces.

Revised:December2011

AN:00111/2011

Afteroraladministrationtodogs,pyrantelembonateispoorlyabsorbed.Maximum

plasmaconcentrationof79µg/Lisobtainedafterabout2hours.Itisrapidlyand

extensivelymetabolisedintheliver,thenrapidlyexcreted,mainlyinthefaeces(the

unchangedform)andinurine(themetabolites).

Revised:December2011

AN:00111/2011

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Liverpowderflavour

Tabletgradeinactiveyeast

Sodiumlaurilsulfate

Croscarmellosesodium

PovidoneK30

Anhydrouscolloidalsilica

Cellulosemicrocrystalline

Magnesiumstearate

Maizestarch

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-life ofhalvedtablets:7days

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Returnanyhalvedtablettotheopenedblisterpackandusewithin7days.

6.5Natureandcompositionofimmediatepackaging

Natureofimmediatepackaging:

Polyamide-aluminium-PVC/aluminiumblisterpacks.

Packsizes:

Boxcontaining1blisterof2tablets

Boxcontaining2blistersof2tablets

Boxcontaining1blisterof8tablets

Boxcontaining13blistersof8tablets

Boxcontaining52blistersof2tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewith

nationalrequirements.

Revised:December2011

AN:00111/2011

7. MARKETINGAUTHORISATIONHOLDER

CevaAnimalHealthLtd

90TheBroadway

Chesham

Buckinghamshire

HP51EG

8. MARKETINGAUTHORISATIONNUMBER

Vm15052/4057

9. DATEOFFIRSTAUTHORISATION

26November2010

10. DATEOFREVISIONOFTHETEXT

December2011

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