Prowormer Flavoured Tablets for Medium and Small Dogs

Main information

  • Trade name:
  • Prowormer Flavoured Tablets for Medium and Small Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Prowormer Flavoured Tablets for Medium and Small Dogs
    United Kingdom
  • 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

31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

FDA - U.S. Food and Drug Administration

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