X-Spectra Flavoured Tablets for Large Dogs

Main information

  • Trade name:
  • X-Spectra Flavoured Tablets for Large Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • X-Spectra Flavoured Tablets for Large Dogs
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0413/002
  • Authorization date:
  • 23-11-2011
  • EU code:
  • UK/V/0413/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

AN:00824/2012

Revised:February2013

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

X-SPECTRAFlavouredtabletsformediumandsmalldogs[UK]

CESTEMFtabletsfordogs[FR]

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.

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofmixedinfectionsbycestodesandnematodesofthefollowing

species:

Nematodes:

Ascarids: Toxocaracanis,Toxascarisleonina(adultandlateimmature

forms).

Hookworms:Uncinariastenocephala,Ancylostomacaninum(adults).

Whipworms:Trichurisvulpis(adults).

Cestodes:

Tapeworms:Echinococcusspecies,(E.Granulosus,E.Multilocularis),Taenia

species(T.hydatigena,T.pisiformis,T.taeniformis),Dipylidiumcaninum(adult

andimmatureforms).

AN:00824/2012

Revised:February2013

4.3 Contraindications

Donotuseinanimalswithaknownsensitivitytotheactiveingredientsortoany

oftheexcipients.

Seesection4.7below.

4.4Specialwarningsforeachtargetspecies

Dogskepttogetherorinkennelsshouldbetreatedatthesametime.Parasite

resistancetoanyparticularclassofanthelminticmaydevelopfollowingfrequent,

repeateduseofananthelminticofthatclass.

Fleasserveasintermediatehostsforonecommontypeoftapeworm –

Dipylidiumcaninum.Tapeworminfestationmayreoccurunlesscontrolof

intermediatehostssuchasfleas,miceetcisundertaken.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Theproductisnotrecommendedforuseindogsoflessthan3kg

bodyweight.

Indebilitatedorheavilyinfestedanimals,theproductshouldbeusedonly

accordingtoabenefit/riskassessmentbytheresponsibleveterinarian.

ii.Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandsafteradministrationtotheanimal.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshow

thepackageleafletorthelabeltothephysician.

Peoplewithknownhypersensitivitytoanyoftheingredientsshouldavoid

contactwiththeveterinarymedicinalproduct.

4.6 Adversereactions(frequencyandseriousness)

Noneknown.

4.7Useduringpregnancy,lactationorlay

Pregnancy:

Donotuseinpregnantbitchesduringthefirst4weeksofpregnancy.

Lactation:

Theproductmaybeusedduringlactation(seeSection4.9below).

AN:00824/2012

Revised:February2013

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Donotusesimultaneouslywithpiperazine,Levamisoleastheanthelmintic

effectsofpyrantelmaybeantagonized.

Plasmaconcentrationsofpraziquantelmaybedecreasedbyconcomitant

administrationwithdrugsthatincreasetheactivityofcytochromeP-450enzymes

(e.g.dexamethasone,phenobarbital).

Concurrentusewithothercholinergiccompoundscanleadtotoxicity.

4.9Amountstobeadministeredandadministrationroute

Oraluse.

Therecommendeddoseratesare:15mg/kgbodyweightfebantel,5mg/kg

pyrantel(asembonate)and5mg/kgpraziquantel.Thisisequivalentto1tablet

per10kgbodyweight,inasingleadministration.

Dosagesareasfollows:

Bodyweight(kg) Tabletquantity

3-5 ½

>5-10 1

>10-15 1½

>15-20 2

Thetabletsareflavouredandconsequentlytakenbymostdogsvoluntarily.

Thetabletscanbegiventothedogwithorwithoutfood.Nostarvationisneeded

beforeoraftertreatment.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedas

accuratelyaspossible.

Ifthereisariskforre-infestation,theadviceofaveterinarianshouldbesought

regardingtheneedforandthefrequencyofrepeatadministration.Incaseof

confirmedsingleinfestationbycestodeorbynematode,amonovalentproduct

containingacestocideoranematocidealoneshouldbeused.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Insafetystudies,singledosesof5timestherecommendeddoseorgreatergave

risetooccasionalvomiting.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

ATCvetcode:QP52AA51.

Pharmacotherapeuticgroup:anthelmintics.

AN:00824/2012

Revised:February2013

5.1 Pharmacodynamicproperties

Inthisfixedcombinationpyrantelandfebantelactagainstallrelevantnematodes

(ascarids,hookworms,andwhipworms)indogs.Inparticulartheactivityspectrum

coversToxocaracanis,Toxascarisleonina,Uncinariastenocephala,

AncylostomacaninumandTrichurisvulpis.Thiscombinationshowssynergistic

activityinthecaseofhookwormsandfebanteliseffectiveagainstT.vulpis.

Thespectrumofactivityofpraziquantelcoversallimportantcestodespeciesin

dogs,inparticularTaeniaspp,Dipylidiumcaninum,Echinococcusgranulosus

andEchinococcusmultilocularis.Praziquantelactsagainstalladultandimmature

formsoftheseparasites.

Praziquantelisveryrapidlyabsorbedthroughtheparasite’ssurfaceand

distributedthroughouttheparasite.Bothinvitroandinvivostudieshaveshown

thatpraziquantelcausesseveredamagetotheparasiteintegument,resultingin

thecontractionandparalysisoftheparasites.Thereisanalmostinstantaneous

tetaniccontractionoftheparasitemusculatureandarapidvacuolisationofthe

syncytialtegument.Thisrapidcontractionhasbeenexplainedbychangesin

divalentcationfluxes,especiallycalcium.

Pyrantelactsasacholinergicagonist.Itsmodeofactionistostimulatenicotinic

cholinergicreceptorsoftheparasite,inducespasticparalysisofthenematodes

andtherebyallowremovalfromthegastro-intestinal(GI)systembyperistalsis.

Withinthemammaliansystemfebantelundergoesringclosureforming

fenbendazoleandoxfendazole.Itisthesechemicalentitieswhichexertthe

anthelminticeffectbyinhibitionoftubulinpolymerisation.Formationof

microtubulesistherebyprevented,resultingindisruptionofstructuresvitaltothe

normalfunctioningofthehelminth.Glucoseuptake,inparticularisaffected,leading

toadepletionincellATP.Theparasitediesuponexhaustionofitsenergy

reserves,whichoccurs2-3dayslater.

5.2Pharmacokineticparticulars

Afteroraladministrationtodogs,praziquantelisextensivelyandquicklyabsorbed

fromthegastro-intestinaltract.Maximumplasmaconcentrationof752µg/Lis

obtainedinlessthan2hours.Itisrapidlyandextensivelymetabolisedintheliver

intohydroxylatedderivativesoftheparentcompound,thenrapidlyeliminated,

mainlyinurine.

Afteroraladministrationtodogs,febantelismoderatelyabsorbedfromthegastro-

intestinaltract.Febantelisrapidlymetabolisedintheliverintofenbendazoleand

itshydroxyandoxidativederivativeslikeoxfendazole.Maximumplasma

concentrationoffenbendazole(173µg/L)isobtainedafterabout5hours.

Maximumplasmaconcentrationofoxfendazole(147µg/L)isobtainedafterabout

7hours.Theexcretionoccursmainlyinthefaeces.

Afteroraladministrationtodogs,pyrantelembonateispoorlyabsorbed.Maximum

plasmaconcentrationof79µg/Lisobtainedafterabout2hours.Itisrapidlyand

extensivelymetabolisedintheliver,thenrapidlyexcreted,mainlyinthefaeces(the

unchangedform)andinurine(themetabolites).

AN:00824/2012

Revised:February2013

6.1Listofexcipients

Liverpowderflavour

Tabletgradeinactiveyeast

Sodiumlaurilsulfate

Croscarmellosesodium

PovidoneK30

Anhydrouscolloidalsilica

Cellulosemicrocrystalline

Magnesiumstearate

Maizestarch

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Half-tabletsshouldbediscarded.

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcompositionofimmediatepackaging

Natureofimmediatepackaging:

Polyamide-aluminium-PVC/aluminiumblisterpacks.

Packsizes:

Boxcontaining1blisterof2tablets

Boxcontaining2blistersof2tablets

Boxcontaining1blisterof8tablets

Boxcontaining13blistersof8tablets

Boxcontaining52blistersof2tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewith

nationalrequirements.

AN:00824/2012

Revised:February2013

7. MARKETINGAUTHORISATIONHOLDER

CevaAnimalHealthLtd

Unit3,AngloOfficePark

WhiteLionRoad

Amersham

Buckinghamshire

HP79FB

8. MARKETINGAUTHORISATIONNUMBER

Vm15052/4055

9. DATEOFFIRSTAUTHORISATION

Date:26November2010

10 DATEOFREVISIONOFTHETEXT

Date:February2013

Approved 19/04/13