X-Spectra Flavoured Tablets for Medium and Small Dogs

Main information

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

Documents

Localization

  • Available in:
  • X-Spectra Flavoured Tablets for Medium and Small Dogs
    France
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0413/001
  • Authorization date:
  • 23-11-2011
  • EU code:
  • UK/V/0413/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:December2011

AN:00108/2011

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(adults).

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofmixedinfectionsbyadultstagesofcestodesandnematodesofthe

followingspecies:

Nematodes:

Ascarids: Toxocaracanis,Toxascarisleonina.

Hookworms:Uncinariastenocephala,Ancylostomacaninum.

Whipworms:Trichurisvulpis.

Cestodes:

Tapeworms:Taeniaspp.,Dipylidiumcaninum.

4.3 Contraindications

Revised:December2011

AN:00108/2011

Donotuseinanimalswithaknownsensitivitytotheactiveingredientsortoanyofthe

excipients.

Seesection4.7below.

4.4Specialwarningsforeachtargetspecies

Dogskepttogetherorinkennelsshouldbetreatedatthesametime.

Parasiteresistancetoanyparticularclassofanthelminticmaydevelopfollowing

frequent,repeateduseofananthelminticofthatclass.

Fleasserveasintermediatehostsforonecommontypeoftapeworm –Dipylidium

caninum.Tapeworminfestationmayreoccurunlesscontrolofintermediatehostssuch

asfleas,miceetcisundertaken.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Theproductisnotrecommendedforuseindogsoflessthan3kgbodyweight.

Indebilitatedorheavilyinfestedanimals,theproductshouldbeusedonlyaccordingtoa

benefit/riskassessmentbytheresponsibleveterinarian.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandsafteradministrationtotheanimal.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.

Peoplewithknownhypersensitivitytoanyoftheingredientsshouldavoidcontactwith

theveterinarymedicinalproduct.

4.6Adversereactions(frequencyandseriousness)

Noneknown.

4.7Useduringpregnancy,lactationorlay

Pregnancy:

Donotuseinpregnantbitchesduringthefirst4weeksofpregnancy.

Lactation:

Theproductmaybeusedduringlactation(seeSection4.9below).

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Donotusesimultaneouslywithpiperazineorlevamisoleastheanthelminticeffectsof

pyrantelmaybeantagonized.

Plasmaconcentrationsofpraziquantelmaybedecreasedbyconcomitant

administrationwithdrugsthatincreasetheactivityofcytochromeP-450enzymes(e.g.

dexamethasone,phenobarbital).

Concurrentusewithothercholinergiccompoundscanleadtotoxicity.

Revised:December2011

AN:00108/2011

4.9 Amountstobeadministeredandadministrationroute

Oraluse.

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

embonate)and5mg/kgpraziquantel.Thisisequivalentto1tabletper10kg

bodyweight,inasingleadministration.

Dosagesareasfollows:

Bodyweight(kg) Tabletquantity

3-5 ½

>5-10 1

>10-15 1½

>15-20 2

Thetabletsareflavouredandconsequentlytakenbymostdogsvoluntarily.

Thetabletscanbegiventothedogwithorwithoutfood.Nostarvationisneededbefore

oraftertreatment.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedas

accuratelyaspossible.

Ifthereisariskforre-infestation,theadviceofaveterinarianshouldbesought

regardingtheneedforandthefrequencyofrepeatadministration.Incaseofconfirmed

singleinfestationbycestodeorbynematode,amonovalentproductcontaininga

cestocideoranematocidealoneshouldbeused.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Insafetystudies,singledosesof5timestherecommendeddoseorgreatergaveriseto

occasionalvomiting.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

ATCvetcode:QP52AA51.

Pharmacotherapeuticgroup:anthelmintics.

5.1 Pharmacodynamicproperties

Inthisfixedcombinationpyrantelandfebantelactagainstallrelevantnematodes

(ascarids,hookworms,andwhipworms)indogs.Inparticulartheactivityspectrum

coversToxocaracanis,Toxascarisleonina,Uncinariastenocephala,Ancylostoma

caninumandTrichurisvulpis.Thiscombinationshowssynergisticactivityinthecaseof

hookwormsandfebanteliseffectiveagainstT.vulpis.

Revised:December2011

AN:00108/2011

Thespectrumofactivityofpraziquantelcoversallimportantcestodespeciesindogs,in

particularTaeniasppandDipylidiumcaninum.Praziquantelactsagainstalladultforms

oftheseparasites.

aziquantelisveryrapidlyabsorbedthroughtheparasite’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.

Afteroraladministrationtodogs,pyrantelembonateispoorlyabsorbed.Maximum

plasmaconcentrationof79µg/Lisobtainedafterabout2hours.Itisrapidlyand

extensivelymetabolisedintheliver,thenrapidlyexcreted,mainlyinthefaeces(the

unchangedform)andinurine(themetabolites).

6.1Listofexcipients

Liverpowderflavour

Tabletgradeinactiveyeast

Sodiumlaurilsulfate

Croscarmellosesodium

PovidoneK30

Anhydrouscolloidalsilica

Cellulosemicrocrystalline

Magnesiumstearate

Revised:December2011

AN:00108/2011

Maizestarch

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Discardanyunusedhalf-tablets

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

Natureofimmediatepackaging:

Polyamide-aluminium-PVC/aluminiumblisterpacks.

Packsizes:

Boxcontaining1blisterof2tablets

Boxcontaining2blistersof2tablets

Boxcontaining1blisterof8tablets

Boxcontaining13blistersof8tablets

Boxcontaining52blistersof2tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

7. MARKETINGAUTHORISATIONHOLDER

CevaAnimalHealthLtd

90TheBroadway

Chesham

Buckinghamshire

HP51EG

UK

Revised:December2011

AN:00108/2011

8. MARKETINGAUTHORISATIONNUMBER

Vm15052/4055

9. DATEOFFIRSTAUTHORISATION

26November2010

10. DATEOFREVISIONOFTHETEXT

December2011

31-5-2018

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FDA - U.S. Food and Drug Administration

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