Drontal Puppy Suspension

Main information

  • Trade name:
  • Drontal Puppy Suspension
  • Pharmaceutical form:
  • Oral suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Drontal Puppy Suspension
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • pyrantel
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0286/001
  • Authorization date:
  • 19-11-2010
  • EU code:
  • UK/V/0286/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:July2013

AN.00859/2012

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Member

State Proposedname

AT DrontalJunior

DE WelpanfürWelpenundjungeHunde

EE DrontalPuppy

FI Welpanvet

FR DronstopChiot

ES Drontalsuspensiónoralparacachorrosyperros

jóvenes

IE DrontalOralSuspensionforPuppies

IS Welpanvet

LT DrontalPuppy

LV DrontalPuppy

NO Welpanvet

UK DrontalOralSuspensionforPuppies

Febantel15mg/ml/Pyrantel5mg/ml

OralSuspension

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains

Activesubstances:

Febantel 15.00mg

Pyrantel 5.00mg(aspyrantelembonate14.40mg)

Excipients:

Sodiumbenzoate(E211)2.05mg

Sodiumpropionate(E281)2.05mg

Ponceau4R(E124) 0.25mg

Forafulllistofexcipients,seesection6.1.

Revised:July2013

AN.00859/2012

Page2of6

3. PHARMACEUTICALFORM

Oralsuspension

Paleredsuspension

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs(puppiesandyoungdogsuptooneyearofage)

4.2 Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofroundworminfectionsinpuppiesandyoungdogsuptooneyearof

agecausedby:

Ascarids: Toxocaracanis

Toxascarisleonina

Hookworms: Ancylostomacaninum

Uncinariastenocephala

Whipworm: Trichurisvulpis

4.3 Contraindications

Donotusesimultaneouslywithcompoundscontainingpiperazine.Seesections4.7and

4.8.

4.4 Specialwarnings

Parasiteresistancetoanyparticularclassofanthelminticmaydevelopfollowingfrequent

repeateduseofananthelminticofthatclass.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Thesafetyoftheproducthasnotbeenassessedinpuppiesyoungerthan2weeksand

weighinglessthan0.600kg.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandsafteruse,

Avoiddirectcontactwiththeskinandeyes.Incaseofaccidentalspillagewashthe

affectedareaimmediatelywithcleanrunningwater.

Otherprecautions

None

Revised:July2013

AN.00859/2012

Page3of6

4.6Adversereactions(frequencyandseriousness)

Inveryrarecasesmildtransientdigestivetractsigns(e.g.,vomitingdiarrhoea)may

occur.

4.7Useduringpregnancy,lactationorlay

Donotuseinpregnantandlactatingbitches.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Theanthelminticeffectsofbothpyrantel(spasticparalysis)andpiperazine

(neuromuscularparalysis)maybeantagonisedwhenthetwodrugsareusedtogether.

4.9 Amountstobeadministeredandadministrationroute

DosageandTreatmentSchedule

Forasingleoraladminstration15mg/kgbodyweightfebanteland5mg/kgbodyweight

pyrantel(asembonate)correspondingto14.4mg/kgpyrantelembonate,equivalentto1

ml/kgbodyweight.

Throughintrauterineandtrans-mammaryinfection,ascaridinfestationmayoccurindogs

ataveryearlyage.Forsomeanimals,especiallyincaseofsevereinfections,elimination

ofascaridsmaybeincomplete,andapotentialriskofinfectionstohumanscannotbe

excluded.Whereepidemiologicallyappropriate,itisrecommendedthattreatmentshould

bestartedat2weeksofageandshouldbeperformedrepeatedlyatsuitableintervals

(forexampleevery2weeks),untilweaning.Otherwisetreatmentshouldbebasedupon

confirmedinfection,forexampletheresultsoffaecalexaminations.

MethodofAdministration

Oraladministration.Theproductmaybegivendirectlytotheanimalormixedwith

feed.Nospecialdietarymeasuresarenecessary.

Mixtheproductbyinversionofthecontainerbeforedrawingtherequireddose.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Dosesofupto5timesthetherapeuticleveloftheproducthavebeenadministeredto

puppiesandyoungdogswithoutclinicalsignsofintolerancearising.

At10timestherecommendeddosethefirstsignofintolerance –vomiting–wasevident.

4.11Withdrawalperiod(s)

Notapplicable.

Revised:July2013

AN.00859/2012

Page4of6

5. PHARMACOLOGICALPROPERTIES

Fixedcombinationoftwoanthelmintics:atetrahydro-pyrimidinederivative,pyrantel(as

theembonate)andapro-benzimidazole,febantel.

ATCvetcodeQP52AF02.

5.1 Pharmacodynamicproperties

Inthisfixedcombinationproduct,thepyrantelandfebantelactsynergisticallyagainst

nematodes(ascarids,hookwormsandwhipworms)ofdogs.Inparticular,thespectrumof

activitycoversToxocaracanis,AncyclostomacaninumandTrichurisvulpis.Published

dataarealsoavailabletoconfirmthatToxascarisleoninaandUncinariastenocephala

arealsosusceptibletothisparticularcombinationofactives.

Febantel,N-{2-[2,3-bis,(methoxycarbonyl)-guanidino]-5-(phenylthio)phenyl}-2-

methoxyacetamide,isapro-benzimidazole.Withinthemammaliansystemfebantel

undergoesringclosureformingfenbendazoleandoxfendazole.Itisthesechemical

entitieswhichexerttheanthelminticeffectbyinhibitionoftubulinpolymerization.

Formationofmicrotubulesistherebyprevented,resultingindisruptiontostructuresvital

tothenormalfunctioningofthehelminth.Glucoseuptake,inparticular,isaffected,

leadingtodepletionincellATP.Theparasitediesuponexhaustionofitsenergy

reserves,whichoccurs2-3dayslater.

Pyrantel,(E)-1,4,5,6-Tetrahydro-1-methyl-2-[2-(2-thienyl)vinyl]pyrimidinepamoate

belongstothetetrahydropyrimidinetype.Itsmodeofactionistostimulatenicotinic

cholinergicreceptorsinducingspasticparalysisandtherebyallowingremovalfromthe

gastro-intestinal(GI)systembyparalysis.

5.2 Pharmacokineticparticulars

Literaturereportsindicateafteroralapplicationoftherecommendeddoseof1ml/kg

bodyweight(correspondingto14.4mg/kgpyrantelembonateand15mg/kgfebantel)

maximumserumconcentrationsforfebantelwerefoundbetween1and6hourswithwith

aC

of0.019mg/ltwohoursafterdosing.Asfebantelasapro-drugismetabolisedto

fenbendazolwhichisfurtherconvertedtooxfendazole,alsothesemetaboliteswere

measured.C

offebendazolewas0.130mg/lafter3hoursandC

ofoxfendazole

was0.157mg/latabout5hoursafterapplication.

TheC

ofpyrantel(measuredaspyrantelbase)was0.084mg/l2.5hoursafter

application.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumbenzoate(E211)

Sodiumpropionate(E281)

Ponceau4R(E124)

Sodiumdihydrogenphosphatedihydrate

Sorbitanoleate(E494)

PovidoneK25(E1202)

Polysorbate80(E433)

Revised:July2013

AN.00859/2012

Page5of6

Docusatesodium

Bentonite(E558)

Citricacidanhydrous(E330)

Xanthangum(E415)

Propyleneglycol(E1520)

Purifiedwater

6.2Incompatibilities

Noneknown

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproduct

aspackagedforsale:

5years

Shelf-lifeafterfirstopeningtheimmediate

packaging:

12weeks

6.4.Specialprecautionsforstorage

Donotuseafterexpirydate.

Thisunopenedveterinarymedicinalproductdoesnotrequireanyspecialstorage

conditions.Afteropening,storetheproductatatemperaturenotexceeding25ºC.

6.5Natureandcompositionofimmediatepackaging

Materialoftheprimarycontainer:

Whitehighdensitypolyethylene

bottle

Whitepolypropylenescrewclosure

Colourlesslowdensity

polyethyleneadapterinsert

Containervolumes: 50ml,100ml

(Notallpacksizesmaybe

marketed)

Devicessupplied(ifrelevant) 5mltransparentpolypropylene

syringewithrubberplunger

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

Revised:July2013

AN.00859/2012

Page6of6

7. MARKETINGAUTHORISATIONHOLDER

UK IE

Bayerplc,

AnimalHealthDivision,

BayerHouse,

StrawberryHill,

Newbury,

BerkshireRG141JA BayerLtd,

AnimalHealthDivision,

TheAtrium,

BlackthornRoad,

Dublin18.

Ireland

8. MARKETINGAUTHORISATIONNUMBER

UK IE

Vm00010/4102 VPA10021/53/1

9. DATEOFFIRSTAUTHORISATION

17April1998

10. DATEOFREVISIONOFTHETEXT

July2013

APPROVED 3/07/13

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