Duowin

Main information

  • Trade name:
  • Duowin
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Duowin
    Greece
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • permethrin
  • Therapeutic area:
  • Dogs Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0129/001
  • Authorization date:
  • 18-03-2011
  • EU code:
  • UK/V/0129/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:March2011

AN:01719/2010

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

DUOWIN,CutaneousSpray,Solution.

(ES:DOGLY,soluciónparapulverizacióncutáneaenperros)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

For100ml:

Activesubstances:

Permethrin(Cis:Trans40:60).................................................................................................. 1.88 g

Pyriproxyfen................................................................................................................................ 20 mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Cutaneousspray,solution.

Clearandpaleyellowsolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentandpreventionofflea(Ctenocephalidesfelis)andtick(Rhipicephalus

sanguineus,Ixodesricinus)infestations.

Againstfleas:

Treatmentandpreventionofanewinfestationbyadultfleasfor6weeks.

Preventionoffleamultiplicationfor10weeksbysterilizingtheeggs.

Againstticks:

Treatmentandpreventionofanewinfestationfor4weeks.

4.3 Contraindications

Donotuseoncats.

Seealsosections4.5.and4.7.

4.4 Specialwarningsforeachtargetspecies

FLAMMABLE.

Keeptreatedanimalsawayfromfiresandothersourcesofheatforatleast30minutesfollowing

sprayinganduntilthefuristotallydry.

Underdosingshouldbeavoidedinordertomaintaintheclaimeddurationofefficacy.

Careshouldbetakentoaccuratelyweightheanimalandtocomplywiththerecommendednumberof

activationsofthepumpasDUOWINisbeingapplied.

Ifsignsofdiseasepersistorappearconsultyourveterinarysurgeonorveterinarypractitioner.

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareassuchas

carpetsandsoftfurnishingswhichshouldbetreatedwithasuitableinsecticideand

vacuumedregularly.Thiswillaidreductioninenvironmentalchallengeandmaximisethe

durationofprotectionagainstre-infestationgivenbyDUOWIN.

4.5 Specialprecautionsforuse

Revised:March2011

AN:01719/2010

i/Specialprecautionsforuseinanimals

Donotuseonpuppiesunder2monthsofage.

Donotuseonsickorconvalescentdogs.

Preventtreatedanimalsfromlickingorgroomingthemselves,andinmultianimalhouseholdsprevent

otheranimalsfromgroomingtreateddogs,atleastuntilthecoatisdry.

CatsarenotabletometabolizetheamountofpermethrincontainedinDuowinSpray.

TopreventaccidentalcontactwithDuowinSpraykeepcatsawayfromtreateddogsuntilhaircoatisdry.Itis

importanttoensurethatcatsdonotlickoffthesolutionfromtreateddogs.

Life-threateningpoisoningmayoccur.Symptomsaresevereseizuresandataxiawhichcanresultincatdeath.In

caseofaccidentalcontactthecatshouldbeimmediatelywashedoffwithamildshampooordishwasher

detergent.Subsequentlyaveterinaryadviceshouldbesought.

ii/Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Useimpervioushouseholdgloves(e.g.:rubberneopreneorvinyl)whenusingtheproduct.

Donotsprayonnakedflameoranyincandescentmaterial.

FLAMMABLE.

Donotsmoke,drinkoreatwhilehandlingtheproduct.

Donotinhalespraymist.Useonlyinwellventilatedareas.

Avoidcontactwithskinandeyes.Washhandsandexposedskinthoroughlyafteruse.

Incaseofaccidentaleyecontact,flusheyesabundantlywithwater.

Keepawayfromfoodordrink.

Avoidprolongedexposure.

iii/Otherprecautions

Donotallowdogstoenterpondsorstreamsonthedaytheyhavebeentreated.

4..6 Adversereactions(frequencyandseriousness)

Rarecasesofpruritus,gastrointestinalsignsorbehaviouralchanges(agitationorapathy),havebeen

observedwhichdisappearrapidlywithouttreatment.

Inveryrareoccasions,dogsmayshowneurologicalsymptomssuchastremorsandhypersalivation.

4.7 Useduringpregnancy,lactationorlay

Donotuseonnursingbitches.

Consultyourveterinarysurgeonforappropriatetreatmentoffleaandtickinfestationsinpuppiesand

nursingbitches.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

DonotuseanyotherectoparasiticideinconjunctionwithDuowin.

4.9 Amountstobeadministeredandadministrationroute

Forexternaluseonly.

Onepumpactivationdeliversapproximately3.0ml.

Thedosageis5mlofsolutionperkgbodyweightwhichcanbeachievedby5pump

activationsfor3kgbodyweight.

Thisisequivalentto94mgPermethrinand1mgPyriproxyfenperkgbodyweight.

Weightofdog 3kg 7kg 10kg 15kg 20kg 30kg 40kg

Numberofpump

Revised:March2011

AN:01719/2010

activations 5 12 17 25 34 50 67

Sprayontotheanimalhaircoat(avoidingtheeyes)inordertowetitentirely.Whilespraying,ruffle

thecoatandapplyagainstthelayofthehairsothattheproductpenetratesdowntotheskin.Care

shouldbetakentoavoidsprayingintotheeyesoftheanimal.Allowtheproducttodrynaturally

withoutwipingthecoat.

Donotwashorshampoodogsaftertreatment.

Shouldyouneedtoshampooyourdog,itisrecommendedtorenewtheapplicationoftheproduct

afterwardsinordertomaintaintheprotectionagainstfleaandtickinfestation.

Dogswhichhavebeenrepeatedlyexposedtoheavyrainorwhichenterwaterfrequently

shouldberetreated.

TheproductisaPrescriptionOnlyMedicinewhichcanbeusedaccordingtoparasitepressure.

Retreatmentmaybeadvisedatmonthlyintervalsincaseofstrongfleainfestation.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Atolerancestudyperformedonpuppiesfrom2monthsofageat5timestherecommendeddosage

showednoadversereactions.However,shouldsignsofintoleranceoccur(hyperaesthesia,ataxia,

erythema,tremors),shampoothedogthoroughlyandrepeatedlyinordertoeliminatetheproduct.

Incaseofmoreseveresignsofpoisoning(convulsions),immediatesymptomatictreatmentshouldbe

undertakenunderveterinarysurveillance.Nospecificantidotetopermethrinisknown,however

neurologicalsymptomsshouldbetreatede.g.withatropineandanti-convulsivantagents.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Ectoparasiticidesfortopicaluse,includinginsecticides

ATCcode:QP53AC54

Theproductispresentedasaninsecticidalandacaricidalsolutionfortopicaluse,

containinganassociationofanadulticidalactiveingredient,Permethrin,andanovicidal

andlarvicidalactiveingredient,Pyriproxyfen.

5.1 Pharmacodynamicproperties

Permethrinisasyntheticpyrethroidwhichrapidlykillsfleasandticksbyinducingrepetitive

nervedischargesleadingtoeventualparalysisofparasites.Thoseeffectsareattributedto

variationsintimeandamountofNa+andK+ionscrossingtheaxonicmembranesduring

thepotentialofaction.Inadditiontothekillingeffect,permethrinalsoexertsarapidknock-

downeffect.Ithasalsorepellentpropertiesoninsects,whichfacilitatetheflushingofthe

fleasfromtreatedareas.

Pyriproxyfenisaninsectgrowthinhibitor.Itpreventsthedevelopmentofeggsandlarvae

thuspreventingtheestablishmentofnewadultfleas.

Theproductcontainsanorganiccopolymerwhichfacilitatestheattachmentoftheactive

ingredients.

5.2 Pharmacokineticparticulars

Theproductisfortopicaluseonlyandpermethrinandpyriproxifenhavelimitedabsorptionthroughtheskin.

Revised:March2011

AN:01719/2010

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

LuvisetCAN

JasmineperfumeE-96711

Methyletherofpropyleneglycol

Purifiedwater.

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

6.4. Specialprecautionsforstorage

Storethecontainerupright.

6.5 Natureandcompositionofimmediatepackaging

250or500mlbottlesmadeofhighdensitypolyethylenestoppedwithscrewstoppersmadeofhigh

densitypolyethylene.

Mechanicalsprayingdevicemadeofpolypropylene.

Cartonbox.

Cartonboxcontainingone250mlpolyethylenebottleandonemechanicalsprayingdevice;

Cartonboxcontainingone500mlpolyethylenebottleandonemechanicalsprayingdevice.

Cartonboxcontainingone250mlpolyethylenebottlefittedwithonemechanicalsprayingdevice.

Cartonboxcontainingone500mlpolyethylenebottlefittedwithonemechanicalsprayingdevice.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwastematerials

derivedfromtheuseofsuchproducts

Dangeroustofishandcrustaceans.

Donotusesprayinareascontainingaquaria,fishtanksandbowls.

Donotcontaminatewaterwaysorditcheswiththeproductoremptycontainers

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnational

requirements.

7. MARKETINGAUTHORISATIONHOLDER

VIRBACS.A.

1èreavenue-L.I.D.-2065m

06516-CARROS(FRANCE)

8. MARKETINGAUTHORISATIONNUMBER(S)

Revised:March2011

AN:01719/2010

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

04/05/2005

10 DATEOFREVISIONOFTHETEXT

Dateoflastrevision:December2009

29-8-2018

Vectra 3D (Ceva SantE Animale)

Vectra 3D (Ceva SantE Animale)

Vectra 3D (Active substance: dinotefuran, pyriproxyfen, permethrin) - Centralised - Renewal - Commission Decision (2018)5783 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2555/R/9

Europe -DG Health and Food Safety