Cyclio

Main information

  • Trade name:
  • Cyclio 10% spot-on for cats
  • Pharmaceutical form:
  • Spot-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Cyclio 10% spot-on for cats
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ECTOPARACITICIDES, INSECTICIDES AND REPELLENTS
  • Therapeutic area:
  • Cats

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0114/001
  • Authorization date:
  • 21-02-2011
  • EU code:
  • FR/V/0114/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CYCLIO60mgSPOT-ONSOLUTIONFORCATS

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Foronepipettecontaining0.6mlsolution:

Activesubstance:

Pyriproxyfen........................................................60mg

Excipient(s):

Butylatedhydroxytoluene(E321)...........................0.6mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Spot-onsolution.

Clearsolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cats.

4.2 Indicationsforuse,specifyingthetargetspecies

Preventionoffleamultiplication(adultandlarvalstagesofCtenocephalidesfelissensitiveto

pyriproxyfen)incatsbyinhibitingeggdevelopmentfor3months.

4.3 Contraindications

Donotuseinkittensweighinglessthan1kgorinsickorconvalescingcats.

4.4 Specialwarningsforeachtargetspecies

Incaseseveralanimalsarepartofthesamehousehold,appropriatetreatmentshouldbecarriedoutfor

eachanimal.

Asforanyparasiticidalproduct, itsfrequentand repeated usemaycausethedevelopmentof

parasiteresistanceto theactiveingredient.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Infestationsoccurringduringtheinitialadministrationorappearingduringthetreatmentperiodmaybe

eliminatedwithappropriatemedicinalinsecticides.

Theinfluenceofbathingorwettingimmediatelyaftertreatmenthasnotbeenevaluated.Therefore,itis

likelythattheefficacywillbereducediftheanimaliswettedorshampooedimmediatelyafterthe

treatment.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Avoidcontactwithskinandeyes.Incaseofaccidentalcontact,rinseabundantlywithwater.

Incaseofeyeirritation,seekmedicalattention.

Washhandsafteruse.

4..6Adversereactions(frequencyandseriousness)

Amongtheraresuspectedadversereactions,transientcutaneousreactionsontheapplicationsite

(squamosis,localalopecia,pruritus,erythema)andgeneralpruritusoralopeciahavebeenreported

afteruse.Exceptionally,hypersalivationorvomitinghavebeenobservedaftertreatment.

4.7 Useduringpregnancy,lactationorlay

Studiesperformedinlaboratoryanimals(rats,mice,rabbits)didnotshowanyteratogenicor

embryotoxiceffectsofpyriproxyfenattherapeuticdoses.

ItisnotrecommendedtouseCyclio60mgSpot-OnSolutionforCatsonpregnantorlactatingqueens.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Fromclinicalfieldstudies,nointeractionwasobservedbetweenorganophosphateorpyrethroid

compoundsandpyriproxyfen.

4.9 Amountstobeadministeredandadministrationroute

Forexternaluseonly.

Singleadministrationofonepipettepercat(equivalenttoaminimaldosageof10mgperkg

bodyweight).Thisdosagemaybeachievedbyapplyingonepipetteof0.6mlforacatweighing

between1kgand6kg.

Cyclioshouldbeadministereddirectlyontheskinoftheanimal,atthebaseoftheneck.Careshouldbe

takentomaintaincontactbetweenthepipetteandskinduringtheadministrationoftheproduct.Extract

thecontentsbycarefullysqueezingthebottomofthetube4times.

Asecondapplicationcanbemade3monthsafterthefirsttoprolongefficacyforafurther3months

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Studieshaveshowntheabsenceofundesirableeffectsatdosesupto3timestherecommendeddose

dailyforthreeconsecutivedays.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:otherparasiticidesfortopicaluse

ATCvetcode:QP53AX23

5.1 Pharmacodynamicproperties

Pyriproxyfenisaninhibitoroffleagrowth,whichhastheabilitytomimicthejuvenilehormone.The

moleculeprevents,bycontact,theemergenceofadultinsectsbyblockingthedevelopmentofeggs

(ovicidaleffect)andlarvae(larvicidaleffect),whicharesubsequentlyeliminated.

Followingcontactand/oringestionbyadultfleas,themoleculealsoactsbysterilisingeggsduringtheir

maturationandbeforebeinglaid.

5.2 Pharmacokineticparticulars

Pyriproxyfenisdistributedoverthecoatofthetreatedanimalinsufficientamounttoinducewithin24

hoursaftertheadministrationoftheproductasterilisingactivityonboththeeggsandfemaleadult

fleas.

Afteradministrationoftherecommendeddosagetocats,betweentheshoulderblades,pyriproxyfenis

rapidlydistributedoverthecoatwithin24hourswithsubstantiallevelsappearinginthefuratthebase

ofthetail.Simultaneously,maximumconcentrationsof10000µg/gand230µg/garemeasured

respectivelynearthesiteofapplicationandinthemiddleregion(backandflanks).Pyriproxyfen

remainsinthefurwithdetectablelevelslastingatleast84dayspost-treatment.Withregardsto

plasmaticconcentration,thepercutaneousabsorptionofpyriproxyfenislowwithanabsolute

bioavailabilityof25%overthe3monthsperiodoftimeafterapplicationoftheproduct.The

pyriproxyfenplasmapeak(24ng/ml)isreachedafter3to8hours.Theeliminationhalf-lifeof

pyriproxyfeninplasmaisof32days.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Butylatedhydroxytoluene(E321),

Diethyleneglycolmonoethylether.

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

6.4.Specialprecautionsforstorage

Nospecialprecautionsforstorage.

6.5 Natureandcompositionofimmediatepackaging

Polypropylenepipettesandclosurecontaining0.6mlofsolution.

Boxcontaining1pipette.

Boxcontaining2pipettes.

Boxcontaining4pipettes.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

Theproductshouldnotenterwatercoursesasthismaybedangerousforfishandotheraquatic

organisms.

7. MARKETINGAUTHORISATIONHOLDER

VIRBAC–1 ère

avenue-2065mL.I.D.-F-06516Carros-France

Tel:+33492087304

Fax:+33492087348

e-mail: dar@virbac.fr

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateofthefirstauthorisation:27/07/2000.

Dateoflastrenewal:16/09/2004.

10 DATEOFREVISIONOFTHETEXT

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