Cyclio 2% spot-on for large dogs

Main information

  • Trade name:
  • Cyclio 2% spot-on for large dogs
  • Pharmaceutical form:
  • Spot-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Cyclio 2% spot-on for large dogs
    France
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0114/004
  • Authorization date:
  • 21-02-2011
  • EU code:
  • FR/V/0114/004
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CYCLIO60mgSPOT-ONSOLUTIONFORLARGEDOGS

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Foronepipettecontaining3mlofsolution:

Activesubstance:

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

Excipient(s):

Butylhydroxyanisole(E320).................................0.540mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Spot-onsolution.

Clearsolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Preventionoffleamultiplication(adultandlarvalstagesofCtenocephalidesfelissensitiveto

pyiproxyfen)indogsweighingover15kgbyinhibitingeggdevelopmentfor3months.

4.3 Contraindications

Donotuseinpuppieslessthan1monthofageorinsickorconvalescingdogs.

4.4 Specialwarningsforeachtargetspecies

Incaseseveralanimalsarepartofthesamehousehold,appropriatetreatmentshouldbecarriedoutfor

eachanimal.

Asforanyparasiticidalproduct, itsfrequentand repeated usemaycausethedevelopmentof

parasiteresistanceto theactiveingredient.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Infestationsoccurringduringtheinitialadministrationorappearingduringthetreatmentperiodmaybe

eliminatedwithappropriatemedicinalinsecticides.

Theinfluenceofbathingorwettingimmediatelyaftertreatmenthasnotbeenevaluated.Thereforethe

efficacymaybereducediftheanimaliswettedorshampooedupto3daysafterthetreatment.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Avoidcontactwithskinandeyes.Incaseofaccidentalcontact,rinseabundantlywithwater.

Incaseofeyeirritation,seekmedicalattention.

Washhandsafteruse.

4..6Adversereactions(frequencyandseriousness)

Amongextremelyraresuspectedadversereactionstransientcutaneousreactionsaspruritus,erythema

havebeenobservedafteruseindogs.

4.7 Useduringpregnancy,lactationorlay

Studiesperformedinlaboratoryanimals(rats,mice,rabbits)didnotshowanyteratogenicor

embryotoxiceffectsofpyriproxyfenattherapeuticdoses.

Thesafetyoftheproductinpregnantofnursingbitcheshasbeendemonstrated.TheuseofCyclioDog

inpregnantornursingbitchesispossible.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Fromclinicalfieldstudies,nointeractionwasobservedbetweenorganophosphateorpyrethroid

compoundsandpyriproxyfen.

4.9 Amountstobeadministeredandadministrationroute

Forexternaluseonly.

Singleadministrationofoneortwopipetteperdog(equivalenttoaminimaldosageof2mgperkg

bodyweight).Thisdosagemaybeachievedbyapplying:

-onepipetteof3.0mlforadogweighingover15kgupto30kg

-twopipettesof3.0mlforadogweighingover30kg.

Cyclioshouldbeadministereddirectlyontheskinoftheanimal,atthebaseoftheneck.Careshouldbetakento

maintaincontactbetweenthepipetteandskinduringtheadministrationoftheproduct.Extractthecontentsby

carefullysqueezingthebottomofthetube4times.

Asecondapplicationcanbemade3monthsafterthefirsttoprolongefficacyforafurther3months.

Preventdogsfromswimminginpondsandwaterwaysforuptothreedaysafterthetreatment.

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

(ovicidal)andlarvae(larvicidal),whicharesubsequentlyeliminated.

Followingcontactand/oringestionbyadultfleas,themoleculealsoactsbysterilisingeggsduringtheir

maturationandbeforebeinglaid.

5.2 Pharmacokineticparticulars

Pyriproxyfenisdistributedoverthecoatofthetreatedanimalinsufficientamounttoinducewithin24

hoursaftertheadministrationoftheproductasterilisingactivityonboththeeggsandfemaleadult

fleas.

Afteradministrationoftherecommendeddosagetodogs,betweentheshoulderblades,pyriproxyfenis

rapidlydistributedoverthecoatwithin24hourswithsubstantiallevelsappearinginthefuratthebase

ofthetail.Simultaneously,maximumconcentrationsof800µg/gand66µg/garemeasuredrespectively

neartheapplicationsiteandinthemiddleregion(backandflanks).Pyriproxyfenremainsinthefur

withdetectablelevelslastingatleast42dayspost-treatment.

Withregardstoplasmaticconcentration,thepercutaneousabsorptionofpyriproxyfenislowwithan

absolutebioavailabilityof37%overthe3monthsperiodoftimeafterapplicationoftheproduct.The

pyriproxyfenplasmapeak(2.8ng/ml)isreachedafter1to3days.Theeliminationhalf-lifeof

pyriproxyfeninplasmaisof6days.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Butylatedhydroxyanisole(E320),

Diethyleneglycolmonoethylether.

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

6.4.Specialprecautionsforstorage

Nospecialprecautionsforstorage.

6.5 Natureandcompositionofimmediatepackaging

Polypropylenepipettesandclosurecontaining3mlofsolution.

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

{MM/YYYY}or<monthYYYY>

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As many parts of the U.S. face an excessive heat warning, know how to spot heat stroke–and know when it's time to get medical help. http://bit.ly/2tO5WkM pic.twitter.com/wF6D2CbUEe

As many parts of the U.S. face an excessive heat warning, know how to spot heat stroke–and know when it's time to get medical help. http://bit.ly/2tO5WkM  pic.twitter.com/wF6D2CbUEe

FDA - U.S. Food and Drug Administration