Cyclio 2% spot-on for small dogs

Main information

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

Documents

Localization

  • Available in:
  • Cyclio 2% spot-on for small dogs
    Italy
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0114/002
  • Authorization date:
  • 21-02-2011
  • EU code:
  • FR/V/0114/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CYCLIO12mgSPOT-ONSOLUTIONFORSMALLDOGS

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Foronepipettecontaining0.6mlsolution:

Activesubstance:

Pyriproxyfen........................................................12mg

Excipient(s):

Butylatedhydroxyanisole(E320)...........................0.108mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Spot-onsolution.

Clearsolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Preventionoffleamultiplication(adultandlarvalstagesofCtenocephalidesfelissensitiveto

pyriproxyfen)indogsweighingfrom0.6kgupto6kgbyinhibitingeggdevelopmentfor3months.

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)

Amongtheextremelyraresuspectedreactions,transientcutaneousreactionsaspruritus,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.

Singleadministrationofonepipetteperdog(equivalenttoaminimaldosageof2mgperkg

bodyweight).Thisdosagemaybeachievedbyapplyingonepipetteof0.6mlforadogweighingfrom

0.6kgupto6kg.

Cyclioshouldbeadministereddirectlyontheskinoftheanimal,atthebaseoftheneck.Careshouldbe

takentomaintaincontactbetweenthepipetteandskinduringtheadministrationoftheproduct.Extract

thecontentsbycarefullysqueezingthebottomofthetube4times.

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

Polypropylenepipettesandclosurecontaining0.6mlofsolution.

Boxcontaining1pipette.

Boxcontaining2pipettes.

Boxcontaining4pipettes.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnationalrequirements.

Theproductshouldnotenterwatercoursesasthismaybedangerousforfishandotheraquaticorganisms.

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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FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

The FDA has approved Semintra (telmisartan oral solution), the first FDA-approved animal drug to control systemic hypertension in cats. Semintra is an oral solution administered either directly into the cat’s mouth or on top of a small amount of food.

FDA - U.S. Food and Drug Administration

23-5-2018

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

FDA’s CVM is evaluating the design of studies intended to support the standard of effectiveness for new animal drugs to prevent heartworm disease in dogs. The FDA is requesting public input on evaluating these products to assist in the potential development of alternative study designs.

FDA - U.S. Food and Drug Administration

23-5-2018

Ten Thousand Villages Canada recalls Choo-Choo Train & Blocks Set

Ten Thousand Villages Canada recalls Choo-Choo Train & Blocks Set

Health Canada's sampling and evaluation program has determined that the recalled toy does not meet the Canadian safety requirements for toys. The numbered blocks are small parts and the toy may further break apart exposing more small parts, posing a choking hazard for young children.

Health Canada

30-4-2018

Stonewall Kitchen Voluntarily Recalls a Limited Amount of Basil Pesto Aioli due to Mislabeling and Undeclared Presence of the Dairy Allergen, Egg

Stonewall Kitchen Voluntarily Recalls a Limited Amount of Basil Pesto Aioli due to Mislabeling and Undeclared Presence of the Dairy Allergen, Egg

Stonewall Kitchen is voluntarily recalling a limited amount of 10.25oz Basil Pesto Aioli with an Enjoy By date of 28 Sep 2019 which may contain the undeclared allergen egg, as we may have inadvertently placed the label for our Basil Pesto on a small portion of our most recent production run.

FDA - U.S. Food and Drug Administration

12-12-2017

Keep Your Dogs and Cats Safe From Holiday Hazards

Keep Your Dogs and Cats Safe From Holiday Hazards

From tinsel to table scraps, holiday hazards for pets abound. Here are some tips to help you keep them safe.

FDA - U.S. Food and Drug Administration

10-8-2017

Bravecto® may cause convulsions in dogs on rare occasions

Bravecto® may cause convulsions in dogs on rare occasions

The European Medicines Agency has reviewed the adverse events of Bravecto®, a veterinary medicine used to treat flea and tick infestations in dogs. The conclusion is that the medicine may on very rare occasions cause convulsions in dogs – primarily in dogs with pre-existing epilepsy.

Danish Medicines Agency

13-6-2017

Annual report 2016 - Clinical trials of medicines

Annual report 2016 - Clinical trials of medicines

LLast year, the Danish Medicines Agency received 286 clinical trial applications. This is a small decline compared to 2015. However, the number of clinical trial applications has remained stable at around 300 applications per year since 2013.

Danish Medicines Agency

7-9-2018

Consumer story: Georgia and breast implant associated cancer

Consumer story: Georgia and breast implant associated cancer

Learn how to spot the warning signs for breast implant associated cancer in our new consumer story

Therapeutic Goods Administration - Australia

29-6-2018

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

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

5-6-2018

Advance notice - update to an eCTD file download for version 3.1

Advance notice - update to an eCTD file download for version 3.1

The TGA intends to make a small amendment to the eCTD validation criteria

Therapeutic Goods Administration - Australia

24-5-2018

#ThrowBackThursday- May 24, 1977- Bureau of Medical Devices and Diagnostic Products renamed Bureau of Medical Devices and new Office of Small Manufacturers Assistance created, as required by law. #OnThisDay #FDAHistory

#ThrowBackThursday- May 24, 1977- Bureau of Medical Devices and Diagnostic Products renamed Bureau of Medical Devices and new Office of Small Manufacturers Assistance created, as required by law. #OnThisDay #FDAHistory

#ThrowBackThursday- May 24, 1977- Bureau of Medical Devices and Diagnostic Products renamed Bureau of Medical Devices and new Office of Small Manufacturers Assistance created, as required by law. #OnThisDay #FDAHistory

FDA - U.S. Food and Drug Administration

14-5-2018

This Nat’l Women’s Health Week, put health at the top of your to-do list & make small changes for a healthier you!  http://thndr.me/tIP5vF pic.twitter.com/meiQNdblO1

This Nat’l Women’s Health Week, put health at the top of your to-do list & make small changes for a healthier you! http://thndr.me/tIP5vF pic.twitter.com/meiQNdblO1

This Nat’l Women’s Health Week, put health at the top of your to-do list & make small changes for a healthier you! http://thndr.me/tIP5vF  pic.twitter.com/meiQNdblO1

FDA - U.S. Food and Drug Administration