Fypryst 2.5 mg/ml Cutaneous Spray, Solution for Cats and Dogs

Main information

  • Trade name:
  • Fypryst 2.5 mg/ml Cutaneous Spray, Solution for Cats and Dogs
  • Pharmaceutical form:
  • Cutaneous spray, solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Fypryst 2.5 mg/ml Cutaneous Spray, Solution for Cats and Dogs
    Hungary
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • fipronil
  • Therapeutic area:
  • Cats, Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0407/001
  • Authorization date:
  • 25-07-2012
  • EU code:
  • UK/V/0407/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

UnitedKingdom

VeterinaryMedicinesDirectorate

WoodhamLane

NewHaw

Addlestone

SurreyKT153LS

DECENTRALISEDPROCEDURE

PUBLICLYAVAILABLEASSESSMENTREPORTFORAVETERINARY

MEDICINALPRODUCT

Fypryst2.5mg/mlCutaneousSpraySolutionforCatsandDogs

Fypryst2.5mg/mlCutaneousSpraySolutionforCatsandDogs UK/V/0407/001/DC

KrkaDd ApplicationforDecentralisedProcedure

PubliclyAvailableAssessmentReport

MODULE1

PRODUCTSUMMARY

EUProcedurenumber UK/V/0407/001/DC

Name,strengthand

pharmaceuticalform Fypryst2.5mg/mlCutaneousSpraySolutionfor

CatsandDogs

Applicant KRKA,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

Activesubstance Fipronil

ATCVetcode QP53AX15

Targetspecies CatsandDogs

Indicationforuse Thetreatmentandpreventionoffleaandtick

infestationsincatsanddogs,andaspartofa

treatmentstrategyforFleaAllergyDermatitisin

catsanddogs.

TheproductisactiveagainstIxodesspp.

includingIxodesricinus,importantasthevector

ofLymedisease.Theproductcontrols

infestationswithTrichodectescanisbitinglice

ondogs,andFelicolasubrostratusbitingliceon

cats.

Theproductisactiveforupto3monthsagainst

fleasindogs,andupto2monthsincats,

dependingontheenvironmentalchallenge.Itis

effectiveagainsttickinfestationsforuptoone

monthindogsandcats,dependingonthelevel

ofenvironmentalchallenge.

Fypryst2.5mg/mlCutaneousSpraySolutionforCatsandDogs UK/V/0407/001/DC

KrkaDd ApplicationforDecentralisedProcedure

PubliclyAvailableAssessmentReport

MODULE2

TheSummaryofProductCharacteristics(SPC)forthisproductisavailableon

theHeadsofMedicinesAgencies(veterinary)(HMA(v))website( www.hma.eu ).

Fypryst2.5mg/mlCutaneousSpraySolutionforCatsandDogs UK/V/0407/001/DC

KrkaDd ApplicationforDecentralisedProcedure

PubliclyAvailableAssessmentReport

MODULE3

PUBLICASSESSMENTREPORT

Legalbasisoforiginal

application GenericapplicationinaccordancewithArticle

13(1)ofDirective2001/82/ECasamended.

Dateofcompletionofthe

originaldecentralised

procedure 25 th July2012.

Dateproductfirstauthorised

intheReferenceMember

State(MRPonly) Notapplicable.

ConcernedMemberStatesfor

originalprocedure Bulgaria,Estonia,Hungary,Latvia,Lithuania,

Poland,Romania,Slovakia,Slovenia.

I.SCIENTIFICOVERVIEW

ThiswasagenericapplicationaccordingtoArticleforwhichthereference

productisFrontlineSpray0.25%w/vCutaneousSpraySolution,marketedinthe

UKformorethan10years.Theproductisforthetreatmentandpreventionof

fleaandtickinfestationincatsanddogsandmaybeusedaspartofatreatment

strategyforFleaAllergyDermatitisintheseanimals.Theproducthasefficacy

againstIxodesspp.includingIxodesricinusandcontrolsinfestationcausedby

TrichodectescanisindogsandFelissubrostratusincats.Fipronilexhibits

insecticidalandacaricidalactivityagainstfleas(Ctenocephalidesspp),ticks

(Rhipicephalusspp.,Ixodesspp.)andlice(Trichodectesspp.andFelicolaspp.)

inthedogandcat.

Theproductisproducedandcontrolledusingvalidatedmethodsandtestswhich

ensuretheconsistencyoftheproductreleasedonthemarket.Ithasbeen

shownthattheproductcanbesafelyusedinthetargetspecies,theslight

reactionsobservedareindicatedintheSPC 1 .Theproductissafefortheuser,

andfortheenvironment,whenusedasrecommended.Suitablewarningsand

precautionsareindicatedintheSPC.Theefficacyoftheproductwas

demonstratedaccordingtotheclaimsmadeintheSPC.Theoverallbenefit/risk

analysisisinfavourofgrantingamarketingauthorisation.

SPC –SummaryofProductCharacteristics.

Fypryst2.5mg/mlCutaneousSpraySolutionforCatsandDogs UK/V/0407/001/DC

KrkaDd ApplicationforDecentralisedProcedure

PubliclyAvailableAssessmentReport

II. QUALITYASPECTS

A. Composition

Theproductcontains2.5mg/mlfipronilandtheexcipientscopovidone,isopropyl

alcoholandpurifiedwater.

Thecontainer/closuresystemconsistsofopaque,white,highdensity

polyethylenebottlesfittedwithapumpsprayer,andcomesin100ml,250mlor

500mlsizes,deliveringrespectively0.5ml,1.5mlor3.0mlofproduct.The

particularsofthecontainersandcontrolsperformedareprovidedandconformto

theregulation.

Thechoiceoftheformulationandabsenceofpreservativearejustified.The

productisanestablishedpharmaceuticalformanditsdevelopmentis

adequatelydescribedinaccordancewiththerelevantEuropeanguidelines.

B. MethodofPreparationoftheProduct

Theproductismanufacturedfullyinaccordancewiththeprinciplesofgood

manufacturingpracticefromalicensedmanufacturingsite.Processvalidation

dataontheproducthavebeenpresentedinaccordancewiththerelevant

Europeanguidelines.

C. ControlofStartingMaterials

Theactivesubstanceisfipronil,anestablishedactivesubstancenotdescribedin

theEuropeanPharmacopoeia.Theactivesubstanceismanufacturedin

accordancewiththeprinciplesofgoodmanufacturingpractice.

Theactivesubstancespecificationisconsideredadequatetocontrolthequality

ofthematerial.Batchanalyticaldatademonstratingcompliancewiththis

specificationhavebeenprovided.Suitabledatawereprovidedintheformofan

ActiveSubstanceMasterFile.

D. SpecificMeasuresconcerningthePreventionoftheTransmission

ofAnimalSpongiformEncephalopathies

TherearenosubstanceswithinthescopeoftheTSEGuidelinepresentorused

inthemanufactureofthisproduct.

E. Controlonintermediateproducts

Notapplicable.

F. ControlTestsontheFinishedProduct

Fypryst2.5mg/mlCutaneousSpraySolutionforCatsandDogs UK/V/0407/001/DC

KrkaDd ApplicationforDecentralisedProcedure

PubliclyAvailableAssessmentReport

Thefinishedproductspecificationcontrolstherelevantparametersforthe

pharmaceuticalform.Thetestsinthespecification,andtheirlimits,havebeen

justifiedandareconsideredappropriatetoadequatelycontrolthequalityofthe

product.Satisfactoryvalidationdatafortheanalyticalmethodshavebeen

provided.Batchanalyticaldatafromtheproposedproductionsitehavebeen

provideddemonstratingcompliancewiththespecification.Testsonthefinished

productincludethoseforfillvolume,identificationoffipronil,relatedsubstances

andmicrobiologicalquality.

G. Stability

Stabilitydataontheactivesubstancehavebeenprovidedinaccordancewith

applicableEuropeanguidelines,demonstratingthestabilityoftheactive

substancewhenstoredundertheapprovedconditions.Validationbatcheswere

analysedafterstorageatvarioustimepointsat25 o C/60%RH,30 o C/65%RH,

and40 o C/75%RH.Afreeze-thawcyclingtestandphotostabilitytestwerealso

performed.Somestabilitytestcontinuedpost-approval.Testingofin-useshelf-

lifewasalsoperformedoveratwelvemonthsperiod,at25 o C/60%RH.

H. GeneticallyModifiedOrganisms

Notapplicable.

J. OtherInformation

Theshelf-lifeoftheproductaspackagedforsalewasdeterminedfromstability

studiestobetwoyears.Shelf-lifeafteropeningoftheimmediatepackagingis

oneyear.

III. SAFETY AND RESIDUES ASSESSMENT(PHARMACO-

TOXICOLOGICAL)

AsthisisagenericapplicationaccordingtoArticle13,andbioequivalencewitha

referenceproductwasacceptedviapharmaceuticalsimilarity,resultsof

pharmacologicalandtoxicologicaltestsarenotrequired.Theapplicantprovided

auserriskassessmentandanenvironmentalriskassessment.

Warningsandprecautionsaslistedontheproductliteraturearethesameas

thoseofthereferenceproductandareadequatetoensuresafetyoftheproduct

tousersandtheenvironment.

III.A SafetyTesting

UserSafety

Theapplicanthasprovidedausersafetyassessmentincompliancewiththe

relevantguidelinewhichconcludedthatastheproducthasbeenshowntobe

pharmaceuticallyequivalenttothereferenceproduct,anyhazardsandrisks

Fypryst2.5mg/mlCutaneousSpraySolutionforCatsandDogs UK/V/0407/001/DC

KrkaDd ApplicationforDecentralisedProcedure

PubliclyAvailableAssessmentReport

fromtheproductarethesame.Warningsandprecautionsaslistedonthe

productliteratureareadequatetoensuresafetytousersoftheproduct.

Thisproductcancausemucousmembraneandeyeirritation.Therefore,

contactoftheproductwithmouthandeyesshouldbeavoided.

Operatorswithaknownhypersensitivitytotheactivesubstanceor

alcoholorwithasthmashouldavoidcontactwiththeproduct.Avoid

contentscomingintocontactwiththefingers.Ifthisoccurs,washhands

withsoapandwater.

Afteraccidentalocularexposuretheeyeshouldberinsedcarefullywith

plainwater.

Treatedanimalsshouldnotbehandleduntilthefurisdry,andchildren

shouldnotbeallowedtoplaywithtreatedanimalsuntilthefurisdry.Itis

thereforerecommendedthatanimalsarenottreatedduringtheday,but

shouldbetreatedduringtheearlyevening,andthatrecentlytreated

animalsarenotallowedtosleepwithowners,especiallychildren.

Sprayanimalsintheopenairorawellventilatedroom.

Donotbreathespray.Donotsmoke,drinkoreatduringapplication.

WearPVCornitrileglovesduringtreatmentofanimals.Itis

recommendedtowearawaterproofapronfortheprotectionofclothing.

Ifclothingbecomesheavilywettedwiththeproduct,itshouldberemoved

andwashedbeforere-use.

Disposeofglovesafteruseandthenwashhandswithsoapandwater.

Washsplashesfromskinwithsoapandwaterimmediately.Ifirritation

occurs,seekmedicaladvice.Peoplewithknownsensitivityorasthma

maybeparticularlysensitivetotheproduct.Donotuseproductifyou

havepreviouslyexperiencedareactiontoit.

Treatmentofmultipleanimals:Goodventilationisparticularlyimportant

whereseveralanimalsaretobetreated.Treatmultipleanimalsoutside,

orreducethebuildupofvapourbyremovingtheanimalsfromthe

treatmentroomwhilethealcoholisevaporatingandensurethatthe

treatmentroomiswellventilatedbetweenindividualtreatments.In

addition,ensurethatthedryingroomiswellventilatedandavoidhousing

severalrecentlytreatedanimalswithinthesameairspace.

Ecotoxicity

Theapplicantprovidedafirstphaseenvironmentalriskassessmentin

compliancewiththerelevantguidelinewhichshowedthatnofurtherassessment

wasrequiredbeyondaninvestigationofthepossiblerisktoaquaticlife,should

theproductbepassedfromdogstowatercourses.Thisinformationwas

subsequentlyprovided.Theassessmentconcludedthatwarningsand

precautionsaslistedontheproductliteratureareadequatetoensuresafetyto

theenvironmentwhentheproductisusedasdirected.TheSPCreflectsthe

warningsasdefinedbythereferenceproduct.

Fypryst2.5mg/mlCutaneousSpraySolutionforCatsandDogs UK/V/0407/001/DC

KrkaDd ApplicationforDecentralisedProcedure

PubliclyAvailableAssessmentReport

IV CLINICALASSESSMENT(EFFICACY)

AsthisisagenericapplicationaccordingtoArticle13,andbioequivalencewitha

referenceproductwasacceptedviapharmaceuticalsimilarity,efficacystudies

werenotrequired.Theefficacyclaimsforthisproductareequivalenttothoseof

thereferenceproduct.

IV.APre-ClinicalStudies

Pharmacology

AsthisisagenericapplicationaccordingtoArticle13,andbioequivalencewitha

referenceproductwasacceptedviapharmaceuticalsimilarity,pharmacological

studieswerenotrequired.Theefficacyclaimsforthisproductareequivalentto

thoseofthereferenceproduct.

ToleranceintheTargetSpeciesofAnimals

AsthisisagenericapplicationaccordingtoArticle13,andbioequivalencewitha

referenceproductwasacceptedviapharmaceuticalsimilarity,tolerancestudies

werenotrequired.

Resistance

AsthisisagenericapplicationaccordingtoArticle13,andbioequivalencewitha

referenceproductwasacceptedviapharmaceuticalsimilarity,resistancestudies

werenotrequired.

IV.B ClinicalStudies

LaboratoryTrials

AsthisisagenericapplicationaccordingtoArticle13,andbioequivalencewitha

referenceproductwasacceptedviapharmaceuticalsimilarity,laboratorystudies

werenotrequired.

FieldTrials

AsthisisagenericapplicationaccordingtoArticle13,andbioequivalencewitha

referenceproductwasacceptedviapharmaceuticalsimilarity,fieldstudieswere

notrequired.

VOVERALLCONCLUSIONANDBENEFIT –RISKASSESSMENT

Thedatasubmittedinthedossierdemonstratethatwhentheproductisusedin

accordancewiththeSummaryofProductCharacteristics,thebenefit/riskprofile

Fypryst2.5mg/mlCutaneousSpraySolutionforCatsandDogs UK/V/0407/001/DC

KrkaDd ApplicationforDecentralisedProcedure

PubliclyAvailableAssessmentReport

forthetargetspeciesisfavourableandthequalityandsafetyoftheproductfor

humansandtheenvironmentisacceptable.

Fypryst2.5mg/mlCutaneousSpraySolutionforCatsandDogs UK/V/0407/001/DC

KrkaDd ApplicationforDecentralisedProcedure

PubliclyAvailableAssessmentReport

MODULE4

POST-AUTHORISATIONASSESSMENTS

TheSPCandpackageleafletmaybeupdatedtoincludenewinformationonthe

quality,safetyandefficacyoftheveterinarymedicinalproduct.ThecurrentSPC

isavailableontheHeadsofMedicinesAgencies(veterinary)(HMA(v))website

( www.hma.eu ).

Thissectioncontainsinformationonsignificantchangeswhichhavebeenmade

aftertheoriginalprocedurewhichareimportantforthequality,safetyorefficacy

oftheproduct.

None