Alfamed Fipronil 2.5 mg/ml Cutaneous Spray Solution for Cats & Dogs

Main information

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

Documents

Localization

  • Available in:
  • Alfamed Fipronil 2.5 mg/ml Cutaneous Spray Solution for Cats & Dogs
    Romania
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0397/006
  • Authorization date:
  • 21-03-2012
  • EU code:
  • UK/V/0397/006
  • 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

Vetflea2.5mg/mlcutaneousspray,Solutionforcatsanddogs

Vetflea2.5mg/mlcutaneousspray,Solutionforcatsanddogs UK/V/0397/006/DC

Alfamed ApplicationforDecentralisedProcedure

PubliclyAvailableAssessmentReport

MODULE1

PRODUCTSUMMARY

EUProcedurenumber UK/V/0397/006/DC

Name,strengthand

pharmaceuticalform Vetflea2.5mg/mlcutaneousspray,Solutionfor

catsanddogs

Applicant

Alfamed

13èmerue –L.I.D.

06517CarrosCedex

France

Activesubstance(s) Fipronil

ATCVetcode QP53AX15

Targetspecies Catsanddogs

Indicationforuse Treatmentoffleainfestation(Ctenocephalides

spp.)indogsandcats.

Treatmentoftickinfestation(Ixodesricinus,

Rhipicephalussanguineous)indogsandcats.

Treatmentofbitingliceinfestationindogs

(Trichodectes canis) and cats (Felicola

subrostratus).

Theproductcanbeusedaspartofatreatment

strategyforthecontrolofFleaAllergy

Dermatitis(FAD).

Insecticidalefficacyagainstnewinfestations

withadultfleaspersistsforupto6weeksin

catsandupto3monthsindogs,dependingon

environmentalchallenge.

Theproducthasapersistentacaricidalefficacy

forupto4weeksagainstticks,dependingon

thelevelofenvironmentalchallenge.

Vetflea2.5mg/mlcutaneousspray,Solutionforcatsanddogs UK/V/0397/006/DC

Alfamed ApplicationforDecentralisedProcedure

PubliclyAvailableAssessmentReport

MODULE2

TheSummaryofProductCharacteristics(SPC)forthisproductisavailableon

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

Vetflea2.5mg/mlcutaneousspray,Solutionforcatsanddogs UK/V/0397/006/DC

Alfamed ApplicationforDecentralisedProcedure

PubliclyAvailableAssessmentReport

MODULE3

PUBLICASSESSMENTREPORT

Legalbasisoforiginal

application Generichybridapplicationinaccordancewith

Article13(3)ofDirective2001/82/ECas

amended.

Dateofcompletionofthe

originaldecentralised

procedure 21March2012

Dateproductfirstauthorised

intheReferenceMember

State(MRPonly) Notapplicable

ConcernedMemberStatesfor

originalprocedure Belgium,Hungary,Romania

I.SCIENTIFICOVERVIEW

ThiswasagenerichybridapplicationforwhichthereferenceproductisFrontline

spray,2.5mg/mlcutaneousspray,solutionbyMerialAnimalHealthLtd,

authorisedintheUKsince1994.

Bioequivalencetothereferenceproductcannotbedemonstratedthrough

bioavailabilitystudiesdueofthenatureoftheproduct(acutaneousspraywith

littletonotrans-cutaneousabsorbsion).

TheindicationsforVetflea2.5mg/mlcutaneousspray,Solutionforcatsand

dogsareforthetreatmentoffleainfestation(Ctenocephalidesspp.)indogsand

cats,treatmentoftickinfestation(Ixodesricinus,Rhipicephalussanguineous)in

dogsandcats,andtreatmentofbitingliceinfestationindogs(Trichodectes

canis)andcats(Felicolasubrostratus).Theproductcanbeusedaspartofa

treatmentstrategyforthecontrolofFleaAllergyDermatitis(FAD).Insecticidal

efficacyagainstnewinfestationswithadultfleaspersistsforupto6weeksin

catsandupto3monthsindogs,dependingonenvironmentalchallenge.The

producthasapersistentacaricidalefficacyforupto4weeksagainstticks,

dependingonthelevelofenvironmentalchallenge.

Theproductisrecommendedtobeadministeredat3to6mlperkgbodyweight

(7.5to15mgofactiveingredientperkgbodyweight),dependingonthelengthof

hair.Theproductisadministeredbymechanicalpumpsprayforexternaluse

onlybysprayingtheentirebodyoftheanimal.Theproductcomesinthree

presentationsof100ml,250ml,and500ml.Therecommendeddosagecanbe

achievedwith6to12pumpapplicationsperkgbodyweightofthe100ml

presentation,or2to4pumpapplicationsofthe250mlpresentation,or1to2

pumpapplication(s)ofthe500mlpresentation.

Vetflea2.5mg/mlcutaneousspray,Solutionforcatsanddogs UK/V/0397/006/DC

Alfamed ApplicationforDecentralisedProcedure

PubliclyAvailableAssessmentReport

Theproductisproducedandcontrolledusingvalidatedmethodsandtestswhich

ensuretheconsistencyoftheproductreleasedonthemarket.

Ithasbeenshownthattheproductcanbesafelyusedinthetargetspecies;any

adversereactionsobservedareindicatedintheSPC 1 .

Theproductissafefortheuserandfortheenvironment,whenusedas

recommended.SuitablewarningsandprecautionsareindicatedintheSPC.

Theefficacyoftheproductwasdemonstratedaccordingtotheclaimsmadein

theSPC.Theoverallrisk/benefitanalysisisinfavourofgrantingamarketing

authorisation.

II. QUALITYASPECTS

A. Composition

Theproductcontainsfipronilandexcipientscopovidone,isopropylalcoholand

water(purified).

Thecontainerforthisproductisawhiteopaquehigh-densitypolyethylenebottle

sealedwithamechanicaltriggerpump.Theproductispresentedin100ml,250

ml,and500mlpacksizes.Theparticularsofthecontainersandcontrols

performedareprovidedandconformtotheregulation.Theabsenceof

preservativeisjustified.

Theproductisanestablishedpharmaceuticalformanditsdevelopmentis

adequatelydescribedinaccordancewiththerelevantEuropeanguidelines.

B. MethodofPreparationoftheProduct

Theproductismanufacturedfullyinaccordancewiththeprinciplesofgood

manufacturingpracticefromalicensedmanufacturingsite.

Theproductismanufacturedusingasimplemixingmethod.Atamaintained

temperatureinasuitablevessel,fipronil,copovidoneandpurifiedwaterare

mixedtogether.Thesolutionisthenfilledintobottlesandsealedwiththedose

deliverydevice.

Processvalidationdataonthreebatchesoftheproduct,filledintoallbottle

sizes,havebeenpresentedinaccordancewiththerelevantEuropean

guidelines.

C. ControlofStartingMaterials

Theactivesubstanceisfipronilandismanufacturedinaccordancewiththe

manufacturer’sspecification.Theactivesubstancespecificationisconsidered

adequatetocontrolthequalityofthematerial.Batchanalyticaldataonthree

batchesdemonstratingcompliancewiththisspecificationhavebeenprovided.

Theexcipientscopovidone,isopropyl,andpurifiedwateraredescribedinthe

EuropeanPharmacopoeia

SummaryofProductCharacteristics.

Vetflea2.5mg/mlcutaneousspray,Solutionforcatsanddogs UK/V/0397/006/DC

Alfamed ApplicationforDecentralisedProcedure

PubliclyAvailableAssessmentReport

D. SpecificMeasuresconcerningthePreventionoftheTransmission

ofAnimalSpongiformEncephalopathies

Theapplicanthasstatedthattherearenosubstanceswithinthescopeofthe

TSEGuidelinepresentorusedinthemanufactureofthisproduct.

E. Control on intermediateproducts

Notapplicable.

F. ControlTestsontheFinishedProduct

Thefinishedproductspecificationcontrolstherelevantparametersforthe

pharmaceuticalform.Thetestsinthespecification,andtheirlimits,havebeen

justifiedandareconsideredappropriatetoadequatelycontrolthequalityofthe

product.Batchanalyticaldataon3batchesofeachpresentationmanufactured

attheproposedmanufacturingsitehavebeenprovideddemonstrating

compliancewiththespecification.Testsincludethoseforappearance,clarity,

identificationandmicrobiologicalquality.Satisfactoryvalidationdataforthe

analyticalmethodshavebeenprovided.

G. Stability

Stabilitydataon3batchesoftheactivesubstancehavebeenprovidedin

accordancewithapplicableEuropeanguidelines,demonstratingthestabilityof

theactivesubstancewhenstoredundertheapprovedconditions.Testsinclude

thoseforappearance,solubility,meltingpointandrelatedsubstances.

Stabilitydataon3batchesofeachpresentationoftheproducthavebeen

providedinaccordancewithapplicableEuropeanguidelines,demonstratingthe

stabilityoftheproductwhenstoredundertheapprovedconditions.Testsinclude

thoseforappearanceofsolution,clarity,assayoffipronilcontent,and

microbiologicalquality.

J. OtherInformation

Theapplicationwassupportedwithregardtoquality.Thefollowingprecautions

areincludedontheSPCandproductliterature:

Highlyflammable.

Donotstoreabove25°C.

Protectfromdirectsunlight.

Thefinishedproducthasashelf-lifeof3years,andanin-useshelf-lifeof1year.

Vetflea2.5mg/mlcutaneousspray,Solutionforcatsanddogs UK/V/0397/006/DC

Alfamed ApplicationforDecentralisedProcedure

PubliclyAvailableAssessmentReport

III. SAFETY AND RESIDUES ASSESSMENT(PHARMACO-

TOXICOLOGICAL)

ThisisagenerichybridapplicationaccordingtoArticle13(3)where

bioequivalencecannotbedemonstratedthroughbioavailabilitystudies.

However,theproducthasbeenshowntobepharmaceuticallyequivalenttothe

referenceproduct,FrontlineSpray0.25%w/vCutaneousSpraySolution.Both

productsaresolutionsandtheyareusedinthesamespecies,forthesame

indications,inthesamedosesandusingthesameadministrationmethodand

thereforebioequivalencecanbeassumed.Thereforeitisconsideredjustified

thattheapplicanthasnotprovidedpharmacologicalortoxicologicaldatain

supportofthisapplication.

Warningsandprecautionsaslistedontheproductliteraturearesimilartothose

ofthereferenceproductandareadequatetoensuresafetyoftheproductto

usersandtheenvironment.

III.A SafetyTesting

UserSafety

Theapplicanthasprovidedausersafetyassessmentincompliancewiththe

relevantguideline.Theassessmentstatesthattheproductisclinicallyequivalent

tothereferenceproduct,andthatitisquantitativelyandqualitativelythesamein

termsofcompositionanditisintendedforuseinthesametargetspecies,with

thesameindicationclaimsanddoserate.Giventhattheproductis

pharmaceuticallyequivalenttothereferenceproductandtheriskmanagement

measuresproposedarealsothesameasforthereferenceproduct,theseare

consideredtobeacceptable.Warningsandprecautionsaslistedontheproduct

literatureareadequatetoensuresafetytousersoftheproduct.

Ecotoxicity

Theapplicantprovidedafirstphaseenvironmentalriskassessmentin

compliancewiththerelevantguidelinewhichshowedthatnofurtherassessment

isrequired.Theassessmentconcludedthatitisunlikelythattheproductwould

directlyentertheenvironmentwhenusedasdirected.Warningsandprecautions

aslistedontheproductliteratureareadequatetoensuresafetytothe

environmentwhentheproductisusedasdirected.

IV CLINICALASSESSMENT(EFFICACY)

ThisisagenerichybridapplicationaccordingtoArticle13(3)where

bioequivalencecannotbedemonstratedthroughbioavailabilitystudies.

However,theproducthasbeenshowntobepharmaceuticallyequivalenttothe

referenceproduct,FrontlineSpray0.25%w/vCutaneousSpraySolution.Both

productsaresolutionsandtheyareusedinthesamespecies,forthesame

indications,inthesamedosesandusingthesameadministrationmethodand

thereforebioequivalencecanbeassumed.Thereforenodatahavebeen

Vetflea2.5mg/mlcutaneousspray,Solutionforcatsanddogs UK/V/0397/006/DC

Alfamed ApplicationforDecentralisedProcedure

PubliclyAvailableAssessmentReport

presentedfortheclinicalassessment(efficacy)andthisisconsideredtobe

acceptable.

VOVERALLCONCLUSIONANDBENEFIT –RISKASSESSMENT

Thedatasubmittedinthedossierdemonstratethatwhentheproductisusedin

accordancewiththeSummaryofProductCharacteristics,thebenefit/riskprofile

forthetargetspeciesisfavourableandthequalityandsafetyoftheproductfor

humansandtheenvironmentisacceptable.

Vetflea2.5mg/mlcutaneousspray,Solutionforcatsanddogs UK/V/0397/006/DC

Alfamed ApplicationforDecentralisedProcedure

PubliclyAvailableAssessmentReport

MODULE4

POST-AUTHORISATIONASSESSMENTS

TheSPCandpackageleafletmaybeupdatedtoincludenewinformationonthe

quality,safetyandefficacyoftheveterinarymedicinalproduct.ThecurrentSPC

isavailableontheHeadsofMedicinesAgencies(veterinary)(HMA(v))website

( www.hma.eu ).

Thissectioncontainsinformationonsignificantchangeswhichhavebeenmade

aftertheoriginalprocedurewhichareimportantforthequality,safetyorefficacy

oftheproduct.

None