FRONTLINE COMBO SPOT ON CAT

Main information

  • Trade name:
  • FRONTLINE COMBO SPOT ON CAT
  • Pharmaceutical form:
  • Spot-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FRONTLINE COMBO SPOT ON CAT
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic area:

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0139/005
  • Authorization date:
  • 19-12-2011
  • EU code:
  • FR/V/0139/005
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

FrontlineComboSpotonCat

SUMMARYOFPRODUCTCHARACTERISTICS

FrontlineComboSpotonCat

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ONCAT

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachpipetteof0.5mlcontains:

Fipronil............................................................................................................50.00mg

(S)-methoprene...............................................................................................60.00mg

Butylhydroxyanisole(E320)...............................................................................0.10mg

Butylhydroxytoluene(E321)..............................................................................0.05mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Spot-onsolution.

Clearambersolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Catsandferrets.

4.2 Indicationsforuse,specifyingthetargetspecies

Incats:

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticksand/orbitinglice.

-Eliminationoffleas(Ctenocephalidesspp.).Insecticidalefficacyagainstnewinfestationswith

adultfleaspersistsfor4weeks.Preventionofthemultiplicationoffleasbyinhibitingthe

developmentofeggs(ovicidalactivity),larvaeandpupae(larvicidalactivity)originatingfromeggs

laidbyadultfleasforsixweeksafterapplication.

-Eliminationofticks(Ixodesricinus,Dermacentorvariabilis,Rhipicephalussanguineus).The

producthasapersistentacaricidalefficacyforupto2weeksagainstticks(basedonexperimental

data).

- Eliminationofbitinglice(Felicolasubrostratus).

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergyDermatitis

(FAD).

Inferrets:

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticks.

-Eliminationoffleas(Ctenocephalidesspp.).Insecticidalefficacyagainstnewinfestationswith

adultfleaspersistsfor4weeks.Preventionofthemultiplicationoffleasbyinhibitingthe

developmentofeggs(ovicidalactivity),larvaeandpupae(larvicidalactivity)originatingfromeggs

laidbyadultfleas.

-Eliminationofticks(Ixodesricinus,).Theproducthasapersistentacaricidalefficacyfor4weeks

againstticks(basedonexperimentaldata).

FrontlineComboSpotonCat

eu-frontline-combo-cat-201208-pi-p 3

4.3 Contraindications

Intheabsenceofavailabledata,theproductshouldnotbeusedonkittenslessthan8weeksoldand/or

weighinglessthan1kg.Theproductshouldnotbeusedonferretslessthan6monthsold.

Donotuseonsick(e.g.systemicdiseases,fever)orconvalescentanimals.

Donotuseinrabbits,asadversedrugreactionswithevenmortalitycouldoccur. Inabsence

ofstudies,theuseoftheproductisnotrecommendedinnon-targetspecies.

4.4 Specialwarningsfortargetspecies

Avoidthecontactwiththeanimal’seyes.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimalcannotlickitoff

andtomakesurethatanimalsdonotlickeachotherfollowingtreatment.

Nodataontheeffectofbathing/shampooingontheefficacyoftheproductincatsandferretsare

available.However,basedoninformationavailablefordogsshampooedasfrom2daysafter

applicationoftheproduct,itisnotrecommendedtobathanimalswithin2daysafterapplicationofthe

product.

Theremaybeanattachmentofsingleticks.Forthisreasonatransmissionofinfectiousdiseases

cannotbecompletelyexcludedifconditionsareunfavourable.

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareassuchascarpetsand

softfurnishingswhichshouldbetreated,incaseofmassiveinfestationandatthebeginningofthe

controlmeasures,withasuitableinsecticideandvacuumedregularly.

Thepotentialtoxicityoftheproductforkittensoflessthan8weeksofageincontactwithatreated

queenisnotdocumented.Specialcareshouldbetakeninthiscase.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Thisproductcancausemucousmembrane,skinandeyeirritation.Therefore,contactoftheproduct

withmouth,skinandeyesshouldbeavoided.

Animalsoroperatorswithaknownhypersensitivitytoinsecticidesoralcoholshouldavoidcontactwith

FrontlineComboSpotOnCat.Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,

washhandswithsoapandwater.

Afteraccidentalexposuretheeyeshouldberinsedcarefullywithpurewater.

Washhandsafteruse.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,andchildrenshouldnotbe

allowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itisthereforerecommendedthat

animalsarenottreatedduringtheday,butshouldbetreatedduringtheearlyevening,andthatrecently

treatedanimalsarenotallowedtosleepwithowners,especiallychildren.

Donotsmoke,drinkoreatduringapplication.

4.6 Adversereactions(frequencyandseriousness)

Donotoverdose.

Cats

FrontlineComboSpotonCat

eu-frontline-combo-cat-201208-pi-p 4

Amongtheveryraresuspectedadversereactions,transientskinreactionsontheapplicationsite

(scaling,localhairloss,itching,redness)andgeneralitchingorhairlosshavebeenreportedafteruse.

Excessivesalivation,reversiblenervoussigns(increasedsensitivitytostimulation,depression,other

nervoussigns)orvomitinghavealsobeenobservedafteruse.

Iflickingoccurs,abriefperiodofexcessivesalivationmaybeobservedduemainlytothenatureofthe

carrier.

4.7 Useduringpregnancy,lactationorlay

Cats

Theproductcanbeusedduringpregnancy andlactation .

Fortreatmentduringthelactatingperiod,seesection4.5 i)

Ferrets

Laboratorystudiesincatshavenotproducedanyevidenceofteratogenic,foetotoxicormaternotoxic

effects.Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedinferretsduring

pregnancyandlactation.Useonlyaccordingtotherisk-benefitassessmentbytheresponsible

veterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Onepipetteof0.5mlpercat,correspondingtoaminimumrecommendeddoseof5mg/kgforfipronil

and6mg/kgfor(S)-methoprene,bytopicalapplicationtotheskin.

Intheabsenceofsafetystudies,theminimumtreatmentintervalis4weeks.

Onepipetteof0.5mLperferretcorrespondingtoadoseof50mgforfiproniland60mgfor(S)-

methopreneperferret,bytopicalapplicationtotheskin.

Theminimumtreatmentintervalis4weeks.

Methodofadministration:

Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethecontentsremainwithinthe

mainbodyofthepipette.Snapbackthetip.Partthecoatonthebackoftheanimalatthebaseofthe

neckinfrontoftheshoulderbladesuntiltheskinisvisible.Placethetipofthepipetteontheskinand

squeezethepipetteseveraltimestoemptyitscontentscompletelyanddirectlyontotheskininone

spot.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theriskofexperiencingadverseeffectsmayincreasewithoverdosing(seesection4.6).

Incats

Noundesirableeffectswereobservedintargetanimalsafetystudiesincatsandkittensaged8weeks

andolderandweighingabout1kgtreatedonceamonthatfivetimestherecommendeddoseforsix

consecutivemonths.

Itchingmayoccurfollowingtreatment.

Overdoseapplicationoftheproductwillcauseastickyappearanceofhairsatthetreatmentspot.

However,shouldthisoccur,itwilldisappearwithin24hourspostapplication.

Inferrets

FrontlineComboSpotonCat

eu-frontline-combo-cat-201208-pi-p 5

Inferretsaged6monthsandolderandtreatedonceevery2weeksforfourtreatments,atfivetimes

therecommendeddose,bodyweightlosswasobservedinsomeanimals.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Theproductisaninsecticidalandacaricidalsolutionfortopicaluse,containinganassociationofan

adulticidalactiveingredient,fipronil,incombinationwithanovicidalandlarvicidalactiveingredient,(S)-

methoprene.

ATCvetcode:QP53AX65,groupEctoparasiticidesfortopicaluseQP53.

5.1 Pharmacodynamicproperties

Fipronilisaninsecticideandacaricidebelongingtothephenylpyrazolefamily.Itactsbyinteracting

withligand-gatedchloridechannels,inparticularthosegatedbytheneurotransmittergamma-

aminobutyricacid(GABA),therebyblockingpre-andpost-synaptictransferofchlorideionsacrosscell

membranes.Thisresultsinuncontrolledactivityofthecentralnervoussystemanddeathofinsectsor

acarines.Fipronilkillsfleaswithin24hours,ticks(Dermacentorvariabilis,Rhipicephalus

sanguineus,Ixodesscapularis,Ixodesricinus,Haemaphysalislongicornis,Haemaphysalis

flava,Haemaphysaliscampanulata)andlicewithin48hourspost-exposure.

(S)-Methopreneisaninsectgrowthregulator(IGR)oftheclassofcompoundsknownasjuvenile

hormoneanaloguesthatinhibitthedevelopmentofimmaturestagesofinsects.Thiscompoundmimics

theactionofjuvenilehormoneandcausesimpaireddevelopmentanddeathofthedevelopingstagesof

fleas.Theon-animalovicidalactivityof(S)-methopreneresultsfromeitherdirectpenetrationofthe

eggshellofnewlylaideggsorfromabsorptionthroughthecuticleoftheadultfleas.(S)-methopreneis

alsoeffectiveinpreventingflealarvaeandpupaefromdeveloping,whichpreventscontaminationofthe

environmentoftreatedanimalswiththeimmaturestagesoffleas.

5.2 Pharmacokineticparticulars

Studiesofmetabolismoffipronilhavedemonstratedthatthemajormetaboliteisthesulfonederivative

offipronil.

(S)-methopreneisextensivelydegradedintocarbondioxideandacetatethataresubsequently

incorporatedintoendogenousmaterials.

Thepharmacokineticprofilesaftertopicalapplicationoffiproniland(S)-methopreneincombination

werestudiedincatsincomparisontointravenousdosingoffipronilor(S)-methoprenealone.This

establishedabsorptionandotherpharmacokineticparametersunderconditionsmimickingclinical

practice.Thetopicalapplication,withadditionalpotentialoralexposurefromlicking,resultedinoverall

systemicabsorptionoffipronil(18%)withameanmaximumconcentration(C

)ofapproximately

100ng/mlfiproniland13ng/mloffipronilsulfoneinplasma.

Peakfipronilplasmaconcentrationsarerapidlyattained(meant

approximately6h)anddeclinewith

ameanterminalhalf-lifeofapproximately25h.

Fipronilisslightlymetabolisedtofipronilsulfoneincats.

Plasmaconcentrationsof(S)-methopreneweregenerallybelowthelimitofquantitation(20ng/ml)in

catsaftertopicalapplication.

FrontlineComboSpotonCat

eu-frontline-combo-cat-201208-pi-p 6

Both(S)-methopreneandfipronil,togetherwithitsmajormetabolite,arewell-distributedinthehaircoat

ofcatswithinonedayafterapplication.Theconcentrationsoffipronil,fipronilsulfoneand(S)-

methopreneinthehaircoatdecreasewithtimeandaredetectableforatleast59daysafterdosing.

Parasitesarekilledthroughcontactratherthanbysystemicexposure.

Nopharmacologicalinteractionbetweenfiproniland(S)-methoprenewasnoted.

Thepharmacokineticprofileoftheproducthasnotbeeninvestigatedinferrets.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Butylhydroxyanisole(E320)

Butylhydroxytoluene(E321)

Ethanol

Polysorbate80(E433)

Polyvidone

Diethyleneglycolmonoethylether

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years.

6.4.Specialprecautionsforstorage

Donotstoreabove30°C.Storeintheoriginalpackage.

6.5 Natureandcompositionofimmediatepackaging

Natureofprimarypackaging

Agreenpipettecomposedofaheat-formedshell(polypropyleneandpolyacrylonitrile-methylate

copolymer)andafilm(polyethyleneterephthalate,aluminium,andpolyacrylonitrile-methylate

copolymer).

Salespresentation(s)andadministrativenumber(s)ofidentification

Blistercardof1x0.5mlpipettewithascoredtip

Boxof1blistercardof3x0.5mlpipetteswithascoredtip

Boxof2blistercardsof3x0.5mlpipetteswithascoredtip

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

FrontlineComboSpotonCat

eu-frontline-combo-cat-201208-pi-p 7

Fiproniland(S)-methoprenemayadverselyaffectaquaticorganisms.Donotcontaminateponds,

waterwaysorditcheswiththeproductoremptycontainers.

7. MARKETINGAUTHORISATIONHOLDER

MERIAL

8. MARKETINGAUTHORISATIONNUMBER(S)

Tobecompletednationally

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Tobecompletednationally

10 DATEOFREVISIONOFTHETEXT

{MM/YYYY}

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

FrontlineComboSpotOnCat

LABELLINGANDPACKAGELEAFLET

FrontlineComboSpotOnCat

A.LABELLING

FrontlineComboSpotOnCat

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

FRONTLINECOMBOSPOTONCAT

Boxof3pipettes(or6pipettes)

CASEN°1:Thetextbelowcorrespondstothecaseswherealltheinformationofthepackage

leafletCANbeconveyedontheouterpackagingandcontainer.Consequently,inthatcase,no

separateleafletisprovidedincompliancewiththecurrentQRDTemplate.

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ONCAT

FIPRONIL10%w/v(S)METHOPRENE12%w/v

[Wherethereissufficientspace,‘w/v’willbeaddedafterthepercentagesoftheactivesubstances.

Wherethereisalackofspace,anasteriskwillbeaddednexttothepercentageswithanexplanatory

noteplacedclosetotheProductname.]

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Clearambersolutioncontaining:

Fipronil............................................................................................................50.00mg

(S)-methoprene...............................................................................................60.00mg

Butylhydroxyanisole(E320)...............................................................................0.10mg

Butylhydroxytoluene(E321)..............................................................................0.05mg

Excipient(s):q.s...................................................................................................0.5ml

3. PHARMACEUTICALFORM

Spot-onsolution

4. PACKAGESIZE

[ifinthecaseofaboxof3pipettes:]

3PIPETTESOF0.5ml

[ifinthecaseofaboxof6pipettes:]

6PIPETTESOF0.5ml

5. TARGETSPECIES

CATS

FERRETS

6. INDICATION(S)

Incats:

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticksand/orbitinglice.

-Eliminationoffleas(Ctenocephalidesspp.).Insecticidalefficacyagainstnewinfestationswith

adultfleaspersistsfor4weeks.Preventionofthemultiplicationoffleasbyinhibitingthe

developmentofeggs(ovicidalactivity),larvaeandpupae(larvicidalactivity)originatingfromeggs

laidbyadultfleasforsixweeksafterapplication.

FrontlineComboSpotonCat

-Eliminationofticks(Ixodesricinus,Dermacentorvariabilis,Rhipicephalussanguineus).The

producthasapersistentacaricidalefficacyforupto2weeksagainstticks(basedonexperimental

data).

- Eliminationofbitinglice(Felicolasubrostratus).

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergyDermatitis

(FAD).

Inferrets:

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticks.

-Eliminationoffleas(Ctenocephalidesspp.).Insecticidalefficacyagainstnewinfestationswith

adultfleaspersistsfor4weeks.Preventionofthemultiplicationoffleasbyinhibitingthe

developmentofeggs(ovicidalactivity),larvaeandpupae(larvicidalactivity)originatingfromeggs

laidbyadultfleas.

-Eliminationofticks(Ixodesricinus).Theproducthasapersistentacaricidalefficacyfor upto 4

weeksagainstticks(basedonexperimentaldata).

Fipronilkillsfleaswithin24hoursandticksandlicewithin48hourspost-exposure.

7. METHODANDROUTE(S)OFADMINISTRATION

Spoton

METHODOFADMINISTRATION

1-Takethepipetteoutofitspackaging

2-Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethecontentsremainwithinthe

mainbodyofthepipette.Snapbackthetip.

3-Partthecoatonthebackoftheanimalatthebaseoftheneckinfrontoftheshoulderbladesuntil

theskinisvisible.Placethetipofthepipetteontheskinandsqueezethepipetteseveraltimestoempty

itscontentscompletelyanddirectlyontotheskininonespot.

Dosage

Onepipetteof0.5mlpercat,correspondingtoaminimumrecommendeddoseof5mg/kgforfipronil

and6mg/kgfor(S)-methoprene,bytopicalapplicationtotheskin.

Onepipetteof0.5mLperferretcorrespondingtoadoseof50mgforfiproniland60mgfor(S)-

methopreneperferret,bytopicalapplicationtotheskin.

8. WITHDRAWALPERIOD

[NOTAPPLICABLE]

9. SPECIALWARNING(S),IFNECESSARY

Forexternaluseonly.

Useduringpregnancyandlactation

FrontlineComboSpotOnCatcanbeusedduringpregnancy andlactation incats. Fortreatmentduring

thelactatingperiod,seesectionPrecautionsbelow.

Useonlyaccordingtobenefit/riskassessmentbyaresponsibleveterinarianinferrets.

Precautions

FrontlineComboSpotonCat

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimalcannotlickitoff

andtomakesurethatanimalsdonotlickeachotherfollowingtreatment.

Nodataontheeffectofbathing/shampooingontheefficacyoftheproductincatsandferretsare

available.However,basedoninformationavailablefordogsshampooedasfrom2daysafter

applicationoftheproduct,itisnotrecommendedtobathanimalswithin2daysafterapplicationofthe

product.

Avoidthecontactwiththeanimal’seyes.

Theremaybeanattachmentofsingleticks.Forthisreasonatransmissionofinfectiousdiseases

cannotbecompletelyexcludedifconditionsareunfavourable.

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareassuchascarpetsand

softfurnishingswhichshouldbetreated,incaseofmassiveinfestationandatthebeginningofthe

controlmeasures,withasuitableinsecticideandvacuumedregularly.

Thepotentialtoxicityoftheproductforkittensoflessthan8weeksofageincontactwithatreated

queenisnotdocumented.Specialcareshouldbetakeninthiscase.

Contraindications

Intheabsenceofavailabledata,theproductshouldnotbeusedonkittenslessthan8weeksoldand/or

weighinglessthan1kg.Theproductshouldnotbeusedinferretslessthan6monthsold.

Donotuseonsick(e.g.systemicdiseases,fever)orconvalescentanimals.

Donotuseinrabbits,asadversedrugreactionswithevenmortalitycouldoccur. Inabsence

ofstudies,theuseoftheproductisnotrecommendedinnon-targetspecies.

UndesirableEffects

Donotoverdose.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedhere,pleaseinformyourveterinary

surgeon.

Cats

Amongtheveryraresuspectedadversereactions,transientskinreactionsontheapplicationsite

(scaling,localhairloss,itching,redness)andgeneralitchingorhairlosshavebeenreportedafteruse.

Excessivesalivation,reversiblenervoussigns(increasedsensitivitytostimulation,depression,other

nervoussigns)orvomitinghavealsobeenobservedafteruse.

Iflickingoccurs,abriefperiodofexcessivesalivationmaybeobservedduemainlytothenatureofthe

carrier.

Overdose

Theriskofexperiencingadverseeffectsmayhoweverincreasewithoverdosing(seeUndesirable

Effects).

Cats

Noundesirableeffectswereobservedintargetanimalsafetystudiesincatsandkittensaged8weeks

andolderandweighingabout1kgtreatedonceamonthatfivetimestherecommendeddoseforsix

consecutivemonths.

Itchingmayoccurfollowingtreatment.

Overdoseapplicationoftheproductwillcauseastickyappearanceofhairsatthetreatmentspot.

However,shouldthisoccur,itwilldisappearwithin24hourspostapplication.

Ferrets

Inferretsaged6monthsandolderandtreatedonceevery2weeksforfourtreatments,atfivetimes

therecommendeddose,bodyweightlosswasobservedinsomeanimals.

FrontlineComboSpotonCat

Userwarnings

Thisproductcancausemucousmembrane,skinandeyeirritation.Therefore,contactoftheproduct

withmouth,skinandeyesshouldbeavoided.

Animalsoroperatorswithaknownhypersensitivitytoinsecticidesoralcoholshouldavoidcontactwith

FrontlineComboSpotOnCat.Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,

washhandswithsoapandwater.

Afteraccidentalexposuretheeyeshouldberinsedcarefullywithplainwater.

Washhandsafteruse.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,andchildrenshouldnotbe

allowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itisthereforerecommendedthat

animalsarenottreatedduringtheday,butshouldbetreatedduringtheearlyevening,andthatrecently

treatedanimalsarenotallowedtosleepwithowners,especiallychildren.

Donotsmoke,drinkoreatduringapplication.

10. EXPIRYDATE

EXP{MM-YYYY}

11. SPECIALSTORAGECONDITIONS

Donotstoreabove30°C.Storeintheoriginalpackage.

Do notuseaftertheexpirydatestated onthepackageafterEXP.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Fiproniland(S)-methoprenemayadverselyaffectaquaticorganisms.Donotcontaminateponds,

waterwaysorditcheswiththeproductoremptycontainers.

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.Askyourveterinarysurgeon

howtodisposeofmedicinesnolongerrequired.Thesemeasuresshouldhelptoprotectthe

environment.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

[Tobecompletednationally,bydefault:]

MERIAL

29, avenueTonyGarnier

69007 Lyon, FRANCE

16. MARKETINGAUTHORISATIONNUMBER(S)

FrontlineComboSpotonCat

[Tobecompletednationally]

17. MANUFACTURER’SBATCHNUMBER

BN{number}

Additionalinformation:

[Manufacturer]

MERIAL

4 cheminduCalquet

31300Toulouse, France

FrontlineComboSpotonCat

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

FRONTLINECOMBOSPOTONCAT

Boxof3pipettes(or6pipettes)

CASEN°2:Thetextbelowcorrespondstothecaseswherealltheinformationofthepackage

leafletcannotbeconveyedontheouterpackagingandthecontainer(forexamplefor

multilingualpackaging).Consequentlyapackageleafletisadded(seethecorresponding

template).

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ONCAT

FIPRONIL10%w/v(S)METHOPRENE12%w/v

[Wherethereissufficientspace,‘w/v’willbeaddedafterthepercentagesoftheactivesubstances.

Wherethereisalackofspace,anasteriskwillbeaddednexttothepercentageswithanexplanatory

noteplacedclosetotheProductname.]

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Composition

Fipronil............................................................................................................50.00mg

(S)-methoprene...............................................................................................60.00mg

Butylhydroxyanisole(E320)...............................................................................0.10mg

Butylhydroxytoluene(E321)..............................................................................0.05mg

Excipient(s):q.s...................................................................................................0.5ml

3. PHARMACEUTICALFORM

Spot-onsolution.

4. PACKAGESIZE

[ifinthecaseofaboxof3pipettes:]

3PIPETTESOF0.5ml

[ifinthecaseofaboxof6pipettes:]

6PIPETTESOF0.5ml

5. TARGETSPECIES

CATS

FERRETS

6. INDICATION(S)

Readthepackageleafletbeforeuse.

[Moreinformationisprovidedinthepackageleaflet.Seethecorrespondingtemplate.]

7. METHODANDROUTE(S)OFADMINISTRATION

FrontlineComboSpotonCat

Spoton

METHODOFADMINISTRATION

1-Takethepipetteoutofitspackaging

2-Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethecontentsremainwithinthe

mainbodyofthepipette.Snapbackthetip.

3-Partthecoatonthebackoftheanimalatthebaseoftheneckinfrontoftheshoulderbladesuntil

theskinisvisible.Placethetipofthepipetteontheskinandsqueezethepipetteseveraltimestoempty

itscontentscompletelyanddirectlyontotheskininonespot.

8. WITHDRAWALPERIOD

<NOTAPPLICABLE>

9. SPECIALWARNING(S),IFNECESSARY

Forexternaluseonly.

Readthepackageleafletbeforeuse.

[Moreinformationisprovidedinthepackageleaflet.Seethecorrespondingtemplate.]

10. EXPIRYDATE

EXP{MM-YYYY}

11. SPECIALSTORAGECONDITIONS

Readthepackageleafletbeforeuse.

[Moreinformationisprovidedinthepackageleaflet.Seethecorrespondingtemplate.]

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Readthepackageleafletbeforeuse.

[Moreinformationisprovidedinthepackageleaflet.Seethecorrespondingtemplate.]

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

[Tobecompletednationally,bydefault:]

FrontlineComboSpotonCat

MERIAL

29, avenueTonyGarnier

69007 Lyon, FRANCE

16. MARKETINGAUTHORISATIONNUMBER(S)

[Tobecompletednationally]

17. MANUFACTURER’SBATCHNUMBER

BN{number}

FrontlineComboSpotonCat

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

FRONTLINECOMBOSPOTONCAT

Blistercardof1pipette

Theinformationmentionedbelowisalltheinformationvisibleexternallyonthispackaging,

eitherontheblistercardoronthecombinedlabelpackage-leafletinsertedinit.

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ONCAT

FIPRONIL10%w/v(S)METHOPRENE12%w/v

[Wherethereissufficientspace,‘w/v’willbeaddedafterthepercentagesoftheactivesubstances.

Wherethereisalackofspace,anasteriskwillbeaddednexttothepercentageswithanexplanatory

noteplacedclosetotheProductname.]

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

FIPRONIL(S)-METHOPRENE

3. PHARMACEUTICALFORM

Spot-onsolution.

4. PACKAGESIZE

1PIPETTEOF0.5ml

5. TARGETSPECIES

CATS

FERRETS

6. INDICATION(S)

Readthepackageleafletbeforeuse.

[Moreinformationisprovidedontheinteriorsideofthecombinedlabelpackageleaflet,seethe

correspondingpackageleaflettemplate.]

7. METHODANDROUTE(S)OFADMINISTRATION

Spoton

Readthepackageleafletbeforeuse.

[Moreinformationisprovidedontheinteriorsideofthecombinedlabelpackageleaflet,seethe

correspondingpackageleaflettemplate.]

8. WITHDRAWALPERIOD

NotApplicable

FrontlineComboSpotonCat

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

[Moreinformationisprovidedontheinteriorsideofthecombinedlabelpackageleaflet,seethe

correspondingpackageleaflettemplate.]

10. EXPIRYDATE

EXP{MM-YYYY}

11. SPECIALSTORAGECONDITIONS

Readthepackageleafletbeforeuse.

[Moreinformationisprovidedontheinteriorsideofthecombinedlabelpackageleaflet,seethe

correspondingpackageleaflettemplate.]

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Readthepackageleafletbeforeuse.

[Moreinformationisprovidedontheinteriorsideofthecombinedlabelpackageleaflet,seethe

correspondingpackageleaflettemplate.]

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

[Tobecompletednationally,bydefault:]

MERIAL

29, avenueTonyGarnier

69007 Lyon, FRANCE

16. MARKETINGAUTHORISATIONNUMBER(S)

[Tobecompletednationally]

17. MANUFACTURER’SBATCHNUMBER

BN{number}

FrontlineComboSpotonCat

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

FRONTLINECOMBOSPOTONCAT

1pipette

TheImmediatepackagingisapipette:theinformationbelowappearsontheshelloronthe

operculeofthepipette.

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBO

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

FIPRONIL50mg(S)-METHOPRENE60mg

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

0.5ml

4. ROUTE(S)OFADMINISTRATION

[Pictogramofadropofproductfallingfromapipetteontheskinoftheanimalthusshowingtheroute

ofadministration]

5. WITHDRAWALPERIOD

NotApplicable

6. BATCHNUMBER

{number}

7. EXPIRYDATE

{MM-YYYY}

8. THEWORDS“FORANIMALTREATMENTONLY”

[Pictogramofacatandaferretindicatingtheveterinaryuse]

[InAddition]MERIAL

[Pictogramofacatandaferretindicatingthetargetspecies]

FrontlineComboSpotonCat

MINIMUMPARTICULARSTOAPPEARONBLISTERSORSTRIPS

FRONTLINECOMBOSPOTONCAT

Boxof3pipettes:1blisterof3pipettes

Boxof6pipettes:2blistersof3pipettes

Theblisterpackageisthesameinbothcases:theinformationbelowappearsontheblistershell

orontheblistercapoftheblisterpackage.

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ONCAT

FIPRONIL(S)METHOPRENE

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

MERIAL

3. EXPIRYDATE

{MM-YYYY}

4. BATCHNUMBER

{number}

5. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

[or]

ADUS.VET.-USAGEVETERINAIRE-FORVETERINARYUSE

6. ADDITIONALINFORMATION

0.5ml

FIPRONIL10%w/v(S)METHOPRENE12%w/v

FrontlineComboSpotOnCat

B.PACKAGELEAFLET

FrontlineComboSpotOnCat

FRONTLINECOMBOSPOT-ONCAT

Boxof3pipettes

Boxof6pipettes

TheleafletdescribedbelowappliestoCaseN°2whereapackageleafletisaddedin

thepackaging.

InCaseN°1noleafletisneeded.

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

[Tobecompletednationally,bydefault:]

MERIAL

29, avenueTonyGarnier

69007 Lyon, FRANCE

MERIAL

4 cheminduCalquet

31300 Toulouse

France

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ONCAT

FIPRONIL10%w/v(S)METHOPRENE12%w/v

[Wherethereissufficientspace,‘w/v’willbeaddedafterthepercentagesoftheactivesubstances.

Wherethereisalackofspace,anasteriskwillbeaddednexttothepercentageswithanexplanatory

noteplacedclosetotheProductname.]

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

FrontlineComboSpotOnCatisaclearambersolutioncontaining:

Fipronil50.00mg

(S)-methoprene60.00mg

Butylhydroxyanisole(E320)0.10mg

Butylhydroxytoluene(E321)0.05mg

Excipient(s):q.s0.5ml.

4. INDICATION(S)

Incats:

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticksand/orbitinglice.

-Eliminationoffleas(Ctenocephalidesspp.).Insecticidalefficacyagainstnewinfestationswith

adultfleaspersistsfor4weeks.Preventionofthemultiplicationoffleasbyinhibitingthe

developmentofeggs(ovicidalactivity),larvaeandpupae(larvicidalactivity)originatingfromeggs

laidbyadultfleasforsixweeksafterapplication.

-Eliminationofticks(Ixodesricinus,Dermacentorvariabilis,Rhipicephalussanguineus).The

producthasapersistentacaricidalefficacyforupto2weeksagainstticks(basedonexperimental

data).

FrontlineComboSpotonCat

- Eliminationofbitinglice(Felicolasubrostratus).

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergyDermatitis

(FAD).

Inferrets:

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticks.

-Eliminationoffleas(Ctenocephalidesspp.).Insecticidalefficacyagainstnewinfestationswith

adultfleaspersistsfor4weeks.Preventionofthemultiplicationoffleasbyinhibitingthe

developmentofeggs(ovicidalactivity),larvaeandpupae(larvicidalactivity)originatingfromeggs

laidbyadultfleas.

-Eliminationofticks(Ixodesricinus).Theproducthasapersistentacaricidalefficacyfor4weeks

againstticks(basedonexperimentaldata).

5. CONTRAINDICATIONS

Intheabsenceofavailabledata,theproductshouldnotbeusedonkittenslessthan8weeksoldand/or

weighinglessthan1kg.Theproductshouldnotbeusedinferretslessthan6monthsold.

Donotuseonsick(e.g.systemicdiseases,fever)orconvalescentanimals.

Donotuseinrabbits,asadversedrugreactionswithevenmortalitycouldoccur. Inabsence

ofstudies,theuseoftheproductisnotrecommendedinnon-targetspecies.

6. ADVERSEREACTIONS

Donotoverdose.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

Cats

Amongtheveryraresuspectedadversereactions,transientskinreactionsontheapplicationsite

(scaling,localhairloss,itching,redness)andgeneralitchingorhairlosshavebeenreportedafteruse.

Excessivesalivation,reversiblenervoussigns(increasedsensitivitytostimulation,depression,other

nervoussigns)orvomitinghavealsobeenobservedafteruse.

Iflickingoccurs,abriefperiodofexcessivesalivationmaybeobservedduemainlytothenatureofthe

carrier.

7. TARGETSPECIES

Targetspecies:Cats,Ferrets.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Routeofadministration:external,bytopicalapplicationtotheskin.

Dosage:

Onepipetteof0.5mlpercat.Intheabsenceofsafetystudies,theminimumtreatmentintervalis

4weeks.

Onepipetteof0.5mlperferret.Theminimumtreatmentintervalis4weeks.

9. ADVICEONCORRECTADMINISTRATION

Methodofadministration:seeouterpackaging.

10. WITHDRAWALPERIOD

FrontlineComboSpotonCat

[NotApplicable]

11. SPECIALSTORAGEPRECAUTIONS

Storage

Do notstoreabove30

C. Storeintheoriginalpackage.

Keepoutofthereachandsightofchildren.

DonotuseaftertheexpirydatestatedonthecartonafterEXP.

12. SPECIALWARNING(S)

Precautions

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimalcannotlickitoff

andtomakesurethatanimalsdonotlickeachotherfollowingtreatment.

Nodataontheeffectofbathing/shampooingontheefficacyoftheproductincatsandferretsare

available.However,basedoninformationavailablefordogsshampooedasfrom2daysafter

applicationoftheproduct,itisnotrecommendedtobathanimalswithin2daysafterapplicationofthe

product.

Avoidthecontactwiththeanimal’seyes.

Theremaybeanattachmentofsingleticks.Forthisreasonatransmissionofinfectiousdiseases

cannotbecompletelyexcludedifconditionsareunfavourable.

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareassuchascarpetsand

softfurnishingswhichshouldbetreated,incaseofmassiveinfestationandatthebeginningofthe

controlmeasures,withasuitableinsecticideandvacuumedregularly.

Thepotentialtoxicityoftheproductforkittensoflessthan8weeksofageincontactwithatreated

queenisnotdocumented.Specialcareshouldbetakeninthiscase.

Overdose

Theriskofexperiencingadverseeffectmayhoweverincreasewithoverdosing(seesection6Adverse

reactions).

Cats

Noundesirableeffectswereobservedintargetanimalsafetystudiesincatsandkittensaged8weeks

andolderandweighingabout1kgtreatedonceamonthatfivetimestherecommendeddoseforsix

consecutivemonths.

Itchingmayoccurfollowingtreatment.

Overdoseapplicationoftheproductwillcauseastickyappearanceofhairsatthetreatmentspot.

However,shouldthisoccur,itwilldisappearwithin24hourspostapplication.

Ferrets

Inferretsaged6monthsandolderandtreatedonceevery2weeksforfourtreatments,atfivetimes

therecommendeddose,bodyweightlosswasobservedinsomeanimals.

Userwarnings

Thisproductcancausemucousmembrane,skinandeyeirritation.Therefore,contactoftheproduct

withmouth,skinandeyesshouldbeavoided.

Animalsoroperatorswithaknownhypersensitivitytoinsecticidesoralcoholshouldavoidcontactwith

FrontlineComboSpotOnCat.Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,

washhandswithsoapandwater.

Afteraccidentalexposuretheeyeshouldberinsedcarefullywithplainwater.

Washhandsafteruse.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,andchildrenshouldnotbe

allowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itisthereforerecommendedthat

FrontlineComboSpotonCat

animalsarenottreatedduringtheday,butshouldbetreatedduringtheearlyevening,andthatrecently

treatedanimalsarenotallowedtosleepwithowners,especiallychildren.

Donotsmoke,drinkoreatduringapplication.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIAL,IFANY

Fiproniland(S)-methoprenemayadverselyaffectaquaticorganisms.Donotcontaminateponds,

waterwaysorditcheswiththeproductoremptycontainers.

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.Askyourveterinarysurgeon

howtodisposeofmedicinesnolongerrequired.Thesemeasuresshouldhelptoprotectthe

environment.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Useduringpregnancy,lactationorlay

Theproductcanbeusedduringpregnancy andlactation incats. Fortreatmentduringthelactating

period,seesectionPrecautionsabove.

Useonlyaccordingtobenefit/riskassessmentbyaresponsibleveterinarianinferrets.

Pharmacodynamicproperties

Fipronilkillsfleaswithin24hoursandticksandlicewithin48hourspost-exposure.

Blistercardof1x0.5mlpipette

Boxof1blistercardof3x0.5mlpipettes

Boxof2blistercardsof3x0.5mlpipettes

Notallpacksizesmaybemarketed.

FrontlineComboSpotonCat

FRONTLINECOMBOSPOT-ONCAT

Blistercardof1pipette

Thispackagingcontainsacombinedlabelpackage-leaflet.Theinformationmentionedbelow

appearsontheinteriorsideofthiscombinedlabelpackage-leaflet.

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

[Tobecompletednationally,bydefault:]

MERIAL

29, avenueTonyGarnier

69007 Lyon, FRANCE

MERIAL

4 cheminduCalquet

31300Toulouse

France

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ONCAT

FIPRONIL10%w/v(S)METHOPRENE12%w/v

[Wherethereissufficientspace,‘w/v’willbeaddedafterthepercentagesoftheactivesubstances.

Wherethereisalackofspace,anasteriskwillbeaddednexttothepercentageswithanexplanatory

noteplacedclosetotheProductname.]

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

FrontlineComboSpotOnCatisaclearambersolutioncontaining:

Fipronil50.00mg

(S)-methoprene60.00mg

Butylhydroxyanisole(E320)0.10mg

Butylhydroxytoluene(E321)0.05mg

Excipient(s):q.s0.5ml.

4. INDICATION(S)

Incats:

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticksand/orbitinglice.

-Eliminationoffleas(Ctenocephalidesspp.).Insecticidalefficacyagainstnewinfestationswith

adultfleaspersistsfor4weeks.Preventionofthemultiplicationoffleasbyinhibitingthe

developmentofeggs(ovicidalactivity),larvaeandpupae(larvicidalactivity)originatingfromeggs

laidbyadultfleasforsixweeksafterapplication.

-Eliminationofticks(Ixodesricinus,Dermacentorvariabilis,Rhipicephalussanguineus).The

producthasapersistentacaricidalefficacyforupto2weeksagainstticks(basedonexperimental

data).

- Eliminationofbitinglice(Felicolasubrostratus).

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergyDermatitis

(FAD).

FrontlineComboSpotonCat

Inferrets:

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticks.

-Eliminationoffleas(Ctenocephalidesspp.).Insecticidalefficacyagainstnewinfestationswith

adultfleaspersistsfor4weeks.Preventionofthemultiplicationoffleasbyinhibitingthe

developmentofeggs(ovicidalactivity),larvaeandpupae(larvicidalactivity)originatingfromeggs

laidbyadultfleas.

-Eliminationofticks(Ixodesricinus).Theproducthasapersistentacaricidalefficacyfor4weeks

againstticks(basedonexperimentaldata).

5. CONTRAINDICATIONS

Intheabsenceofavailabledata,theproductshouldnotbeusedonkittenslessthan8weeksoldand/or

weighinglessthan1kg.Theproductshouldnotbeusedinferretslessthan6monthsold.

Donotuseonsick(e.g.systemicdiseases,fever)orconvalescentanimals.

Donotuseinrabbits,asadversedrugreactionswithevenmortalitycouldoccur. Inabsence

ofstudies,theuseoftheproductisnotrecommendedinnon-targetspecies.

Intheabsenceofsafetystudies,theminimumtreatmentintervalis4weeksincatsandinferrets.

6. ADVERSEREACTIONS

Donotoverdose.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

Cats

Amongtheveryraresuspectedadversereactions,transientskinreactionsontheapplicationsite

(scaling,localhairloss,itching,redness)andgeneralitchingorhairlosshavebeenreportedafteruse.

Excessivesalivation,reversiblenervoussigns(increasedsensitivitytostimulation,depression,other

nervoussigns)orvomitinghavealsobeenobservedafteruse.

Iflickingoccurs,abriefperiodofexcessivesalivationmaybeobservedduemainlytothenatureofthe

carrier.

7. TARGETSPECIES

Cat

Ferret

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Routeofadministration:external,bytopicalapplicationtotheskin.

Dosage:

Onepipetteof0.5mlpercatcorrespondingtoaminimumrecommendeddoseof5mg/kgforfipronil

and6mg/kgfor(S)-methoprene.

Onepipetteof0.5mLperferretcorrespondingtoadoseof50mgforfiproniland60mgfor(S)-

methopreneperferret,bytopicalapplicationtotheskin.

9. ADVICEONCORRECTADMINISTRATION

Methodofadministration

Tackthepipetteoutofitspackaging.

Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethecontentsremainwithinthe

mainbodyofthepipette.Snapbackthetip.Partthecoatonthebackoftheanimalatthebaseofthe

FrontlineComboSpotonCat

neckinfrontoftheshoulderbladesuntiltheskinisvisible.Placethetipofthepipetteontheskinand

squeezethepipetteseveraltimestoemptyitscontentscompletelyanddirectlyontotheskininone

spot.

10. WITHDRAWALPERIOD

NotApplicable

11. SPECIALSTORAGEPRECAUTIONS

Storage

Do notstoreabove30

C. Storeintheoriginalpackage.

Keep outofthereachand sightofchildren.

Do notuseaftertheexpirydatestated onthepackageafterEXP.

12. SPECIALWARNING(S)

Precautions

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimalcannotlickitoff

andtomakesurethatanimalsdonotlickeachotherfollowingtreatment.

Nodataontheeffectofbathing/shampooingontheefficacyoftheproductincatsandferretsare

available.However,basedoninformationavailablefordogsshampooedasfrom2daysafter

applicationoftheproduct,itisnotrecommendedtobathanimalswithin2daysafterapplicationofthe

product.

Avoidthecontactwiththeanimal’seyes.

Theremaybeanattachmentofsingleticks.Forthisreasonatransmissionofinfectiousdiseases

cannotbecompletelyexcludedifconditionsareunfavourable.

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareassuchascarpetsand

softfurnishingswhichshouldbetreated,incaseofmassiveinfestationandatthebeginningofthe

controlmeasures,withasuitableinsecticideandvacuumedregularly.

Thepotentialtoxicityoftheproductforkittensoflessthan8weeksofageincontactwithatreated

queenisnotdocumented.Specialcareshouldbetakeninthiscase.

Overdose

Theriskofexperiencingadverseeffectmayhoweverincreasewithoverdosing(seeUndesirable

Effects).

Cats

Noundesirableeffectswereobservedintargetanimalsafetystudiesincatsandkittensaged8weeks

andolderandweighingabout1kgtreatedonceamonthatfivetimestherecommendeddoseforsix

consecutivemonths.

Itchingmayoccurfollowingtreatment.

Overdoseapplicationoftheproductwillcauseastickyappearanceofhairsatthetreatmentspot.

However,shouldthisoccur,itwilldisappearwithin24hourspostapplication.

Ferrets

Inferretsaged6monthsandolderandtreatedonceevery2weeksforfourtreatments,atfivetimes

therecommendeddose,bodyweightlosswasobservedinsomeanimals.

UserWarnings

Thisproductcancausemucousmembrane,skinandeyeirritation.Therefore,contactoftheproduct

withmouth,skinandeyesshouldbeavoided.

Animalsoroperatorswithaknownhypersensitivitytoinsecticidesoralcoholshouldavoidcontactwith

FrontlineComboSpotOnCat.Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,

washhandswithsoapandwater.

FrontlineComboSpotonCat

Afteraccidentalexposuretheeyeshouldberinsedcarefullywithpurewater.

Washhandsafteruse.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,andchildrenshouldnotbe

allowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itisthereforerecommendedthat

animalsarenottreatedduringtheday,butshouldbetreatedduringtheearlyevening,andthatrecently

treatedanimalsarenotallowedtosleepwithowners,especiallychildren.

Donotsmoke,drinkoreatduringapplication.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIAL,IFANY

Fiproniland(S)-methoprenemayadverselyaffectaquaticorganisms.Donotcontaminateponds,

waterwaysorditcheswiththeproductoremptycontainers.

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.Askyourveterinarysurgeon

howtodisposeofmedicinesnolongerrequired.Thesemeasuresshouldhelptoprotectthe

environment.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Useduringpregnancy,lactationorlay

Theproductcanbeusedduringpregnancy andlactation incats. Fortreatmentduringthelactating

period,seesectionPrecautionsabove.

Useonlyaccordingtobenefit/riskassessmentbyaresponsibleveterinarianinferrets.

Pharmacodynamicproperties

Fipronilkillsfleaswithin24hoursandticksandlicewithin48hourspost-exposure.

Blistercardof1x0.5mlpipette

Boxof1blistercardof3x0.5mlpipettes

Boxof2blistercardsof3x0.5mlpipettes

Notallpacksizesmaybemarketed.

FrontlineComboSpotonCat

ADDITIONALINFORMATIONTOAPPEARONTHEOUTERPACKAGE

FRONTLINECOMBOSPOTONCAT

Boxof3pipettes(or6pipettes)

Boxof1pipette(onlyhighlightedtext)

Eliminatesfleasonyourcatandprotectsagainstre-infestationfor4weeks.

Inhibitsthedevelopmentoffleaeggs,flealarvaeandpupae(for6weeksincats),thuspreventing

contaminationofyourpet’senvironmentforthesameperiod.

Eliminatesticksonyourcatandprotectsagainstre-infestationforupto2weeks.

Eliminatesbitingliceonyourcat.

CanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergyDermatitis(FAD)incats.

Preventscontaminationoftheenvironmentoftreatedanimalswiththeimmaturestagesoffleas.

Eliminatesfleasonyourferretandprotectsagainstre-infestationfor4weeks.

Eliminatesticksonyourferretandprotectsagainstre-infestationforupto4weeks.

{icons}

13-12-2018

Pest categorisation of Septoria malagutii

Pest categorisation of Septoria malagutii

Published on: Wed, 12 Dec 2018 The Panel on Plant Health performed a pest categorisation of Septoria malagutii, the causal agent of annular leaf spot of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. malagutii is present in Bolivia, Ecuador, Peru and Venezuela. The pest is not known to occur in the EU and is listed as Septoria lycopersici var. malagutii in Annex IAI of Directive 2000/29/EC, meaning its introduction into t...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

Europe - EFSA - European Food Safety Authority Publications

12-12-2018

dormakaba USA Inc. recalls Stanley Commercial Hardware Locksets

dormakaba USA Inc. recalls Stanley Commercial Hardware Locksets

The lockset can fail to open, posing an entrapment hazard and inability to vacate a location in an emergency.

Health Canada

11-12-2018

FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.

FDA - U.S. Food and Drug Administration

10-12-2018

The J.M. Smucker Company Issues Voluntary Recall of Specific Lots of 9Lives® Protein Plus® Wet, Canned Cat Food Due to Low Levels of Thiamine (Vitamin B1)

The J.M. Smucker Company Issues Voluntary Recall of Specific Lots of 9Lives® Protein Plus® Wet, Canned Cat Food Due to Low Levels of Thiamine (Vitamin B1)

The J.M. Smucker Company today announced a voluntary recall of specific lots of 9Lives® Protein Plus® wet, canned cat food due to possible low levels of thiamine (Vitamin B1). No illnesses related to this issue have been reported to date and the product is being recalled out of an abundance of caution.

FDA - U.S. Food and Drug Administration

10-12-2018

Public Notification: On Demand contains hidden drug ingredient

Public Notification: On Demand contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use On Demand, a product promoted and sold for sexual enhancement on various websites, including www.goodlifeondemand.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

7-12-2018

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Published on: Thu, 06 Dec 2018 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐t...

Europe - EFSA - European Food Safety Authority Publications

6-12-2018

Kroger Louisville Division Recalls Abound Chicken and Brown Rice Dog Food Because of Elevated Vitamin D Levels

Kroger Louisville Division Recalls Abound Chicken and Brown Rice Dog Food Because of Elevated Vitamin D Levels

Following a recall by Sunshine Mills, Inc., the Kroger Louisville division announced it has removed from sale Abound Chicken & Brown Rice Recipe dog food produced by the supplier. The dog food was sold in one Kroger store located at 2440 Bardstown Road in Louisville, KY. Only Abound Chicken & Brown Rice Recipe dog food with the listed UPC numbers and Best by Dates are affected by this recall. The recall was initiated because the product had the potential to contain an elevated level of Vitamin D, which ...

FDA - U.S. Food and Drug Administration

6-12-2018

King Soopers and City Market Recalls Abound Chicken and Brown Rice Dog Food Because of Elevated Vitamin D Levels

King Soopers and City Market Recalls Abound Chicken and Brown Rice Dog Food Because of Elevated Vitamin D Levels

Following a recall by Sunshine Mills, Inc., King Soopers announced it has removed from sale Abound Chicken & Brown Rice Recipe dog food produced by Sunshine Mills, Inc. sold in King Soopers and City Market stores, located in Colorado, Utah, New Mexico and Wyoming. Only Abound Chicken & Brown Rice Recipe dog food with the listed UPC numbers and Best by Dates are affected by this recall. The recall was initiated because the product had the potential to contain an elevated level of Vitamin D, which may caus...

FDA - U.S. Food and Drug Administration

1-12-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Published on: Fri, 30 Nov 2018 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with a genetically modified Trichoderma reesei (strain DP‐Nzd22) by DuPont. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The endo‐1,4‐β‐xylanase is intended to be used in distilled alcohol production, bakery and brewery. Residual amounts of total organic solids (TOS) are removed during the production of dis...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

Public Notification: MOB Candy contains hidden drug ingredients

Public Notification: MOB Candy contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use MOB Candy, a product promoted and sold for sexual enhancement on various websites and in some retail stores.

FDA - U.S. Food and Drug Administration

30-11-2018

Public Notification: Willy Go Wild contains hidden drug ingredients

Public Notification: Willy Go Wild contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Willy Go Wild, a product promoted and sold for sexual enhancement on various websites and in some retail stores.

FDA - U.S. Food and Drug Administration

30-11-2018

Understanding ASF spread and emergency control concepts in wild boar populations using individual‐based modelling and spatio‐temporal surveillance data

Understanding ASF spread and emergency control concepts in wild boar populations using individual‐based modelling and spatio‐temporal surveillance data

Published on: Thu, 29 Nov 2018 African swine fever (ASF) infection is circulating in Eurasia since a decade within wild boar populations without a demonstrated vector host. Further the infection was recurrently translocated by spatio‐temporal dynamics that is incompatible with wild boar movement characteristics. Management actions are required in areas affected by ASF. Control measures address areas with recent focal introduction and areas with ASF circulating several seasons or endemic occurrence. In v...

Europe - EFSA - European Food Safety Authority Publications

28-11-2018

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Mylan Pharmaceuticals ULC is voluntarily recalling four lots of Mylan-Valsartan tablets (40 mg, 80 mg, 160 mg and 320 mg strength) after testing found low levels of an impurity, N-nitrosodiethylamine (NDEA).

Health Canada

28-11-2018

Allergen Alert: Kitchen Cravings Strawberry and Mixed Berry Parfaits with Trace Tree Nuts

Allergen Alert: Kitchen Cravings Strawberry and Mixed Berry Parfaits with Trace Tree Nuts

Kwik Trip, Inc. located in La Crosse, WI is recalling Kitchen Cravings Strawberry and Mixed Berry Parfaits in an 8.25 oz. cup because they may contain undeclared traces of cashews or almonds

FDA - U.S. Food and Drug Administration

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Published on: Mon, 26 Nov 2018 The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous c...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Public Notification: Pink Granada contains hidden drug ingredients

Public Notification: Pink Granada contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Pink Granada, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

21-11-2018

Public Notification: America Treasure contains hidden drug ingredient

Public Notification: America Treasure contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use America Treasure, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

20-11-2018

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in soyabean. The data submitted in support of the request were found to be sufficient to derive MRL proposals for soyabean. The applicant provided a new validated analytical method to control residues of pyraclostrobin on the commodity u...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the request...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 16 Nov 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices

FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices

FDA alerted health care providers and patients about the serious complications that can occur when using medications not approved for use with implanted pumps that deliver medication into the spinal fluid to treat or manage pain.

FDA - U.S. Food and Drug Administration

8-11-2018

Public Notification: Best Leopard Miracle of Honey contains hidden drug ingredients

Public Notification: Best Leopard Miracle of Honey contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Best Leopard Miracle of Honey, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

8-11-2018

Public Notification: Gold Max Blue contains hidden drug ingredient

Public Notification: Gold Max Blue contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Gold Max Blue, a product promoted and sold for sexual enhancement on various websites, including www.goldmaxblue.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

8-11-2018

Public Notification: Leopard Secret Miracle Honey contains hidden drug ingredient

Public Notification: Leopard Secret Miracle Honey contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Leopard Secret Miracle Honey, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

8-11-2018

Manage Your Asthma: Know Your Triggers and Treatment Options

Manage Your Asthma: Know Your Triggers and Treatment Options

You can manage your asthma by taking medications approved by the FDA. Before going to the pharmacy, get a proper diagnosis from a doctor and together develop an asthma action plan.

FDA - U.S. Food and Drug Administration

6-11-2018

FDA Approves Experior for Reduction of Ammonia Gas Released from Beef Cattle Waste

FDA Approves Experior for Reduction of Ammonia Gas Released from Beef Cattle Waste

FDA announced today the approval of Experior (lubabegron Type A medicated article), a beta-adrenergic agonist/antagonist drug that, when fed to beef cattle under specific conditions, results in less ammonia gas released as a by-product of their waste.

FDA - U.S. Food and Drug Administration

1-11-2018

Meer regie voor patiënt in medisch dossier GGZ

Meer regie voor patiënt in medisch dossier GGZ

Staatssecretaris Paul Blokhuis (VWS) stelt €45 miljoen beschikbaar voor betere gegevensuitwisseling in de geestelijke gezondheidszorg, meer medicatieveiligheid en betere beschikbaarheid van e-health. Als gegevens gestandaardiseerd worden uitgewisseld kan de patiënt veiliger en makkelijker over zijn gegevens beschikken. Daarmee is de patiënt eigenaar van de gegevens en in staat meer regie te hebben. De patiënt bepaalt welke gegevens hij deelt en welke zorgaanbieder die gegevens krijgt.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

FDA - U.S. Food and Drug Administration

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

FDA Warns Two Firms about Monensin Contamination in Horse Feed

FDA Warns Two Firms about Monensin Contamination in Horse Feed

FDA has issued warning letters to two feed mills that mixed horse feed containing monensin, an animal drug that is toxic and potentially lethal to horses. This should be a reminder to all feed manufacturers making medicated feeds that they must remain vigilant about adhering to CGMP requirements.

FDA - U.S. Food and Drug Administration

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.

Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.

Liveyon, LLC (“Liveyon”) is a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, CA. Liveyon marketed and distributed these products under the trade name ReGen Series®. Liveyon has voluntarily recalled all ReGen Series® products due to reported possible adverse reactions.

FDA - U.S. Food and Drug Administration

10-10-2018

Spiraledge Inc. recalls Backless Yoga Chair

Spiraledge Inc. recalls Backless Yoga Chair

The chairs may have missing screws or washers, loose screws or inadequate spot welding, resulting in potential collapse of the chair and injury to the user.

Health Canada

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

5-10-2018

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Today the New York State Department of Agriculture and Markets alerted consumers to a pasteurization problem with one of Sprout Creek Farm's pasteurized cow's milk cheeses, "Margie," made on 8/28/2018. Sprout Creek Farm is located in Poughkeepsie, NY. The reason for the recall is the air temperature at the start and end of the pasteurization process is required to be above 150deg F per the Grade "A" Pasteurized Milk Ordinance; the batch in question did not meet that standard. The recall pertains only to...

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Shengan Natural Model contains hidden drug ingredient

Public Notification: Shengan Natural Model contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Shengan Natural Model, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: USA for Women contains hidden drug ingredient

Public Notification: USA for Women contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use USA for Women, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: In Shape contains hidden drug ingredient

Public Notification: In Shape contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use In Shape, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: ProSolution contains hidden drug ingredient

Public Notification: ProSolution contains hidden drug ingredient

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Pro Solution, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: FX75000 contains hidden drug ingredient

Public Notification: FX75000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use FX75000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Baschi Quick Slimming Capsule contains hidden drug ingredients

Public Notification: Baschi Quick Slimming Capsule contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Baschi Quick Slimming Capsule, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: V-Max contains hidden drug ingredient

Public Notification: V-Max contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use V-Max, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

26-11-2018

Erivedge (Roche Registration GmbH)

Erivedge (Roche Registration GmbH)

Erivedge (Active substance: vismodegib) - PSUSA - Modification - Commission Decision (2018)7973 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10140/201801

Europe -DG Health and Food Safety

26-11-2018

Ranexa (Menarini International Operations Luxembourg S.A.)

Ranexa (Menarini International Operations Luxembourg S.A.)

Ranexa (Active substance: ranolazine) - PSUSA - Modification - Commission Decision (2018)7980 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/805/PSUSA/2611/201801

Europe -DG Health and Food Safety

26-11-2018

Efient (Daiichi Sankyo Europe GmbH)

Efient (Daiichi Sankyo Europe GmbH)

Efient (Active substance: prasugrel) - PSUSA - Modification - Commission Decision (2018)7978 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2499/201802

Europe -DG Health and Food Safety

23-11-2018

Orfadin (Swedish Orphan Biovitrum International AB)

Orfadin (Swedish Orphan Biovitrum International AB)

Orfadin (Active substance: Nitisinone) - PSUSA - Modification - Commission Decision (2018)7890 of Fri, 23 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2169/201802

Europe -DG Health and Food Safety

22-11-2018

Ozurdex (Allergan Pharmaceuticals Ireland)

Ozurdex (Allergan Pharmaceuticals Ireland)

Ozurdex (Active substance: dexamethasone) - PSUSA - Modification - Commission Decision (2018)7886 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1140/PSUSA/985/201801

Europe -DG Health and Food Safety

22-11-2018

Selincro (H. Lundbeck A/S)

Selincro (H. Lundbeck A/S)

Selincro (Active substance: nalmefene) - PSUSA - Modification - Commission Decision (2018)7889 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10120/201802

Europe -DG Health and Food Safety

14-11-2018

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or   manage pain:  https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/xPfuw  #FDA #MedicalDevice pic.twitter.com/kgDSx2PQzn

FDA - U.S. Food and Drug Administration

2-11-2018

#DYK the @US_FDA recently authorized the first direct-to-consumer test   for detecting genetic variants that may be associated with medication   metabolism? Learn more about the authorization:  https://go.usa.gov/xPVUt  #MedicalDevice #FDA

#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt  #MedicalDevice #FDA

#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

1-11-2018

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here:  https://go.u

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here: https://go.u

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here: https://go.usa.gov/xPysF  #MedicalDevice

FDA - U.S. Food and Drug Administration

2-10-2018

NexoBrid (MediWound Germany GmbH)

NexoBrid (MediWound Germany GmbH)

NexoBrid (Active substance: Concentrate of proteolytic enzymes enriched in bromelain) - PSUSA - Modification - Commission Decision (2018)6460 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10028/201712

Europe -DG Health and Food Safety