Bolfo Spray

Main information

  • Trade name:
  • Bolfo Spray
  • Pharmaceutical form:
  • Cutaneous spray, solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Bolfo Spray
    Netherlands
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0160/001
  • Authorization date:
  • 23-03-2011
  • EU code:
  • NL/V/0160/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BAYFOSpray2.5mg/gforcatsanddogs

BOLFOSpray2.5mg/gforcatsanddogs [NL]

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Pergramspray:

Activesubstance:

Propoxur 2.5mg.

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Dermalspray,solution.

Ready-to-usesprayingsolutionforcutaneoususebasedon0.25%activesubstanceinanecofriendly

propellantgasmixtureofpropaneandbutaneinaratioofabout15:85.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogandcat.

4.2 Indicationsforuse,specifyingthetargetspecies

Toeliminateanexistingflea( Ctenocephalidesfelis) and/ortick(Dermacentorvariabilis,Ixodesricinus

Rhipicephalussanguineus)burdenfromdogsandcats.

Theproductcanbeusedaspartofatreatmentagainstfleaallergydermatitis(FAD).

4.3 Contraindications

Donotuseonsickorconvalescinganimals.

Donotuseonlactatinganimals.

Donotuseonanimalsunder3monthsofage.

Donotapplyontoanimalswithextensiveskinlesions.

4.4 Specialwarningsforeachtargetspecies

Dependingonthehairlength,season,andinfestationpressurefromtheenvironment,retreatmentmaybe

necessaryafteroneuptofourweeks.

Besidesthefleasonthedogorcat,alsofleaeggs,-larvesand-pupaecanbepresentintheenvironment.

Afteracertaintime,thesecangrowoutintonewadultfleas.Foranefficientfleacontrol,alsothesestages

inthesurroundingsofthedogorcatneedtobefoughtwithabiocidalproductpermittedforsuchuse.

90-100%oftheticksondogswillbekilled,butsomedeadtickscanremainontheanimalbeforefalling

off.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Donotsprayintoeyesornose.

Dogsshouldnotbeallowedtoswiminwatercoursesforatleast24hoursaftertreatment(seesection6.6).

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Keepawayfromfoodandanimalfeed.

Donotsprayinthedirectionofaflameorahotobject.

Keepawayfromsourcesofignition.Donotsmoke.

Donotpierceorburncan,alsoafteruse.

Useonlyoutdoors,orelseinawellventilatedarea.

Donotinhalespraymistandavoidallcontactwithskin,eyes,ormouthasthisproductmightbetoxic

afterinhalation,directskincontact,andingestion,itisirritatingtoeyes,anditmaycausedrowsinessor

dizziness.

Thisproductshouldnotbehandledbypregnantwomeninthethirdtrimesterofpregnancyasitmay

induceuteruscontractions.

Protecteyes/faceduringtreatmentandwashhandsafterwards.

Incaseofcontactwitheyesorskin,washwithplentyofwaterimmediately.

Incaseofaccidentalingestionorifyoufeelunwell,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.

Treatedanimalsshouldnotbehandledespeciallybychildrenuntilthefurisdry.Thismaybeensuredby

treatingtheanimalsforinstanceintheevening.Recentlytreatedanimalsshouldnotbeallowedtosleep

togetherwiththeirowner,especiallychildren.

4.6 Adversereactions(frequencyandseriousness)

Inveryrarecasesvomitinganddiarrheacanbeobserved.

4.7 Useduringpregnancy,lactationorlay

Fromresultsoflaboratorytestswithdifferentanimalspeciesitisshownthattherearenoadverseeffects

tobeexpectedduringpregnancy.Donotuseonlactatinganimals.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Donotuseanotherinsecticideconcurrentlyontheanimal.

4.9 Amountstobeadministeredandadministrationroute

Spraytheanimal’sfuragainstthelieofthehairuntiltheentirecoatisslightlywetted.

Theproductcanbeusedaspartofatreatmentagainstfleaallergydermatitis.Ifnecessary,consulta

veterinarianforfurthersupport.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Testsondogsandcatswithtwicetherecommendeddoseoftheactivesubstancerevealednosignsof

intolerance.

Multipleoverdosingandpotentialswallowingbyhumansoranimalscanhoweverleadtosignsof

carbamatepoisoningsuchasextensivesalivation,miosis(constrictionofthepupils),vomitingordiarrhea.

Insuchcases,seekimmediatemedicalassistance.

Antidote:Atropinesulphate.

4.11 Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:ectoparasiticides(fortopicaluse);

ATCvetcode:QP53AE02

5.1 Pharmacodynamicproperties

Propoxurisanectoparasiticideofthecarbamicacidtype andaffectsthenervoussystemofthepresent

insectsviadirectcontactfollowedbyingestion.Asaconsequenceoftheinhibitionofcholinesteraseby

propoxur,atoxicaccumulationoftheneurotransmitteracetylcholineisobservedatthecholinergicnerve

ends.Thisresultsinanefficientkillingoffleasandticks.Mammaliantoxicity,however,isratherlow.

Whenusedaccordingtotheleaflet,theeffectonfleasandticksondogsandcatsisalmostimmediate

(within24-48hours).

Bymeansofthesprayingsolution,theactivesubstancepropoxurisdirectlybroughtontothesiteof

action.

5.2 Pharmacokineticproperties

Theactiveingredientpropoxurisappliedasasprayinthefur.Thedistributionoverthewholebody

surfacetakesplacebythepersonadministeringtheproduct;anyspreadingoftheformulationitselfisnot

necessary.Thevolatilesolventsevaporateimmediatelyandthemicrocristallineactivesubstanceremains

onthefur.Inthecatandthedogmostofthesubstancewillremaininthefur

Metabolisationofpropoxurisquick.Themajorroutesofmetabolisminratswereshowntobe

depropylationto2-hydroxyphenyl-N-methylcarbamateandsubsequenthydrolysistoisopropoxyphenol.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Anhydrouscitricacid

Isopropylalcohol

Propane

Butane

6.2 Incompatibilities

Donotmixwithanotherveterinarymedicinalproduct.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

6.4 Specialprecautionsforstorage

Donotstoreabove30

C.Donotrefrigerateorfreeze.

Pressurisedcontainer.Protectfromsunlight.

6.5 Natureandcompositionofimmediatepackaging

Aluminiumspraycanof250ml.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnationalrequirements.

Propoxurmayadverselyaffectaquaticorganismsandbees.Donotcontaminateponds,waterwaysor

ditcheswiththeproductoremptycontainers.

7. MARKETINGAUTHORISATIONHOLDER

NL:

BayerB.V.

AnimalHealthDivision

Energieweg1

NL-3641RTMijdrecht

CMSs:

tobecompletedlocally

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/LASTRENEWALOFTHE

AUTHORISATION

10. DATEOFREVISIONOFTHETEXT

ANNEXIII

LABELLINGANDPACKAGELEAFLET

A.LABELLING

Thereisnocartonbox;

Thelabelingtextaswellasthepackageleaflettextisprintedonthebottle.

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

Aluminiumspraycanof250ml(Allinformationappearsonthelabelling.)

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Bayfo ® Spray2.5mg/gforcatsanddogs

Bolfo ® Spray2.5mg/gforcatsanddogs [NL]

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Pergramspray:

Activesubstance:

2.5mgpropoxur.

3. PHARMACEUTICALFORM

Dermalspray

4. PACKAGESIZE

250ml

5. TARGETSPECIES

forcatsanddogs

6. INDICATION(S)

Toeliminateanexistingflea( Ctenocephalidesfelis) and/ortick(Dermacentorvariabilis,Ixodesricinus

Rhipicephalussanguineus)burdenfromdogsandcats.

Theproductcanbeusedaspartofatreatmentagainstfleaallergydermatitis(FAD).

7. CONTRAINDICATIONS

Donotuseonsickorconvalescinganimals.

Donotuseonlactatinganimals.

Donotuseonanimalsunder3monthsofage.

Donotapplyontoanimalswithextensiveskinlesions.

8. ADVERSEREACTIONS

Inveryrarecasesvomitinganddiarrheacanbeobserved.

Ifyoudetermineanyseriousadverseeffectorotherreactionnotindicatedinthispackageleaflet,inform

yourveterinarian.

9. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Spraytheanimal’sfuragainstthelieofthehairuntiltheentirecoatisslightlywetted.

Theproductcanbeusedaspartofatreatmentagainstfleaallergydermatitis.Ifnecessary,consulta

veterinarianforfurthersupport.

10. WITHDRAWALPERIOD

-

11.SPECIALWARNING(S)

Donotsprayintoeyesornose.

Dogsshouldnotbeallowedtoswiminwatercoursesforatleast24hoursaftertreatment.

Donotuseanotherinsecticideconcurrentlyontheanimal.

Dependingonthehairlength,season,andinfestationpressurefromtheenvironment,retreatmentmaybe

necessaryafteroneuptofourweeks.

Besidesthefleasonthedogorcat,alsofleaeggs,-larvesand-pupaecanbepresentintheenvironment.

Afteracertaintime,thesecangrowoutintonewadultfleas.Foranefficientfleacontrol,alsothesestages

inthesurroundingsofthedogorcatneedtofoughtwithabiocidalproductpermittedforsuchuse.

90-100%oftheticksondogswillbekilled,butsomedeadtickscanremainontheanimalbeforefalling

off.

Donotsprayinthedirectionofaflameorahotobject.Keepawayfromsourcesofignition.Donot

smoke.Donotpierceorburncan,alsoafteruse.Onlyuseoutdoors,orelseinawellventilatedarea.Do

notinhalespraymistandavoidallcontactwithskin,eyes,ormouthasthisproductmightbetoxicafter

inhalation,directskincontact,andingestion,itisirritatingtoeyesanditmaycausedrowsinessor

dizziness.Thisproductshouldnotbehandledbypregnantwomeninthethirdtrimesterofpregnancyasit

mayinduceuteruscontractions.Protecteyes/faceduringtreatmentandwashhandsafterwards.Incaseof

contactwitheyesorskin,washwithplentyofwaterimmediately.Incaseofaccidentalingestionorifyou

feelunwell,seekmedicaladviceimmediatelyandshowthepackageleafletorthelabeltothephysician.

Treatedanimalsshouldnotbehandledespeciallybychildrenuntilthefurisdry.Thismaybeensuredby

treatingtheanimalsforinstanceintheevening.Recentlytreatedanimalsshouldnotbeallowedtosleep

togetherwiththeirowner,especiallychildren.

Donotmixwithanotherveterinarymedicinalproduct.

12. EXPIRYDATE

EXP:

13. SPECIALSTORAGEPRECAUTIONS

Donotstoreabove30°C.Donotrefrigerateorfreeze.

Pressurisedcontainer.Protectfromsunlight.

Keepawayfromfoodandanimalfeed.

14. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnationalrequirements.

Propoxurmayadverselyaffectaquaticorganismsandbees.Donotcontaminateponds,waterwaysor

ditcheswiththeproductoremptycontainers.

15. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Freesale.

16. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofreachandsightofchildren.

17. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

Marketingauthorisationholder:

NL:

BayerB.V.

AnimalHealthDivision

Energieweg1

NL-3641RTMijdrecht

CMSs:

tobecompletedlocally

Manufacturerforthebatchrelease:

KVPPharma+VeterinärProdukteGmbH

ProjensdorferStr.324

D-24106Kiel

Germany

18. MARKETINGAUTHORISATIONNUMBER

19. MANUFACTURER’SBATCHNUMBER

Lot:

20. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

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