Bolfo Shampoo

Main information

  • Trade name:
  • Bolfo Shampoo
  • Pharmaceutical form:
  • Shampoo
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Bolfo Shampoo
    Greece
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • propoxur
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0161/001
  • Authorization date:
  • 23-03-2011
  • EU code:
  • NL/V/0161/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BOLFOshampoo1.1mg/mlfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Permlshampoo:

Activesubstance:

Propoxur 1.1mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Shampoo.

Ready-to-use0.1%solutionforshampooingofthefur.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dog.

4.2 Indicationsforuse,specifyingthetargetspecies

Toeliminateanexistingfleaburden(Ctenocephalidesfelis)fromdogs.

Theproductcanbeusedaspartofatreatmentagainstfleaallergydermatitis(FAD).

4.3Contraindications

Donotuseonsickorconvalescinganimals.

Donotuseonlactatinganimals.

Donotuseonanimalsunder3monthsofage.

Donotapplyontoanimalswithextensiveskinlesions.

4.4Specialwarningsforeachtargetspecies

Theshampookillspresentfleasimmediately,butdoesnotprovideanyresidualeffect.Asa

consequence,retreatmentmaybenecessaryafter3to7days,dependingonthehairlength,season,

andinfestationpressurefromtheenvironment.

Besidesthefleasonthedog,alsofleaeggs,-larvesand-pupaecanbepresentintheenvironment.

Afteracertaintime,thesecangrowoutintonewadultfleas.Foranefficientfleacontrol,alsothese

stagesinthesurroundingsofthedogsneedtobefought.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Avoidcontactwiththeeyesandmucosaeofthedog.

Dogsshouldnotbeallowedtoswiminwatercoursesaslongasthetreatedfurisstillwet(see

section6.6).

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproduct

toanimals

Avoidallcontactwithskin,eyes,ormouthasthisproductmightbetoxicafterdirectskincontact

andafteringestion,anditcancauseeyeandskinirritation.

Thisproductshouldnotbehandledbypregnantwomeninthethirdtrimesterofpregnancyasitmay

induceuteruscontractions.

Wearrubberhouseholdglovesduringtreatmentandwashhandsafterwards.

Incaseofcontactwitheyesorskin,washwithplentyofwaterimmediately.

Incaseofaccidentalingestionorifyoufeelunwell,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.

4.6 Adversereactions(frequencyandseriousness)

Inveryrarecasesvomitinganddiarrheacanbeobserved.

4.7 Useduringpregnancy,lactationorlay

Fromresultsoflaboratorytestswithdifferentanimalspeciesitisshownthattherearenoadverse

effectstobeexpectedduringpregnancy.

Donotuseonlactatingdogs.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Donotuseanotherinsecticideconcurrentlyontheanimal.

4.9 Amountstobeadministeredandadministrationroute

Thoroughlywashthedogwithtepidwaterinadvance,inordertowetthefur.Rubthefur

thoroughlyandcarefullywiththeshampoo,notforgettingthehead,neck,andears.

Avoidcontactwiththeeyesandmucosaeofthedog.Letthefoamworkinduringabout5minutes;

thenrinseIncaseofaccidentalcontactwiththeeyes,washwithplentyofwaterimmediately.

Theproductcanbeusedaspartofatreatmentagainstfleaallergydermatitis.Ifnecessary,consulta

veterinarianforfurthersupport.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Whenusedasrecommended,anoverdoseisalmostimpossiblebecauseoftherouteof

administration.

Incaseofaccidentalswallowing,signsofcarbamatepoisoningsuchasextensivesalivation,miosis

(constrictionofthepupils),vomitingordiarrheacanoccur.Insuchcases,seekimmediatemedical

assistance.

Antidote:Atropinesulphate.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:ectoparasiticides(fortopicaluse),

ATCvet-code:QP53AE02

5.1 Pharmacodynamicproperties

Propoxurisanectoparasiticideofthecarbamicacidtypeandaffectsthenervoussystemofthe

presentinsectsviadirectcontactfollowedbyingestion.Asaconsequenceoftheinhibitionof

cholinesterasebypropoxur,atoxicaccumulationoftheneurotransmitteracetylcholineisobservedat

thecholinergicnerveends.Thisresultsinanefficientkillingoffleasandticks.Mammaliantoxicity,

however,isratherlow.Whenusedaccordingtotheleaflet,theeffectonfleasondogsisimmediate.

5.2 Pharmacokineticproperties

Itisplausiblethatmostoftheappliedquantityoftheactivesubstancewillbewashedoffwhen

rinsingthefur.Therefore,aresidualeffectoraprolongedactioncannotbeexpected.

Theactiveingredientpropoxurisappliedasashampoointhewettenedfur.Thedistributionoverthe

wholebodysurfacetakesplacebythepersonadministeringtheproduct;anyspreadingofthe

formulationitselfisnotnecessary.After(aperiodof)5minutestheshampooiswashedoutofthe

fur.Theabsorptionthroughtheskinisabsentornegligible,especiallyherewherethecontactperiod

isveryshort.

Metabolisationofpropoxurisquick.Themajorroutesofmetabolisminratswereshowntobe

depropylationto2-hydroxyphenyl-N-methylcarbamateandsubsequenthydrolysisto

isopropoxyphenol.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Triethanolaminealkylbenzenesulphonate

Sodiumalkylbenzenesulphonate

Oleinicaciddiethanolamine

Anhydrouscitricacid

Perfume

Polyethyleneglycol400

6.2 Incompatibilities

Donotmixwithanotherveterinarymedicinalproduct.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:5years.

6.4 Specialprecautionsforstorage

Donotstoreabove30°C.Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

WhiteHDPEtubeof100mlwithpolypropylenescrewcap.

WhiteHDPEbottleof250mlwithpolypropylenesnapcap.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnational

requirements.

Propoxurmayadverselyaffectaquaticorganismsandbees.Donotcontaminateponds,waterwaysor

ditcheswiththeproductoremptycontainers

7. MARKETINGAUTHORISATIONHOLDER

NL:

BayerB.V.

AnimalHealthDivision

Energieweg1

NL-3641RTMijdrecht

CMSs:

tobecompletedlocally

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/LASTRENEWALOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

ANNEXIII

LABELLINGANDPACKAGELEAFLET

A.LABELLING

Thereisnocartonbox;

Thelabelingtextaswellasthepackageleaflettextarerepresentedonthebottle.

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

HDPEtube(100ml)withPPscrewcap.

HDPEbottle(250ml)withPPsnapcap.(Allinformationappearsonthelabelling.)

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Bolfo ® Shampoo1.1mg/mlfordogs

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

per1mlshampoo:

Activesubstance:

1.1mgpropoxur.

3. PHARMACEUTICALFORM

Shampoo

4. PACKAGESIZE

100ml

or

250ml

5. TARGETSPECIES

fordogs

6. INDICATION(S)

Toeliminateanexistingfleaburden(Ctenocephalidesfelis)fromdogs.

Theproductcanbeusedaspartofatreatmentagainstfleaallergydermatitis(FAD).

7. CONTRAINDICATIONS

Donotuseonsickorconvalescinganimals.

Donotuseonlactatinganimals.

Donotuseonanimalsunder3monthsofage.

Donotapplyontoanimalswithextensiveskinlesions.

8. ADVERSEREACTIONS

Inveryrarecasesvomitinganddiarrheacanbeobserved.

Ifyounoticeanyseriousadverseeffectorotherreactionnotindicatedinthispackageleaflet,inform

yourveterinarian.

9. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Thoroughlywashthedogwithtepidwaterinadvance,inordertowetthefur.Rubthefur

thoroughlyandcarefullywiththeshampoo,notforgettingthehead,neckandears.Avoidcontact

withtheeyesandmucosaeofthedog.

Letthefoamworkinduringabout5minutes;thenrinsethoroughlywithtepidwaterandrubthefur

dry.Incaseofaccidentalcontactwiththeeyes,washwithplentyofwaterimmediately.

Theproductcanbeusedaspartofatreatmentagainstfleaallergydermatitis.Ifnecessary,consulta

veterinarianforfurthersupport.

10. WITHDRAWALPERIOD

-

11. SPECIALWARNING(S)

Donotuseanotherinsecticideconcurrentlyontheanimal.

Dogsshouldnotbeallowedtoswiminwatercoursesaslongasthetreatedfurisstillwet.

Theshampookillspresentfleasimmediately,butdoesnotprovideanyresidualeffect.Asa

consequence,retreatmentmaybenecessaryafter3to7days,dependingonthehairlength,season,

andinfestationpressurefromtheenvironment.

Besidesthefleasonthedog,alsofleaeggs,-larvesand-pupaecanbepresentintheenvironment.

Afteracertaintime,thesecangrowoutintonewadultfleas.Foranefficientfleacontrol,alsothese

stagesinthesurroundingsofthedogsneedtobefought.

Avoidallcontactwithskin,eyes,ormouthasthisproductmightbetoxicafterdirectskincontact

andafteringestion,anditcancauseeyeandskinirritation.Thisproductshouldnotbehandledby

pregnantwomeninthethirdtrimesterofpregnancyasitmayinduceuteruscontractions.

Wearrubberhouseholdglovesduringtreatmentandwashhandsafterwards.

Incaseofcontactwitheyesorskin,washwithplentyofwaterimmediately.

Incaseofaccidentalingestionorifyoufeelunwell,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.

Donotmixwithanotherveterinarymedicinalproduct.

Forexternaluseonly.

12. EXPIRYDATE

EXP:

13. SPECIALSTORAGEPRECAUTIONS

Donotstoreabove30°C.Donotfreeze.

14. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnational

requirements.

Propoxurmayadverselyaffectaquaticorganismsandbees.Donotcontaminateponds,waterwaysor

ditcheswiththeproductoremptycontainers.

15. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Freesale.

16. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofreachandsightofchildren.

17. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,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