BYEMITE 500 mg/ml Concentrate for spraying emulsion for laying hens

Main information

  • Trade name:
  • BYEMITE 500 mg/ml Concentrate for spraying emulsion for laying hens
  • Pharmaceutical form:
  • Cutaneous solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BYEMITE 500 mg/ml Concentrate for spraying emulsion for laying hens
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • phoxime
  • Therapeutic area:
  • Chicken Layers

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0196/001
  • Authorization date:
  • 23-07-2010
  • EU code:
  • FR/V/0196/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ByeMite500mg/mlconcentrateforsprayingemulsionforlayinghens(allMSexceptIS,FIandSE)

Baymitevet.500mg/mlconcentrateforsprayingemulsionforlayinghens(IS,FIandSE)

Phoxim

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Phoxim 500mg/ml

Excipient(s):

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Concentrateforsprayingemulsion

Clearslightlyyellowtobrownliquid

4. CLINICALPARTICULARS

4.1 Targetspecies

Layinghens.

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofinfestationsofpoultryredmites(Dermanyssusgallinae)sensitivetoorganophosphates,

intherearingbuildingsofpulletsandlayinghens,inthepresenceoftheanimals.

4.3 Contraindications

Donotuseinbroilerfarms.

4.4 Specialwarnings

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Asthemitesdonotparasitethehensconstantlybuthideandmultiplyinhabitatsashortdistanceaway

fromthem,itiscriticallyimportantduringthemanualandautomatedsprayingprocedurestodirectthe

sprayconenotdirectlyontothehens,butontothecages,thebatteryinfrastructureandauxiliaries

(metalposts,feedtroughs,eggconveyorbeltsetc.)nearthehens.

Donotspraydirectlyontothebirds.Removefeedandeggsbeforetreatment.Anylooselitterinthe

layingnestsshouldberemovedbeforesprayapplication.Discardeggslaidduringandonthesame

dayafterthetreatment.

Cleaning,disinfectionandkillingofmitesintheemptypoultryhouseareimportantstepsforthe

controlofDermanyssusgallinae.Inaddition,anyintroductionofnewmitesintoapoultryhouseby

contaminatedmaterialsorpeople,wildbirdsorrodents,shouldbeprevented.Useofthisproduct

shouldberestrictedtothosecaseswhereitsuseisunavoidablebecausetheDermanyssusinfestation

hasbecomeoverwhelming.

Theproductshouldnotbesprayedwithinonemonthbeforetheplannedcleaningofthefacility.

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetheriskofdevelopmentof

resistanceandcouldultimatelyresultinineffectivetherapy:Toofrequentandrepeateduse

ofectoparassiticidesfromthesameclass,overanextendedperiodoftime.

Aswithotherparasites,resistancetoacaricidesinpopulationsofmitesresultsfromtheselectionof

individualswithlowerinherentsusceptibility,followingexposuretotheseacaricides.Resistance

developmentcanbeacceleratediflessthaneffectiveapplicationdosesareused.

Todelaythedevelopmentofphoxim-resistantDermanyssusstrainsitisrecommendedthat

treatmentofstockedlayerhousesshouldbe

-restrictedtothosecaseswhereatreatmentforanimalwelfareandeconomicreasonsis

unavoidable.

-thecleaninganddisinfectionofthepoultryhouseduringtheserviceperiodmustbeperformed

accurately

-thedosingisaccuratelycalculatedandasufficientamountofproductisprepared

-itispaidspecialattentionthatallsurfacesandhidingplacesaroundthehensaresufficiently

wetted

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Phoximisaskinsensitizerandslightlyirritatingtotheskinandeyes.Personswithknown

hypersensitivitytotheactivesubstanceshouldavoidcontactwiththeproduct.

Phoximisanorganophosphoruscompound.Donotuseifundermedicaladvicenottoworkwithsuch

compounds.Ifyouhavepreviouslyfeltunwellafterusingaproductcontaininganorganophosphorus

compound,consultyourdoctorbeforeworkingwiththisproductandshowthedoctortheproduct

label.

MedicalAdvicetoDoctors:Poisoningfromorganophosphoruscompoundsresultsfromblockageof

acetylcholinesterase,witharesultantover-activityofacetylcholine.Symptomsincludeheadache,

exhaustionandweakness,mentalconfusiontogetherwithblurredvision,excessivesalivationand

sweating,cramp-likeabdominalpain,chesttightness,diarrhoea,constrictedpupils,andbronchorrhea.

Thesemaydevelopforupto24hoursafterexposure.Severepoisoningcanincludegeneralmuscle

twitching,lossofco-ordination,extremedifficultywithbreathingandconvulsionswhichmayleadto

unconsciousnessintheabsenceofmedicaltreatment.Treatsymptomaticallyandseekurgenthospital

transferifpoisoningissuspected.

Thisproductisintendedtobeappliedbyveterinarians,pestcontroloperatorsorbyinformedfarmers,

whoareadvisedbyaveterinarian.Theproductshouldnotbeusedwithoutwearingprotective

equipmentasspecifiedbelow,whilsthandlingtheproductandadministeringthespraysolution.The

usermustcomplywithallrequirementsforprotectiveclothingandfollowallusersafety

recommendations.Ensurethatspareprotectiveclothingisavailableincaseanyitemsbecome

damaged.Nopersonnel,withtheexceptionofthesprayoperator,shouldbepresentinthepoultry

houseduringsprayapplication.Personnelshouldnotre-enterthepoultryhouseuntilthemorning(or

greaterthan12hours)aftersprayapplication.

Protectiveoverallwithhood:

CategoryIII,type4(spray-tightclothing)accordingtoEuropeanlegislation.Fastenthecuffsofthe

overallstotheprotectivegloveswithadhesivetape.

Facemaskandfilter:

FullfacemaskwithcombinationfilterA2P3orhigher.Ifthecharacteristicaromaticodourofthe

productisapparent,checkthatthemaskfitsproperlyand/orchangethefilter.

Protectivegloves:

NitrilerubberglovesaccordingtoEN374,permeationclass4(>120minutes)orhigher.

Adheretothemaximumexposuretime,whichisspecificfortheprotectiveequipment.

Product(emulsionconcentrate)

Avoiddirectcontactoftheproductwiththeskin.Changetheglovesortheprotectiveoverallafter

visiblecontactwiththeproduct.Incaseofaccidentalspillageontotheskinwashwithwaterandsoap.

Incaseofaccidentalspillageintotheeyeswashwithplentyofwater.

Sprayingsolution

Avoidanycontactofthesprayingsolutionwiththeskinduringapplicationandundressing.Wash

handswithwaterandsoapafterundressing.Donotre-usetheprotectiveoverall.

Keeptheproductandthesprayingsolutionawayfromfood,drinkandanimalfeed.Whenhandlingthe

productorthesprayingsolutiondonoteat,drinkorsmoke.

Otherprecautions

Phoximishighlytoxictofishandaquaticinvertebrates.Toreducetheenvironmentalimpactof

phoxim,restrictthenumberofannualhenhousetreatmentsto2,i.e.toatotalof4applications.In

addition,whenspreadingmanurederivedfromtreatedanimalsonagriculturalland,asafetydistance

of10metrestoadjacentsurfacewatersmustbekepttoavoidexposureoftheaquaticenvironment.

4.6 Adversereactions(frequencyandseriousness)

Thestressreactionscausedbythesprayingorthetemporarywithholdingoffeedduringthespraying

maycauseaminordecreaseinegglayingthenextday.

4.7 Useduringpregnancy,lactationorlay

Notapplicable.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Prepareaspraysolutionof2000ppmphoximbydilutionoftheveterinarymedicinalproductatarate

of100mLper25Lwaterandstirthoroughly.Applythisspraysolutionatarateof25Lperthousand

henplacesontothesurfacesthatdirectlysurroundthehensandweretheparasiteshide,i.e.cage

wires,ancillaryequipment,metalposts,feedthroughs,conveyorbelts,layingnestsetc.Useaspray

devicewhichdeliverscoarsespraydroplets.Conductarepeattreatment7dayslater.Preparethe

aqueoussolutionfreshlybeforeapplication.Theamountofthespraysolutionshouldbecalculated

carefullyandthewholeamountshouldbeappliedtothetreatedarea.Toreducetheenvironmental

impactofphoxim,restrictthenumberofannualhenhousetreatmentsto2,i.e.toatotalof4

applications.

Thespraysolutionissprayedontothecagesinthepresenceofpoultry.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Doublingtherecommendeddosagedoesnotcausesideeffects.Inonestudywith4timesthe

recommendeddosage,sneezingin60%ofthebirdsandatransientinterruptionoflayingfor2daysin

8%ofthebirdswereobserved.

Organophosphatepoisoninginahenmaybetreatedbyintramuscularinjectionof0.5to1.0mg

atropineperkgbodyweight.

4.11Withdrawalperiod(s)

Removeeggsbeforetreatment.Discardeggslaidduringandonthesamedayafterthetreatment.

Eggs: 12hours

Meatandoffal: 25daysafterthesecondtreatment

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup: Ectoparasiticides,insecticidesandrepellents,organophosphorous

compounds

ATCvetcode: QP53AF01

5.1 Pharmacodynamicproperties

Phoximisaninhibitoroftheenzymecholinesterase(AChE)atthenervesynapses.

Theinhibitionoftheenzymeisirreversibleunderphysiologicalconditions.Postsynapticaccumulation

ofacetylcholineinterfereswithnormalimpulsetransmissioninthearthropod’snervoussystem.A

phaseofmarkedhyperexcitationandconvulsionisfollowedbyparalysisanddeathoftheparasite.

PhoximisactiveagainstDermanyssusgallinae.

Phoximisacontactinsecticideandthemitesarekilledwhilstandaftercrawlingonthosephoxim-

treatedsurfaces.

5.2 Pharmacokineticparticulars

Phoximishydrolysedintoinactivecompoundsandexcretedchieflyviatheurine.

Environmentalproperties

Phoximishighlytoxictofishandaquaticinvertebrates.Phoximistoxictobees.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

n-Butanol

CalciumsaltofDodecylbenzolsulphonicacid

p-Methylphenylethyl(2,7)-phenoxy-polyglycol(27)-ether

p-Methylphenylethyl(2,7)-phenoxy-polyglycol(17)-ether

Xylene

Methylisobutylketone

6.2 Incompatibilities

Donotmixwithotherproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale 30months

Shelf-lifeafterfirstopeningtheimmediatepackaging 6months

Shelflifeafterdilutionaccordingtodirections: 24hours.

6.4.Specialprecautionsforstorage

Donotstoreabove25

C.

6.5 Natureandcompositionofimmediatepackaging

Bottleof250mLwithchild-proofclosure COEX(polyethylene/polyamide)

Screwcap polypropylene/polypropylene

Bottleof1Lwithchild-proofclosure COEX(polyethylene/polyamide)

Screwcap polypropylene/polypropylene

Bottleof5Lwithchild-proofclosure COEX(polyethylene/polyamide)

Screwcap polypropylene/polyethylene

Innersideofsealingdisc polyethylene

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.Phoximishighlytoxictofish

andaquaticinvertebrates.Theproductshouldnotenterwatercoursesasthismaybedangerousfor

fishandotheraquaticorganisms.

7. MARKETINGAUTHORISATIONHOLDER

[tobecompletednationally]

8. MARKETINGAUTHORISATIONNUMBER(S)

[tobecompletednationally]

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

[tobecompletednationally]

10. DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Veterinarymedicinalproductsubjecttoprescription.

24-10-2018

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