Bayvarol

Main information

  • Trade name:
  • Bayvarol Strips
  • Pharmaceutical form:
  • Bee-hive strip
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Bayvarol Strips
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • flumethrin
  • Therapeutic area:
  • Bees

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0227/001
  • Authorization date:
  • 09-01-2011
  • EU code:
  • UK/V/0227/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:December2011

AN.01933/2010

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Bayvarol3.6mgBee-hivestripsforhoneybees

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

OneBee-hivestripcontains:

Activesubstance

Flumethrin(85%) 4.23mg

(equivalentto3.6mgFlumethrin100%)

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Bee-hivestrips

Milkywhiteplasticstrips.

4. CLINICALPARTICULARS

4.1 Targetspecies

Honeybees

4.2 Indicationsforuse,specifyingthetargetspecies

ForthediagnosisandcontrolofflumethrinsensitiveVarroajacobsoniin

honeybees.

4.3 Contraindications

None

4.4 Specialwarningsforeachtargetspecies

None

Revised:December2011

AN.01933/2010

4.5 Specialprecautionsforuse

i) Specialprecautionsforuseinanimals

None

ii) Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Washhandsafterhandlingthestrips,beforemealsandafterwork.When

usingdonoteatdrinkorsmoke.

Donotopenfoilbagsuntilimmediatelypriortouse.

Avoidthestripscomingintocontactwithhoneytobeharvestedforhuman

consumption.

iii) Otherprecautions

None

4.6 Adversereactions(frequencyandseriousness)

TherewerenoadverseeffectsinthosecoloniestreatedwithBayvarolstrips

andthosewithaplacebocontrol.

4.7 Useduringpregnancy,lactationorlay

Notapplicable

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amount(s)tobeadministeredandadministrationroute

Bayvarolstripsareintendedforin-hiveuse.

BayvarolStripsaresuspendedintothespacesbetweenthecombsinthe

centralbrood-rearingareainsuchawaythattheycanbeoccupiedbybeeson

bothsides.Bothtabsarebentupwardsinthesamedirectionatthemarked

foldlinesandhookedoverthetopedgeofthewoodenframe.

Forlargecoloniesoccupyingseveralbroodchambers,twostripscanbejoined

togetherend-to-endwhichenablestheirinsertionintoandremovalfromthe

beespaceswithouthavingtoseparatethebroodchambers.

Normallydevelopedcoloniesreceivefourstrips.

Revised:December2011

AN.01933/2010

Nucleiandyoungcoloniesandnewlycollectedswarmsreceivehalfthatdose

i.e.twostrips

Largecoloniesoccupyingseveralbroodchambersreceivefourstripsper

chamberwhicharedistributedoverthecentralbeespacesineachbrood

chamber.

TimeandDurationofUse

BestefficacyistobeexpectedwhenBayvarolisusedinlatesummerafterthe

honeyharvest.Ideallythestripsshouldnotbeusedduringthepeakhoney

flowperiods.However,Bayvarolcanbeusedatanytimeoftheyearfor

diagnosisorinsevereinfestationswherethereisathreattothesurvivalofthe

colony.

Diagnosis

Thestripsareinsertedintothecolonyfor24hours.

Beforeinsertingthestripsthefloortrayiscoveredwithacleansheetofpaper.

ThisisthencheckedforthepresenceofdeadVarroamites24hourslater.

Treatment

Thestripsshouldbeleftinthecoloniesforamaximumofsixweeksandthen

removed.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Studiesinwhichdoublethenormalnumberofstripswereusedduringthe

winterperiodshowednoadverseeffectsonthebeesoranyadverseeffecton

subsequentbreeding.

4.11Withdrawalperiod(s)

Nowithdrawalperiodforhoneyisrequiredregardlessofwhenintheyear

Bayvarolisused.Otherbeeproduceshouldnotbetakenforhuman

consumptionuntilthespringfollowingtreatment.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Ectoparasiticidesfortopicaluse,incl.insecticides

ATCVetCode:QP53AC05

Flumethrinisasyntheticpyrethroidcompoundactingbypre-andpost-

synapticinductionofrepetitiveactionpotentialsandperturbationofaxonal

impulsesbychangesinK+/Na+permeability.

Revised:December2011

AN.01933/2010

5.1 Pharmacodynamicproperties

FlumethrinisatypeIIsyntheticpyrethroidandcausesalong-lasting

prolongationofthenormallytransientincreaseinsodiumpermeabilityofthe

nervemembraneduringexcitation,resultinginlong-lastingtrainsofrepetitive

firing.Theα-cyanogrouponthephenoxy-fluorobenzylalcoholmoietyis

consideredtoberesponsibleforthelong-lastingprolongationofsodium

permeability.ThetypeIIpyrethroidsproduceadistinctpoisoningsyndrome

whichischaracterisedbychoreoathetosis(sinuouswrithingofthewholebody)

andsalivation.

5.2 Pharmacokineticparticulars

ABSORPTION:Percutaneousabsorptioninmammalsisminimal.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Lowdensitypolyethylene

6.2 Incompatibilities

Noneknown

6.3 Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

5years

Shelf-lifeafterfirstopeningtheimmediatepackaging:6weeks

6.4 Specialprecautionsforstorage

Donotstoreabove25ºC.

Storeawayfromfood,drinkandanimalfeedingstuffs.

6.5 Natureandcompositionofimmediatepackaging

Aluminium/Polyester/PEfoilbagcontaining4bee-hivestrips

Packsize(s):

5bagspercartonand200bagspercarton.

Notallpacksizesmaybemarketed.

Revised:December2011

AN.01933/2010

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Bayvarolshouldnotenterwatercoursesasthismaybedangerousforfishand

otheraquaticorganism.Thereforedonotcontaminateponds,waterwaysand

ditcheswiththestriporusedpackaging.

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

UK:

IE:

Bayerplc,

AnimalHealthDivision,

BayerHouse,

StrawberryHill,

Newbury,

BerkshireRG141JA BayerLtd,

AnimalHealthDivision,

TheAtrium,

BlackthornRoad,

Dublin18,

Ireland

8. MARKETINGAUTHORISATIONNUMBERS

UKOnly:

IEOnly

Vm00010/4090 VPA10021/50/1

9. DATEOFFIRSTAUTHORISATION

UKOnly:

IEOnly

17July1992 28July1992

10. DATEOFREVISIONOFTHETEXT

December2011

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable