Apistan

Main information

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

Documents

Localization

  • Available in:
  • Apistan
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • fluvalinate
  • Therapeutic area:
  • Bees

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0403/001
  • Authorization date:
  • 14-07-2011
  • EU code:
  • UK/V/0403/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:August2011

AN:02140/2010

Page1of4

SUMMARYOFPRODUCTSCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Apistan10.3%w/wbeehivestrip[UK]

Apistanvet10.3%w/wbeehivestrip[SE]

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstancemg/strip

Taufluvalinate824

Forafulllistofexcipients,pleaseseesection6.1.

3. PHARMACEUTICALFORM

Beehivestrip

8gpolymerstripmeasuringapproximately25x3x0.075cm.

4. CLINICALPARTICULARS

4.1 Targetspecies

Thehoneybee,Apismellifera

4.2 Indicationsforuse,specifyingthetargetspecies

Controlofvarroosis(Varroadestructor(formerlyknownasVarroajacobsoni))inhoneybee

colonies

4.3 Contraindications

Noneknown

4.4 Specialwarningsforeachtargetspecies

None

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Ifsignsofdiseaseappearorpersistthenconsultyourveterinarysurgeon.

ii. Specialprecautionsforthepersonadministeringtheveterinarymedicinal

producttoanimals

Avoidcontactwithskin,mouthandeyes.

Weargloveswhenhandlingstrips.

Washhandsthoroughlyafterhandlingstrips.

Donotsmoke,drinkoreatduringapplication.

4.6 Adversereactions(frequencyandseriousness)

None

4.7 Useduringpregnancy,lactationorlay

Notapplicable

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown

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4.9 Amount(s)tobeadministeredandadministrationroute

Dose:

2Apistanstripsperbroodchamberperbeehive.

Administration:

Stripsaresuspendedmid-waybetweenthebroodframessothatthebeescanwalkonboth

sidesofthestrip.Onestripissuspendedbetweenframes3&4andtheotherbetween

frames7&8withinthebroodchamber.

Treatmentduration6-8weeks,afterwhichtimethestripsmustberemovedanddisposed

of.Thestripsshouldnotberemovedfromthehiveforatleast6weeks.Donotleavethe

stripsinthehiveformorethan8weeks.Thetreatmentperiodshouldbekeptasshortas

possibleinordertoreducethelikelihoodoftraceresiduesinbroodwaxandtoavoidthe

developmentofmiteresistance.

Smallandwinteringbeecoloniesandnucleirequireonestriponly,suspendedthroughthe

beeorbroodcluster.

Stripsshouldnotbeplacedinthehoneysupers.

Theefficacyismaximisediftheproductisusedinlatesummerafterthemainhoneyharvest

(whentheamountofbeebroodpresentisdiminishing).However,inthecaseofsevere

infestations,Apistancanbeusedatanytimeofyear.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Notreatmentspecified.Incaseofdoubt,removeproductfromthecolony.

4.11Withdrawalperiod(s)

Honey-Zerodays

Donotuseduringhoneyflow.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:

Antiparasiticproducts,insecticidesandrepellents,Ectoparaciticides,includinginsecticides

andrepellents,Ectoparasiticidesfortopicaluse,includinginsecticides,Pyrethrinsand

pyrethroids,fluvalinate.

ATCVetCode:

QP53AC10

5.1 Pharmacodynamicproperties

Tau-fluvalinateisanectoparasiticideofthecyanopyrethroidclassofcompounds,whichact

bycausingrapiddepolarisationoftheaxonalmembranes.Themoleculeisoflowtoxicityto

honeybeesinparticularduetothepoorfitofthemoleculeinpotentialreceptorsitesinthis

species.InVarroadestructor,uptakeisrapidanddeathresultsfromhyperexcitabilityand

nervousexhaustion.

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5.2 Pharmacokineticproperties

Tau-fluvalinateactsbycontact.MoleculesoftheActivePharmaceuticalIngredientmigrateto

thestripsurfaceataproscribedrate,determinedbythereservoirloadingofthepolymer.

Beeswalkoverthestripsandpickupsurfacemoleculesoftau-fluvalinate.Varroamitesin

contactwiththebeesaresubjectedtothemolecule,whichislethaltomitesbutofrelatively

lowhazardtobees.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Polyvinylchloride

Bis(2-ethylhexyl)phthalate

Butylbenzylphthalate

Epoxidizedsoybeanoil

Stearicacid

6.2 Incompatibilities

Noneknown

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years

6.4 Specialprecautionsforstorage

Keepstripsinoriginal,unopenedpackaginguntilreadytouse

Donotstoreabove25ºC

Protectfromdirectsunlight

Storeinoriginalpackagingonly

Donotstorestripsnearpesticidesorotherchemicalsubstanceswhichcouldcontaminate

theproduct

Storeawayfromfoodstuffs

Replaceunusedstripsintheoriginalpackaging

Usestripsforonetreatmentonly-donotre-usestrips

6.5 Natureandcompositionofimmediatepackaging

Interiorlaminatedfoilpouchholding10Apistanstrips;containedinouterpaperpouch

bearingtheproductlabel.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts,ifappropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

Extremelydangeroustofishandaquaticlife.Donotcontaminateponds,waterwaysor

ditcheswithstripsoremptypackaging.

7. MARKETINGAUTHORISATIONHOLDER

Vita(Europe)Limited

VitaHouse

LondonStreet

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AN:02140/2010

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Basingstoke

Hampshire

RG217PG

UK

8. MARKETINGAUTHORISATIONNUMBER

Vm17017/4000

9. DATEOFFIRSTAUTHORISATION

26November1998

10. DATEOFREVISIONOFTHETEXT

August2011