Startect

Main information

  • Trade name:
  • Startect Dual Active Oral Solution for Sheep
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Startect Dual Active Oral Solution for Sheep
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • sodium fluoride
  • Therapeutic area:
  • Sheep

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0380/001
  • Authorization date:
  • 23-11-2011
  • EU code:
  • UK/V/0380/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

STARTECTDualActiveOralSolutionforSheep

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

ActiveSubstances

Derquantel

Abamectin

Excipients

Butylatedhydroxytoluene

Forafulllistofexcipients,see

(mg/ml)

10

1.0

0.5

3. PHARMACEUTICALFORM

OralSolution

Acleartohazy,colourlesstoyellow-brownsolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Sheep

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4.2 Indicationsforuse,specifyingthetargetspecies

STARTECTDualActiveisabroadspectrumanthelminticforthetreatment

andcontrolofmixedgastro-intestinalnematodeinfectionsandassociated

diseasesofsheep.Thespectrumofactivityisasfollows:

AdultandImmatureGastro-intestinalNematodes:

Haemonchuscontortus (includinginhibitedlarvalstages)

Teladorsagia(Ostertagia)circumcincta(includinginhibitedlarvalstages)

Teladorsagia(Ostertagia)trifurcata

Trichostrongylusaxei

Trichostrongyluscolubriformis

Trichostrongylusvitrinus

Cooperiacurticei

Cooperiaoncophora

Nematodirusspathiger

Nematodirusfilicollis

Nematodirusbattus

Strongyloidespapillosus

Oesophagostomumvenulosum(adult)

Trichurisovis

Chabertiaovina

Lungworms:

Dictyocaulusfilaria (adult)

Thisproductiseffectiveagainststrainsofparasitesresistantto

benzimidazoles,levamisole,macrocycliclactones,andcombinationsof

these.

4.3 Contraindications

Donotuseindogsassevereadversereactionsmayoccur.

Donotuseinhorsesassevereadversereactions,includingfatalities,will

occur.

Donotexceedtherecommendeddoserate.

4.4 Specialwarningsforeachtargetspecies

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincrease

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theriskofdevelopmentofresistanceandcouldultimatelyresultinineffective

therapy:

Underdosing,whichmaybeduetounderestimationofbodyweight,

misadministrationoftheproductorlackofcalibrationofthedosing

device.

Toofrequentandrepeateduseofanthelminticsfromthesameclass

overanextendedperiodoftime.

Assessbodyweightasaccuratelyaspossiblebeforecalculatingdosage.

Suspectedclinicalcasesofresistanceshouldbefurtherinvestigatedusing

theappropriatetests,e.g.(FaecalEggCountReductionTest).Wherethe

resultsofthetest(s)stronglysuggestresistancetoaparticularanthelmintic,

ananthelminticbelongingtoanotherpharmacologicalclassandhavinga

differentmodeofactionshouldbeused.

4.5 Specialprecautionsforuse

i.Specialprecautionsforuseinsheep

TherecommendeddoseofSTARTECTDualActiveis0.2ml/kg;

dosesof0.9ml/kgandhigher(4.5Xtherecommendeddose)can

causesignsoftoxicityandmayleadtofatalities.

Ifanimalsarebatchedfordosingitisveryimportantthatcareful

considerationbegiventotheweightrangewithineachgroup,toavoid

theriskofoverdosingsmalleranimals.Arepresentativesampleof

animalsshouldbeweighedbeforetreatment.

Accuracyandproperfunctioningofthedosagedeviceshouldbe

checked.

ThesafetyofSTARTECTDualActivehasnotbeenestablishedin

sheepundersixweeksofageorweighinglessthan10kg.

ii.Specialprecautionsforthepersonadministeringtheveterinary

medicinalproducttoanimals

Donoteat,smokeordrinkwhilehandlingtheproduct.

Wearimpermeablerubberglovesduringuse.

Avoidingestion,inhalationandeyeandskincontact.Washhands

afterhandlingtheproduct.Incaseofaccidentalingestion,seek

medicaladviceimmediately.Showpackageleafletorlabeltothe

physician.

Incaseofaccidentaleyeorskincontact,washaffectedareas

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immediatelywithcleanrunningwaterandseekmedicalattentionif

irritationpersists.

iii.

Otherprecautions

4.6 Adversereactions(frequencyandseriousness)

Mildtransientcoughingisverycommonlyreportedfollowingdrenching.

4.7 Useduringpregnancy,lactationorlay

Theproductcanbeusedinpregnant,lactatingandbreedinganimals.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amount(s)tobeadministeredandadministrationroute

STARTECTDualActiveisaready-to-useoralsolution.

Thedoseforsheepis2mgderquanteland0.2mgabamectinperkg

bodyweight.i.e.1mlofproductper5kgbodyweight.

Drenchsheeporally,usingadrenchgunwithsiliconesealed‘o’rings.

Checkdoseratesandtheaccuracyofthedrenchgunbeforetreatment

commences.

Donotunder-orover-dose.Toensureadministrationofacorrectdose,body

weightshouldbedeterminedasaccuratelyaspossible.Ifanimalsaretobe

treatedcollectivelyratherthanindividually,theyshouldbegroupedaccording

totheirbodyweightanddosedaccordingly.Setthedosingguntodeliverthe

correctdosevolumefortheweightofsheeptobetreated(seefigure1).

Figure1

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Gentlyplacethenozzleofthedrenchgunoverthebackofthetongueand

depressthetrigger(seefigure2).

Figure2

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Dosesof0.9ml/kgandhigherhavebeenassociatedwithsymptomsof

toxicity.Signsoftoxicityincludedullness,depression,incoordination,

weakness,decreasedgastrointestinalmotilityandabnormalbreathing

pattern,recumbencyanddeath.Non-fataladverseeventshavebeenshown

tobefullyreversible.Supportiveveterinarycareisindicated;thereisno

knownantidote.

4.11 Withdrawalperiod(s)

Meatandoffal:14days

Milk:donotuseinlactatingewesproducingmilkforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Endectocides

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ATCVetCode:QP54AA52

5.1 Pharmacodynamicproperties

Derquantelisthefirstmemberofthespiroindoles,anovelclassof

anthelminticswithadifferentmodeofactionfromexistinganthelmintic

classes.Itactsasanantagonistatnicotiniccholinergicreceptors(nAChR).It

preventscontractionofsomaticmuscleintheparasitesbyblockingACh-

inducedactivationofcationchannelsinthemusclemembrane.Thisblockade

resultsinflaccidparalysisinnematodes.

Abamectinisamemberofthemacrocycliclactone(ML)familyof

anthelmintics.Abamectinexertsitsanthelminticeffectbybindingto

glutamate-gatedchloride(GluCl)channelsexpressedonnematodeneurones

andpharyngealmusclecells.Thisleadstoanincreasedpermeabilityofthe

cellmembranetochlorideionswithhyperpolarisationofnerveormusclecells

resultinginparalysisanddeathoftheparasite.

5.2 Pharmacokineticproperties

AfterasingleoraladministrationofSTARTECTDualActive,maximum

concentrationsofderquantelof108ng/mlwerereachedat4.2h.The

terminalt1/2ofderquantelwas9.3handtheabsolutebioavailabilitywas

56.3%.Themaximumconcentrationofabamectinafteroraladministrationof

STARTECTDualActivewas31.1ng/mlandwasreachedat24hpost-dose.

Theterminalt1/2ofabamectinwas28handtheabsolutebioavailabilitywas

69.7%.

Themetabolismofderquantelisextensiveandcomplex.Derquantel

undergoesbiotransformationtoalargenumberofmetabolitesoverashort

timeperiodandasaresult,extensivevariationinmetaboliteshasbeenfound

overtissuesandtimeperiods.

Highestconcentrationsofabamectinwerefoundinliverandfatwithmuch

lowerconcentrationsbeingpresentinkidneyandmuscle.By10and14days

theconcentrationsinmanykidneyandfatsampleswereclosetoorbelow

thelimitofdetection.AbamectinB

wasthemajorcomponentinalltissues.

Afteroraladministration,themajorityofderquanteliseliminatedinthefaeces

andasmallerpartintheurine,whileabamectinisalmostentirelyexcreted

viathefaeceswitheliminationinurinebeingnegligible.”

Pharmacokineticstudiesinsheephavedemonstratedthatthereareno

negativeinteractionsbetweenthe2activeprinciples,derquanteland

abamectin,inSTARTECTDualActive.

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5.3 Environmentalproperties

Theproductistoxictodunginsects.Itisexcretedmainlyinfaecesandit

cannotbeexcludedthatinsectsusingdungexcretedaftertreatmentmaybe

adverselyaffected.UsingtheproductstrictlyinaccordancewiththeSPCwill

keepthisrisktoaminimum.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Butylatedhydroxytoluene

Glycerolformal

Triacetin

Propyleneglycoldicaprylate

6.2 Incompatibilities

Nottobemixedwithotherveterinarymedicinalproductsbefore

administration.

6.3 Shelflife

Shelf-lifeofveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:12months.

6.4 Specialprecautionsforstorage

Donotrefrigerateorfreeze.

6.5 Natureandcompositionofimmediatepackaging

PurplesquarebottombackpackHDPEpolymerbottles(1Land5L)withdraw

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offtubes(whiteLDPE,tubewithEDPMvalve)andchildresistantlids.Purple

jerrycan,(15L)HDPEpolymer,withwhitecap.15Ljerrycanhas

polypropylenetapwithO-ringsiliconesealwithtamperprooflid.

Packsizes:1L,5Land15Lmulti-dosepacks.Notallpacksizesmaybe

marketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts,if

appropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfrom

suchveterinarymedicinalproductsshouldbedisposedofinaccordancewith

localrequirements.

Extremelydangeroustofishandaquaticlife.Donotcontaminatewater

courseswiththeproductorusedcontainer.

7. MARKETINGAUTHORISATIONHOLDER

PfizerLtd

RamsgateRoad

Sandwich

Kent

CT139NJ

8. MARKETINGAUTHORISATIONNUMBER

Vm 00057/4420

9. DATEOFFIRSTAUTHORISATION

13January2012

10. DATEOFREVISIONOFTHETEXT

January2012