Dectomax Pour On Solution for Cattle 5mg/ml

Main information

  • Trade name:
  • Dectomax Pour-on for cattle
  • Pharmaceutical form:
  • Pour-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Dectomax Pour-on for cattle
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • doramectin
  • Therapeutic area:
  • Cattle Females, Cattle Male

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0120/001
  • Authorization date:
  • 12-01-2011
  • EU code:
  • UK/V/0120/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:December2011

AN:01227/2011

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Dectomax10mg/mlSolutionforInjectionforPigs(UK)

Zearl10mg/mlSolutionforInjectionforPigs(IE)

Dectomax®S10mg/mlSolutionforInjectionforPigs(AT)

DectomaxVet.,10mg/ml,SolutionforInjection(Pigs)(DK)

Zearlpigs(FR)

Dectomax10mg/mlSolutionforInjectionforPigs(BE,LU)

Dectomax ® SSolutionforInjection10mg/mlforPigs(DE)

Dectomax10mg/mlSolutionforInjectionforPigs(ES)

DectomaxforPigsVet.(SE)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlDectomaxInjectionSolution10mg/mlcontainsthefollowing:

Activesubstance:

Doramectin 10mg (1)

Excipient(s):

Butylhydroxyanisole(E320) 0.1mg

Containsnooverageandassumesapotencyof100percent.Theactual

amountofdoramectinaddedwilldependonthepotencyoftheingoing

drugsubstance.

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Colourlesstopaleyellowsterileoilysolution.

4. CLINICALPARTICULARS

4.1Targetspecies

Pigs.

4.2Indicationsforuse,specifyingthetargetspecies

Fortreatmentofmangemites,gastrointestinalroundworms,lungworms,

kidneywormsandsuckingliceinpigs.

Gastrointestinalnematodes(adultsandfourthstagelarvae)

Hyostrongylusrubidus

Ascarissuum

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Strongyloidesransomi(adultsonly)

Oesophagostomumdentatum

Oesophagostomumquadrispinulatum

Lungworms

Metastrongylusspp.(adultsonly)

Kidneyworms

Stephanurusdentatus(adultsonly)

SuckingLice

Haematopinussuis

MangeMites

Sarcoptesscabiei

Dectomaxinjectionforpigsprotectspigsagainstinfectionorreinfection

withSarcoptesscabieifor18days.

4.3Contraindications

Theproducthasbeenformulatedspecificallyforpigs.Itshouldnotbe

administeredtootherspeciesassevereadversereactions,including

fatalitiesindogs,mayoccur.Donotuseincaseofhypersensitivitytothe

activesubstanceoranyoftheexcipients.

4.4Specialwarningsforeachtargetspecies

Careshouldbetakentoavoidthefollowingpracticesbecausethey

increasetheriskofdevelopmentofresistanceandcouldultimatelyresultin

ineffectivetherapy:

-toofrequentandrepeateduseofanthelminticsfromthesameclass,over

anextendedperiodoftime.

-underdosing,whichmaybeduetounderestimationofbodyweight,

misadministrationoftheproduct,orlackofcalibrationofadosingdevice(if

any).

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurther

investigatedusingappropriatetests(e.g.faecaleggcountreductiontest).

Wheretheresultsofthetest(s)stronglysuggestresistancetoaparticular

anthelmintic,ananthelminticbelongingtoadifferentpharmacologicalclass

andhavingadifferentmodeofactionshouldbeused.

4.5Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Avermectinsmaynotbewelltoleratedinallnon-targetspecies.

Casesofintolerancewithfataloutcomearereportedindogs,

especiallyCollies,OldEnglishSheepdogsandrelatedbreedsor

crosses,andalsointurtles/tortoise.Careshouldbetakentoavoid

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ingestionofspilledproductoraccesstocontainersbytheseother

species.

Whentreatinggroupsofanimals,useasuitableautomaticdosing

deviceandventeddraw-offapparatus.

Fortreatmentofindividualpigs,theuseofappropriatesized

needlesanddisposablesyringesshouldbeadvisedbya

veterinarian.Forthetreatmentofpigletsweighing16kgorless,a

1mLdisposablesyringegraduatedinincrementsof0.1mLorless

shouldbeused.

Usedry,sterileequipmentandfollowasepticprocedures.Avoid

introductionofcontamination.Vialstoppersmustnotbebroached

morethan20times.Swabtheseptumbeforeremovingeachdose.

ii. Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Readpackageinsertbeforeuse.

Donotsmokeoreatwhilehandlingtheproduct.Washhandsafter

use.

Takecaretoavoidaccidentalself-administration –seekmedical

attentionshouldanyspecificsignsbenoticed.

Advicetomedicalpractitioners:Incaseofaccidentalselfinjection

specificsymptomshaverarelybeenobservedandthereforeany

casesshouldbetreatedsymptomatically.

4.6Adversereactions(frequencyandseriousness)

Nonehavebeenobserved.

4.7Useduringpregnancy,lactationorlay

Theproductisindicatedforuseinbreedingandlactatingsowsandin

breedingboars.

4.8Interactionwithothermedicinalproductsandotherformsof

interaction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

Asingletreatmentof0.3ml(3mgdoramectin)per10kgbodyweight,(1ml

per33kg)equivalentto300

g/kgbodyweight,administeredby

intramuscularinjection.

Pigletsweighing16kgorlessshouldbedosedinaccordancewiththe

followingtable:

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Bodyweight(kg) Dose(mL)

Lessthan4kg 0.1mL

5-7kg 0.2mL

8-10kg 0.3mL

11-13kg 0.4mL

14-16kg 0.5mL

Toensureadministrationofacorrectdose,bodyweightshouldbe

determinedasaccuratelyaspossible;accuracyofthedosingdevice

shouldbechecked.

Ifanimalsaretobetreatedcollectivelyratherthanindividually,theyshould

begroupedaccordingtotheirbodyweightanddosedaccordingly,inorder

toavoidunder-andover-dosing.

4.10Overdose(symptoms,emergencyprocedures,antidotes),if

necessary

Overdosesupto10timesthelabelrecommendeddoseresultedinno

clinicalsignsthatcouldbeattributedtotreatmentwithdoramectin.

4.11Withdrawalperiod(s)

Meatandoffal:56days.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:AntiparasiticProductsInsecticidesand

Repellents/Endectocides

ATCvetCode:QP54AA03

5.1Pharmacodynamicproperties

Doramectinisanantiparasiticagent,isolatedfromfermentationofselected

strainsderivedfromthesoilorganismStreptomycesavermitilis.Itisa

macrocycliclactoneandiscloselyrelatedtoivermectin.Bothcompounds

shareawidespectrumofantiparasiticactivityandproduceasimilar

paralysisinnematodesandparasiticarthropods.Macrocycliclactones

activateglutamategatedchloridechannels(GluCl)foundonmuscle

membranesofthepharynxandparticularneuronesofinvertebrate

parasites.Theselectivetoxicityofthemacrocycliclactonesas

antiparasiticsisattributedtothisactiononchannelsthatarenotpresentin

thehostanimal.Thereisevidencethatthemembranesofthemusclecells

oftheinvertebratefemalereproductivetractmaybemoresensitiveto

macrocycliclactonesthanreceptorsonnerveorothermuscleandthismay

explainthedramaticbuttemporaryreductionineggproductioninparasites

notkilledoreliminatedbydrugtherapy.

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5.2Pharmacokineticparticulars

Maximumplasmaconcentrationofdoramectinoccursinpigs3daysafter

intramuscularadministrationoftheproduct.Theeliminationhalf-lifeis

aroundsixdays.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Butylhydroxyanisole(E320)

Ethyloleate

Sesameoil

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelflifeafterfirstopeningtheimmediatepackaging:28days.

6.4.Specialprecautionsforstorage

Donotstoreabove30

C.

Donotrefrigerateorfreeze.

Protectfromdirectsunlight –donotremovefromtheprotectiveplastic

overwrap.

6.5Natureandcompositionofimmediatepackaging

Dectomaxwillbesuppliedin:

Opaqueplasticoverwrappedvialof50ml

Opaqueplasticoverwrappedvialof200ml

Opaqueplasticoverwrappedvialof500ml

Consistingofmulti-dose,rubbercapped,amberglassvialscontaininga

clearcolourlesstopaleyellow,sterileoilysolution.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Extremelydangerousforfishandaquaticlife.Donotcontaminateponds,

waterwaysorditcheswiththeproductorusedcontainer.

Anyunusedproductorwastematerialsshouldbedisposedofin

accordancewithnationalrequirements.

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7. MARKETINGAUTHORISATIONHOLDER

ElancoAnimalHealth

EliLilly&CompanyLimited

LillyHouse

PriestlyRoad

Basingstoke

Hampshire

RG249NL

8. MARKETINGAUTHORISATIONNUMBER

Vm 00006/4120

9. RENEWALOFTHEAUTHORISATION

Date:8September2008

10.DATEOFREVISIONOFTHETEXT

Date:December2011

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.