Vectin Horse Oral Paste 18.7 mg/g

Main information

  • Trade name:
  • Vectin Horse Oral Paste 18.7 mg/g
  • Pharmaceutical form:
  • Oral paste
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Vectin Horse Oral Paste 18.7 mg/g
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ivermectin
  • Therapeutic area:
  • Horses Food, Other Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0173/001
  • Authorization date:
  • 28-05-2008
  • EU code:
  • UK/V/0173/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SummaryofProductCharacteristics

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VectinHorseOralPaste18.7mg/g(UK)

BimectinHorsepastefürPferde(AT)

MaximecVet(DK)

DiapecPGel(DE)

Maximec(EL)

Maximec,pastaparacavalos18.7mg/g(PT)

MaximecEquinopastaparaOral18.7mg/g(ES)

BimectinePate(FR)

MaximecPasta(IT)

BimectinHorseOralPaste18.7mg/g(IE)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveSubstances

Ivermectin 18.7mg/g Active

ForfulllistofexcipientsseeSection6.1.

3. PHARMACEUTICALFORM

OralPaste

Ayellow,gel-likepasteofuniformconsistency.

4. CLINICALPARTICULARS

4.1 Targetspecies

Horses

4.2 Indicationsforuse,specifyingthetargetSspecies

Theproductisindicatedforthetreatmentofnematodeorarthropodinfestationsin

horsesdueto:

Largestrongyles

Strongylusvulgaris(adultsand4 th

larval[arterial]stages)

S. edentatus(adultsand4 th

larval[tissue]stages)

S. equinus(adults)

Triodontophorusspp.(adults)

Triodontophorusbrevicauda

Triodontophorusserratus

SmallStrongyles

Adultsandimmatures(fourthstagelarvae)smallstrongylesorcyathostomesunless

otherwisestated.Ivermectinisnoteffectiveagainsttheencystedlarvalstagesofthe

smallstrongyles.

Coronocyclusspp.

Coronocycluscoronatus

Coronocycluslabiatus

Coronocycluslabratus

Cyathostomumspp.

Cyathostomumcatinatum

Cyathostomumpateratum

Cylicocyclusspp.

Cylicocyclusashworthi

Cylicocycluselongatus

Cylicocyclusinsigne

Cylicocyclusleptostomum

Cylicocyclusnassatus

Cylicostephanusspp.

Cylicostephanuscalicatus

Cylicostephanusgoldi

Cylicostephanuslongibursatus

Cylicostephanusminutus

Cylicodontophorusspp.

Cylicodontophorusbicornatus

Parapoteriostomumspp.

Parapoteriostomummettami

Petrovinemaspp.

Petrovinemapoculatum

Poteriostomumspp.

Lungworms(adultandinhibitedfourthstagelarvae)

Dictyocaulusarnfieldi

Pinworms(adultandinhibitedfourthstagelarvae)

Oxyurisequi

Ascarids(adultsandthird&fourthstagelarvae)

Parascarisequorum

Hairworms(adults)

Trichostrongylusaxei

Large-mouthstomachworms(adults)

Habronema muscae

Neckthreadworms(microfilariae)

Onchocercaspp.

Intestinalthreadworms(adults)

Strongyloideswesteri

Stomachbots(oralandgastricstages)

Gasterophilusspp.

4.3 Contraindications

None.

4.4 Specialwarningsforeachtargetspecies

Careshouldbetakento avoidthefollowingpracticesbecausetheyincreasetheriskof

developmentofresistanceandcouldultimatelyresultinineffectivetherapy:

Toofrequentandrepeateduseofanthelminticsfromthesameclass,overan

extendedperiodoftime.

Underdosing,whichmaybedueto underestimationofbodyweightor

misadministrationoftheproduct.

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigated

usingappropriatetests(e.g.FaecalEggCountReductionTest).Wheretheresultsof

thetests(s)stronglysuggestresistanceto aparticularanthelmintic,ananthelmintic

belongingto anotherpharmacologicalclassandhavingadifferentmodeofaction

shouldbeused.

ResistancetoivermectinhasbeenreportedinParascarisequoruminhorses.

Therefore,theuseofthisproductshouldbebasedonlocalfarmepidemiological

informationaboutsusceptibilityofnematodesandrecommendationsonhowto limit

furtherselectionforresistancetoanthelmintics.

4.5 Specialprecautionsforuse

(i) Precautionsforuseinanimals

Specialwarningfornon-targetspecies:Theproducthasbeenformulatedforusein

horsesonly.Cats,Dogs,especiallyCollies,OldEnglishSheepdogsandrelatedbreed

orcrosses,andalsoturtlesandtortoisesmaybeadverselyaffectedbythe

concentrationofivermectininthisproductiftheyareallowedto ingestspilledpaste

orhaveaccesstousedsyringes.

Parasiteresistanceto anyparticularclassofanthelminticmaydevelopfollowing

frequent,repeateduseofananthelminticofthatclass.

(ii) Specialprecautionsto betakenby thepersonadministeringtheveterinary

medicinalproductto animals

Donoteat,drinkorsmokewhilehandlingtheproduct.Avoidcontactwithskinand

eyes.Ifaccidentalskincontactoccurs,washtheaffectedareaimmediatelywithsoap

andwater.Ifaccidentaleyeexposureoccurs,flushtheeyesimmediatelywithwater

and,ifnecessary,getmedicalattention.

Washhandsafteruse.

4.6 Adversereactions(frequencyandseriousness)

SomehorsescarryingheavyinfectionofOnchocercamicrofilariaehaveexperienced

oedemaandpruritusfollowingdosing,assumedto betheresultofdeathoflarge

numbersofmicrofilariae.Thesesignsresolvewithinafewdaysbutsymptomatic

treatmentmaybeadvisable.

4.7 Useduringpregnancylactationorlay

Studiesperformedinlaboratoryanimalsshowednoteratogenicorembryotoxiceffect

ofivermectinattherecommendeddosesduringtherapy.

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduring

pregnancyandlactation.Useonlyaccordingtorisk/benefitanalysisbythe

responsibleveterinarysurgeon.

Pleasereferalsoto 5.3 or5.11

4.8 InteractionwithothermedicinalproductsandotherFormsofInteraction

TheeffectsofGABAagonistsareincreasedbyivermectin.

4.9 Amountstobeadministeredandadministrationroute

Administerorallyasasingledoseratetohorsesattherecommendeddoselevelof

0.2mgivermectinperkilogramofbodyweight.Eachsyringedelivers120mg

ivermectin,sufficientto treat600kgofbodyweight.

Toensureadministrationofacorrectdose, bodyweightshouldbedeterminedas

accuratelyaspossible.

Ifanimalsareto betreatedcollectivelyratherthanindividually,theyshouldbe

groupedaccordingto theirbodyweightanddosed accordingly,inordertoavoid

under-orover-dosing.

Thisisasingledoseproduct.Discardafteruse.

DosingInstructions:

Eachweightmarkingonthesyringeplungerwilldeliversufficientpastetotreat

100kgbodyweight.Unlocktheknurledringbymaking¼ turnandslidetheknurled

ringuptheplungershaftsothatthesidenearestthebarrelisattheprescribedweight

marking.Turntheknurledring¼ turnto lockinplace.Makesurethehorse’smouth

containsnofeed.Removetheplasticcap fromthetipofthenozzle.Insertthesyringe

intothehorse’smouthattheinterdentalspace.Advancetheplungerasfarasitwill

go,depositingthemedicationonthebaseofthetongue.Immediatelyraisethe

horse’sheadforafewsecondsafterdosing.

Thetreatmentscheduleshouldbebasedonthelocalepidemiologicalsituation.

4.10 Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Mildtransitorysigns(slowedpupillarylightresponseanddepression)havebeenseen

atadoseof1.8mg/kg(9timestherecommendeddoselevel).Othersignsseenat

higherdosesincludesmydriasis,ataxia,tremors,stupor,comaanddeath.Theless

severesignshavebeentransitory.Noantidotehasbeenidentified;however,

symptomatictherapymaybebeneficial.

4.11 WithdrawalPeriods

Meatandoffal34 days.

Donotuseinmaresproducingmilkforhumanconsumption.

5. PHARMACEUTICALPROPERTIES

5.1 Pharmacodynamicproperties

Pharmacotherapeuticgroup:Endectocide

ATCvetcode:QP54AA01

Ivermectinisamemberofthemacrocycliclactoneclassofendectocides.

Compoundsoftheclassbindselectivelyandwithhighaffinitytoglutamate-gated

chlorideionchannelswhichoccurininvertebratenerveandmusclecells.Thisleads

to anincreaseinthepermeabilityofthecellmembranetochlorideionsand

hyperpolarizationofthenerveormusclecell,resultinginparalysisanddeathofthe

parasite.Compoundsofthisclassmayalsointeractwithotherligand-gatedchloride

channels,suchasthosegatedbytheneurotransmittergamma-aminobutyricacid

(GABA).

Themarginofsafetyforcompoundsofthisclassisattributabletothefactthat

mammalsdo nothaveglutamate-gatedchloridechannels,themacrocycliclactones

havealowaffinityforothermammalianligand-gatedchlorideandtheydo notreadily

crosstheblood-brainbarrier.

5.2 PharmacokineticsProperties

Followingadministrationoftheproduct,ivermectinisrapidlyabsorbed toreachpeak

plasmaconcentrationinseveralhours.Thispeakfallsoffgraduallyoverseveral

days.

Ivermectiniseliminatedprimarilyviathefaeces.Thehighestresiduelevelsarefound

infat.

Atadoserateof0.2mgivermectinperkilogramofbodyweight,plasmalevelsof

ivermectinreachameanC

concentrationof40.44ng/mlandameanT

max at8.35

hours.Thispeak fallsoffgraduallyto anaveragelevelof3 ng/mlat10 days.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

MaizeOil

Polysorbate80

AppleFlavour

ColloidalAnhydrousSilica

6.2 Majorincompatibilities

Noneknown.

6.3 Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2 years.

Tobeusedimmediatelyafterfirstopeningtheoralsyringe.

6.4 Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

Highdensitypolyethylenepre-filleddose-graduateddisposablesyringecontaining

6.42 gofproduct.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsor

wastematerialsderivedfromtheuseofsuchproducts,ifappropriate

EXTREMELYDANGEROUSTOFISHANDAQUATICLIFE.Donot

contaminatesurfacewatersorditcheswithproductorusedcontainers.

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewith

nationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

Bimeda,(adivisionofCrossVetpharmGroupLtd.)

BroomhillRoad,

Tallaght,

Dublin24, Ireland

8. MARKETINGAUTHORISATIONNUMBER

Vm12597/4031 (UK)

Z.Nr.:8-00581(AT)

21717(DK)

400683.00.00 (DE)

73961/04/6-6-2005 (EL)

51473 (PT)

1563 ESP(ES)

DossierNo.12174,(FR)

Boîtede1 applicateurgraduéde6.42gdepâte:678763 3 (FR)

Boîtede1 applicateurgraduéde6.42gdepâte:678765 6 (FR)

A.I.C.n.103738011 (IT)

VPA10960/48/1(IE)

9. DATEOFFIRSTAUTHORISATIONORDATEOFRENEWALOF

THEAUTHORISATION

Dateofrenewal:17 th

April2008

10. DATEOFREVISIONOFTHETEXT

May2008

19-9-2018

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