Bimectin Plus

Main information

  • Trade name:
  • Bimectin Plus
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Bimectin Plus
    Romania
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ivermectin, combinations
  • Therapeutic area:
  • Cattle

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0384/001
  • Authorization date:
  • 22-12-2010
  • EU code:
  • UK/V/0384/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:March2011

AN:00092/2010

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BimectinPlus,10/100mg/mlSolutionforInjectionforCattle-UK,DK,BE,PT,RO

BimectinFluke,10/100mg/ml,SolutionforInjectionforCattle-DE

CevamecD,10/100mg/ml,Solutioninjectablepourbovins-FR

RenomecPlus,10/100mg/ml,Solucioninyectableparabovinos-ES

MaximecPlus,10/100mg/ml,SolutionforinjectionforCattle –PL,IT

IvermectinClorsulon

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstances:

1mlcontains:

Ivermectin 10mg

Clorsulon 100mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection

Aclearcolourlesstopaleyellowsterilenon-aqueoussolution

4. CLINICALPARTICULARS

4.1Targetspecies

Cattle

4.2Indicationsforuse,specifyingthetargetspecies

Theproductisindicatedforthetreatmentofmixedtrematodeandnematodeor

arthropodinfestationsofthefollowingparasites:

Gastrointestinalroundworms(adultandfourth-stagelarvae):

Ostertagiaostertagi(includinginhibitedlarvalstages)

O.lyrata

Haemonchusplacei

Trichostrongylusaxei

T.colubriformis

Cooperiaoncophora

C.punctata

C.pectinata

Bunostomumphlebotomum

Oesophagostamumradiatum

Strongyloidespapillosus(adult)

N.spathiger(adult)

N.helvetianus(adult)

Lungworms(adultandfourth-stagelarvae)

Dictyocaulusviviparous

Revised:March2011

AN:00092/2010

Liverfluke(adult):

Fasciolahepatica

Eyeworms(adult):

Thelaziaspp

Warbles(parasiticstages):

Hypodermabovis

H.lineatum

Mangemites:

Psoroptesbovis

Sarcoptesscabieivar.bovis

Suckinglice:

Linognathusvituli

Haematopinuseurysternus

Solenopotescapillatus.

Theproductmayalsobeusedasanaidinthecontrolofbitinglice(Damaliniabovis)

andthemangemiteChorioptesbovis,butcompleteeliminationmaynotoccur.

Persistentactivity

Theproductgivenattherecommendeddosageof1ml/50kgbodyweightcontrolsre-

infectionwithHaemonchusplacei,Cooperiaspp.andTrichostrongylusaxeiacquired

upto14daysaftertreatment,OstertagiaostertagiandOesophagostomumradiatum

acquiredupto21daysaftertreatmentandDictyocaulusviviparusacquiredupto28

daysaftertreatment.

4.3Contraindications

Thisproductisnottobeusedintramuscularlyorintravenously.

Thisproductisalowvolumeproductauthorisedforuseincattle.Itmustnotbeused

inotherspeciesassevereadversereactions,includingfatalitiesindogs,mayoccur,

especiallyCollies,OldEnglishSheepdogsandrelatedbreedsorcrosses.

4.4Specialwarningsforeachtargetspecies

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetherisk

ofdevelopmentofresistanceandcouldultimatelyresultinineffectivetherapy:

Toofrequentandrepeateduseofanthelminticsfromthesameclass,overan

extendedperiodoftime.

Underdosing,whichmaybeduetounderestimationofbodyweight,

misadministrationoftheproduct,orlackofcalibrationofthedosingdevice(if

any).

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigated

usingappropriatetests(e.g.FaecalEggCountReductionTest).Wheretheresults

ofthetest(s)stronglysuggestresistancetoaparticularanthelmintic,ananthelmintic

belongingtoanotherpharmacologicalclassandhavingadifferentmodeofaction

shouldbeused.

Revised:March2011

AN:00092/2010

4.5Specialprecautionsforuse

i) Specialprecautionsforuseinanimals

Thisproductdoesnotcontainanyantimicrobialpreservative.Swabseptumbefore

removingeachdose.

ii) Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Donotsmokeoreatwhilsthandlingtheproduct.

Washhandsafteruse.

Wearglovesandglasseswhenhandlingtheveterinarymedicinalproduct.Direct

contactwiththeskinshouldbeavoided.

Takecaretoavoidself-injection:theproductmaycauselocalirritationand/orpainat

theinjectionsite.Incaseofaccidentalselfinjection,seekmedicaladviceandshow

thelabeltothedoctor.

iii)Otherprecautions

Theproductisverytoxictoaquaticorganismsanddunginsects.Treatedcattle

shouldnothavedirectaccesstoponds,streamsorditchesfor14daysafter

treatment.Longtermeffectsondunginsectscausedbycontinuousorrepeateduse

cannotbeexcluded.Thereforerepeattreatmentsonapasturewithinaseason

shouldonlybegivenontheadviceofaveterinarian.

4.6Adversereactions(frequencyandseriousness)

Transitorydiscomforthasbeenobservedinsomecattlefollowingsubcutaneous

administration.Alowincidenceofsofttissueswellingattheinjectionsitehasbeen

observed.Thesereactionsdisappearedwithouttreatment.

4.7Useduringpregnancy,lactationorlay

Canbeusedinpregnancyandlactation.

Canbeusedinbreedinganimals.

Seesection4.11.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

Revised:March2011

AN:00092/2010

4.9Amountstobeadministeredandadministrationroute

Dosageanddurationoftreatment

200μgivermectinand2mgclorsulonperkgbodyweightcorrespondingtoasingle

doseof1mlper50kgbodyweight.

Methodofadministration

Theproductshouldbeadministeredonlybysubcutaneousinjectionundertheloose

skininfrontoforbehindtheshoulder.

Dividedosesinexcessof10mlbetweendifferentinjectionsitesandusedifferent

sitestothoseusedforotherparenteralmedications.

Asterile17gauge½inch(15-20mm)needleisrecommended.Replacewithafresh

sterileneedleafterevery10-12animalsorsooneriftheneedlebecomessoiled.

Whenthetemperatureoftheproductisbelow5°C,difficultyinadministrationmaybe

encounteredduetoincreasedviscosity.Warmingtheproductandinjection

equipmenttoabout15°Cwillgreatlyincreasetheeasewithwhichtheproductcanbe

injected.

Whenusingthe500mlpacksizeuseonlyautomaticsyringeequipment.Forthe

50mlpacksize,useofamultidosesyringeisrecommended.

Thetimingoftreatmentshouldbebasedonepidemiologicalfactorsandshouldbe

customisedforeachindividualfarm.Adosingprogramshouldbeestablishedbya

qualifiedprofessionalperson.

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyas

possible;accuracyofthedosingdeviceshouldbechecked.

Ifanimalsaretobetreatedcollectivelyratherthanindividually,toavoidunder-or

over-dosing,theyshouldbegroupedaccordingtotheirbodyweightanddosed

accordingly.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Adoseof25mlproductper50kgbodyweight(25timestherecommendeddoselevel)

mayresultinaninjectionsitelesion,includingtissuenecrosis,oedema,fibrosisand

inflammation.Nootherdrug-relatedreactionshavebeenobserved.

4.11Withdrawalperiod(s)

Meatandoffal: 66days

Milk: Donotuseincattleproducingmilkforhumanconsumption.

Donotuseinnon-lactatingdairycowsincludingpregnant

heiferswithin60daysofcalving.

Revised:March2011

AN:00092/2010

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Endectocides,macrocycliclactones,avermectins,

ivermectin-combinations

ATCvetcode:QP54AA51

5.1Pharmacodynamicproperties

Ivermectinisamemberofthemacrocycliclactoneclassofendectocidesandhasa

uniquemodeofaction.Ithasbroadandpotentantiparasiticactivity.Itbinds

selectivelyandwithhighaffinitytoglutamate-gatedchlorideionchannelswhich

occurininvertebratenerveandmusclecells.Thisleadstoanincreaseinthe

permeabilityofthecellmembranetochlorideionswithhyperpolarisationofthenerve

ormusclecell,resultinginparalysisanddeathoftheparasite.Compoundsofthis

classmayalsointeractwithotherligand-gatedchloridechannelssuchasthose

gatedbytheneurotransmittergamma-amino-butyricacid(GABA).

Themarginofsafetyforcompoundsofthisclassisattributabletothefactthat

mammalsdonothaveglutamate-gatedchloridechannels,thatthemacrocyclic

lactoneshavealowaffinityforothermammalianligand-gatedchloridechannelsand

theydonotreadilycrosstheblood-brainbarrier.

Clorsulonisrapidlyabsorbedinthebloodstream.Itisboundtotheerythrocytesand

plasmawhichareingestedbythefluke.Clorsuloninhibitstheglycolyticenzymesin

theflukeanddeprivesitofitsmainsourceofmetabolicenergy.

5.2Pharmacokineticproperties

Aftersubcutaneousadministrationof2mgclorsulonand0.2mgivermectinperkg

bodyweight,theplasmaprofiledemonstratedaslow,steadyabsorptionofivermectin

whichreachedamaximumplasmaconcentrationatamediantimeof1.50days.In

contrast,clorsulonappearedrapidlyabsorbedwithamaximumplasmaconcentration

atamediantimeof0.25days.Theterminalhalflifeforthetwoactiveingredients

weredeterminedasfollows:Ivermectinapproximately3.79daysandClorsulon

approximately3.58days

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerolformal

Propyleneglycol

Monoethanolamine

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

Revised:March2011

AN:00092/2010

6.4.Specialprecautionsforstorage

Protectfromlight.

Keepthecontainerintheoutercartoninordertoprotectfromlight.

6.5Natureandcompositionofimmediatepackaging

Containermaterial: Highdensitypolyethylene

Containerclosure: Siliconisedgreybromobutylrubberstopperwithtamperevident

aluminiumoverseal.

Containercolour: Natural

Containervolume: 50ml,250mlor500ml

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

EXTREMELYDANGEROUSTOFISHANDAQUATICLIFE.Donotcontaminate

surfacewatersorditcheswiththeproductorusedcontainer.Anyunusedveterinary

medicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproducts

shouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

CrossVetpharmGroupLtd

BroomhillRoad

Tallaght

Dublin24

Ireland

8. MARKETINGAUTHORISATIONNUMBER

Vm12597/4051

9. DATEOFFIRSTAUTHORISATION

19February2010

10.DATEOFREVISIONOFTHETEXT

March2011