Alverin Plus Solution for Injection for Cattle

Main information

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

Documents

Localization

  • Available in:
  • Alverin Plus Solution for Injection for Cattle
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0399/001
  • Authorization date:
  • 22-06-2011
  • EU code:
  • UK/V/0399/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:November2011

AN:01750/2010

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

AlverinPlus10/100mg/mlSolutionforInjectionforCattle(UKandPL)

LevatumSuper10/100mg/mlSolutionforInjectionforCattle(AT,BE,CZ,EE,LV,

LU,LT,NL,PT,SK)

LevatumPlus10/100mg/mlSolutionforInjectionforCattle(ES,IT)

LevatumFluke10/100mg/mlSolutionforInjectionforCattle(DE)

LevatumD10/100mg/mlSolutionforInjectionforCattle(FR)

Levatumvet10/100mg/mlSolutionforInjectionforCattle(FI)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlofsolutioncontains:

Activesubstances:

Ivermectin10mg

Clorsulon100mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection

Aclearcolourlesstopaleyellowcolouredsterilenon-aqueoussolution

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle

4.2 Indicationsforuse,specifyingthetargetspecies

Theproductisindicatedforthetreatmentofmixedinfestationofadultliverflukeandgastro-

intestinalroundworms,lungworms,eyeworms,and/ormitesandliceofbeefandnon-lactating

dairycattle.

Gastrointestinalroundworms(adultandfourth-stagelarvae):

Ostertagiaostertagi(includinginhibitedlarvalstages)

O.lyrata

Haemonchusplacei

Trichostrongylusaxei

T.colubriformis

Cooperiaoncophora

C.punctata

C.pectinata

Bunostomumphlebotomum

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AN:01750/2010

Oesophagostamumradiatum

Strongyloidespapillosus(adult)

Nematodirusspathiger(adult)

Nematodirushelvetianus(adult)

Trichurisspp(adult)

Lungworms(adultandfourth-stagelarvae)

Dictyocaulusviviparus

Liverfluke(adult):

Fasciolahepatica

Eyeworms(adult):

Thelaziaspp

Warbles(parasiticstages):

Hypodermabovis

H.lineatum

Mangemites:

Psoroptesbovis

Sarcoptesscabieivar.bovis

Suckinglice:

Linognathusvituli

Haematopinuseurysternus

Solenopotescapillatus.

Theproductmayalsobeusedasanaidinthetreatmentofbitinglice(Damaliniabovis)and

themangemiteChorioptesbovis,butcompleteeliminationmaynotoccur.

Persistentactivity

Theproductgivenattherecommendeddosageof1ml/50kgbodyweightcontrolsre-infection

withHaemonchusplacei,Cooperiaspp.andTrichostrongylusaxeiacquiredupto14days

aftertreatment,OstertagiaostertagiandOesophagostomumradiatumacquiredupto21

daysaftertreatmentandDictyocaulusviviparusacquiredupto28daysaftertreatment.

4.3 Contraindications

Donotuseintramuscularlyorintravenously.

Theproductisalowvolumeproductauthorisedforuseincattle.Donotuseinotherspecies

assevereadversereactions,includingfatalitiesindogs,mayoccur(especiallyCollies,Old

EnglishSheepdogsandrelatedbreedsorcrosses)Donotuseinanimalswithknown

hypersensitivitytotheactivesubstancesortoanyoftheexcipients.

4.4Specialwarningsforeachtargetspecies

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetheriskof

developmentofresistanceandcouldultimatelyresultinineffectivetherapy:

Toofrequentandrepeateduseofanthelminticsfromthesameclass,overanextended

periodoftime.

Underdosing,whichmaybeduetounderestimationofbodyweight,misadministration

oftheproduct,orlackofcalibrationofthedosingdevice(ifany).

Revised:November2011

AN:01750/2010

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigatedusing

appropriatetests(e.g.FaecalEggCountReductionTest).Wheretheresultsofthetest(s)

stronglysuggestresistancetoaparticularanthelmintic,ananthelminticbelongingtoanother

pharmacologicalclassandhavingadifferentmodeofactionshouldbeused.

4.5 Specialprecautionsforuse

i) Specialprecautionsforuseinanimals

Thisproductdoesnotcontainanyantimicrobialpreservative.Swabseptumbeforeremoving

eachdose.

ii) Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Donotsmoke,eatordrinkwhilsthandlingtheproduct.

Washhandsafteruse.Directcontactwiththeskinshouldbeavoided.Takecaretoavoid

self-injection:theproductmaycauselocalirritationand/orpainattheinjectionsite.Incaseof

accidentalselfinjection,seekmedicaladviceandshowthelabeltothedoctor.

iii) Otherprecautions

Theproductisverytoxictoaquaticorganismsanddunginsects.Treatedcattleshouldnot

havedirectaccesstoponds,streamsorditchesfor14daysaftertreatment.Longtermeffects

ondunginsectscausedbycontinuousorrepeatedusecannotbeexcluded.Therefore

repeatedtreatmentsonapasturewithinaseasonshouldonlybegivenontheadviceofa

veterinarian.

4.6Adversereactions(frequencyandseriousness)

Transitorydiscomforthasbeenobservedinsomecattlefollowingsubcutaneous

administration.Alowincidenceofsofttissueswellingattheinjectionsitehasbeenobserved.

Thesereactionsdisappearedwithouttreatment.

4.7Useduringpregnancy,lactationorlay

Canbeusedinpregnancyandlactation.

Canbeusedinbreedinganimals.

Seesection4.11.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Dosageanddurationoftreatment

Asingledoseof1mlper50kgbodyweight,i.e.200µgivermectinand2mgclorsulonperkg

bodyweight.

Methodofadministration

Theproductshouldbeadministeredonlybysubcutaneousinjectionunderthelooseskinin

frontoforbehindtheshoulder.

Revised:November2011

AN:01750/2010

Dividedosesgreaterthan10mlbetweentwoinjectionsites.Asterile17gauge½inch(15-

20mm)needleisrecommended.Replacewithafreshsterileneedleafterevery10-12

animalsorsooneriftheneedlebecomessoiled.

Differentinjectionsitesshouldbeusedforotherparenteralproductsadministered

concurrently.Whenusingthe500mlpacksizeuseonlyautomaticsyringeequipment.Forthe

50mlpacksize,useofamultidosesyringeisrecommended.

Thetimingoftreatmentshouldbebasedonepidemiologicalfactorsandshouldbe

customisedforeachindividualfarm.Adosingprogramshouldbeestablishedbyasuitably

qualifiedperson.Toensureacorrectdosage,bodyweightshouldbedeterminedas

accuratelyaspossible;accuracyofthedosingdeviceshouldbechecked.

Ifanimalsaretobetreatedcollectivelyratherthanindividually,toavoidunder-orover-dosing,

theyshouldbegroupedaccordingtotheirbodyweightanddosedaccordingly.

Whenthetemperatureoftheproductisbelow5ºC,difficultyinadministrationmaybe

encounteredduetoincreasedviscosity.Warmingtheproductandinjectionequipmentto

about15ºCwillgreatlyincreasetheeasewithwhichtheproductcanbeinjected.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Adoseof25mlproductper50kgbodyweight(25timestherecommendeddoselevel)may

resultinaninjectionsitelesion,includingtissuenecrosis,oedema,fibrosisandinflammation.

Nootherdrug-relatedreactionshavebeenobserved.

4.11Withdrawalperiod(s)

Meatandoffal: 66days

Milk: Donotuseincattleproducingmilkforhumanconsumption.

Donotuseinnon-lactatingdairycowsincludingpregnantheifers

within60daysofcalving.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Endectocides,ivermectin,combinations

ATCvetcode:QP54AA51

5.1 Pharmacodynamicproperties

Ivermectinisamemberofthemacrocycliclactoneclassofendectocidesandhasaunique

modeofaction.Ithasbroadandpotentantiparasiticactivity.Itbindsselectivelyandwithhigh

affinitytoglutamate-gatedchlorideionchannelswhichoccurininvertebratenerveandmuscle

cells.Thisleadstoanincreaseinthepermeabilityofthecellmembranetochlorideionswith

hyperpolarisationofthenerveormusclecell,resultingandparalysisanddeathoftheparasite.

Compoundsofthisclassmayalsointeractwithotherligand-gatedchloridechannelssuchas

thosegatedbytheneurotransmittergamma-amino-butyricacid(GABA).

Themarginofsafetyforcompoundsofthisclassisattributabletothefactthatmammalsdo

nothaveglutamate-gatedchloridechannels,thatthemacrocycliclactoneshavealowaffinity

forothermammalianligand-gatedchloridechannelsandtheydonotreadilycrosstheblood-

brainbarrier.

Revised:November2011

AN:01750/2010

Clorsulonisasulfonamide.Clorsulonisrapidlyabsorbedinthebloodstream.Itisboundto

theerythrocytesandplasmawhichareingestedbythefluke.Clorsuloninhibitstheglycolytic

enzymesintheflukeanddeprivesitofitsmainsourceofmetabolicenergy.

5.2Pharmacokineticproperties

Aftersubcutaneousadministrationof2mgclorsulonand0.2mgivermectinperkgbodyweight,

theplasmaprofiledemonstratedtheslow,steadyabsorptionofivermectinwhichreacheda

maximumplasmaconcentrationatamediantimeof1.50days.Incontrast,clorsulon

appearedrapidlyabsorbedwithmaximumplasmaatamediantimeof0.25days.The

terminalhalflifeforthetwoactiveingredientsweredeterminedasfollows:379daysfor

ivermectinand3.58daysforclorsulon.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerolformal

Propyleneglycol

Monoethanolamine(forpHadjustment)

6.2Incompatibilities

Intheabsenceofcompatibilitystudiesdonotmixwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeafterfirstopeningtheimmediatepackaging:Followingwithdrawalofthefirstdose,

usetheproductwithin28days.Discardunusedmaterial.

6.4.Specialprecautionsforstorage

Protectfromlight.

Keepthecontainerintheoutercartoninordertoprotectfromlight.

6.5Natureandcompositionofimmediatepackaging

Containermaterial:Highdensitypolyethylene

Containerclosure: Siliconisedgreybromobutylrubberstopper

Containercolour: Natural

Containervolume: 50ml,250mlor500ml

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

EXTREMELYDANGEROUSTOFISHANDAQUATICLIFE.

Donotcontaminatesurfacewatersorditcheswiththeproductorusedcontainer.

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7. MARKETINGAUTHORISATIONHOLDER

ChanelleAnimalHealth,7RodneyStreet,LiverpoolL19HZUnitedKingdom

8. MARKETINGAUTHORISATIONNUMBER

Vm11990/4055

9. DATEOFFIRSTAUTHORISATION

29November2011

10. DATEOFREVISIONOFTHETEXT

November2011