Animec Super Solution for Injection for Cattle

Main information

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

Documents

Localization

  • Available in:
  • Animec Super Solution for Injection for Cattle
    Italy
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0383/001
  • Authorization date:
  • 23-02-2011
  • EU code:
  • UK/V/0383/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:May2011

AN:00128/2010

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

AnimecSuperSolutionforInjectionforCattle

AnimecPlusSolucióninyectableparabovino(Spain)

AnimecPlusSolutionforInjectionforCattle(Italy)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstances:

Ivermectin10mg/ml

Clorsulon100mg/ml

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Solutionforinjection

Aclearcolourlesstopaleyellowcolourednon-aqueoussolution.

4. CLINICALPARTICULARS

4.1TargetSpecies

Cattle

4.2Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofmixedinfestationofadultliverflukeandgastro-intestinal

roundworms,lungworms,eyeworms,and/ormitesandliceofbeefandnon-lactating

dairycattle.

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AN:00128/2010

GastrointestinalRoundworms(adultandfourth-stagelarvae):

Ostertagiaostertagi(includinginhibitedlarvalstages)

O.lyrata

Haemonchusplacei

Trichostrongylusaxei

T.colubriformis

Cooperiaoncophora

C.punctata

C.pectinata

Bunostomumphlebotomum

Oesophagostomumradiatum

Strongyloidespapillosus(adult)

Nematodirushelvetianus(adult)

Nematodirusspathiger(adult)

Trichurisspp.(adult)

Lungworm(adultandfourth-stagelarvae):

Dictyocaulusviviparus

LIVERFLUKE(ADULT):

FASCIOLAHEPATICA

EYEWORMS(ADULT):

Thelaziaspp.

Warbles(parasiticstages):

Hypodermabovis

H.lineatum

Mangemites:

Psoroptesbovis

Sarcoptesscabieivar.Bovis

Revised:May2011

AN:00128/2010

SuckingLice:

Linognathusvituli

Haematopinuseurysternus

Solenopotescapillatus

AnimecSuperSolutionforInjectionforCattlemayalsobeusedasanaidinthe

treatmentofbitinglice(Damaliniabovis)andthemangemiteChorioptesbovis,but

completeeliminationmaynotoccur.

PersistentActivity

AnimecSuperSolutionforInjectionforCattlegivenattherecommendeddosageof1

ml/50kgbodyweightcontrolsre-infectionwithHaemonchusplacei,Cooperiaspp.and

Trichostrongylusaxei,acquiredupto14daysaftertreatment,Ostertagiaostertagiand

Oesophagostomumradiatumacquiredupto21daysaftertreatmentandDictyocaulus

viviparusacquiredupto28daysaftertreatment.

4.3Contraindications

Donotusethisproductintravenouslyorintramuscularly.Thisproductisalowvolume

productauthorisedforuseincattle.Itmustnotbeusedinotherspeciesassevere

adversereactions,includingfatalitiesindogs,mayoccur,especiallyCollies,OldEnglish

Sheepdogsandrelatedbreedsorcrosses.Donotuseinanimalswithaknown

sensitivitytotheactiveingredientortoanyoftheexcipients.

4.4Specialwarningsforeachtargetspecies

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetheriskof

developmentofresistanceandcouldultimatelyresultinineffectivetherapy:

Toofrequentandrepeateduseofanthelminticsfromthesameclass,overanextended

periodoftime

Underdosing,whichmaybeduetounderestimationofbodyweight,misadministrationof

theproduct,orlackofcalibrationofthedosingdevice(ifany).

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigated

usingappropriatetests(e.g.FaecalEggCountReductionTest).Wheretheresultsof

thetest(s)stronglysuggestresistancetoaparticularanthelmintic,ananthelmintic

Revised:May2011

AN:00128/2010

belongingtoanotherpharmacologicalclassandhavingadifferentmodeofaction

shouldbeused.

Revised:May2011

AN:00128/2010

4.5Specialprecautionsforuse

i) Specialprecautionsforuseinanimals

Thisproductdoesnotcontainanyantimicrobialpreservative.Swabseptumbefore

removingeachdose.ToavoidsecondaryreactionsduetothedeathofHypoderma

larvaeintheoesophagusorthespine,itisrecommendedtoadministertheproductat

theendoftheperiodofflyactivityandbeforethelarvaereachtheirrestingsites:seek

professionaladviceonthecorrecttimingoftreatment.

ii) Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Donoteat,drinkorsmokewhilsthandlingtheproduct.

Washhandsafteruse.

Directcontactwiththeskinshouldbeavoided.Takecaretoavoidself-injection:the

productmaycauselocalirritationand/orpainatthesiteofinjection.Incaseof

accidentalselfinjection,seekmedicaladviceandshowthelabeltothedoctor.

iii) Otherprecautions

Treatedcattleshouldnothavedirectaccesstoponds,streamsorditchesfor14days

aftertreatment.

4.6Adversereactions(frequencyandseriousness)

Transientdiscomforthasbeenobservedinsomecattlefollowingsubcutaneous

administration.Alowincidenceofsofttissueswellingatthesiteofinjectionhasbeen

observed.Thesereactionsdisappearedwithouttreatment.

4.7Useduringpregnancy,lactationorlay

Canbeusedinpregnancyandlactation.

Canbeusedinbreedinganimals.

Seesection4.11.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

Revised:May2011

AN:00128/2010

4.9Amountstobeadministeredandadministrationroute

Dosageanddurationoftreatment

Asingledoseof1mlper50kgbodyweight,i.e.200µgivermectinand2mgclorsulonper

kgbodyweight(equivalentto1mlofAnimecSupersolutionforinjectionforcattleper

50kgbodyweight.

Methodofadministration

Theproductshouldbeadministeredonlybysubcutaneousinjectionunderthelooseskin

infrontoforbehindtheshoulder.

Dividedosesgreaterthan10mlbetweentwoinjectionsites.Asterile17gauge½inch

(15-20mm)needleisrecommended.

Differentinjectionsitesshouldbeusedforotherparenteralproductsadministered

concurrently.Whenusingthe500mlpacksizeuseonlyautomaticsyringeequipment.

Forthe50mlpacksize,useofamultidosesyringeisrecommended.

Thetimingoftreatmentshouldbebasedonepidemiologicalfactorsandshouldbe

customisedforeachindividualfarm.Adosingprogramshouldbeestablishedbya

qualifiedprofessionalperson.

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyas

possible;accuracyofthedosingdeviceshouldbechecked.

Ifanimalsaretobetreatedcollectivelyratherthanindividually,toavoidunder-orover-

dosing,theyshouldbegroupedaccordingtotheirbodyweightanddosedaccordingly.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Adoseof25mlper50kgbodyweight(25timestherecommendeddoselevel)may

resultininjectionsitelesions,includingtissuenecrosis,oedema,fibrosisand

inflammation.

Nootherdrug-relatedreactionshavebeenobserved.

Revised:May2011

AN:00128/2010

4.11Withdrawalperiod(s)

Meatandoffal: 66days

Milk: Donotuseincattleproducingmilkforhumanconsumption.

Donotuseinnon-lactatingdairycowsincludingpregnant

heiferswithin60daysofcalving.

5. PHARMACOLOGICALPROPERTIES

PharmacotherapeuticGroup:Endectocides

ATCVetCode:QP54AA51

5.1Pharmacodynamicproperties

Ivermectinisamemberofthemacrocycliclactoneclassofendectocides,whichhavea

uniquemodeofaction.Ithasbroadandpotentantiparasiticactivity.Itbindsselectively

andwithhighaffinitytoglutamate-gatedchlorideionchannelswhichoccurin

invertebratenerveandmusclecells.Thisleadstoanincreaseinthepermeabilityofthe

cellmembranetochlorideionswithhyperpolarizationofthenerveormusclecell,

resultinginparalysisanddeathoftheparasite.Compoundsofthisclassmayalso

interactwithotherligand-gatedchloridechannels,suchasthosegatedbythe

neurotransmittergamma-aminobutyricacid(GABA)

Themarginofsafetyforcompoundsofthisclassisattributabletothefactthatmammals

donothaveglutamate-gatedchloridechannels,themacrocycliclactoneshavealow

affinityforothermammalianligandgatedchloridechannelsandtheydonotreadilycross

theblood-brainbarrier.

Clorsulonisasulphonamideandisrapidlyabsorbedinthebloodstream.Itisboundto

theerythrocytesandplasmawhichareingestedbythefluke.Clorsuloninhibitsthe

glycolyticenzymesintheflukeanddeprivesitofitsmainsourceofmetabolicenergy.

5.2Pharmacokineticproperties

Aftersubcutaneousadministrationoftheproductattherecommendeddose,2mg

clorsulonand0.2mgivermectinperkgbodyweight,theplasmaprofiledemonstratedthe

slow,steadyabsorptionofivermectinwithmeanmaximumplasmalevelsof65ng/ml

reachedat39hours.Incontrast,clorsulonappearedrapidlyabsorbedwithmean

maximumplasmalevelsof2.5ug/mlreachedat8hours.Theterminalhalflifeforthetwo

Revised:May2011

AN:00128/2010

activeingredientsweredeterminedasfollows:Ivermectinapproximately4daysand

Clorsulonapproximately5.8days

Revised:May2011

AN:00128/2010

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

GlycerolFormal

PropyleneGlycol

Monoethanolamine

6.2Incompatibilities

Intheabsenceofcompatibilitiesstudiesdonotmixwithotherveterinarymedicinal

products.

6.3Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeafterfirstopeningtheimmediatepackaging:Followingwithdrawalofthefirst

dose,usetheproductwithin28days.Discardunusedmaterial.

6.4SpecialPrecautionsforstorage

Protectfromlight.

Keepthecontainerintheoutercartoninordertoprotectfromlight.

6.5Natureandcompositionofimmediatepackaging

Containermaterial: Highdensitypolyethylene

Containerclosure: Siliconisedgreybromobutylrubberstopper

Containercolour: Natural

Containervolume: 50,250or500ml

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts.

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

EXTREMELYDANGEROUSTOFISHANDAQUATICLIFE.

Donotcontaminatesurfacewatersorditcheswithproductorusedcontainer.

Revised:May2011

AN:00128/2010

7. MARKETINGAUTHORISATIONHOLDER

ChanelleAnimalHealth

7RodneyStreet

Liverpool

L19HZ

UnitedKingdom

8. MARKETINGAUTHORISATIONNUMBER

Vm11990/4054

9. DATEOFFIRSTAUTHORISATION

16April2010

10.DATEOFREVISIONOFTHETEXT

May2011

15-6-2018

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