CYDECTIN 0.1% ORAL DRENCH FOR SHEEP

Main information

  • Trade name:
  • CYDECTIN 0.1% ORAL DRENCH FOR SHEEP
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CYDECTIN 0.1% ORAL DRENCH FOR SHEEP
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • moxidectin
  • Therapeutic area:
  • Sheep

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0026/001
  • Authorization date:
  • 11-04-2011
  • EU code:
  • FR/V/0026/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

[Version7.2,12/2008]

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Zermex10%LAforCattle

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Moxidectin 100 mg/ml

Excipient(s):

BenzylAlcohol 70 mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle

4.2 Indicationsforuse,specifyingthetargetspecies

Incattleweighingfrom100 to 500 kgbodyweight

Treatmentandpreventionofmixedinfestationsbythefollowinggastro-intestinalnematodes,

respiratorynematodesand certainarthropod parasites:

Adultand immaturegastro-intestinalnematodes:

. Haemonchusplacei

. Haemonchuscontortus

. Ostertagia ostertagi(includinginhibited larvae)

. Trichostrongylusaxei

. Trichostrongyluscolubriformis

. Nematodirushelvetianus(adultsonly)

. Nematodirusspathiger

. Cooperia surnabada

. Cooperia oncophora

. Cooperia pectinata

. Cooperia punctata

. Oesophagostomumradiatum

. Bunostomumphlebotomum(adultsonly)

. Chabertiaovina(adultsonly)

. Trichurisspp.(adultsonly)

Adultand immaturerespiratorytractnematode

. Dictyocaulusviviparus

Warblegrubs(migratinglarvae)

. Hypoderma bovis

. Hypoderma lineatum

Lice

. Linognathusvituli

. Haematopinuseurysternus

. Solenopotescapillatus

. Bovicolabovis(aid incontrol)

Mangemites

. Sarcoptesscabiei

. Psoroptesovis

. Chorioptesbovis(aid incontrol)

Thedrughasapersistentactionand protectscattleforacertaindurationagainstinfectionor

re-infectionwiththefollowingparasitesfortheperiod indicated:

Protectionperiod(days)

Species

Dictyocaulusviviparus 120

Ostertagia ostertagi 120

Haemonchusplacei 90

Oesophagostomumradiatum 150

Trichostrongylusaxei 90

Linognathusvituli 133

TheproductiseffectiveagainstHypodermalarvaeatthetimeoftreatmentbutitspersistentactivity

againstHypodermahasnotbeenevaluated.

Iftheproductisgivenbeforetheend oftheflyseasoncomplimentarytreatmentwithaproduct

effectiveagainstHypodermamayberequired.

Persistentefficacyperiodshavenotbeenestablished forparasitespeciesotherthanthoseincluded in

theabovelist. Therefore, re-infectionofanimalsonpasturecontaminated byparasitesotherthan

theseremainspossiblebeforetheend ofthe90 dayminimumpersistencyperiod demonstrated for

specificspecies.

4.3 Contraindications

Do notuseinlactatinganimalsproducingmilk forhumanconsumptionorindustrialpurposes

orwithin80 daysofexpected parturition.

Do notuseincattlelessthan100 kgbodyweightorgreaterthan500 kg.

4.4 Specialwarnings

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Inorderto preventabscesses, astrictaseptictechniqueisrecommended.

Zermex10%LAforCattlehasbeenformulated specificallyforsubcutaneousinjectionin

dorsalsurfaceoftheearofcattleand mustnotbegivenbyanyotherrouteofadministrationor

to anyotherspecies.

To avoid possiblesecondaryreactionsbythedeathofHypodermalarvaeinthespineorthe

oesophagusofanimals, itisrecommended to administeraproducteffectiveagainstHypoderma

larvaeaftertheend offlyactivityand beforethelarvaereachtheirrestingsites. Consultyour

veterinarysurgeononthecorrecttimingofthistreatment.

Immunityto nematodesdependsonadequateexposureto infection. Althoughnotnormallythecase,

circumstancescould occurinwhichanthelminticcontrolmeasuresmightincreasethevulnerabilityof

cattleto re-infection. Animalsmaybeatrisk towardstheend oftheirfirstgrazingseason,

particularlyiftheseasonislong, orinthefollowingyeariftheymoveonto heavilycontaminated

pasture. Insuchinstances, furthercontrolmeasuresmaybenecessary.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Avoid directcontactwithskinand eyes.

Washhandsafteruse.

Do notsmoke, drink oreatwhilehandlingtheproduct.

Takecareto avoid self-injection. Adviceto MedicalPractitionersincaseofaccidentalselfinjection:

Treatsymptomatically.

4.6 Adversereactions(frequencyandseriousness)

Immediateordelayed swellingmaybefound attheinjectionsite. Onrareoccasions(approx1%),

theseswellingsmayfurtherdevelopinto abscesses. Thefrequencyofinjectionsiteswellingstendsto

behigherintheheavieranimals. Thesideeffectsgenerallydisappear, withouttreatment, within14

daysofadministration, somemaypersistforup to 5 weeksinanumberofanimals(<5%)and in

veryrareoccasionslonger.

Onrareoccasions, depressionand ataxiacanbeobserved afterinjection.

4.7 Useduringpregnancy,lactationorlay

Canbeused duringpregnancy. However, note4.3. Contra-Indications.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Dosageis0.5ml/50kgbodyweight,equivalentto1.0mgmoxidectin/kgbodyweight,givenbya

singlesubcutaneousinjectionintheearusingan18gauge,25–40mm hypodermicneedle.The

50mlvialstoppersmustnotbebroached morethan20 times. Useautomaticsyringeequipmentfor

the200 mlvial.

Theinjectionshould begivensubcutaneouslyintheloosetissuesonthedorsalsurfaceoftheear, just

distalto thedistaledgeoftheauricularcartilage.

Thedorsal(outer)surfaceoftheearshould firstbecleansed withantisepticand allowed to brieflyair

dry. Palpatetheedgeoftheauricularcartilageclosestto thehead, onthedorsal(hairy)surfaceof

theear. Fromthislandmark, takingcareto avoid blood vessels(artery, vein), theneedleshould be

inserted subcutaneouslystartingatapointapproximately3 to 3.5 cmdistalto thisedge(awayfrom

thehead), and directed towardsthebaseoftheear, and theneedleadvanced to thehub. Atthis

point, gentlyaspiratethesyringeto confirmthattheneedleisnotinablood vessel.

Uponinjection, theresultingdepotshould residejustdistalto theedgeoftheauricularcartilage.

Followingadministration, theneedleiswithdrawnfromtheskinaspressureisapplied forseveral

secondswiththethumb atthepointofinsertion.

Dueto thelonglastingprotectionagainstDictyocaulusviviparusand thestomachworms,

Ostertagia ostertagiandHaemonchusplacei, asingletreatmentwiththeformulationatturn-out

helpscontrolparasiticbronchitis(lungworm)and parasiticgastro-enteritisthroughoutthegrazing

seasonbyreducingthebuild-up ofinfectivelarvaeonpastureassociated withtheseparasites. For

bestresultstheinjectionshould begivento eachcalfoftargetweightto begrazed together

immediatelypriorto beingturned outto pasture. Animalsshould besetstocked throughoutthe

grazingseasonormoved to apasturewhichhasnotbeengrazed byothercattleearlierintheseason.

Diagram: Earinjectionprocedure

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Reactionsattheinjectionsitehavetobeexpected morefrequentlyand severedependingon

theinjected volume. Systemicsignsofoverdosesareconsistentwiththemodeofactionof

moxidectin. Thesesignsaremanifested astransientsalivation, depression, drowsinessand

ataxia24 to 36hourspost-treatment. Thesystemicsignsusuallydisappearwithin36 to 72

hourswithouttreatment. Atdoses>3 timestherecommended dosedivided onbothears, the

systemicsignsincluded recumbency, muscletremor, ruminaltympanyand dehydration, which

wereresolved aftertreatmentwithfluids. Thesystemicsignscanlastforafewdaysto ten

days. Thereisno specificantidote.

Theinjectionsiteis

approximately3.5cm(1.5

inches)distaltothedistal

edgeoftheauricular

cartilage.

Useonehandtograspand

steadytheear.

Injectsubcutaneouslyusingan

18gaugex1inchneedle.

Injectcontents.Depotshouldbe

justdistaltothedistaledgeof

theauricularcartilage.

Applypressureatthepointof

insertionastheneedleis

withdrawnfromtheskintohelp

sealtheopening.

4.11Withdrawalperiod(s)

Meatand offal: 108 days.

Milk:Notpermitted foruseinlactatinganimalsproducingmilk forhumanconsumptionorindustrial

purposesorwithin80 daysofexpected parturition.

Thewithdrawalperiod isbased solelyonasingleinjectionat theearsiteofinjection.

5. PHARMACOLOGICALPROPERTIES

ATCvetCodeQP54 AB02

Moxidectinisanendectocideactiveagainstawiderangeofinternalandexternalparasitesandisa

secondgenerationmacrocycliclactoneofthemilbemycinfamily.

5.1 Pharmacodynamicproperties

MoxidectininteractswithGABAreceptorsand chloridechannels.

Theneteffectistoopenthechloridechannelsonthepostsynapticjunctiontoallowtheinflowof

chlorideionsandinduceanirreversiblerestingstate.Thisresultsinflaccidparalysisandeventual

deathofparasitesexposed to thedrug.

5.2 Pharmacokineticparticulars

Moxidectinisabsorbedfollowingsubcutaneousinjectionwithmaximumbloodconcentrationsbeing

achieved24to48hourspostinjection.Thedrugisdistributedthroughoutthebodytissuesbutdue

to itslipophilicityitisconcentratedmainlyinthefat. Thedepletionhalflifeinfatis26–32 days.

Moxidectinundergoeslimitedbiotransformationbyhydroxylationinthebody.Theonlysignificant

routeofexcretionisthefaeces.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Benzylalcohol

Sorbitonmonooleate

Propyleneglycoloctanoatedecanotate

Nitrogen

6.2 Incompatibilities

Do notmixwithanyotherveterinarymedicinalproduct.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackaged forsale:2 years

Shelf-lifeafterfirstopeningtheimmediatepackaging:28 days

6.4.Specialprecautionsforstorage

Do notstoreabove25°C.

Protectfromlight.

6.5 Natureandcompositionofimmediatepackaging

Natureoftheprimarycontainer:

HDPEvial

Chlorinated butylrubberstopper

Aluminiumflip offseal(50 mlvial)

Aluminiumseal(200 ml)

Presentationsto besold and identificationnumbers:

Boxcontaining1 vialof50mlsize

Box1 vialof200mlsize

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Extremelydangerousforfishandaquaticorganisms.Donotcontaminateponds,waterwaysor

ditcheswiththeproductoremptycontainer.

Anyunusedveterinarymedicinalproductorwastematerialsderived fromsuchveterinarymedicinal

productsshould bedisposed ofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

FortDodgeAnimalHealth

FlandersRoad

HedgeEnd

Southampton

SO30 4QH

UK

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm01596/