Cydectin TriclaMox Oral Solution for Sheep

Main information

  • Trade name:
  • Cydectin TriclaMox Oral Solution for Sheep
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Cydectin TriclaMox Oral Solution for Sheep
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Moxidectin, combinations
  • Therapeutic area:
  • Sheep

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0201/001
  • Authorization date:
  • 11-04-2011
  • EU code:
  • FR/V/0201/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

CydectinTriclaMox1mg/ml+50mg/mlOralsolutionforsheep

PARTIB SummaryofProductCharacteristics

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CydectinTriclaMox1mg/ml+50mg/mlOralSolutionforsheep

Austria,Germany:CydectinTriclaMox1mg/ml+50mg/mloraleLösungfürSchafe

Belgium:CydectinTriclaMox1mg/ml+50mg/mlOraleOplossingvoorschapen,:Cydectin

TriclaMox1mg/ml+50mg/mlsolutionoralepourovins,CydectinTriclaMox1mg/ml+50mg/ml

oraleLösungfürSchafe

Denmark:CydectinTriclaMox1mg/ml+50mg/mlOralopløsningtilfår

France,Luxembourg:CydectineTriclaMox1mg/ml+50mg/mlsolutionoralepourovins

Greece:CydectinTriclaMox1mg/ml+50mg/mlΠόσιμοδιάλυμαγιαπρόβατα

Iceland:CydectinTriclaMox1mg/ml+50mg/mlMixtúra,lausnhandasauðfé

Italy:CydectinTriclaMox1mg/ml+50mg/mlSoluzioneOraleperPecore

Ireland,UK:CydectinTriclaMox1mg/ml+50mg/mlOralSolutionforsheep

TheNetherlands:CydectinTriclaMox1mg/ml+50mg/mlOraleOplossingvoorschapen

Portugal:CydectinTriclaMox1mg/ml+50mg/mlSoluçãoOralparaOvinos

Spain:CydectinTriclaMox1mg/ml+50mg/mlSoluciónOralparaOvino

Sweden:CydectinTriclaMox1mg/ml+50mg/ml,Orallösningtillfår

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstances

Moxidectin

Triclabendazole 1.0mg

50.0mg

Excipients

Benzylalcohol

Butylhydroxytoluene

Forafulllistofexcipients,seesection6.1

40.0mg

1.0mg

CydectinTriclaMox1mg/ml+50mg/mlOralsolutionforsheep

PARTIB SummaryofProductCharacteristics

3. PHARMACEUTICALFORM

Oralsolution

Aclearyellowtobrownliquid

4. CLINICALPARTICULARS

4.1 TargetSpecies

Sheep

4.2 Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofmixednematodeandflukeinfectionsinsheep,causedbymoxidectinand

triclabendazolesensitivestrainsof:

Theproducthasapersistentefficacyandprotectssheepagainstinfectionorre-infectionwiththe

followingparasitesfortheperiodindicated:

Species Protectionperiod

(days)

Teladorsagiacircumcincta 35

Parasite Adultstage L4 Inhibitedstages

Gastro-intestinalnematodes:

Haemonchuscontortus

Teladorsagiacircumcincta

Ostertagiatrifurcata

Trichostrongylusaxei

Trichostrongyluscolubriformis

Trichostrongylusvitrinus

Nematodirusbattus

Nematodirusspathiger

Nematodirusfilicolis

Strongyloidespapillosus

Cooperiacurticei

Cooperiaoncophora

Oesophagostomumcolumbianum

Oesophagostomumvenulosum

Chabertiaovina

Trichurisovis

Respiratorytractnematode:

Dictyocaulusfilaria

Liverfluke: Adultstage EarlyImmature

stages LateImmature

stages

Fasciolahepatica

CydectinTriclaMox1mg/ml+50mg/mlOralsolutionforsheep

PARTIB SummaryofProductCharacteristics

Clinicaltrials,afterexperimentalandnaturalinfection,haveshownthattheproductiseffective

againstcertainbenzimidazoleresistantstrainsof:

.Haemonchuscontortus

.Teladorsagiacircumcincta

.Trichostrongyluscolubriformis

.Cooperiacurticei

4.3 Contraindications

Donotuseincasesofhypersensitivitytotheactivesubstance(s)ortoanyoftheexcipient(s).

4.4 Specialwarningsforeachtargetspecies

oCareshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetheriskof

developmentofresistanceandcouldultimatelyresultinineffectivetherapy:

Toofrequentandrepeateduseofanthelminticsfromthesameclass,overanextended

periodoftime.

Underdosing,whichmaybeduetounderestimationofbodyweight,misadministrationof

theproduct,orlackofcalibrationofthedosingdevice(ifany).

oSuspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigatedusing

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

suggestresistancetoaparticularanthelmintic,ananthelminticbelongingtoanotherpharmacological

classandhavingadifferentmodeofactionshouldbeused.

oResistancetomacrocycliclactoneshasbeenreportedinTeladorsagiainsheepinanumberof

countries.In2008,throughoutEurope,moxidectinresistanceisveryrare;ithasbeenreportedina

singlecaseinvolvingalevamisole-,benzimidazoleandivermectin-resistantstrainofTeladorsagia

circumcincta.ResistancetotriclabendazolehasbeenreportedinFasciolahepaticainsheepinsome

Europeancountries.Thereforetheuseofthisproductshouldbebasedonlocal(regional,farm)

epidemiologicalinformationaboutsusceptibilityofparasites,localhistoryoftreatmentsand

recommendationsonhowtousetheproductundersustainableconditionstolimitfurtherselection

forresistancetoantiparasiticcompounds.Theseprecautionsareespeciallyimportantwhen

moxidectinisbeingusedtocontrolresistantstrains.

4.5 Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Thisproductshouldnotbeusedforthetreatmentofsingleinfections.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproduct

toanimals

Avoiddirectcontactwithskinandeyes.

Washhandsafteruse.

Donotsmoke,drinkoreatwhenusingthisproduct.

CydectinTriclaMox1mg/ml+50mg/mlOralsolutionforsheep

PARTIB SummaryofProductCharacteristics

Wearimpermeablerubberglovesduringuse.

4.6 Adversereactions(frequencyandseriousness)

Noneknown.

4.7 Useduringpregnancy,lactationorlay

Thisproductissafeforuseinbreedinganimals.SeealsoSection4.11.

4.8 Interactionswithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Shouldbegivenasasingleoraldrenchof1ml/5kgbodyweight,equivalentto0.2mgmoxidectin/kg

bodyweightand10mgtriclabendazole/kgbodyweight,usinganystandarddrenchingequipment.

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyaspossible;accuracyof

thedosingdeviceshouldbechecked.Ifanimalsaretobetreatedcollectivelyratherthanindividually,

theyshouldbegroupedaccordingtotheirbodyweightanddosedaccordingly,inordertoavoidunder-

oroverdosing.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Signsofoverdoseshavenotbeenseenat3and5timestherecommendeddose.However,iftheydo

occurtheyshouldbeconsistentwiththemodeofactionofmoxidectinand/ortriclabendazoleand

wouldbemanifestedastransientsalivation,depression,drowsiness,ataxiaandreducedfoodintake8

to12hourspost-treatment.Treatmentisnotgenerallynecessaryandrecoveryisgenerallycomplete

within1to5days.Thereisnospecificantidote.

4.11Withdrawalperiod(s)

Meatandoffal:31days

Milk: notauthorizedforuseinewesproducingmilkintendedforhumanconsumptionincluding

duringthedryperiod.Donotusewithin1yearpriortothefirstlambinginewesintendedtoproduce

milkforhumanconsumption.

notpermittedforuseinsheepproducingmilkintendedforhumanconsumption.

Notpermittedforuseinpregnantdairyeweswithin2monthspriortoparturition .

CydectinTriclaMox1mg/ml+50mg/mlOralsolutionforsheep

PARTIB SummaryofProductCharacteristics

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:antiparasiticproduct,endectocide

ATCvetcode:QP54AB52,moxidectincombination

5.1 Pharmacodynamicproperties

Moxidectinisanendectocideactiveagainstawiderangeofinternalandexternalparasitesandisa

secondgenerationmacrocycliclactoneofthemilbemycinfamily.Itsprincipalmodeofactionis

interferingwithneuromusculartransmissionoftheGABA(gammaaminobutyricacid)-gatedor

glutamate-gatedchloridechannels.MoxidectinstimulatesthereleaseofGABAandincreasesits

bindingtothepostsynapticreceptors,andbindstotheglutamate-gatedchloridechannels.Thenet

effectistoopenthechloridechannelsonthepostsynapticjunctiontoallowtheinflowofchlorideions

andinduceanirreversiblerestingstate.Thisresultsinflaccidparalysisandeventualdeathofparasites

exposedtothedrug.

Triclabendazoleisaflukicidebelongingtothebenzimidazolegroupofanthelmintics.Itiswell

establishedthatbenzimidazoleanthelminticsselectivelybindtoβ-tubulin,thuscausingthe

depolymerisationofmicrotubulesandthesubsequentdisruptionofmicrotubule-basedprocessesin

helminths.

5.2 Pharmacokineticparticulars

Moxidectinisdistributedthroughoutthebodytissuesbutduetoitslipophilicitythehighestdrug

concentrationsareobtainedinfattissue.Moxidectinundergoesbiotransformationbyhydroxylation.

Theonlysignificantrouteofexcretionisthefaeces.Themainpharmacokineticparametersof

moxidectinwhenadministeredinthefinalformulationwerethefollowing:AUC

58ng.day.mL -1 ,

12ng.mL -1 ,Tmax:6hoursandplasmahalf-life3.5days.

Themajorityoftheoraldoseoftriclabendazoleinrats,sheep,goatsandrabbitsiseliminatedinfaeces

after6-10days,asunchangeddrugorproductsofbiliaryexcretion.Urinaryexcretionisminimal.

Sulphone,sulphoxide,ketoneand4-hydroxytriclabendazolederivativesarethemainmetabolites

identifiedinplasma.Themainpharmacokineticparametersoftheactivemetabolitetriclabendazole

sulfoxidewhentriclabendazonewasadministeredinthefinalcombinedformulationwere:AUC

608

µg.h.mL -1 ,C

10µg.mL -1 ,T

21handplasmahalf-life20h.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Benzylalcohol

Butylhydroxytoluene

Polysorbate80

Sorbitanoleate

Propyleneglycol,dicaprylocaprate

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

CydectinTriclaMox1mg/ml+50mg/mlOralsolutionforsheep

PARTIB SummaryofProductCharacteristics

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:24months.

Shelf-lifeafterfirstopeningtheimmediatepackaging:6months.

6.4 Specialprecautionsforstorage

Donotstoreabove25°C.

Protectfromlight.

Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

1litre,2.5litreand5litrepolyethylenecontainerswithpolypropylenescrew-cap.

Notallpacksizesmaybemarketed

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Theproductshouldnotenterwatercoursesasthismaybedangerousforfishandotheraquatic

organisms.

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

PfizersubsidiariesinEUmemberstates

8. MARKETINGAUTHORISATIONNUMBERS

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

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