CYDECTIN 1% injectable solution for cattle

Main information

  • Trade name:
  • CYDECTIN 1% injectable solution for cattle
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CYDECTIN 1% injectable solution for cattle
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • moxidectin
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0020/003
  • Authorization date:
  • 14-11-2011
  • EU code:
  • FR/V/0020/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

MRP5Yrenewal

D55Rev1.(version –13-Oct-09)

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

MRP5Yrenewal

D55Rev1.(version –13-Oct-09)

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CYDECTIN1%w/vSolutionforInjectionforcattle

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance<s>:

Moxidectin: 10mg

Excipient(s):

BenzylAlcohol(E1519) 40.00mg

ButylatedHydroxytoluene(E321) 2.5mg

Disodiumedetate(E385)0.27mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection

Yellowtopaleyellowsolution,freefromsuspendedmatter.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle

4.2 Indicationsforuse,specifyingthetargetspecies

Moxidectinisanendectocidewithactivityagainstawiderangeofinternalandexternalparasites

ofcattle.

Cattle

Moxidectinisindicatedfortreatmentandpreventionofinfectionscausedby:

-Adultandimmaturegastro-intestinalnematodes:

.Haemonchusplacei

.Haemonchuscontortus

.Ostertagiaostertagi(includinginhibitedlarvae)

.Trichostrongylusaxei

.Trichostrongyluscolubriformis

.Nematodirushelvetianus(adultsonly)

.Nematodirusspathiger

.Cooperiasurnabada

.Cooperiaoncophora

.Cooperiapectinata

MRP5Yrenewal

D55Rev1.(version –13-Oct-09)

.Cooperiapunctata

.Oesophagostomumradiatum

.Bunostomumphlebotomum(adultsonly)

.Chabertiaovina(adultsonly)

.Trichurisspp.(adultsonly)

MRP5Yrenewal

D55Rev1.(version –13-Oct-09)

-Adultandimmaturerespiratorytractnematode

.Dictyocaulusviviparus

-Warblegrubs(migratinglarvae)

.Hypodermabovis

.Hypodermalineatum

-Lice

.Linognathusvituli

.Haematopinuseurysternus

.Solenopotescapillatus

.AidinthecontrolofDamaliniabovis

-Mangemites

.Sarcoptesscabiei

.Psoroptesovis

.AidinthecontrolofChorioptesbovis

MoxidectinhasapersistenteffectagainstOstertagiafor5weeksandagainstDictyocaulus

for6weeks.

4.3 Contraindications

Donotuseinlactatinganimalsproducingmilkforhumanconsumptionorindustrialpurposesor

within60daysbeforeparturition.

Donotuseinhorses.

Donotuseindogs

4.4 Specialwarningsforeachtargetspecies

“Careshouldbetakentoavoidthefollowingpractices,becausetheyincreasetheriskof

developmentofresistanceandcouldultimatelyresultinineffectivetherapy:

- Toofrequentandrepeateduseofanthelminticsfromthesameclass,overanextended

periodoftime;

- Under-dosingwhichmayduetounderestimationofbodyweight,misadministrationofthe

product,orlackofcalibrationofthedosingdevice(Ifany).

- Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigatedusing

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

stronglysuggestresistancetoaparticularanthelmintic,ananthelminticbelongingtoanother

pharmacologicalclassandhavingadifferentmodeofactionshouldbeused.”

.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Becauseoftheparticularsusceptibility,itisnotrecommendedtotreatcalvesoflessthan8

weeks.ToavoidpossibleincidenceofsecondaryreactionsbythedeathofHypodermalarvae

inthespineortheoesophagusofanimals,itisrecommendedtoadministerCydectin1%

MRP5Yrenewal

D55Rev1.(version –13-Oct-09)

injectableaftertheendofflyactivityandbeforethelarvaereachtheirrestingsites.The

veterinarysurgeonshouldgiveadviceonthecorrecttimingoftreatment.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Avoiddirectcontactwithskinandeyes.

Washhandsafteruse.

Donotsmoke,drinkoreatwhilehandlingtheproduct.

Takecaretoavoidselfinjection.

AdvicetoMedicalPractictionersincaseofaccidentalselfinjection:Treatanyspecificsigns

symptomatically.

4..6Adversereactions(frequencyandseriousness)

Drowsiness,depression,lethargy,apathyandweaknesscanbeobservedaftertreatment.

Incaseofhypersensitivityreactions,asymptomatictreatmentisrequired.

4.7 Useduringpregnancy,lactationorlay

Moxidectinhasbeenshowntobesafeforuseinpregnantandlactatinganimalsandbreeding

bulls.Howevernote4.3.Contra-Indications.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

TheeffectsofGABAagonistsareincreasedbymoxidectin.

4.9 Amountstobeadministeredandadministrationroute

1ml/50kglivebodyweight,equivalentto0.2mgmoxidectin/kglivebodyweightgiven

subcutaneouslyinfrontoforbehindtheshoulderusinga16-18gauge(1.5-1.2mm)1/2inch.

(1.5cm)needle.

Theuseofamultidoseequipmentwithadrawoffneedleisrecommendedfor200mland500ml

packaging.

Toensureadministrationofacorrectdosage,bodyweightshouldbedeterminedasaccuratelyas

possible;accuracyofthedosingshouldbechecked.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Symptomsofoverdosesareconsistentwiththemodeofactionofmoxidectinandgenerallydo

notoccuratlessthan3timestherecommendeddose.Theyaremanifestedastransient

salivation,depression,drowsinessandataxia8to12hourspost-treatment.Treatmentisnot

generallynecessaryandrecoveryisgenerallycompletewithin24to48hours.

Thereisnospecificantidote.

MRP5Yrenewal

D55Rev1.(version –13-Oct-09)

4.11Withdrawalperiod(s)

Meatandoffal:65days.

Milk:Notpermittedforuseincattleproducingmilkforhumanconsumptionorindustrialpurposes

orwithin60daysbeforeparturition.

5. PHARMACOLOGICALPROPERTIES

Moxidectin,ATCvetcode:QP54AB02

5.1 Pharmacodynamicproperties

Moxidectinisanendectocideactiveagainstawiderangeofinternalandexternalparasitesandis

asecondgenerationmacrocycliclactoneofthemilbemycinfamily.Moxidectinstimulatesthe

releaseofGABAandincreasesitsbindingtothepostsynapticreceptors.Theneteffectisto

openthechloridechannelsonthepostsynapticjunctiontoallowtheinflowofchlorideionsand

induceanirreversiblerestingstate.Thisresultinflaccidparalysisandeventualdeathofparasites

exposedtothedrug.

Thereisnoevidencethatmoxidectinhasanyotherpharmacologicaleffectonanymammalian

organortissue.Theonlytoxiceffectsseenintoxicologyoruseanimalsafetytestsareentirely

consistentwithitsneuromusculartransmissionmodeofaction.

5.2 Pharmacokineticparticulars

Moxidectinisrapidlyandcompletelyabsorbedfollowingsubcutaneousinjectionwithmaximum

bloodconcentrationsbeingachieved8-12hourspostinjection.Thedrugisdistributedthroughout

thebodytissuesbutduetoitslipophilicitythetargettissueisfatwhereconcentrationsare10-

20timesthoseofinothertissues.Thedepletionhalflifeinfatis23-28days.

Moxidectinundergoeslimitedbiotransformationbyhydroxylationinthebody.Theonlysignificant

routeofexcretionisthefaeces.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Benzylalcohol(E1519)

Butylatedhydroxytoluene(E321)

Disodiumedetate(E385)

Polysorbate80

Propyleneglycol

Sodiumphosphatedibasic

Sodiumphosphatemonobasic

Phosphoricacidand/orSodiumhydroxide

Waterforinjection

MRP5Yrenewal

D55Rev1.(version –13-Oct-09)

6.2 Incompatibilities

NottobemixedwithotherVeterinaryMedicinalProductsbeforeadministration.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:36months

Shelflifeoftheveterinarymedicinalproductaftertheopeningtheimmediatepackaging:6

months.

6.4.Specialprecautionsforstorage

Donottoreabove25°C.Protectfromlight.

6.5 Natureandcompositionofimmediatepackaging

Polyethylenecontainersof50,200and500mlcontentsealedwithbromobutylstoppers.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Theproductcanbetoxicforfishandotheraquaticorganisms.Donotcontaminatepondsor

othersurfacewaterswiththeproductorusedcontainers.

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

FortDodgeAnimalHealthsubsidiariesinEuropeanmemberstates

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT