CYDECTIN

Main information

  • Trade name:
  • CYDECTIN 1% INJECTABLE SOLUTION FOR SHEEP
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CYDECTIN 1% INJECTABLE SOLUTION FOR SHEEP
    Ireland
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0020/001
  • Authorization date:
  • 14-11-2011
  • EU code:
  • FR/V/0020/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

CYDECTIN1%W/VINJECTABLESOLUTIONforsheep

Eachmlcontains

Moxidectin 10.00mg

Excipients

BenzylAlcohol 40.00mg

Butylatedhydroxytoluene 2.50mg

Disodiumedetate ………………….. 0.27mg

QSP1.000ml

Forafulllistofexcipients,seesection6.1

SolutionforInjection

Acleartopaleyellowsolution.

4.1.Targetspecies

Sheep

4.2.Indicationsforuse,specifyingthetargetspecies

Insheep:

Moxidectinisindicatedfortreatmentofinfectionscausedbymoxidectinsensitivestrainsof:

-Gastro-intestinalnematodes:

.Haemonchuscontortus

.Ostertagia(Teladorsagia)circumcincta(includinginhibitedlarvae)

.Trichostrongylusaxei(adults)

.Trichostrongyluscolubriformis(adultsandL3)

.Nematodirusspathiger(adults)

.Cooperiacurticei(macmasteri)(adults)

.Cooperiapunctata(adults)

.Gaigeriapachyscelis(L3)

.Oesophagostomumcolumbianum(L3)

.Chabertiaovina(adults)

-Respiratorytractnematodes

Dictyocaulusfilaria(adults)

- LarvaeofDiptera

.Oestrusovis:L1,L2,L3

- Mangemites

SUMMARYOFPRODUCTCHARACTERISTICS

1.Nameofveterinarymedicinalproduct

2.Qualitativeandquantitativecomposition

3.Pharmaceuticalform

4.Clinicalparticulars

Moxidectinhasapersistenteffectof:

.5weeksagainstOstertagiacircumcincta,Haemonchuscontortus,Psoroptesovis

.4weeksagainstGaigeriapachyscelis,Oesophagostomumcolumbianum

.2weeksagainstTrichostrongyluscolubriformis

TrialshaveshownthatmoxidectiniseffectiveagainststrainsofHaemonchus.contortus

resistanttobenzimidazoles,ivermectinanddoramectin.

4.3.Contraindications

See4.8and4.11

4.4.Specialwarningsforeachtargetspecies

None

4.5.Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Takecaretoaccuratelydoseyounglambstoavoidoverdosing

ii)Specialprecautionstobetakenbythepersonadministeringthemedicinalproductto

animals

Respectgoodveterinarypractice

Avoiddirectcontactwithskinandeyes.

Washhandsafteruse.

iii)Otherprecautions

None

4.6.Adversereactions(frequencyandseriousness)

Inveryrareoccasions,transientsalivation,depression,drowsinessandataxiamaybereportedin

treatedanimals.Notreatmentisgenerallynecessary.Thesymptomsresolvein24to48hours.

Thereisnospecificantidote

4.7.Useduringpregnancy,lactationorlay

Laboratorystudies(rat,rabbit)haveshownthatmoxidectinhasnoteratogenicorembryotoxic

effectsatthetherapeuticdose.

Theveterinarymedicinalproducthasbeenshowntobesafeforuseinpregnantewes.Usein

pregnantewesispossible.

4.8.Interactionwithothermedicinalproductsandotherformsofinteraction

Donotuseinanimalsvaccinatedagainstfootrot

4.9.Amount(s)tobeadministeredandadministrationroute

200µgmoxidectin/kglivebody(equivalentto0.1ml/5kglivebody

weight)asasinglesubcutaneousinjection

Formange,curativetreatmentnecessitatestwoinjections10daysapart.

Preventativetreatmentisasingleinjection.

Administrationshouldbedoneinfrontorbehindtheshoulderusinganeedleof1.5to1.2

mmdiameterand1.5cmlength

Theuseofmultidosingequipmentisrecommendedforthe200and500mlbottles.

4.10.Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

.Symptomsofmoxidectinoverdosesarethesameasthoseobservedinveryrareoccasionsatthe

recommendeddose(see4.6).

4.11.Withdrawalperiods

Meatandoffal:82days.

Milk:Notpermittedforuseinewesproducingmilkforhumanconsumptionorindustrialpurposes

orinpregnantordryewesfor60daysbeforelambing.

Pharmacotherapeuticgroup:endectocide(milbemycinfamily)

ATCVet:QP54AB02

5.1.Pharmacodynamicproperties

Moxidectinisaparasiticideactiveagainstawiderangeofinternalandexternalparasitesandisa

secondgenerationmacrocycliclactoneofthemilbemycinfamily.Itsprincipalmodeofactionis

interferingwithGABA(gammaaminobutyricacid)receptorsinvolvedinneuromusculartransmission.

MoxidectinstimulatesthereleaseofGABAandincreasesitsbindingtothepostsynapticreceptors.

Theneteffectistoopenthechloridechannelsonthepostsynapticjunctiontoallowtheinflowof

chlorideionsandinduceanirreversiblerestingstate.Thisresultsinflaccidparalysisandeventual

deathofparasitesexposedtothedrug.

5.2Pharmacokineticparticulars

Moxidectinisrapidlyandcompletelyabsorbedfollowingsubcutaneousinjectionwithmaximumblood

concentrationsbeingachievedabout8hourspostinjection.Thedrugisdistributedthroughoutthe

bodytissuesbutduetoitslipophilicityfatconcentrationsare10to20timesthoseinothertissues.

Theeliminationhalflifeinfatisabout7days.

Moxidectinundergoespartialbiotransformationbyhydroxylationinthebodyandtheonlysignificant

routeofexcretionisthefaeces.

6.1.Listofexcipients

Polysorbate80

Sodiumphosphateanhydrous

Sodiumacidphosphatemonohydrate

Benzylalcohol

Butylatedhydroxytoluene

Disodiumedetate

Propyleneglycol

Waterforinjectablepreparations

6.2.Incompatibilities

NottobemixedwithotherVeterinaryMedicinalProductsbeforeadministration.

6.3.Shelf-life

36monthsfromdateofmanufacture.

Afterfirstopeningusetheveterinarymedicinalproductwithin1month

5.Pharmacologicalproperties

6.Pharmaceuticalparticulars

6.4.Specialprecautionsforstorage

Protectfromlight.

Donotstoreabove25°C

6.5.Natureandcontentsofimmediatepackaging

Cardboxwith50mlhighdensitypolyethylenecontainerswithbromobutyl

rubberstoppers.andaluminiumcaps.

Cardboxwith200mlhighdensitypolyethylenecontainerswithbromobutylrubber

stoppers.andaluminiumcaps.

Cardboxwith500mlhighdensitypolyethylenecontainerswithbromobutylrubber

stoppers.andaluminiumcaps.

6.6. Specialprecautionsforthedisposalofunusedproductorwastematerialsderivedfrom

theuseofsuchproducts,ifappropriate

Theveterinarymedicinalproductcanbetoxicforfishandaquaticorganisms.Anyunusedveterinary

medicinalproductorwastematerialderivedfromsuchveterinarymedicinalproductsshouldbe

disposedofinaccordancewiththelocalrequirements.

7. Marketingauthorisationholder

FORTDODGEVETERINARIAS.A.

Ctra.CamprodonS/N 

LaRiba 

*

17813Girona

Spain

8. Marketingauthorisationnumber

There are no safety alerts related to this product.

16-5-2018

Bravecto Plus (Intervet International B.V.)

Bravecto Plus (Intervet International B.V.)

Bravecto Plus (Active substance: fluralaner / moxidectin) - Centralised - Authorisation - Commission Decision (2018)3019 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4440

Europe -DG Health and Food Safety