Cydectin TriclaMox 5 mg/ml + 200 mg/ml Pour-on Solution for cattle

Main information

  • Trade name:
  • Cydectin TriclaMox 5 mg/ml + 200 mg/ml Pour-on Solution for cattle
  • Pharmaceutical form:
  • Pour-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Cydectin TriclaMox 5 mg/ml + 200 mg/ml Pour-on Solution for cattle
    Austria
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0201/002
  • Authorization date:
  • 15-12-2011
  • EU code:
  • FR/V/0201/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CydectinTriclaMox5 mg/ml+ 200 mg/mlPour-onSolutionforcattle

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstances

Moxidectin 5.0 mg

Triclabendazole 200.0 mg

Excipients

Butylhydroxytoluene(E321) 5.0 mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Pour-onsolution.

Aclear,amberliquid.

4. CLINICALPARTICULARS

4.1 TargetSpecies

Cattle

4.2 Indicationsforuse, specifyingthetargetspecies

Incattle:

Treatmentofmixedtrematode(fluke)andnematodeinfectionscausedbymoxidectinand

triclabendazolesensitivestrainsof:

Parasite Adultstage Inhibitedstages

NEMATODES L4

Gastro-intestinalnematodes:

Haemonchusplacei

Ostertagia ostertagi

Trichostrongylusaxei

Nematodirushelvetianus

Cooperia oncophora

Cooperia punctata

Oesophagostomumradiatum

Bunostomumphlebotomum

Respiratorytractnematode:

Dictyocaulusviviparus

TREMATODES

Liverfluke: 6–8 weeks

immatures

Fasciolahepatica

Theproducthasapersistenteffectinpreventingre-infectionbyOstertagia ostertagi

andbyDictyocaulusviviparusfor5 weeksafterasingledose.

4.3 Contraindications

Donotuseincasesofknownhypersensitivitytotheactivesubstance(s)ortoanyofthe

excipient(s).

4.4 Specialwarningsforeachtargetspecies

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetheriskof

developmentofresistanceandcouldultimatelyresultinineffectivetherapy:

Toofrequentandrepeateduseofanthelminticsfromthesameclass,over

anextendedperiodoftime.

Underdosing,whichmaybeduetounderestimationofbodyweight,

misadministrationoftheproduct,orlackofcalibrationofthedosingdevice(ifany).

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigatedusing

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

suggest resistance to a particular anthelmintic,ananthelminticbelongingtoanother

pharmacologicalclassandhavingadifferentmodeofactionshouldbeused.

In2010,noconfirmedresistancetomoxidectinincattleparasiteshasbeenreportedinEurope,

however,resistancetoothermacrocycliclactones(MLs)hasbeenreportedmainlyinCooperia

oncophorainsomeEuropeancountries,andresistancetomoxidectinhasbeenreportedinthe

SouthernHemisphere.ResistancetootherMLsinsomestrainsofCooperiaspp.canimply

concurrentresistancetoMoxidectin.ResistancetotriclabendazolehasbeenreportedinFasciola

hepaticaincattleinsomeEuropeancountries.TriclabendazoleresistantF.hepaticahostedin

sheepcanbetransferredtocattlegrazingthesamepasture.Thereforetheuseofthisproduct

shouldbebasedonlocal(regional,farm)epidemiologicalinformationaboutsusceptibilityof

parasites,localhistoryoftreatmentsandrecommendationsonhowtolimitfurtherselectionfor

resistancetoanthelmintics.

Thisproductshouldnotbeusedforthetreatmentofsingleinfections.

Ithasbeenshownthatrainfallimmediatelybeforeorwithin2hoursaftertreatmentwillnotaffect

theefficacyoftheproduct.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Thisproducthasbeenformulatedspecificallyforpour-onadministrationforcattleandmustnotbe

givenbyanyotherrouteofadministrationorto anyotherspecies.

Allanimalsinagroupshouldbetreated.

ii. Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Weargloves,protectiveworkclothingandsafetyglasseswhenusingtheproduct

Donotsmoke,drinkoreatwhilehandlingtheproduct.

Avoiddirectcontactwithskinandeyes

Washhandsafteruse

Ifsplashedintheeyeorontheskin,washwithplentyofclean,runningwaterimmediately.

Peoplewithknownhypersensitivitytotheactivesubstanceshouldnothandletheproduct.If

irritationpersists,seek medicaladviceandshowthelabelto thedoctor.

4.6 Adversereactions(frequencyandseriousness)

Noneknown.

4.7 Useduringpregnancy,lactationorlay

Theproductissafeforuseinpregnantandlactatinganimals.

4.8 Interactionswithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Forexternaluseonly.

0.5mgmoxidectin/kgbodyweightand20mgtriclabendazole/kgbodyweight(equivalentto1ml

ofsolutionfor10 kg)andasasingletopicalapplication.

Tobeadministereddirectlytothehairandskinalongthemidlineofthebackoftheanimalfrom

thewithersto thetailhead.

Applyto cleanhealthyskin.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedasaccuratelyas

possible;accuracyofthedosingdeviceshouldbechecked.Ifanimalsaretobetreatedcollectively

ratherthanindividually,theyshouldbegroupedaccordingtotheirbodyweightanddosed

accordingly,inorderto avoidunder-oroverdosing.

Shakebeforeuse.

DirectionsforusingtheSqueeze-PourSystem(500 mland1 litrebottlesonly):

Step 1:Removescrewcap fromdispensingchamberonly.Removefoilseal.

Step2:Gentlysqueezethebottletofillthemeasuringchamberwiththerequiredamountof

liquid.

Step 3:Pourthemeasuredvolumeoffluidfromthechamberontotheanimalasdirected.

Repeatsteps2 and3 forsubsequentanimals

Step 4:Reapplythescrewcap tothedispensingchamberafteruse.

Directionsforusinga pour-onapplicator(2.5 and5 litrebackpack):

Connectthepour-onapplicatorto thebackpack asfollows:

Attachtheopenendofthedraw-offtubingtothecap withthestem.

Replaceshippingcap withthecap thathasthedraw-offtubing.Tightenthedraw-offcap.

Gentlyprimethepour-onapplicator,checkingforleaks.

Followmanufacturer’sdirectionsforcorrectuseandcareofequipment.

4.10 Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Signsofoverdoseshavenotbeenseenat5timestherecommendeddose.However,iftheydo

occurtheyshouldbeconsistentwiththemodeofactionofmoxidectinandwouldbemanifestedas

transientsalivation,depression,drowsinessandataxia.Treatmentisnotgenerallynecessaryand

recoveryisgenerallycompletewithin24 to 48 hours.Thereisnospecificantidote.

4.11 Withdrawalperiod(s)

Meatandoffal:143days

Milk:Do notuseincattleofanyageintendedto producemilkforhumanconsumption.

Duetothesignificantlikelihoodofcross-contaminationofnon-treatedanimalswiththisproduct

duetogrooming(licking),treatedanimalsshouldbehousedseparatelyfromnon-treatedanimals

throughoutthewithdrawalperiod.Non-compliancewiththisrecommendationmayleadto

residuesviolationsinnon-treatedanimals.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:antiparasiticproduct,endectocides

ATCvetcode:QP54AB52,moxidectincombination

5.1 Pharmacodynamicproperties

Moxidectinisanendectocideactiveagainstawiderangeofinternalandexternalparasitesandisa

secondgenerationmacrocycliclactoneofthemilbemycinfamily.Itsprincipalmodeofactionis

interferingwithneuromusculartransmissionoftheGABA(gammaaminobutyricacid)-gatedor

glutamate-gatedchloridechannels.MoxidectinstimulatesthereleaseofGABAandincreasesits

bindingtothepostsynapticreceptors,andbindstotheglutamate-gatedchloridechannels.Thenet

effectistoopenthechloridechannelsonthepostsynapticjunctiontoallowtheinflowofchloride

ionsandinduceanirreversiblerestingstate.Thisresultsinflaccidparalysisandeventualdeathof

parasitesexposedtothedrug.

Triclabendazoleisaflukicidebelongingtothebenzimidazolegroupofanthelmintics.Itiswell

establishedthatbenzimidazoleanthelminticsselectivelybindtoβ-tubulin,thuscausingthe

depolymerisationofmicrotubulesandthesubsequentdisruptionofmicrotubule-basedprocessesin

helminths.

5.2 Pharmacokineticparticulars

Moxidectinisdistributedthroughoutthebodytissuesbutduetoitslipophilicitythehighestdrug

concentrations are obtained infattissue.Moxidectinundergoesbiotransformationby

hydroxylation.Theonlysignificantrouteofexcretionisthefaeces.Themainpharmacokinetic

parametersofmoxidectinwhenadministeredaspour-oninthefinalcombinedformulationofthis

productwerethefollowing:AUClast50.9ng.d.mL-1,Cmax4.69ng.mL-1,Tmax8.7d,MRT

10.74 d.

Themajorityoftheoraldoseoftriclabendazoleinrats,sheep,goatsandrabbitsiseliminatedin

faecesafter6-10days,asunchangeddrugorproductsofbiliaryexcretion.Urinaryexcretionis

minimal.Sulphone,sulphoxide,ketoneand4-hydroxytriclabendazolederivativesarethemain

metabolitesidentifiedinplasma.Plasmakineticstudiesofsulfoxideandsulfonederivativesin

variousspeciesafteroraladministrationshowedthesulfoxidetopredominateinrabbits,sheepand

humans,andthesulfoneinthehorse,dogandcattle.Themainpharmacokineticparametersof

triclabendazolesulfoxidewhenadministeredinthefinalcombinedformulationofthisproduct

were:AUClast26.9µg.h.mL-1,Cmax2.92µg.mL-1,Tmax3.3d,MRT9.72d.Themain

pharmacokineticparametersoftriclabendazolesulfonewhenadministeredinthefinalcombined

formulationwere:AUClast110.2µg.h.mL-1,Cmax7.78µg.mL-1,Tmax12.9 d, MRT12.98 d.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Butylhydroxytoluene(E321)

γ-Hexalactone

Cineole

CaprylocaproylMacrogolglycerides

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwith

otherveterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2 years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:6 months.

6.4 Specialprecautionsforstorage

Donotstoreabove25°C.

Protectfromlight.

Donotfreeze.

Ifaccidentallyfrozen,shakevigorouslybeforeuse.

6.5 Natureandcompositionofimmediatepackaging

0.5, 1,2.5and5litreHDPEcontainerswithpolypropylenescrewcap andpolyethyleneinnerseal

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Theproductshouldnotenterwatercoursesasthismaybedangerousforfishandotheraquatic

organisms.

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

PfizersubsidiariesinEUmemberstates

8. MARKETINGAUTHORISATIONNUMBERS

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSUPPLY,SALEAND/ORUSE

Tobesuppliedonlyonveterinaryprescription.

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Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

31-7-2018

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 200-pound tubs of Mintrate® 36-15 Breed Right Tub cattle feed, product number 54549AAA6H, because the product may contain elevated levels of non-protein nitrogen, which could be harmful to cattle. Excessive levels of non-protein nitrogen can be toxic to cattle and can cause muscle tremors (especially of face and ears), abdominal pain, bloat, frothy salivation, excessive urination, teeth grinding, incoordination, ...

FDA - U.S. Food and Drug Administration

17-7-2018

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Volgend jaar worden zo’n 650.000 kinderen extra opgeroepen om zich te laten inenten tegen de zeer ernstige infectieziekte meningokokken. Het gaat om kinderen die zijn geboren na 1 januari 2001 en voor mei 2004. Dat laat staatssecretaris Paul Blokhuis (VWS) weten in een brief aan de Tweede Kamer. Reden voor deze maatregel is dat in de afgelopen jaren een stijging te zien is van het aantal mensen dat de infectie meningokokken type W oploopt. Met deze extra vaccinatieronde moet die groei worden ingedamd. He...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

29-3-2007

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

As of 23 April 2007, the reimbursement status of lipid lowering medicinal products will be changed. The decision includes all lipid lowering medicinal products with marketing authorisations in Denmark on 15 March 2007.

Danish Medicines Agency

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

18-4-2018

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (Active substance: Autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo) - Orphan designation - Commission Decision (2018)2405 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/246/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (Active substance: Adeno-associated viral vector serotype 9 encoding miRNA against human superoxide dismutase 1) - Orphan designation - Commission Decision (2018)2404 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/254/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Active substance: Adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene) - Orphan designation - Commission Decision (2018)2403 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/255/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1893 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/222/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1892 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/217/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1891 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/225/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1890 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/224/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Active substance: Recombinant modified ricin toxin A-chain subunit) - Orphan designation - Commission Decision (2018)1889 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/242/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1894 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/234/17

Europe -DG Health and Food Safety