Noropraz Oral Paste for Horses

Main information

  • Trade name:
  • Noropraz Oral Paste for Horses
  • Pharmaceutical form:
  • Oral paste
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Noropraz Oral Paste for Horses
    Malta
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ivermectin
  • Therapeutic area:
  • Horses

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • IE/V/0311/001
  • Authorization date:
  • 31-07-2013
  • EU code:
  • IE/V/0311/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Noropraz,18.7mg/g+140.3mg/gOralPasteforHorses(IE,UK ,MT )

NoromectinPraziquantelDuo,18.7mg/g+140.3mg/gOralPasteforHorses(AT,BE,BG,CY,CZ,

DK,EE,FI,FR,DE,EL,HU,IT,LV,LT,LU, MT, NO,NL,PL,PT,RO,SK,SI,ES,SE)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramcontains:

Activesubstance:

Ivermectin 18.7mg

Praziquantel 140.3mg

Excipient(s):

TitaniumDioxide(E171) 20mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralpaste

Awhitetooffwhitehomogenouspaste

4. CLINICALPARTICULARS

4.1 Targetspecies

Horses

4.2 Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofmixedcestodeandnematodeorarthropodinfestations,duetoadultandimmature

roundworms,lungworms,botsandtapewormsinhorses:

Nematodes:

Largestrongyle:Strongylusvulgaris(adultandarteriallarvae),Strongylusedentatus(adultandL4

tissuelarvalstages),Strongylusequinus(adult),Tridontophorusspp.(adult)

Smallstrongyle:Cyathostomum:Cylicocyclusspp.,Cylicostephanusspp.,Cylicodontophorusspp.,

Gyalocephalusspp.(adultandnon-inhibitedmucosallarvae)

Parascaris:Parascarisequorum(adultandlarvae)

Oxyuris:Oxyurisequi(larvae)

Trichostrongylus:Trichostrongylusaxei(adult)

Strongyloides:Strongyloideswesteri(adult)

Habronema:Habronemaspp.(adult)

Onchocerca:Onchocercaspp.microfilariaei.e.cutaneousonchocerciasis

Lungworm:Dictyocaulusarnfieldi(adultandlarvae)

Cestodes(Tapeworm):

Anoplocephalaperfoliata(adult),Anoplocephalamagna(adult),Paranoplocephalamamillana(adult)

Dipteraninsects:

Gasterophilusspp.(larvae)

Astapeworminfestationisunlikelytooccurinhorsesbeforetwomonthsofage,treatmentoffoals

belowthisageisnotconsiderednecessary.

4.3 Contraindications

Donotuseinfoalsunder2weeksofage.

Donotuseincaseofhypersensitivitytotheactivesubstancesortoanyoftheexcipients.

4.4 Specialwarnings<foreachtargetspecies>

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetheriskofdevelopmentof

resistanceandcouldultimatelyresultinineffectivetherapy:

-Toofrequentandrepeateduseofanthelminticsfromthesameclass,overanextendedperiod

oftime.

-Underdosing,whichmaybeduetounderestimationofbodyweight,misadministrationofthe

product,orlackofcalibrationofthedosingdevice

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigatedusingappropriate

tests(e.g.FaecalEggCountReductionTest).Wheretheresultsofthetest(s)stronglysuggest

resistancetoaparticularanthelmintic,ananthelminticbelongingtoanotherpharmacologicalclassand

havingadifferentmodeofactionshouldbeused.

Resistancetoivermectin(anavermectin)hasbeenreportedinParascarisequoruminhorsesina

numberofcountriesincludingintheEU.Thereforetheuseofthisproductshouldbebasedonlocal

(regionalfarm)epidemiologicalinformationaboutsusceptibilityofnematodesandrecommendations

onhowtolimitfurtherselectionforresistancetoanthelmintics.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Avermectinsmaynotbewelltoleratedinallnontargetanimals.Casesofintolerancearereportedin

dogs,especiallyCollies,OldEnglishSheepdogsandrelatedbreedsorcrosses,andalsointurtleand

tortoises.

Dogsandcatsshouldnotbeallowedtoingestspilledpasteoraccesstousedsyringesduetothe

potentialforadverseeffectsrelatedtoivermectintoxicity.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Washhandsafteruse.

Donoteat,drinkorsmokewhilehandlingthisproduct.

Avoidcontactwiththeeyesastheproductmaycauseeyeirritation.

Incaseofaccidentaleyecontact,rinseimmediatelywithplentyofwater.

Incaseofaccidentalingestionoreyeirritation,seekmedicaladviceandshowthepackageleafletor

labeltothephysician.

4.6 Adversereactions(frequencyandseriousness)

HorsescarryingheavyinfectionofOnchocercamicrofilariaehaveexperiencedsuchreactionsas

swellinganditchingaftertreatment.Itisassumedthatthesereactionsaretheresultofthedestruction

oflargenumbersofmicrofilariae.

Incaseofveryhighlevelsofinfestation,destructionoftheparasitesmaycauseamildtransientcolic

andloosefaecesinthetreatedhorse.

Colic,diarrheaandanorexiahavebeenreportedinveryrareoccasionsposttreatment,inparticular

whenthereisheavywormburden.

Inveryrareoccasions,allergicreactionssuchashypersalivation,lingualoedemaandurticaria,

tachycardia,congestedmucusmembranes,andsubcutaneousoedemahavebeenreportedfollowing

treatmentwiththeproduct.Aveterinarianshouldbeconsultedifthesesignspersist.

4.7 Useduringpregnancy,lactationorlay

Canbeusedduringpregnancyandlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown

4.9 Amountstobeadministeredandadministrationroute

Singleadministration

200µgofIvermectinand1.5mgofPraziquantelperkgofbodyweightcorrespondingto1.07gof

pasteper100kgbodyweight

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedasaccuratelyaspossible

andthecorrectsyringedivisionselected,asunderdosingmightleadtoanincreasedriskof

developmentofresistancetoanthelminticdrugs.

Weight DosageWeight Dosage

Upto100kg1.070g401–450kg4.815g

101–150kg1.605g451–500kg5.350g

151–200kg2.140g501–550kg5.885g

201–250kg2.675g551–600kg6.420g

251–300kg3.210g601–650kg6.955g

301–350kg3.745g651–700kg7.490g

351–400kg4.280g

Thefirstdivisiondeliversenoughpastetotreat50kg.

Eachsubsequentsyringedivisiondeliversenoughpastetotreat50kgofbodyweight.Thesyringe

shouldbeadjustedtothecalculateddosagebysettingtheringontheappropriateplaceontheplunger.

Thesyringecontains7.49gofpasteanddeliverssufficientpastetotreat700kgofbodyweightatthe

recommendeddoserate.

Directionsforuse

Beforeadministration,adjustthesyringetothecalculateddosagebysettingtheringontheplunger.

Thepasteisadministeredorallybyinsertingthenozzleofthesyringethroughtheinterdentalspace

anddepositingtherequiredamountofthepasteonthebackofthetongue.Theanimal’smouthshould

befreeofanyfood.Immediatelyafteradministration,elevatetheheadofthehorseforafewseconds

toensurethedoseisswallowed.

Theveterinarysurgeonshouldgiveadviceregardingappropriatedosingprogrammesandstock

managementtoachieveadequateparasitecontrolforbothtapewormandroundworminfestations.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Atolerancestudyperformedinfoalsfrom2weeksofagewithdosesupto5timestherecommended

dosageshowednoadversereactions.

Safetystudiesconductedinmaresadministered3timestherecommendeddosageat14dayintervals

duringthewholegestationandlactationdidnotshowanyabortions,anyadverseeffectsonthe

gestation,parturitionandonthemaresgeneralhealth,noranyabnormalitiesonthefoals.

Safetystudiesconductedinstallionsadministered3timestherecommendeddosagedidnotshowany

adverseeffectsinparticularonthereproductiveperformances.

4.11Withdrawalperiod(s)

Horses:Meat&Offal:35days

Notpermittedforuseinhorsesproducingmilkforhumanconsumption

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Endectocides,ivermectin,combinations

ATCvetcode:QP54AA51

5.1 Pharmacodynamicproperties

Ivermectinisamacrocyclic-lactonederivativewhichhasabroadantiparasiticactivityagainst

nematodesandarthropods.Itactsbyinhibitingnerveimpulses.Itsmodeofactionincludesthe

glutamate-gatedchlorideionchannels.Ivermectinbindsselectivelyandwithhighaffinityto

glutamate-gatedchlorideionchannelswhichoccurininvertebratenerveandmusclecells.Thisleads

toanincreaseinthepermeabilityofthecellmembranetochlorideionswithhyperpolarizationofthe

nerveormusclecell,resultinginparalysisanddeathoftherelevantparasites.Compoundsofthisclass

mayalsointeractwithotherligand-gatedchloridechannels,suchasthosegatedbythe

neurotransmittergamma-aminobutyricacid(GABA).Themarginofsafetyforcompoundsofthis

classisattributabletothefactthatmammalsdonothaveglutamate-gatedchloridechannels.

Praziquantelisapyrazinoisoquinolinederivativewhichexertsitsanthelminticactivityagainstmany

speciesofcestodesandtrematodes.Itprimarilyactsbyimpairingbothmotilityandfunctionofthe

suckersofcestodes.Itsmodeofactionincludestheimpairingofneuromuscularco-ordinationbutalso

influencingthepermeabilityoftheintegumentoftheworms,whichleadstoexcessivecalciumand

glucoseloss.Thisinducesspasticparalysisoftheparasitemusculature.

5.2 Pharmacokineticparticulars

Afteradministrationoftherecommendeddosagetohorses,theivermectinplasmapeakwasreached

within24hours.Theivermectinconcentrationwasstillover2ng/ml14daysafteradministration.The

eliminationhalf-lifeofivermectinwas90h..Theeliminationhalf-lifeofpraziquantelwas40min.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Hydrogenatedcastoroil

Hydroxypropylcellulose

Titaniumdioxide(E171)

AppleFlavour

Propyleneglycol

6.2 Incompatibilities

Notapplicable

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:18months

Shelf-lifeafterfirstopeningtheimmediatepackaging:6months

6.4.Specialprecautionsforstorage

Donotstoreabove25

C

Afteruse,replacecapandstorebelow25 o C.

6.5 Natureandcompositionofimmediatepackaging

Anadjustablemultidosesyringecomposedofpolyethylenebarrel,plungerandendcap,with

polypropylenedosingrings.Thesyringecontains7.49gofproductandisfittedwithvariabledose

capacity.

Theoralpasteisavailableinthefollowingpacksizes:

- 1cartonboxcontaining1x7.49gsyringe

- 1cartonboxcontaining2x7.49gsyringes

- 1cartonboxcontaining12x7.49gsyringes

- 1cartonboxcontaining40x7.49gsyringes

- 1cartonboxcontaining48x7.49gsyringes

- 1cartonboxcontaining50x7.49gsyringes

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

EXTREMELYDANGEROUSFORFISHANDAQUATICLIFE.Donotcontaminatesurfacewatersor

ditcheswithproductorusedsyringes.

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited

StationWorks

Newry

Co.Down

BT356JP

UnitedKingdom

8. MARKETINGAUTHORISATIONNUMBER(S)

VPA10999/xxx/xx

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DDmonthYYYY

10 DATEOFREVISIONOFTHETEXT