Equest Pramox

Main information

  • Trade name:
  • Equest Pramox
  • Pharmaceutical form:
  • Oral gel
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Equest Pramox
    France
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0161/001
  • Authorization date:
  • 11-04-2011
  • EU code:
  • FR/V/0161/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

12028EQUESTPRAMOXD90SPC(clean)MAY2010

EQUESTPRAMOXORALGEL

SUMMARYOFPRODUCTCHARACTERISTICS

EquestPramox19.5 mg/g+ 121.7 mg/goralgel

Namesused:

EQUESTPRAMOXORALGELinallthecountriesexcept

Germany:EQUESTPRAMOX19.5 mg/g+121.7 mg/gGelzumeingeben

Spain:EQUESTPRA-MOX

PortugalandPoland:EQUESTPRAMOX19.5 mg/g+ 121.7 mg/goralgel

Denmark:EquestPramox

Sweden:CydectinCompVet.

Eachgcontains:

Activesubstances

Moxidectin

Praziquantel

19.5 mg

121.7 mg

Excipients

Benzylalcohol(E1519)

Butylhydroxytoluene(E321)

Forafulllistofexcipients,seesection6.1

220.0 mg

0.8 mg

OralGel.

Paleyellowtoorange/pinkoralgel.

4.1.Targetspecies

Horses.

4.2.IndicationsforUse,specifyingthetargetspecies

1.Nameoftheveterinarymedicinalproduct

2.Qualitativeandquantitativecomposition

3.Pharmaceuticalform

4.Clinicalparticulars

12028EQUESTPRAMOXD90SPC(clean)MAY2010

Inhorses:

Forthetreatmentofmixedcestodesandnematodesorarthropodsinfections,

causedbymoxidectinandpraziquantelsensitivestrainsof:

Largestrongyles:

Strongylusvulgaris(adultstages)

Strongylusedentatus(adultstages)

Triodontophorusbrevicauda(adults)

Triodontophorusserratus(adults)

Triodontophorus tenuicollis(adults)

Smallstrongyles(adultsandintraluminallarvalstages):

Cyathostomumspp

Cylicocyclusspp

Cylicostephanusspp

Cylicodontophorusspp

Gyalocephalusspp

Ascarids:

Parascarisequorum(adults)

Otherspecies:

Oxyurisequi(adultstages)

Habronema muscae(adults)

Gasterophilusintestinalis(L2,L3)

Gasterophilusnasalis(L2,L3)

Strongyloideswesteri(adults)

Trichostrongylusaxei(adultstages)

Tapeworm(adults):

Anoplocephalaperfoliata

Anoplocephalamagna

Paranoplocephalamammillana

Theeggreappearanceperiodofsmallstrongylesis90 days.

Theproductiseffectiveagainst(developing)intramucosalL4stagesof

smallstrongyles.At8weeksaftertreatment,early(hypobiotic)EL3stages

ofsmallstrongylesareeliminated.

4.3.Contraindications

Donotadministerto youngfoalslessthan6.5 monthsold

Donotuseincaseofhypersensitivityto theactivesubstanceorto anyofthe

excipients

Theproducthasbeenformulatedspecificallyforuseinhorsesonly.Dogs

andcatsmaybeadverselyaffectedbytheconcentrationofmoxidectinin

thisproductiftheyareallowedtoingestspilledgelorhaveaccesstoused

syringes.

12028EQUESTPRAMOXD90SPC(clean)MAY2010

Seealsosection4.7

4.4.Specialwarningsforeachtargetspecies

Careshouldbetakento avoidthefollowingpractices,becausetheyincrease

theriskofdevelopmentofresistanceandcouldultimatelyresultin

ineffectivetherapy:

- Toofrequentandrepeateduseofanthelminticsfromthesameclass,over

anextendedperiodoftime;

- Under-dosingwhichmaydueto underestimationofbodyweight,

misadministrationoftheproduct,orlackofcalibrationofthedosing

device(Ifany).

- Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurther

investigatedusingappropriatetests(e.g.FaecalEggCountReduction

Test).Wheretheresultsofthetest(s)stronglysuggestresistanceto a

particularanthelmintic,ananthelminticbelongingto another

pharmacologicalclassandhavingadifferentmodeofactionshouldbe

used.

Foroptimumcontrolofbots,theproductshouldbeadministeredinthe

autumn,aftertheendoftheflyseasonandbeforespringasthelarvaemay

startto pupateandthereforearelesssensitivetotreatment.

Parasiteresistanceto aparticularclassofanthelminticmaydevelopfollowing

frequent,repeated useofananthelminticofthatclass. Theveterinarianshould

giveadviceregardingappropriatedosingprogrammesand stock management

to achieveadequateparasitecontrolforbothtapewormandroundworm

infestations.

4.5.SpecialPrecautionsforUse

i)Specialprecautionsforuseinanimals

Toavoidoverdosing,careshouldbetakento accuratelydosefoals,

especiallylowbodyweightfoalsorponyfoals.

Donotusethesamesyringetotreatmorethanoneanimalunlesshorses

arerunningtogetherorindirectcontactwitheachotherinthesame

premises.

ii)Specialprecautionsto betakenbythepersonadministeringtheveterinary

medicinalproductto animals

Thisproductmaycauseeyeirritation,skinirritationandskinsensitisation.

Avoidcontactwithskinandeyes.

Useprotectivegloves.

Washhandsoranyexposedareaafteruse.

Donotsmoke,drinkoreatwhilehandlingtheproduct.

Intheeventofeyecontactflushtheeyewithcopiousamountofclean

waterandseek medicaladvice.

12028EQUESTPRAMOXD90SPC(clean)MAY2010

Incaseofaccidentalingestion,seek medicalhelpandshowthedoctorthe

packageinsert.

iii)Otherprecautions

Inordertolimittheimpactofmoxidectinondungfauna,anddueto

insufficientdataregardingenvironmentalriskofpraziquantel,horses

shouldnotbeturnedoutontopasturewithin3 daysoftreatment.

4.6.Adversereactions

Flaccidlowerlip,ataxiaandswellingofthemuzzlecouldbeobservedon

rareoccasionsinyounganimals.Theseadverseeffectsaretransientand

disappearspontaneously.

Incaseofveryhighwormburdens,destructionoftheparasitesmaycausea

mildtransientcolicandloosefaecesinthetreatedhorse.

4.7.Useduringpregnancy,lactationorlay

Donotuseduringpregnancyandlactationinmares

4.8.Interactionwithothermedicinalproductsandotherformsofinteraction

TheeffectsofGABAagonistsareincreasedbymoxidectin.

4.9.Amounttobeadministeredandadministrationroute

Asingleoraldoseof400 µgmoxidectin/kgbodyweightand2.5 mg

praziquantel/kgbodyweightusingthecalibratedsyringeofonegradationper

25 kgliveweight.

Toensureadministrationofacorrectdosage,bodyweightshouldbe

determinedasaccuratelyaspossible;accuracyofthedosingshouldbe

checked.

Useofascaleorweighttapeisrecommendedtoensureaccuratedosing.

Holdthesyringewiththecappedendpointingtotheleftsothatyoucansee

theweightmeasurementsandtickmarks(smallblacklines).Eachtickmark

relatesto25kgofbodyweight.Turnthedialringuntiltheleftsideofthe

ringlinesupwiththeweightoftheanimal.

Asinglesyringetreatsa575 kghorse.

Inthecaseofcestodetreatmentthedoseofpraziquantelintheproducthas

beenselectedto thetop endofthedosingrange.

Veterinaryadviceshouldbegivenonappropriatedosingprogrammesand

stockmanagementto achieveoptimumparasitecontrol.

4.10.Overdose(symptoms,emergencyprocedure,antidotesifnecessary)

12028EQUESTPRAMOXD90SPC(clean)MAY2010

Transientadversereactionsmayoccurattherecommendedtreatmentdosein

foals.Inadultstransientadversereactionsmayoccurat3timesthe

recommendeddose.Thesymptomsaredepression,inappetence,ataxia,

flaccidlowerlipinthe8to24hoursfollowingtreatment.Symptomatic

treatmentisnotgenerallynecessaryandrecoveryisgenerallycomplete

within24 to 72 hours.Thereisnospecificantidote.

4.11.Withdrawalperiod

Meatandoffal:64 days.

Milk:notpermittedforuseinlactatingmaresproducingmilkforhuman

consumption.

Therapeuticgroup:antiparasiticproduct,endectocide

ATCvetcode:QP54 AB52, moxidectincombination

5.1.Pharmacodynamicproperties

Moxidectinisaparasiticideactiveagainstawiderangeofinternaland

externalparasitesandisasecondgenerationmacrocycliclactoneofthe

milbemycinfamily.MoxidectininteractswithGABAreceptorsandchloride

channels.Theneteffectistoopenthechloridechannelsonthepostsynaptic

junctiontoallowtheinflowofchlorideionsandinduceanirreversible

restingstate.Thisresultsinflaccidparalysisandeventualdeathofparasites

exposedtothedrug.

Praziquantelisaparasiticidewidelyusedinmanyspeciesasan

anthelmintic.

Praziquantelisquicklyabsorbedviathetegumentoftheparasiteand

distributed.Invitroandinvivoimportantlesionsofthetegumentofthe

parasiteareseenthatprovokecontractionandparalysisoftheparasite.

Praziquantelmodifiesthepermeabilityoftheparasiticmembranetocalcium

ions,whichdisruptsthemetabolismoftheparasite.

Theproductiseffectiveagainstbenzimidazoleresistantstrainsof

cyathostomes.

5.2.Pharmacokineticparticulars

Moxidectinisabsorbedorallyandmaximumbloodconcentrationis

achievedapproximately6 to8 hoursafteradministration.

Thedrugisdistributedthroughoutthebodytissuesbutduetoits

lipophilicityitisselectivelyconcentratedinthefat.

Theeliminationhalf-lifeis11days.

Moxidectinundergoespartialbiotransformationbyhydroxylationinthe

bodyandtheonlysignificantrouteofexcretionisthefaeces.

Praziquantelisquicklyandalmosttotallyabsorbedinthebody,rapidly

5.PharmacologicalProperties

12028EQUESTPRAMOXD90SPC(clean)MAY2010

Praziquantelisrapidlymetabolisedintheliver.Itsprincipalmetaboliteisa

related4-hydroxycyclohexylcomponent.

6.1.Listofexcipients

Benzylalcohol(E1519)

Butylhydroxytoluene(E321)

Anhydrouscolloidalsilica

Ethanol,anhydrous

Polysorbate80

Ethylcellulose

Propyleneglycoldicaprylate/dicaprate

6.2.Incompatibilities

Noneknown.

6.3.Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2 years

Shelflifeoftheveterinarymedicinalproductafterthefirstopening:6

months

6.4.Specialprecautionsforstorage

Donotstoreabove25°C.

6.5.Natureandcompositionofimmediatepackaging

HDPEsyringe containing11.8 gofgelwithgraduated polypropylene

plungerandLDPEcap packedasfollows:

Boxcontainingonesyringe.

Boxcontaining10 individuallyboxedsyringes.

Boxcontaining20 individuallyboxedsyringes

Boxcontaining20 syringes

Notallpack sizemaybemarketed

6.PharmaceuticalParticulars

12028EQUESTPRAMOXD90SPC(clean)MAY2010

6.6.Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts

Theproductistoxicforfishandaquaticorganisms.

Anyunusedveterinarymedicinalproductsorwastematerialderivedfrom

suchveterinarymedicinalproductsshouldbedisposedofinaccordancewith

localrequirements.

Donotcontaminateponds,waterways,orditcheswiththeproductorused

syringes.

FortDodgeAnimalHealthsubsidiariesintheEuropeanUnionMemberStates.

8.Marketingauthorisationnumber(s)

9.DateofFirstAuthorisation

03May2006

10. Dateofrevisionofthetext

7.Marketingauthorisationholder

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