Relaquine 35 mg/ ml oral gel for horses

Main information

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

Documents

Localization

  • Available in:
  • Relaquine
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Acepromazine
  • Therapeutic area:
  • Horses

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0465/001
  • Authorization date:
  • 21-12-2012
  • EU code:
  • UK/V/0465/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:May2013

AN:00075/2012

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Relaquine35mg/mlOralGelforHorses DE,FR,NL,UK

Relaquinevet35mg/mlOralGelforHorses SE

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Perml

Activesubstance

Acepromazine

(asAcepromazinemaleate) 35.00mg

(47.50mg)

Excipients:

Methylparahydroxybenzoate

0.65mg

Propylparahydroxybenzoate

0.35mg

Forthefulllistofexcipients,seeSection6.1.

3. PHARMACEUTICALFORM

Oralgel.

Clearyellowgelfororaladministration.

4. CLINICALPARTICULARS

4.1. Targetspecies

Horse.

4.2. Indicationsforuse,specifyingthetargetspecies

Forsedationofhorses.

4.3. Contraindications

Donotuseincasesofpost-traumaticshockorhypovolaemia.

Donotuseinanimalsinastateofsevereemotionalexcitation.

Donotuseinanimalswithepilepsy.

Donotuseinpregnantorlactatingmares.

Donotuseinanimalswithheartfailure.

Donotuseinanimalswithhaematologicaldisorders/coagulopathies.

Revised:May2013

AN:00075/2012

Donotuseinanimalssufferingfromhypothermia.

Donotuseinthecaseofknownhypersensitivitytotheactivesubstanceorany

oftheexcipientsoftheproduct.

4.4. Specialwarningsforeachtargetspecies

Sedationlastsforapproximatelysixhours,althoughtheactualtimeanddepthof

sedationareverydependentonthestatusoftheindividualanimal.

Increasingthedosageabovethatrecommended resultsinprolongedactionand

sideeffectsbutnogreatersedation.

4.5. Specialprecautionsforuse

i) Specialprecautionsforuseinanimals

Installions,thelowestdoserangeisindicatedtominimiseprolapseofthepenis.

Theproductshouldbeusedwithcautionandwithreduceddosageinthecaseof

cardiacorhepaticdiseaseorindebilitated,hypovolemicoranaemicanimals.

Acepromazinehasnegligibleanalgesiceffects.Painfulactivitiesshouldbe

avoidedwhenhandlingtranquillizedanimals.

Tranquillizedhorsesshouldbekeptinacalmplaceandsensorialstimulishould

beavoidedasfaraspossible.

ii) Specialprecautionstobetakenbythepersonadministeringthemedicinal

producttoanimals

Washhandsandexposedskinthoroughlyafteruse.

Personswithsensitiveskinorincontinuouscontactwiththeproductareadvised

towearimpermeablegloves.

Avoidcontactwitheyes.

Ifaccidentaleyecontactoccurs,flushgentlywithrunningwaterfor15minutes

andseekmedicaladviceifanyirritationpersists.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.

4.6. Adversereactions(frequencyandseriousness)

Sinceacepromazinedecreasessympatheticnervoussystemtone,atransient

dropinbloodpressuremayoccurafteradministration.

Inhibitionoftemperatureregulation.

Thefollowingreversiblechangesarepossibleinthehaemogram:

-transientdecreaseinerythrocytecountandhaemoglobinconcentration;

-transientdecreaseinthrombocyteandleukocytecounts.

Becauseitincreasesprolactinsecretion,theadministrationofacepromazine

mayleadtodisturbancesinfertility.

Penileprolapsemayoccurduetotherelaxationoftheretractorpenismuscles.

Retractionofthepenisshouldbevisiblewithintwotothreehours.Ifthisdoes

nottakeplace,itisadvisedtocontactaveterinarysurgeon.Lackofretractionis

ofparticularconcerninbreedingstallions.Acepromazinehascaused

paraphimosissometimesinsequeltopriaprism.

Inrarecasesparadoxicalexcitationreactionscandevelop.

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AN:00075/2012

ContradictoryclinicalsignsofaggressivenessandgeneralisedCNSstimulation

mayoccur.

Prolapseofthenictitatingmembranehasalsobeencitedasapossibleadverse

effectinhorses.

4.7. Useduringpregnancy,lactationorlay

Acepromazineshouldnotbeusedinpregnantorlactatingmares.

Acepromazinehasthepotentialtoinducehypotensioninnewbornswhen

administeredasapremedicationforcaesareansectioninthemare.

PleaseseealsoSection4.6relatingtodisturbancesinfertility.

4.8. Interactionwithothermedicinalproductsandotherformsofinteraction

Acepromazinepotentiatestheactionofcentrallydepressantdrugs.

Thesimultaneoususeoforganicphosphateestersincreasesthetoxicityof

acepromazine.

Sinceacepromazinedecreasessympatheticnervoussystemtone,itshouldnot

begivenatthesametimeasbloodpressurereducingdrugs.

Antacidsmaycauseadecreaseinthegastrointestinalabsorptionof

acepromazineafteroraladministration.

Opiatesmayenhancethehypotensiveeffectsofacepromazine.

4.9. Amount(s)tobeadministeredandadministrationroute

Administrationroute

Fororaladministration.Placethesyringeintheanimal'smouthandexpelthe

requireddoseintothecheekpouch.Thegelmayalsobemixedwithfood.

Amount(s)tobeadministered

Moderatesedation: 0.15mgacepromazineperkgbodyweight

Dosageguidelines:

Bodyweight

(kg) 200 300 400 450 500 600

Dose(ml) 1.0 1.5 1.5 2.0 2.5 2.5

Theabovedosageinformationisprovidedasaguideline.Thedosemaybe

variedtoadministerbetween0.5and1.5timestheaboverecommendation

dependingonthelevelofsedationrequired,i.e.formildsedation,administer

halftherecommendeddoseandfordeepersedation,administer1½timesthe

recommendeddose.

Becauseofthedifficultyinensuringtheaccuratedeliveryofsmalldoses,the

productshouldonlybeusedinhorsesoflessthan200kgbodyweightin

accordancewithabenefit/riskassessmentbytheresponsibleveterinarian.

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

Overdosageresultsinanearlieronsetofthesedativesymptomsandina

prolongedeffect.Toxiceffectsareataxia,hypotension,hypothermiaandcentral

nervoussystem(extrapyramidal)effects.

Noradrenaline,butnotadrenaline,canbeusedtocounteractthecardiovascular

effects.

4.11. Withdrawalperiod(s)

Donotuse inhorsesintendedforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Therapeuticgroup: NervousSystem

ATCvetcode: QN05AA04

5.1. Pharmacodynamicproperties

Acepromazineisaphenothiazinederivative.Thisgroupofmoleculesbelongsto

theneuroleptics:theydepressthecentralnervoussystemandexertassociated

effectsontheautonomicsystem.Theseeffectsareduetotheirinterference

withdifferentneurotransmitterreceptors(dopaminergic,adrenergic)andtotheir

interferencewithhypothalamicperformance.Thesedativeactivitystartswithin

15to30minutesoftreatmentandlastsfor6-7hours.

Thedesiredeffectsobservedaftertreatmentwithacepromazineincludea

generaltranquillizingeffect,anti-emeticeffectandaslightanti-histaminiceffect.

Thereisnoanalgesicaction.Theneurolepticeffectsarevariablebetween

individualanimals.

5.2. Pharmacokineticproperties

Acepromazineispartlyabsorbedfromthegastrointestinaltract.Plasmaprotein

bindingishighanditisextensivelydistributedthroughoutthebodytissues.

Plasmalevelsareusuallylow.Acepromazineishighlymetabolised,withthe

urineasthemainrouteofexcretion.

6. PHARMACEUTICALPARTICULARS

6.1. Listofexcipients

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate

Sodiumacetatetrihydrate

Sodiumcyclamate(E952)

Hydroxyethylcellulose

Glycerol(E422)

Purifiedwater

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AN:00075/2012

6.2. Incompatibilities

Simultaneousadministration,oradministrationtohorsesrecentlytreatedwith

organophosphatesshouldbeavoided,sincethesemoleculesenhancethetoxic

effectsofacepromazine.

Simultaneoustreatmentwithbloodpressureloweringproductsshouldbe

avoided.

6.3. Shelflife

Shelf-lifeoftheveterinarymedicinal

productaspackagedforsale:

2years

Shelf-lifeafterfirstopeningtheimmediate

packaging:

28days

6.4. Specialprecautionsforstorage

Donotstoreabove25°C.

Protectfromfrost.

Protectfromlight.

Whenthecontainerisbroached(opened)forthefirsttime,usewithin28days.

Afteruse,replacecaponsyringe.Keepthebroachedsyringeintheoriginal

cartonandstoreinadryplace.

6.5. Natureandcompositionofimmediatepackaging

Container: White,high-densitypolyethylenesyringebarrel.

White,low-densitypolyethylenesyringeplunger.

Closure: White,high-densitypolyethylene,push-fitcap.

Fillvolume: 10ml

Dosingdevice: Theproductispresentedinanoraldosingsyringewhich

isgraduatedat1mlintervals.

6.6. Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

Revised:May2013

AN:00075/2012

7. MARKETINGAUTHORISATIONHOLDER

FlorisVeterinaireProduktenBV

Kempenlandstraat33

5626GKVught

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER

Vm36057/4001

9. DATEOFFIRSTAUTHORISATION

10March2011

10. DATEOFREVISIONOFTHETEXT

May2013

Approved: 24/05/2013