Tranquiline

Main information

  • Trade name:
  • Tranquiline 35mg/ml Oral Gel for Dogs
  • Pharmaceutical form:
  • Oral gel
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Tranquiline 35mg/ml Oral Gel for Dogs
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Acepromazine
  • Therapeutic area:
  • Dogs Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • IE/V/0278/001
  • Authorization date:
  • 23-11-2011
  • EU code:
  • IE/V/0278/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SummaryofProductCharacteristics

1NAMEOFTHEVETERINARYMEDICINALPRODUCT

Tranquiline35mg/mlOralGelforDogs.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Oralgel.

Clearyellowgel.

4CLINICALPARTICULARS

4.1TargetSpecies

Dogs.

4.2Indicationsforuse,specifyingthetargetspecies

Forsedationandanaestheticpre-medication.

Neuroleptanalgesiaincombinationwithamorphinederivative.

Anti-emeticeffect,symptomatictherapyincaseofvomitingandmotionsickness.

4.3Contraindications

Donotuseindogsweighinglessthan17.5kgbodyweight.

Donotuseinanimalsinshock,insevereemotionalexcitation,withanexistingtendencytoconvulsionorduringStatus

epilepticus.

Donotuseincaseofhypersensitivitytotheactivesubstanceoranyoftheexcipients.

4.4Specialwarningsforeachtargetspecies

Acepromazinecanprecipitatefaintinginbrachycephalicdogs.Largebreedsofdogareparticularlysensitiveto

acepromazineandtheminimumdosepossibleshouldbeusedinthesebreeds.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Activesubstance

Acepromazine

(asAcepromazinemaleate) 35.00mg

(47.50mg)

Excipients

Preservatives

Methylparahydroxybenzoate(E218) 0.65mg

Irish Medicines Board

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Date Printed 06/03/2012 CRN 7010059 page number: 1

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproducttoanimals

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyinformingthehealthprofessionalsofphenothiazine

poisoning.Showthepackageleafletorthelabeltothedoctor.DONOTDRIVEassedationandchangesinblood

pressuremayoccur.

Peoplewithknownhypersensitivitytoacepromazineorotherphenothiazinesshouldavoidcontactwiththeveterinary

medicinalproduct.

Personswithsensitiveskinorinfrequentcontactwiththeproductareadvisedtowearimpermeablegloves.

Washhandsandexposedskinthoroughlyafteruse.

Incaseofaccidentalspillageontotheskin,immediatelyafterexposurewashtheexposedskinwithlargeamountsof

water.

Avoidcontactwitheyes.Ifaccidentaleyecontactoccurs,flushgentlywithrunningwaterfor15minutesandseek

medicaladviceifanyirritationpersists.

4.6Adversereactions(frequencyandseriousness)

Sinceacepromazinedecreasessympatheticnervoussystemtone,atransientdropinbloodpressuremayoccurafter

administration.

Inhibitionoftemperatureregulation.

Thefollowingreversiblechangesarepossibleinthehaemogram:

-transientdecreaseinerythrocytecountandhaemoglobinconcentration;

-transientdecreaseinthrombocyteandleukocytecounts.

Becauseitincreasesprolactinsecretion,theadministrationofacepromazinemayleadtodisturbancesinfertility.

4.7Useduringpregnancy,lactationorlay

Teratologicaleffectsaftertheuseofacepromazineinbitcheshave,todate,notbeenreported.However,asnospecific

studyonteratologicaleffectsexists,theuseofacepromazineduringpregnancyisnotrecommendedandshouldonly

takeplacefollowingasuitablebenefit/riskassessmentbytheresponsibleveterinarysurgeon.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Acepromazinepotentiatestheactionofcentrallydepressantdrugs.

Thesimultaneoususeoforganicphosphateestersincreasesthetoxicityofacepromazine.

Sinceacepromazinedecreasessympatheticnervoussystemtone,theproductshouldnotbegivenatthesametimeas

bloodpressurereducingdrugs.

4.9Amountstobeadministeredandadministrationroute

Dosageguidelines

Theproductisfilledintoa10mlpolyethylenesyringe.Theflangedplungerhasalockingringwhichshouldbe

adjustedtosupplythevolumerequiredinaccordancewiththedosageguidelines.1.0mlintervalsareprintedonthe

syringeplunger,buttheplungerisindented/flangedatintervalsof0.5ml.Asingleturnofthelockingringwillmove

theringbackwardsallowingadosevolumeof0.5mltobeexpelled.Twoturnsofthelockingringwillsupplyadose

volumeof1.0ml.Threeturnsofthelockingringarerequiredforadoseof1.5ml.

Indication Dose Dosevolume

Slightsedation 1.0mg/kg 0.5ml ½thesingleoraldose/17.5kgbodyweight

Sedation 2.0mg/kg 1.0ml Singleoraldose/17.5kgbodyweight

Pre-medication 3.0mg/kg 1.5ml 1½timesthesingleoraldose/17.5kg

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/03/2012 CRN 7010059 page number: 2

Thepalatablegelcanalsobemixedwithfood.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosageresultsinanearlieronsetofthesedativesymptomsandinaprolongedeffect.

Toxiceffectsareataxia,hypotension,hypothermiaandextrapyramidaleffects.

Antidote:Noradrenalinecanbeusedtocounteractthecardiovasculareffects.

Possibleantidotetoapnoeaandsyncopewhichmayoccur-methylamphetamineandsolublesteroid.

4.11WithdrawalPeriod(s)

Notapplicable.

5PHARMACOLOGICALorIMMUNOLOGICALPROPERTIES

Therapeuticgroup: NervousSystem

ATCvetcode: QN05AA04

5.1Pharmacodynamicproperties

Acepromazineisaphenothiazinederivative.Thisgroupofmoleculesbelongstotheneuroleptics:theydepressthe

centralnervoussystemandexertassociatedeffectsontheautonomicsystem.Theseeffectsareduetotheirinterference

withdifferentneurotransmitterreceptors(dopaminergic,adrenergic)andtotheirinterferencewithhypothalamic

performance.Thesedativeactivitystartswithin15to30minutesoftreatmentandlastsfor6-7hours.

5.2Pharmacokineticproperties

Acepromazineispartlyabsorbedfromthegastrointestinaltract.Plasmaproteinbindingishighanditisextensively

distributedthroughoutthebodytissues.Plasmalevelsareusuallylow.Acepromazineishighlymetabolised,withthe

urineasthemainrouteofexcretion.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

Sodiumacetatetrihydrate

Sodiumcyclamate(E952)

Hydroxyethylcellulose

Glycerol(E422)

Purifiedwater

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithotherveterinary

medicinalproducts.

6.3Shelf-life

Shelf-lifeoftheveterinarymedicinal

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/03/2012 CRN 7010059 page number: 3

Shelf-lifeafterfirstopeningthe

immediatepackaging: 28days

Keepthebroachedsyringeintheoriginalcartonandstoreinadryplace.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Donotrefrigerateorfreeze.

Protectfromlight.

6.5Natureandcompositionofimmediatepackaging

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwastematerials

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproductsshouldbe

disposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

FlorisVeterinaireProduktenBV

Kempenlandstraat33

5262GKVught

TheNetherlands

8MARKETINGAUTHORISATIONNUMBER(S)

VPA10492/001/001

9DATEOFTHEFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

2ndMarch2012

Container: White,high-densitypolyethylenesyringebarrel.

White,low-densitypolyethylenesyringeplunger.

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

Fillvolume: 10ml

Dosingdevice: Theproductispresentedinanoraldosingsyringewhichisgraduatedat1

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/03/2012 CRN 7010059 page number: 4

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