Urilin Syrup 50 mg/ ml for dogs

Main information

  • Trade name:
  • Urilin Syrup 50 mg/ ml for dogs
  • Pharmaceutical form:
  • Syrup
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Urilin Syrup 50 mg/ml for dogs
    Hungary
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Phenylpropanolamin
  • Therapeutic area:
  • Dogs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0357/001
  • Authorization date:
  • 28-04-2010
  • EU code:
  • UK/V/0357/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised27/08/2010 –AN00637/2009

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Urilin40mg/mlSyrupfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

ActiveSubstance:Phenylpropanolamine40.29mg

(equivalentto50.0mgphenylpropanolaminehydrochloride).

Excipients: Sodiummethylparahydroxybenzoate(E219)1.5mg

Sodiumpropylparahydroxybenzoate(E217)0.15mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Syrup

Clearviscoussolution.

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs

4.2Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofurinaryincontinenceassociatedwithacquiredurethralsphincter

incompetenceinthebitchonly.

Theefficacyofphenylpropanolaminehasonlybeendemonstratedin

ovariohysterectomisedbitches.

4.3Contraindications

Pleaseseesection4.7.

Donotuseinanimalstreatedwithnon-selectivemonoamineoxidaseinhibitors.

Donotuseincasesofknownhypersensitivitytotheactivesubstanceortoanyofthe

excipients

4.4Specialwarningsforeachtargetspecies

Itisnotappropriatetousetheproductforthebehaviouralcauseofinappropriate

urination.

Revised27/08/2010 –AN00637/2009

4.5 Specialprecautionsforuse

(i)Specialprecautionsforuseinanimals

Becausephenylpropanolamineisasympathomimeticagent,itmayaffectthe

cardiovascularsystem,especiallybloodpressureandheartrate,andthereforeshouldbe

usedwithcautioninanimalswithcardiovasculardiseases.

Careshouldbeexercisedintreatinganimalswithsevererenalorhepaticinsufficiency,

diabetesmellitus,hyperadrenocorticism,glaucomaorothermetabolicdisorders.

Inbitcheslessthan1yearoldthepossibilityofanatomicaldisorderscontributingto

incontinenceshouldbeconsideredpriortotreatment.

(ii)Specialprecautionsforthepersonadministeringtheveterinarymedicinal

producttoanimals

Phenylpropanolaminehydrochlorideistoxicwhenoverdosesareingested.Adverse

effectsmayincludedizziness,headache,nausea,insomniaorrestlessness,and

increasedbloodpressure.Highoverdosemaybefatal,especiallyinchildren.

Intheeventofaccidentalskincontact,washthecontaminatedareawithsoapandwater.

Washhandsafteruseoftheproduct.

Intheeventofaccidentaleyecontact,rinsetheeyewithcleanwaterforabout15

minutesandseekmedicaladvice.

Toavoidaccidentalingestiontheproductmustbeusedandkeptoutofthereachand

sightofchildren.

Alwaysreplacethecapfirmlyafterusetoensurethatthechildresistantclosureoperates

correctly.

Intheeventofaccidentalingestion,seekimmediatemedicalattentionshowingthedoctor

thepackageleaflet.

4.6Adversereactions(frequencyandseriousness)

Insomedogs,loosestools,liquiddiarrhoea,adecreaseinappetite,arrhythmiaand

collapsehavebeenreportedfollowingtreatmentwithphenylpropanolamine.Treatment

wascontinueddependingontheseverityoftheundesirableeffectobserved.

Asphenylpropanolamineisasympathomimeticagentitispossibletoproduceawide

rangeofeffectsmostofwhichmimictheresultsofexcessstimulationofthesympathetic

nervoussystem(e.g.effectsontheheartrateandbloodpressure).

Dizzinessandrestlessnesswerealsooccasionallyreported.Hypersensitivitymayoccur

inveryrarecases.

4.7Useduringpregnancy,lactationorlay

Donotuseinpregnantorlactatingbitches.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Careshouldbeexercisedinadministeringtheproductwithothersympathomimetic

drugs,anticholinergicdrugs,tricyclicantidepressantsorspecifictypeBmonoamine

oxidase.

Revised27/08/2010 –AN00637/2009

4.9 Amounttobeadministeredandadministrationroute

Fororaladministration.

0.8mg/kgbodyweightphenylpropanolamine(equivalentto1mg/kgphenylpropanolamine

HCL)threetimesdailyinthefeed,correspondingto0.1mlUrilinsyrup/5kgbodyweight

threetimesdaily.

1dropforevery2.34kgbodyweightthreetimesdailyinfeed.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inhealthydogs,nosideeffectswereobservedatupto5timestherecommendeddose.

Howeveranoverdosecouldproducesignsofexcessivestimulationofthesympathetic

nervoussystem.

Treatmentshouldbesymptomatic.Alpha-adrenergicblockersmaybeappropriateinthe

caseofsevereoverdose.However,nospecificrecommendationondrugsordosages

canbegiven.

4.11Withdrawalperiods

Notapplicable.

5 PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:

Phenylpropanolaminehydrochlorideisasympathomimeticagent.

ATCVetCode:

QG04BX91

5.1Pharmacodynamicproperties

Sympatheticallyinnervatedsmoothmusclesplayaroleinurethralclosure,andboththeα

andβreceptorsarepresent.Theαreceptorsplayaroleinurethralclosurewhileβ

receptorsinnervaterelaxation.Thesmoothmuscleextendstothemid-urethrainfemales.

Theclinicaleffectofphenylpropanolamineisbasedonitsstimulationeffectsonα-

adrenergicreceptors.Thiscausesanincreasein,andstabilisationof,theclosure

pressureintheurethra,whichisinnervatedmainlybytheadrenergicnerves.

PhenylpropanolamineisaracemicmixtureofDandLenantiomers.

5.2Pharmacokineticproperties

Inthedog,themeanhalf-lifeofphenylpropanolamineisapproximately3hourswith

maximalplasmaconcentrationsbeingfoundafterapproximately4hours.No

accumulationofphenylpropanolaminehasbeenobservedafteradoseof1mg/kg3

timesdailyover15days.

Revised27/08/2010 –AN00637/2009

6 PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiummethylparahydroxybenzoate(E219)

Sodiumpropylparahydroxybenzoate(E217)

Maltitolliquid

Saccharinsodium

Citricacidmonohydrate(E330)

Purifiedwater

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelflifeafterfirstopeningtheimmediatepackaging:3months.

6.4Specialprecautionsforstorage

Donotstoreabove25

C.

Keepthecontainerintheoutercarton.

6.5Natureandcontentsofimmediatepackaging

50mlor100mlambertypeIIIglassbottlescontaining45mlor100mlofsyrup,witha

lowdensitypolyethylenedropperandapolypropylenechildresistantscrewcap.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts,ifappropriate

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnational

requirements.

Revised27/08/2010 –AN00637/2009

7 MARKETINGAUTHORISATIONHOLDER

DechraLimited

DechraHouse

JamageIndustrialEstate

TalkePits

Stoke-on-Trent

Staffordshire

ST71XW

UK

8 MARKETINGAUTHORISATIONNUMBER

Vm10434/4003

9 DATEOFFIRSTAUTHORISATION

28January2005

10 DATEOFANYREVISIONOFTHETEXT

27August2010