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

Other information

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

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

19-11-2018

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

One lot each of Option Family Sunscreen Lotion SPF 50 and Personnelle Sport Sunscreen Lotion SPF 50 have been voluntarily recalled by Empack Spraytech Inc. because of bacterial contamination.

Health Canada

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration