PRILIUM 150 MG

Main information

  • Trade name:
  • PRILIUM 150 MG
  • Pharmaceutical form:
  • Powder for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PRILIUM 150 MG
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Imidapril
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0133/002
  • Authorization date:
  • 20-02-2008
  • EU code:
  • FR/V/0133/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

11835 Prilium150 mg/FINALSPC Renewal

PRILIUM150mgpowderfororalsolution

Powderfororalsolution

SUMMARYOFPRODUCTCHARACTERISTICS

11835 Prilium150 mg/FINALSPC Renewal

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

PRILIUM150 mgpowderfororalsolutionfordogs

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Powder/vial

Imidaprilhydrochloride 150 mg

Sodiumbenzoate(E211) 30 mg

Excipientto 0.880 g

Solutionafterreconstitution

Imidaprilhydrochloride 5.0 mg

Sodiumbenzoate(E211) 1.0 mg

Excipientto 1 ml

Forfulllistofexcipients, see6.1.

3.PHARMACEUTICALFORM

Powderfororalsolution.

Vialcontainingawhitepowder. Afterreconstitution, thesolutionislimpid and colourless.

4.CLINICALPARTICULARS

4.1. Targetspecies

Dogsweighingover4 kg

4.2. Indicationsforuse, specifyingthetargetspecies

Indogs:treatmentofmoderateto severeheartfailurecaused bymitralregurgitationorbydilatedcardiomyopathy.

4.3. Contraindications

Do notuseindogswithlowblood pressure.

Do notuseindogswithacuterenalinsufficiency.

Do notuseindogswithcongenitalheartdisease

Do notuseindogshypersensitiveto anACEinhibitor

Do notuseindogswithhemodynamicallyrelevantstenoses(aorticstenosis, mitralvalvestenosis, pulmonal

stenosis)

Do notuseindogswithobstructivehypertrophiccardiomyopathy

4.4. Specialwarningsforeachtargetspecies

None

4.5. Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

11835 Prilium150 mg/FINALSPC Renewal

TheuseofACEinhibitorsindogswithhypovolaemia/dehydrationcanlead toacutehypotension. Insuchcases

thefluid and electrolytebalanceshould berestored immediatelyand treatmentsuspended untilithasbeen

stabilised.

Parametersused formonitoringrenalfunctionshould bechecked atthebeginningofthetreatmentand atregular

timeintervalsthereafter.

ii)Specialprecautionsto betakenbythepersonadministeringthemedicinalproductto animals

Incaseofaccidentalingestion, seek medicaladviceimmediatelyand showthepackageinsertorthelabelto the

physician.

Washhandsafterhavingadministered theveterinarymedicinalproduct. Incaseofcontactwitheyes, rinse

immediatelywithplentyofwater.

Thevialmustbeclosed usingthechild proofstopperbeforebeingstored inthefridge.

iii)Otherprecautions

4.6. Adversereactions(frequencyand seriousness)

Diarrhoea,hypotensionand related symptomssuchasfatigue, dizzinessoranorexiacanoccurinrarecases.

Vomitingcanalso occurinveryrarecases. Insuchcasestreatmentshould bediscontinued untilthepatient’s

conditionhasreturned to normal.

4.7. Useduringpregnancy, lactationorlay

Laboratorystudiesinratsand rabbitsdid notproduceanyevidenceof

teratogenic, embryotoxicormaternotoxiceffects, oreffectsonreproductive

performances,whenimidaprilwasadministered atthetherapeuticdose.

Intheabsenceofdata, do notuseinpregnantorlactatingbitchesorin

breedingdogs.

4.8. Interactionwithothermedicinalproductsand otherformsofinteraction

Intheclinicaltrial, theveterinarymedicinalproducthasbeenused withfurosemideand digoxinand no safety

concernswerenoted.

Howeverdiureticsand alowsodiumdietpotentiatetheeffectofACEinhibitorsbyactivatingtherenin-

angiotensin-aldosteronesystem(RAAS). Diureticsused athighdoses and alowsodiumdietarethusnot

recommended duringatreatmentwithACEinhibitorsinorderto avoid hypotensionwithclinicalsignssuchas

apathy, ataxia, raresyncopeand kidneyfailure. Incaseofjointadministrationwithpotassiumretainingdiuretics,

potassiummustbemonitored becausethereisarisk ofhyperkaliemia.

4.9. Amount(s)to beadministered and administrationroute

Therecommended doseofimidaprilis0.25 mg/kgonceadayperoralroute, ie:

0.05 ml/kgofPRILIUM®150 mgfordogsweighingmorethan4 kg(1ml/20kg).

Theveterinarymedicinalproductcanbeadministered eitherdirectlyinto themouthoftheanimalonanempty

stomachorduringthemeals, oronfood.

Preparationoftheoralsolution:Removethenippleand thestopperofthevialcontainingthepowderand fillwith

tap waterup to themark (30 ml), placethechild proofcap and screwontightly.

Administration:Unscrewthechild proofcap, introducethegraduated syringeinto theapplicator, turnthe

assemblyupsidedownand measurethequantityto administerusingthesyringegraduated inkg. Oncethe

veterinarymedicinalproducthasbeenadministered, replacethechild proofcap back onto thevialand rinsethe

syringewithwater. Storethevialinthefridge.

4.10. Overdose(symptoms, emergencyprocedures, antidotes)

11835 Prilium150 mg/FINALSPC Renewal

Repeated oraldosesup to 5 mg/kg/d ofimidaprilhavebeenwelltolerated inhealthydogs.

Hypotensionmayoccurasasymptomofoverdosagewithsignsofapathyand ataxia.Thetreatmentis

symptomatic.

11835 Prilium150 mg/FINALSPC Renewal

5.1.Withdrawalperiod

Notapplicable.

5.PHARMACOLOGICALPROPERTIES

Imidaprilisanewangiotensin-convertingenzyme(ACE)inhibitor.

ATCvetcode:QC09AA16

5.1 Pharmacodynamicproperties:

Imidaprilisapro-drugwhichishydrolysedin vivoto formanactivemetabolite,imidaprilat.Imidaprilatinhibitsthe

angiotensin-convertingenzyme(ACE). ThisenzymecatalysestheconversionofangiotensinItoangiotensinIIinthe

blood plasmaand tissuesand inhibitsthebreakdownofbradykinin. AsangiotensinIIhasapotentvasoconstrictive

action,whilebradykininisavasodilator,thereducedformationofangiotensinIIandtheinhibitionofbradykinin

breakdownlead to vasodilation.

Imidaprilreducesheartpreloadandafterloadanddecreasesbloodpressurewithoutanycompensatoryincreaseinthe

heartrate.

5.2 Pharmacokineticproperties:

Followingoraladministrationinthedog,imidaprilisrapidlyabsorbed bythegastrointestinaltractand reachesits

maximumplasmaconcentrationwithinlessthanonehour. Thehalf-lifeofimidaprilisabout2 hours.

Imidaprilismainlyhydrolysedintheliverandkidneytoitsactivemetabolite,imidaprilat.Maximumplasma

concentrationsofimidaprilatarereached withinabout5 hoursand declinewithahalf-lifeofmorethan10 hours.

Thebioavailabilityofimidapriland imidaprilatisdecreased bythejointadministrationoffood.

Theproteinbindingofimidapriland imidaprilatismoderate(85%and 53%, respectively).

Afteroraladministrationoftheradio-labelled compound, about40%oftotalradioactivityisexcreted inurineand

about60%inthefaeces.

Aftermultipledosing, theplasmaimidaprilatconcentrationsareabout3timeshigherafterthesecondadministration

thanafterthefirstadministration, butno additionalincreaseisobserved afterfurtheradministrations.

6.PHARMACEUTICALPARTICULARS

6.1. Listofexcipients

Mannitol,

Sodiumbenzoate

6.2. Incompatibilities(majorcases)

Noneknown

6.3. Shelf-life

36 months

Afterreconstitutionaccordingto directions:77 days

6.4. Specialprecautionsforstorage

Beforereconstitution:do notstoreabove25°C

Afterreconstitution:storeat2 °C-8°C(inarefrigerator)

11835 Prilium150 mg/FINALSPC Renewal

6.5. Natureand compositionofimmediatepackaging

Primarypackaging:

amberglassvialoftypeII

bromobutylstopper

polypropyleneorangegraduated syringe

polyethylenesyringeapplicator

highdensitypolyethylene/polyethylenechild proofcap

Salespresentation(s):

boxcontainingone0.880 gpowdervialand one2 mlgraduated syringe

6.6 Specialprecautionsforthedisposalofunused veterinarymedicinalproductorwastematerialsderived

fromtheuseofsuchproducts, ifappropriate

Anyunused productorwastematerialshould bedisposed ofinaccordancewithnationalrequirements.

7.MARKETINGAUTHORISATIONHOLDER

VETOQUINOL

8.MARKETINGAUTHORISATIONNUMBER(S):

9.DATEOFTHEFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION:

10.DATEOFREVISIONOFTHETEXT:

<PROHIBITIONOFSALE, SUPPLYAND/ORUSE>

11835 Prilium150 mg/FINALSPC Renewal

OUTERPACKAGE

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PRILIUM150mgpowderfororalsolutionfordogs

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Powder/vial

Imidaprilhydrochloride 150mg

Sodiumbenzoate(E211) 30mg

Excipientto 0.880g

Solutionafterreconstitution

Imidaprilhydrochloride 5.0mg

Sodiumbenzoate(E211) 1.0mg

Excipientto 1ml

3. PHARMACEUTICALFORM

Powderfororalsolution

4. PACKAGESIZE

Boxcontainingone0.880gpowdervialandone2mlgraduatedsyringe.

5. TARGETSPECIES

Dogsweighingover4kg

6. INDICATIONS

Indogs:treatmentofmoderatetosevereheartfailurecausedbymitralregurgitationorbydilated

cardiomyopathy.

7. METHODANDROUTEOFADMINISTRATION

Theveterinarymedicinalproductcanbeadministeredeitherdirectlyintothemouthoftheanimal

onanemptystomachorduringthemeals,oronfood.

8. WITHDRAWALPERIOD

Notapplicable.

9. SPECIALWARNINGS,IFNECESSARY

Readthepackageleafletbeforeuse.

10.EXPIRYDATE

EXP:

Afterreconstitution:77days

11835 Prilium150 mg/FINALSPC Renewal

11.SPECIALSTORAGEPRECAUTIONS

Beforereconstitution:donotstoreabove25°C

Afterreconstitution:storeat2°C-8°C(intherefrigerator)

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedtheveterinarymedicinalproductorwastematerialshouldbedisposedofin

accordancewithnationalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

FORANIMALTREATMENTONLY

TOBESUPPLIEDONLYONVETERINARYPRESCRIPTION

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

VETOQUINOL

16.MARKETINGAUTHORISATIONNUMBER(S)

BATCHNUMBER:

11835 Prilium150 mg/FINALSPC Renewal

PACKAGELEAFLET

PRILIUM 150 mg powder for oral solution for dogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOFTHE

MANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCHRELEASE,

IFDIFFERENT

MarketingAuthorisationholder

VETOQUINOL

Manufacturerforthebatchrelease:

VETOQUINOL

MAGNYVERNOIS

F-70200LURE

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PRILIUM150mgpowderfororalsolutionfordogs

3. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Powder/vial

Imidaprilhydrochloride 150mg

Sodiumbenzoate(E211) 30mg

Excipientto 0.880g

Solutionafterreconstitution

Imidaprilhydrochloride 5.0mg

Sodiumbenzoate(E211) 1.0mg

Excipientto 1ml

4. INDICATIONS

Indogs:treatmentofmoderatetosevereheartfailurecausedbymitralregurgitationorbydilated

cardiomyopathy.

5. CONTRAINDICATIONS

Donotuseindogswithlowbloodpressure.

Donotuseindogswithacuterenalinsufficiency.

Donotuseindogswithcongenitalheartdisease

DonotuseindogshypersensitivetoanACEinhibitor

Donotuseindogswithhemodynamicallyrelevantstenoses(aorticstenosis,mitralvalve

stenosis,pulmonalstenosis)

Donotuseindogswithobstructivehypertrophiccardiomyopathy

11835 Prilium150 mg/FINALSPC Renewal

6. ADVERSEREACTIONS

Diarrhoea,hypotensionandrelatedsymptomssuchasfatigue,dizzinessoranorexiacanoccurin

rarecases.Insuchcasestreatmentshouldbediscontinueduntilthepatient’sconditionhas

returnedtonormal.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Dogsweighingover4kg

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Therecommendeddoseofimidaprilis0.25mg/kgonceadayperoralroute,ie:

0.05ml/kgofPRILIUM®150mgpowderfororalsolutionfordogsweighingmorethan

4kg(1ml/20kg).

Theveterinarymedicinalproductcanbeadministeredeitherdirectlyintothemouthoftheanimal

onanemptystomachorduringthemeals,oronfood.

Preparationoftheoralsolution:Removethenippleandthestopperofthevialcontainingthe

powderandfillwithtapwateruptothemark(30ml)placethechildproofcapandscrewontightly.

Administration:Unscrewthechildproofcap,introducethegraduatedsyringeintotheapplicator,

turntheassemblyupsidedownandmeasurethequantitytoadministerusingthesyringe

graduatedinkg.Oncetheveterinarymedicinalproducthasbeenadministered,replacethechild

proofcapontothevialandrinsethesyringewithwater.Storethevialinthefridge.

9. ADVICEONCORRECTADMINISTRATION

None.

10.WITHDRAWALPERIOD

Notapplicable.

11.SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Beforereconstitution:donotstoreabove25°C

Afterreconstitution:storeat2°C-8°C(intherefrigerator)

Donotuseaftertheexpirydatestatedonthecarton.

Shelf-lifeafterreconstitution:77days

12.SPECIALWARNINGS

Specialprecautionsforuseinanimals

TheuseofACEinhibitorsindogswithhypovolaemia/dehydrationcanleadtoacutehypotension.

Insuchcasesthefluidandelectrolytebalanceshouldberestoredimmediatelyandtreatment

suspendeduntilithasbeenstabilised.Parametersusedformonitoringrenalfunctionshouldbe

checkedatthebeginningofthetreatmentandatregulartimeintervalsthereafter.

11835 Prilium150 mg/FINALSPC Renewal

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackageinsertor

thelabeltothephysician.

Washhandsafterhavingadministeredtheveterinarymedicinalproduct.Incaseofcontactwith

eyes,rinseimmediatelywithplentyofwater.

Thevialmustbeclosedusingthechildproofstopperbeforebeingstoredinthefridge.

Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandrabbitsdidnotproduceanyevidenceofteratogenic,embryotoxic

ormaternotoxiceffects,oreffectsonreproductiveperformances,whenimidaprilwas

administeredatthetherapeuticdose.Intheabsenceofdata,donotuseinpregnantorlactating

bitchesorinbreedingdogs.

Interactionwithothermedicinalproductsandotherformsofinteraction

Intheclinicaltrial,theveterinarymedicinalproducthasbeenusedwithfurosemideanddigoxin

andnosafetyconcernswerenoted.

HoweverdiureticsandalowsodiumdietpotentiatetheeffectofACEinhibitorsbyactivatingthe

renin-angiotensin-aldosteronesystem(RAAS).Diureticsusedathighdosesandalowsodium

dietarethusnotrecommendedduringatreatmentwithACEinhibitorsinordertoavoid

hypotensionwithclinicalsignssuchasapathy,ataxia,raresyncopeandkidneyfailure.Incaseof

jointadministrationwithpotassiumretainingdiuretics,potassiummustbemonitoredbecause

thereisariskofhyperkaliemia.

Overdose(symptoms,emergencyprocedures,antidotes)

Repeatedoraldosesupto5mg/kg/dofimidaprilhavebeenwelltoleratedinhealthydogs.

Hypotensionmayoccurasasymptomofoverdosagewithsignsofapathyandataxia.The

treatmentissymptomatic.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedtheveterinarymedicinalproductorwastematerialshouldbedisposedofin

accordancewithnationalrequirements.

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste

Askyouveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.Thesemeasures

shouldhelptoprotecttheenvironment.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

DECEMBER2006

15.OTHERINFORMATION

Foranimaltreatmentonly.

Boxcontainingone0.880gwhitepowdervialandone2mlgraduatedorangesyringe.After

reconstitution,thesolutionislimpidandcolourless.

11835 Prilium150 mg/FINALSPC Renewal

11835 Prilium150 mg/FINALSPC Renewal

LABEL

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PRILIUM150mgpowderfororalsolutionfordogs

2. QUANTITYOFTHEACTIVESUBSTANCE

Imidaprilhydrochloride……………………………..150mg

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

Boxcontainingone0.880gpowdervialandone2mlgraduatedsyringe

4. ROUTE(S)OFADMINISTRATION

Theveterinarymedicinalproductcanbeadministeredeitherdirectlyintothemouthoftheanimal

onanemptystomachorduringthemeals,oronfood.

5. WITHDRAWALPERIOD

Notapplicable.

6. BATCHNUMBER

7. EXPIRYDATE

EXP:

Shelf-lifeafterreconstitution:77days

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

KEEPOUTOFREACHANDSIGHTOFCHILDREN

Beforereconstitution:donotstoreabove25°C

Afterreconstitution:storeat2°C-8°C(intherefrigerator)

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