PRILIUM 75 MG

Main information

  • Trade name:
  • PRILIUM 75 MG
  • Pharmaceutical form:
  • Powder for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PRILIUM 75 MG
    Netherlands
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0133/001
  • Authorization date:
  • 04-04-2008
  • EU code:
  • FR/V/0133/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

11834 Prilium75 mg/-FINALSPC /Renewal

PRILIUM75mgpowderfororalsolution

Powderfororalsolution

SUMMARYOFPRODUCTCHARACTERISTICS

11834 Prilium75 mg/-FINALSPC /Renewal

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

PRILIUM75 mgpowderfororalsolutionfordogs

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Powder/vial

Imidaprilhydrochloride 75 mg

Sodiumbenzoate(E211) 30 mg

Excipientto 0.805 g

Solutionafterreconstitution

Imidaprilhydrochloride 2.5 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

Dogsweighingover2 kg

4.2.Indicationsforuse, specifyingthetargetspecies

Indogs:treatmentofmoderatetosevereheartfailurecausedbymitralregurgitationorbydilatedcardiomyopathy.

4.3.Contraindications

Do notuseindogswithlowblood pressure.

Do notuseindogswithacuterenalinsufficiency.

Do notuseindogswithcongenitalheartdisease

Do notuseindogshypersensitiveto anACEinhibitor

Donotuseindogswithhemodynamicallyrelevantstenoses(aorticstenosis,mitralvalvestenosis,pulmonal

stenosis)

Do notuseindogswithobstructivehypertrophiccardiomyopathy

4.4.Specialwarningsforeachtargetspecies

None

4.5.Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

TheuseofACEinhibitorsindogswithhypovolaemia/dehydrationcanleadtoacutehypotension.Insuchcasesthe

fluid and electrolytebalanceshould berestoredimmediatelyandtreatmentsuspendeduntilithasbeenstabilised.

11834 Prilium75 mg/-FINALSPC /Renewal

Parametersused formonitoringrenalfunctionshould becheckedatthebeginningofthetreatmentandatregular

timeintervalsthereafter.

ii)Specialprecautionsto betakenbythepersonadministeringthemedicinalproductto animals

Incaseofaccidentalingestion, seek medicaladviceimmediatelyand showthepackageinsertorthelabeltothe

physician.

Washhandsafterhavingadministeredtheveterinarymedicinalproduct.Incaseofcontactwitheyes,rinse

immediatelywithplentyofwater.

Thevialmustbeclosed usingthechild proofstopperbeforebeingstored inthefridge.

iii)Otherprecautions

4.6.Adversereactions(frequencyand seriousness)

Diarrhoea,hypotensionandrelatedsymptomssuchasfatigue,dizzinessoranorexiacanoccurinrarecases.

Vomitingcanalsooccurinveryrarecases.Insuchcasestreatmentshouldbediscontinued untilthepatient’s

conditionhasreturned to normal.

4.7.Useduringpregnancy, lactationorlay

Laboratorystudiesinratsandrabbitsdidnotproduceanyevidenceofteratogenic,embryotoxicormaternotoxic

effects, oreffectsonreproductiveperformances,whenimidaprilwasadministeredatthetherapeuticdose.Inthe

absenceofdata, do notuseinpregnantorlactatingbitchesorinbreedingdogs.

4.8.Interactionwithothermedicinalproductsand otherformsofinteraction

Intheclinicaltrial,theveterinarymedicinalproducthasbeenusedwithfurosemideand digoxinand no safety

concernswerenoted.

HoweverdiureticsandalowsodiumdietpotentiatetheeffectofACEinhibitorsbyactivatingtherenin-

angiotensin-aldosteronesystem(RAAS).Diureticsusedathighdosesandalowsodiumdietarethusnot

recommendedduringatreatmentwithACEinhibitorsinorderto avoid hypotensionwithclinicalsignssuchas

apathy, ataxia, raresyncopeand kidneyfailure. Incaseofjointadministrationwithpotassiumretainingdiuretics,

potassiummustbemonitored becausethereisarisk ofhyperkaliemia.

4.9.Amount(s)to beadministered and administrationroute

Therecommended doseofimidaprilis0.25 mg/kgonceadayperoralroute, ie:

0.1 ml/kgofPRILIUM®75 mgfordogsweighingmorethan2 kg(1ml/10kg).

Theveterinarymedicinalproductcanbeadministeredeitherdirectlyinto themouthoftheanimalonanempty

stomachorduringthemeals, oronfood.

Preparationoftheoralsolution:Removethenippleandthestopperofthevialcontainingthepowderandfillwith

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

Administration:Unscrewthechildproofcap,introducethegraduatedsyringeintotheapplicator,turntheassembly

upsidedownandmeasurethequantitytoadministerusingthesyringegraduatedinkg.Oncetheveterinary

medicinalproducthasbeenadministered,replacethechildproofcapontothevialandrinsethesyringewithwater.

Storethevialinthefridge.

4.10.Overdose(symptoms, emergencyprocedures, antidotes)

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

Hypotensionmayoccurasasymptomofoverdosagewithsignsofapathyandataxia.Thetreatmentis

symptomatic.

4.11.Withdrawalperiod

Notapplicable.

11834 Prilium75 mg/-FINALSPC /Renewal

11834 Prilium75 mg/-FINALSPC /Renewal

5. PHARMACOLOGICALPROPERTIES

Imidaprilisanangiotensin-convertingenzyme(ACE)inhibitor.

ATCvetcode:QC09AA16

5.1. Pharmacodynamicproperties:

Imidaprilisapro-drugwhichishydrolysedinvivotoformanactivemetabolite,imidaprilat.Imidaprilatinhibitsthe

angiotensin-convertingenzyme(ACE). ThisenzymecatalysestheconversionofangiotensinItoangiotensinIIin

thebloodplasmaandtissuesandinhibitsthebreakdownofbradykinin.AsangiotensinIIhasapotent

vasoconstrictiveaction,whilebradykininisavasodilator,thereducedformationofangiotensinIIandtheinhibition

ofbradykininbreakdownleadtovasodilation.Imidaprilreducesheartpreloadandafterload,anddecreasesblood

pressurewithoutanycompensatoryincreaseintheheartrate.

5.2. Pharmacokineticproperties:

Followingoraladministrationinthedog, imidaprilisrapidlyabsorbedbythegastrointestinaltractandreachesits

maximumplasmaconcentrationwithinlessthanonehour. Thehalf-lifeofimidaprilisabout2 hours.

Imidaprilismainlyhydrolysedintheliverandkidneytoitsactivemetabolite,imidaprilat.Maximumplasma

concentrationsofimidaprilatarereachedwithinabout5hoursanddeclineswithahalf-lifeofmorethan10hours.

Thebioavailabilityofimidapriland imidaprilatisdecreased bythejointadministrationoffood.

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

Afteroraladministrationoftheradio-labelledcompound,about40%oftotalradioactivityisexcretedinurineand

about60%inthefaeces.

Aftermultipledosing,theplasmaimidaprilatconcentrationsareabout3timeshigherafterthesecond

administrationthanafterthefirstadministration,butnoadditionalincreaseisobservedafterfurtheradministrations.

6. PHARMACEUTICALPARTICULARS

6.1. Listofexcipients

Mannitol, sodiumbenzoate,

Hydrochloricacid (forpHadjustement)

6.2. Incompatibilities

Noneknown

6.3. Shelf-life

18 months

Afterreconstitutionaccordingto directions:77 days

6.4. Specialprecautionsforstorage

Beforereconstitution:do notstoreabove25°C

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

6.5. Natureand compositionofimmediatepackaging

Primarypackaging:

amberglassvialoftypeII

bromobutylstopper

polypropylenebluegraduated syringe

polyethylenesyringeapplicator

highdensitypolyethylenecap

11834 Prilium75 mg/-FINALSPC /Renewal

Salespresentation(s):

boxcontainingone0.805 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>

11834 Prilium75 mg/-FINALSPC /Renewal

OUTERPACKAGE

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PRILIUM75 mgpowderfororalsolutionfordogs

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Powder/vial

Imidaprilhydrochloride 75 mg

Sodiumbenzoate(E211) 30 mg

Excipientto 0.805 g

Solutionafterreconstitution

Imidaprilhydrochloride 2.5 mg

Sodiumbenzoate(E211) 1.0 mg

Excipientto 1 ml

3. PHARMACEUTICALFORM

Powderfororalsolution

4. PACKAGESIZE

Boxcontainingone0.805 gpowdervialand one2 mlgraduated syringe.

5. TARGETSPECIES

Dogsweighingover2 kg

6. INDICATIONS

Indogs:treatmentofmoderatetosevereheartfailurecausedbymitralregurgitationorbydilated

cardiomyopathy.

7. METHODANDROUTEOFADMINISTRATION

Theveterinarymedicinalproductcanbeadministeredeitherdirectlyintothemouthoftheanimalonan

emptystomachorduringthemeals, oronfood.

8. WITHDRAWALPERIOD

Notapplicable.

9. SPECIALWARNINGS, IFNECESSARY

Read thepackageleafletbeforeuse.

10.EXPIRYDATE

11834 Prilium75 mg/-FINALSPC /Renewal

EXP:

Afterreconstitution:77 days

11834 Prilium75 mg/-FINALSPC /Renewal

11.SPECIALSTORAGEPRECAUTIONS

Beforereconstitution:do notstoreabove25°C

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

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS, IFANY

Anyunused theveterinarymedicinalproductorwastematerialshould bedisposedofinaccordancewith

nationalrequirements.

13.THEWORDS“FORANIMALTREATMENTONLY” ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE, ifapplicable

FORANIMALTREATMENTONLY

TOBESUPPLIEDONLYONVETERINARYPRESCRIPTION

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keep outofthereachand sightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

VETOQUINOL

16.MARKETINGAUTHORISATIONNUMBER(S)

BATCHNUMBER:

11834 Prilium75 mg/-FINALSPC /Renewal

PACKAGELEAFLET

PRILIUM75mgpowderfororalsolutionfordogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOFTHE

MANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCHRELEASE,

IFDIFFERENT

Marketing Authorisationholder

VETOQUINOL

Manufacturerforthebatchrelease:

VETOQUINOL

MAGNYVERNOIS

F-70200 LURE

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PRILIUM75 mgpowderfororalsolutionfordogs

3. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Powder/vial

Imidaprilhydrochloride 75 mg

Sodiumbenzoate(E211) 30 mg

Excipientto 0.805 g

Solutionafterreconstitution

Imidaprilhydrochloride 2.5 mg

Sodiumbenzoate(E211) 1.0 mg

Excipientto 1 ml

4. INDICATIONS

Indogs:treatmentofmoderatetosevereheartfailurecausedbymitralregurgitationorbydilated

cardiomyopathy.

5. CONTRAINDICATIONS

Do notuseindogswithlowblood pressure.

Do notuseindogswithacuterenalinsufficiency.

Do notuseindogswithcongenitalheartdisease

Do notuseindogshypersensitiveto anACEinhibitor

Donotuseindogswithhemodynamicallyrelevantstenoses(aorticstenosis,mitralvalvestenosis,pulmonal

stenosis)

Do notuseindogswithobstructivehypertrophiccardiomyopathy

11834 Prilium75 mg/-FINALSPC /Renewal

6. ADVERSEREACTIONS

Diarrhoea,hypotensionandrelatedsymptomssuchasfatigue,dizzinessoranorexiacanoccurinrarecases.

Insuchcasestreatmentshould bediscontinued untilthepatient’sconditionhasreturned to normal.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyourveterinary

surgeon.

7. TARGETSPECIES

Dogsweighingover2 kg

8. DOSAGEFOREACHSPECIES, ROUTE(S)ANDMETHODOFADMINISTRATION

Therecommended doseofimidaprilis0.25 mg/kgonceadayperoralroute, ie:

0.1ml/kgofPRILIUM®75mgpowderfororalsolutionfordogsweighingmorethan

2 kg(1ml/10kg).

Theveterinarymedicinalproductcanbeadministeredeitherdirectlyintothemouthoftheanimalonan

emptystomachorduringthemeals, oronfood.

Preparationoftheoralsolution:Removethenippleandthestopperofthevialcontainingthepowderandfill

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

Administration:Unscrewthechild proofcap, introducethegraduated syringeinto theapplicator,turnthe

assemblyupsidedownand measurethequantitytoadministerusingthesyringegraduatedinkg.Oncethe

veterinarymedicinalproducthasbeenadministered, replacethechildproofcapontothevialandrinsethe

syringewithwater. Storethevialinthefridge.

9. ADVICEONCORRECTADMINISTRATION

None.

10.WITHDRAWALPERIOD

Notapplicable.

11.SPECIALSTORAGEPRECAUTIONS

Keep outofthereachand sightofchildren.

Beforereconstitution:do notstoreabove25°C

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

Do notuseaftertheexpirydatestated onthecarton.

Shelf-lifeafterreconstitution:77 days

12.SPECIALWARNINGS

Specialprecautionsforuseinanimals

TheuseofACEinhibitorsindogswithhypovolaemia/dehydrationcanlead toacutehypotension.Insuch

casesthefluid and electrolytebalanceshouldberestoredimmediatelyandtreatmentsuspendeduntilithas

beenstabilised.Parametersused formonitoringrenalfunctionshould bechecked atthebeginningofthe

treatmentand atregulartimeintervalsthereafter.

11834 Prilium75 mg/-FINALSPC /Renewal

Specialprecautionsto betakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackageinsertorthelabelto

thephysician.

Washhandsafterhavingadministeredtheveterinarymedicinalproduct.Incaseofcontactwitheyes,rinse

immediatelywithplentyofwater.

Thevialmustbeclosed usingthechild proofstopperbeforebeingstored inthefridge.

Useduring pregnancy, lactationorlay

Laboratorystudiesinratsandrabbitsdidnotproduceanyevidenceofteratogenic,embryotoxicor

maternotoxiceffects,oreffectsonreproductiveperformances,whenimidaprilwasadministeredatthe

therapeuticdose. Intheabsenceofdata, do notuseinpregnantorlactatingbitchesorinbreedingdogs.

Interactionwithothermedicinalproductsandotherformsofinteraction

Intheclinicaltrial,theveterinarymedicinalproducthasbeenusedwithfurosemideand digoxinand no

safetyconcernswerenoted.

HoweverdiureticsandalowsodiumdietpotentiatetheeffectofACEinhibitorsbyactivatingtherenin-

angiotensin-aldosteronesystem(RAAS). Diureticsused athighdosesand alowsodiumdietarethusnot

recommended duringatreatmentwithACEinhibitorsinordertoavoidhypotensionwithclinicalsignssuch

asapathy, ataxia, raresyncopeand kidneyfailure. Incaseofjointadministrationwithpotassiumretaining

diuretics, potassiummustbemonitored becausethereisarisk ofhyperkaliemia.

Overdose(symptoms, emergency procedures, antidotes)

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

Hypotensionmayoccurasasymptomofoverdosagewithsignsofapathyand ataxia. Thetreatmentis

symptomatic.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS, IFANY

Anyunused theveterinarymedicinalproductorwastematerialshould bedisposedofinaccordancewith

nationalrequirements.

Medicinesshould notbedisposed ofviawastewaterorhousehold waste

Askyouveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.Thesemeasuresshouldhelpto

protecttheenvironment.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

DECEMBER2006

15.OTHERINFORMATION

Foranimaltreatmentonly.

Boxcontainingone0.805 gwhitepowdervialand one2 mlgraduated bluesyringe. After

reconstitution, thesolutionislimpid and colourless.

11834 Prilium75 mg/-FINALSPC /Renewal

11834 Prilium75 mg/-FINALSPC /Renewal

LABEL

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PRILIUM75 mgpowderfororalsolutionfordogs

2. QUANTITYOFTHEACTIVESUBSTANCE

Imidaprilhydrochloride……………………………..75 mg

3. CONTENTSBYWEIGHT, BYVOLUMEORBYNUMBEROFDOSES

Boxcontainingone0.805 gpowdervialand one2 mlgraduated syringe

4. ROUTE(S)OFADMINISTRATION

Theveterinarymedicinalproductcanbeadministeredeitherdirectlyintothemouthoftheanimalonan

emptystomachorduringthemeals, oronfood.

5. WITHDRAWALPERIOD

Notapplicable.

6. BATCHNUMBER

7. EXPIRYDATE

EXP:

Shelf-lifeafterreconstitution:77 days

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

KEEPOUTOFREACHANDSIGHTOFCHILDREN

Beforereconstitution:do notstoreabove25°C

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

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