Benazepril hydrochloride Le Vet 5 mg tablets for dogs

Main information

  • Trade name:
  • Benazepril hydrochloride Le Vet 5 mg tablets for dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Benazepril hydrochloride Le Vet 5 mg tablets for dogs
    France
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0126/002
  • Authorization date:
  • 07-07-2011
  • EU code:
  • NL/V/0126/002
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

PartIB1Summaryofproductcharacteristics

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

NL:BenazeprilhydrochlorideLeVet5mgtablettenvoorhonden

AT:Benakor5mg,TablettenfürHunde

BE:BenakorF5mgtablettenvoorhonden

CZ:BenakorF5mg,tabletypropsy

EE:BenakorF5mgtabletidkoertele

ES:Benakor5mgcomprimidosparaperros

FI:Benakorvet5mgtabletti

FR:BenakorF5compriméspourchiens

IE:Benakor5mgtabletsfordogs

IT:Benakor5mgcompressepercani

LU:BenakorF5mgcompriméspourchiens

NO:Benakorvet.5mgtablettertilhund

PL:BenakorF5mgtabletkidlapsów

PT:Benakor5mgcomprimidosparacães

SK:BenakorF5mgtabletyprepsov

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:4.6mgbenazepril(equivalentto5mgbenazeprilhydrochloride)

Excipient(s):Colourant:Ironoxides(E172)0.5mg

Forafulllistofexcipients,seesection6.1.

3.PHARMACEUTICALFORM

Yellowoblongdivisibletablets,withabreakmarkononeside.

4.CLINICALPARTICULARS

4.1Targetspecies

Dog

4.2Indicationsforuse,specifyingthetargetspecies

Symptomatictreatmentofcongestiveheartfailureindogswithorwithoutadjuncttherapyusedinthe

treatmentofheartfailure.

4.3Contraindications

Donotuseinanydogthathasevidenceofcardiacoutputfailureduetoaorticstenosis,mitralvalve

stenosisorpulmonarystenosisorincaseofhypotension.

DonotuseincaseofknownhypersensitivitytoACEinhibitorsortoanyoftheingredientsoftheproduct.

Seesection4.7

4.4Specialwarningsforeachtargetspecies

None

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Noevidenceofrenaltoxicitytotheproducthasbeenobservedindogsduringclinicaltrials.However,as

isroutineincasesofrenalinsufficiency,itisrecommendedtomonitorplasmaureaandcreatininelevels.

Donotabruptlystoporreducetherapy.

Specialprecautionstobetakenbythepersonadministeringthemedicinalproducttoanimals

Washhandsafteruse.

Pregnantwomenshouldtakespecialcaretoavoidaccidentalexposure,becauseACEinhibitorshavebeen

foundtoaffecttheunbornchildduringpregnancyinhumans.

Incaseofaccidentalingestionbychildren,seekmedicaladviceimmediatelyandshowthepackageleaflet

orthelabeltothephysician.

4.6Adversereactions(frequencyandseriousness)

-atthestartoftreatmentadecreaseofbloodpressuremayoccur.

-inrarecasesfatigueordrowsinessmaybeobserved.

-benazeprilhydrochloridemayleadtoincreasedplasmacreatinineconcentrations.

-onrareoccasionstransientsignsofhypotension,suchaslethargyandataxiamayoccur.

4.7Useduringpregnancyorlactation

Donotuseinpregnantornursingbitchesorinbitchesintendedforbreeding.Safetyoftheproducthasnot

beentestedinbreeding,pregnantorlactatingdogs.Laboratorystudiesinratshaveshownembryotoxic

effectsofbenazeprilatnon-maternotoxicdoses(urinarytractabnormalitiesinthefoetus).Inhumans,

ACEinhibitorshavebeenfoundtobeteratogenicduringpregnancy.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Indogswithheartfailure,benazeprilhasbeengivenincombinationwithdigoxin,diureticsandanti-

arrhythmicdrugswithoutdemonstrableadverseinteractions.

Inman,thecombinationofACEinhibitorsandNSAIDscanleadtoreducedantihypertensiveefficacyor

impairedrenalfunction.Thecombinationofbenazeprilandotherantihypertensiveagents(e.g.calcium

channelblockers,beta-blockersordiuretics),anaestheticsorsedativesmayleadtoadditivehypotensive

effects.ThereforeconcurrentuseofNSAIDsorothermedicationwithahypotensiveeffectshouldbe

consideredwithcare.Renalfunctionandsignsofhypotension(lethargy,weakness,etc.)shouldbe

monitoredcloselyandtreatedasnecessary.

Interactionswithpotassiumpreservingdiureticslikespironolactone,triamterenoramiloridcannotbe

ruledout.Itisrecommendedtomonitorplasmapotassiumlevelswhenusingbenazeprilincombination

withapotassiumsparingdiureticaslifethreateningreactionsareapossibility.

4.9Amountstobeadministeredandadministrationroute

Therecommendedoraldoseis0.25mgbenazeprilhydrochloride/kgbodyweightoncedaily.Thedose

maybedoubled(stilladministeredoncedaily),ifjudgedclinicallynecessaryandadvisedbythe

veterinarysurgeon.

Incaseofusinghalvedtablets:Puttheremaininghalfofadividedtabletbackintheblisterpocketand

storeitinadryplacebelow25°C.Usetheremainingtablethalfforthenextadministration.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Morphologicalchangessuchashypertrophyandhyperplasiaofthejuxtaglomerularapparatus,increaseof

ureaandloweredheartweightinhealthydogsduetoinvolutionhasbeenobservedafterdosesofmore

than10mg/kg.

Transientreversiblehypotensionmayoccurincasesofaccidentaloverdosage.Symptomatictreatment

consistsofintravenousinfusionofwarmisotonicsalinesolution.

4.11Withdrawalperiod(s)

Notapplicable.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:ACEinhibitors,plain

ATCvetcode:QC09AA07

5.1Pharmacodynamicproperties

Benazeprilhydrochlorideisapro-drughydrolysedinvivotobenazeprilate.Benazeprilateisahighly

potentandselectiveinhibitorofangiotensinconvertingenzyme(ACE),thuspreventingtheconversionof

inactiveangiotensinItoactiveangiotensinII.Therefore,itblockseffectsmediatedbyangiotensinII,

includingvasoconstrictionofbotharteriesandveins,retentionofsodiumandwaterbythekidneyand

modellingeffects(includingpathologicalcardiahypertrophyanddegenerativerenalchanges).

Theproductcauseslong-lastinginhibitionofplasmaACEactivityindogs,withmorethan95%inhibition

atpeakeffectandsignificantactivity(>80%indogs)persisting24hoursafterdosing.Itreducestheblood

pressureandvolumeloadontheheartindogswithheartfailure.

Onsetofclinicalefficacycanbeexpectedinapproximately1weekafterinitiationoftherapywith

benazeprilhydrochloride.

5.2Pharmacokineticparticulars

Afteroraladministrationofbenazeprilhydrochloride,peaklevelsofbenazeprilareattainedrapidly(tmax

1.1hindogs)anddeclinequicklyasthedrugispartiallymetabolisedbyliverenzymestobenazeprilate.

Indogs,unchangedbenazeprilandhydrophilicmetabolitesaccountfortheremainder.Indogs,peak

benazeprilateconcentrations(Cmaxof384.16ng/mlafteradoseof1.6mg/kgoftheproduct)are

achievedwithatmaxof1.1hithersystemicbioavailabilityisincomplete(~13%indogs)dueto

incompleteabsorption(38%indogs).

Benazeprilateiseliminatedwithat1/2of2.8hindogs.Benazeprilandbenazeprilateareextensively

boundtoplasmaproteins,andintissuesarefoundmainlyintheliverandthekidney.

Thereisnosignificantdifferenceinthepharmacokineticsofbenazeprilatewhenbenazeprilhydrochloride

isadministeredtofedorfasteddogs.

Benazeprilateisexcreted54%viathebiliaryand46%viatheurinaryrouteindogs.Theclearanceof

benazeprilateisnotaffectedindogswithimpairedrenalfunctionandthereforenoadjustmentofthedose

isrequiredincasesofrenalinsufficiency.

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Silicacolloidalanhydrous(E551)

Microcrystallinecellulose(E460)

Lactoseanhydrous

ColorconPigmentBlend22870yellow(Ironoxides,E172)

Sodiumcyclamate(E952)

SodiumstarchglycolateTypeA

Magnesiumstearate(E470b).

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

PVC/PE/PVDC-Aluminiumblister:12months.

Aluminium/Aluminiumblister:18months.

6.4.Specialprecautionsforstorage

Donotstoreabove25ºCStoreintheoriginalpackage.

6.5Natureandcompositionofimmediatepackaging

1cartoncontains:

1,2,3,4,5,6or7PVC/PE/PVDC/Alu-foilblistersof14tabletseach.

or

1,2,3,4,5,6,7Alu/Alu-foilblistersof14tabletseach.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7.MARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Willeskop212

3421GWOudewater

TheNetherlands

8.MARKETINGAUTHORISATIONNUMBER

<localrequirement>

9.DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

<localrequirement>

10DATEOFREVISIONOFTHETEXT

<localrequirement>

PartIB2 Proposalforpackaging,labellingandpackageinsert

1.Labelling

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BenazeprilhydrochlorideLeVet5mgtabletsfordogs

benazeprilhydrochloride

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

4.6mgbenazepril(equivalentto5mgbenazeprilhydrochloride)

Colouringaid:Ironoxides(E172)0.5mg

3. PHARMACEUTICALFORM

Tablet

4. PACKAGESIZE

14,28,42,56,70,84or98tablets

5. TARGETSPECIES

Dog

6. INDICATION(S)

Symptomatictreatmentofcongestiveheartfailureindogswithorwithoutadjuncttherapyusedinthe

treatmentofheartfailure.

7. METHODANDROUTE(S)OFADMINISTRATION

Fororaluse

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

9. SPECIALWARNING(S),IFNECESSARY

Washhandsafteruse

Pregnantwomenshouldtakespecialcaretoavoidaccidentalexposure,becauseACEinhibitorshavebeen

foundtoaffecttheunbornchildduringpregnancyinhumans.

Incaseofaccidentalingestionbychildren,seekmedicaladviceimmediatelyandshowthislabeltothe

doctor.

10. EXPIRYDATE

EXP{month/year}

11. SPECIALSTORAGECONDITIONS

Donotstoreabove25ºC.

Storeintheoriginalpackage

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Willeskop212

3421GWOudewater

TheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch{number}

MINIMUMPARTICULARSTOAPPEARONBLISTERSORSTRIPS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BenazeprilhydrochlorideLeVet5mgtabletsfordogs

benazeprilhydrochloride

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

LeVet

3. EXPIRYDATE

EXP{month/year}

4. BATCHNUMBER

Batch{number}

5. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly

2.Packageinsert

PACKAGELEAFLET

BenazeprilhydrochlorideLeVet5mgtabletsfordogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

Marketingauthorisationholder:

LeVetB.V.

Willeskop212

3421GWOudewater

TheNetherlands

Manufacturerforthebatchrelease:

ProdulabPharmaB.V.

Forellenweg16

4841SJRaamsdonksveer

TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BenazeprilhydrochlorideLeVet5mgtabletsfordogs

benazeprilhydrochloride

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachtabletcontains:

Activeingredient: 4.6mgbenazepril(equivalentto5mgbenazeprilhydrochloride)

Colouringaid: Ironoxides(E172)0.5mg

4. INDICATION(S)

Symptomatictreatmentofcongestiveheartfailureindogswithorwithoutadjuncttherapyusedinthe

treatmentofheartfailure

5. CONTRAINDICATIONS

Donotuseinanydogthathasevidenceofcardiacoutputfailureduetoaorticstenosis,mitralvalve

stenosisorpulmonarystenosisorincaseofhypotension.

DonotuseincaseofknownhypersensitivitytoACEinhibitorsortoanyoftheingredientsoftheproduct.

Seesection12.

6. ADVERSEREACTIONS

- atthestartoftreatmentadecreaseofbloodpressuremayoccur.

- inrarecasesfatigueordrowsinessmaybeobserved.

- benazeprilhydrochloridemayleadtoincreasedplasmacreatinineconcentrations.

- onrareoccasionstransientsignsofhypotension,suchaslethargyandataxiamayoccur.

7. TARGETSPECIES

Dogs

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Therecommendedoraldoseis0.25mgbenazeprilhydrochloride/kgbodyweightoncedaily.Thedose

maybedoubled(stilladministeredoncedaily),ifjudgedclinicallynecessaryandadvisedbythe

veterinarysurgeon.

Incaseofusinghalvedtablets:Puttheremaininghalfofadividedtabletbackintheblisterpocketand

storeitinadryplacebelow25°C.Usetheremainingtablethalfforthenextadministration.

9. ADVICEONCORRECTADMINISTRATION

Foranimaltreatmentonly.Fororaluseonly.

10. WITHDRAWALPERIOD

Notapplicable.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Donotstoreabove25ºC.

Storeintheoriginalpackage

DonotuseaftertheexpirydatestatedonthecartonafterEXP.

12. SPECIALWARNING(S)

Noevidenceofrenaltoxicitytotheproducthasbeenobservedindogsduringclinicaltrials.However,as

isroutineincasesofrenalinsufficiency,itisrecommendedtomonitorplasmaureaandcreatininelevels.

Donotabruptlystoporreducetherapy.

Washhandsafteruse.

Pregnantwomenshouldtakespecialcaretoavoidaccidentalexposure,becauseACEinhibitorshavebeen

foundtoaffecttheunbornchildduringpregnancyinhumans.

Incaseofaccidentalingestionbychildren,seekmedicaladviceimmediatelyandshowthepackageleaflet

orthelabeltothephysician.

Donotuseinpregnantornursingbitchesorinbitchesintendedforbreeding.Safetyoftheproducthasnot

beentestedinbreeding,pregnantorlactatingdogs.Laboratorystudiesinratshaveshownembryotoxic

effectsofbenazeprilatnon-maternotoxicdoses(urinarytractabnormalitiesinthefoetus).Inhumans,

ACEinhibitorshavebeenfoundtobeteratogenicduringpregnancy.

Morphologicalchangessuchashypertrophyandhyperplasiaofthejuxtaglomerularapparatus,increaseof

ureaandloweredheartweightinhealthydogsduetoinvolutionhasbeenobservedafterdosesofmore

than10mg/kg.

Transientreversiblehypotensionmayoccurincasesofaccidentaloverdosage.Symptomatictreatment

consistsofintravenousinfusionofwarmisotonicsalinesolution.

Indogswithheartfailure,benazeprilhasbeengivenincombinationwithdigoxin,diureticsandanti-

arrhythmicdrugswithoutdemonstrableadverseinteractions.Inman,thecombinationofACEinhibitors

andNSAIDscanleadtoreducedantihypertensiveefficacyorimpairedrenalfunction.Thecombinationof

benazeprilandotherantihypertensiveagents(e.g.calciumchannelblockers,beta-blockersordiuretics),

anaestheticsorsedativesmayleadtoadditivehypotensiveeffects.ThereforeconcurrentuseofNSAIDsor

othermedicationwithahypotensiveeffectshouldbeconsideredwithcare.Renalfunctionandsignsof

hypotension(lethargy,weakness,etc.)shouldbemonitoredcloselyandtreatedasnecessary.

Interactionswithpotassiumpreservingdiureticslikespironolactone,triamterenoramiloridcannotbe

ruledout.Itisrecommendedtomonitorplasmapotassiumlevelswhenusingbenazeprilincombination

withapotassiumsparingdiureticaslifethreateningreactionsareapossibility.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproducts

shouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

<localrequirement>

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Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3261 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3262 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Janumet (Merck Sharp and Dohme Limited)

Janumet (Merck Sharp and Dohme Limited)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3260 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Efficib (Merck Sharp and Dohme Limited)

Efficib (Merck Sharp and Dohme Limited)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3276 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Active substance: Mexiletine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3134 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/074/14/T/03

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Active substance: Ponatinib hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3141 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/212/14/T/02

Europe -DG Health and Food Safety

15-5-2018

Votrient (Novartis Europharm Limited)

Votrient (Novartis Europharm Limited)

Votrient (Active substance: Pazopanib hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3062 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1141/T/46

Europe -DG Health and Food Safety

21-3-2018

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Active substance: Clonidine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)1817 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/11/T/02

Europe -DG Health and Food Safety