Benazecare 20

Main information

  • Trade name:
  • Benazecare 20
  • Pharmaceutical form:
  • Film coated tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Benazecare 20
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • benazepril
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0264/002
  • Authorization date:
  • 28-10-2011
  • EU code:
  • UK/V/0264/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:July2013

AN:00196/2013

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BenazecareFlavour20mgTabletsforDogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Eachtabletcontains20mgbenazeprilhydrochloride

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Beigeoblongtabletwithbreaklineonbothsides.

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs

4.2Indicationsforuse,specifyingthetargetspecies

Dogs:

Treatmentofcongestiveheartfailure.

4.3Contraindications

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyofthe

excipients.

Donotuseincasesofhypotension,hypovolaemia,hyponatraemiaoracute

renalfailure.

Donotuseincasesofcardiacoutputfailureduetoaorticorpulmonary

stenosis.

Donotuseduringpregnancyorlactation(section4.7).

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Noevidenceofrenaltoxicityoftheveterinarymedicinalproduct

hasbeenobservedindogsduringclinicaltrials,however,asis

routineincasesofchronickidneydisease,itisrecommendedto

Revised:July2013

AN:00196/2013

Page2of5

monitorplasmacreatinine,ureaanderythrocytecountsduring

therapy.

iiSpecialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Washhandsafteruse.

Incaseofaccidentaloralingestion,seekmedicaladvice

immediatelyandshowthelabelorthepackageleaflettothe

physician.

Pregnantwomenshouldtakespecialcaretoavoidaccidental

oralexposurebecauseangiotensinconvertingenzyme(ACE)

inhibitorshavebeenfoundtoaffecttheunbornchildduring

pregnancyinhumans.

4.6Adversereactions(frequencyandseriousness)

Indouble-blindclinicaltrialsindogswithcongestiveheartfailure,benazepril

hydrochloridewaswelltoleratedwithanincidenceofadversereactionslower

thanobservedinplacebo-treateddogs.

Asmallnumberofdogsmayexhibittransientvomiting,incoordinationorsigns

offatigue.

Indogswithchronickidneydisease,benazeprilhydrochloridemayincrease

plasmacreatinineconcentrationsatthestartoftherapy.Amoderateincreasein

plasmacreatinineconcentrationsfollowingadministrationofACEinhibitorsis

compatiblewiththereductioninglomerularhypertensioninducedbythese

agents,andisthereforenotnecessarilyareasontostoptherapyintheabsence

ofothersigns.

4.7Useduringpregnancy,lactationorlay

Donotuseduringpregnancyorlactation.Thesafetyofbenazepril

hydrochloridehasnotbeenestablishedinbreeding,pregnantorlactatingdogs.

Embryotoxiceffects(foetalurinarytractmalformation)wereseenintrialswith

laboratoryanimals(rats)atmaternallynon-toxicdoses..

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Indogswithcongestiveheartfailure,benazeprilhydrochloridehasbeengiven

incombinationwithdigoxin,diuretics,pimobendanandanti-arrhythmic

veterinarymedicinalproductswithoutdemonstrableadverseinteractions.

Inhumans,thecombinationofACEinhibitorsandNon-SteroidalAnti-

InflammatoryDrugs(NSAIDs)canleadtoreducedanti-hypertensiveefficacyor

impairedrenalfunction.Thecombinationofbenazeprilhydrochlorideandother

anti-hypertensiveagents(e.g.calciumchannelblockers, β-blockersor

diuretics),anaestheticsorsedativesmayleadtoadditivehypotensiveeffects.

Therefore,concurrentuseofNSAIDsorothermedicationswithahypotensive

effectshouldbeconsideredwithcare.Renalfunctionandsignsofhypotension

(lethargy,weaknessetc)shouldbemonitoredcloselyandtreatedasnecessary.

Revised:July2013

AN:00196/2013

Page3of5

Interactionswithpotassiumpreservingdiureticslikespironolactone,triamterene

oramiloridecannotberuledout.Itisrecommendedtomonitorplasma

potassiumlevelswhenusingbenazeprilhydrochlorideincombinationwitha

potassiumsparingdiureticbecauseoftheriskofhyperkalaemia.

4.9Amountstobeadministeredandadministrationroute

BenazecareFlavour20mgtabletsshouldbegivenorallyoncedaily,withor

withoutfood.Thedurationoftreatmentisunlimited.

BenazecareFlavour20mgtabletsshouldbeadministeredorallyataminimum

doseof

0.25mg(range0.25-0.5)benazeprilhydrochloride/kgbodyweightoncedaily,

accordingtothefollowingtable:

BENAZECAREFLAVOUR20mg

Weightofdog

(kg) Standard

Dose Double

Dose

>20 –40

>40 –80 0.5tablet

1tablet 1tablet

2tablets

Thedosemaybedoubled,stilladministeredoncedaily,toaminimumdoseof

0.5mg/kg(range0.5-1.0),ifjudgedclinicallynecessaryandadvisedbythe

veterinarysurgeon.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Benazeprilhydrochloridereducederythrocytecountsinnormaldogswhen

dosedat150mg/kgbodyweightoncedailyfor12months,butthiseffectwas

notobservedattherecommendeddoseduringclinicaltrialsindogs.

Transientreversiblehypotensionmayoccurincasesofaccidentaloverdose.

Therapyshouldconsistofintravenousinfusionofwarmisotonicsaline.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:ACEInhibitors,plain.

ATCvetcode:QC09AA07

5.1Pharmacodynamicproperties

Benazeprilhydrochlorideisaprodrughydrolysedinvivotoitsactivemetabolite,

benazeprilat.BenazeprilatisahighlypotentandselectiveinhibitorofACE,thus

preventingtheconversionofinactiveangiotensinItoactiveangiotensinIIand

therebyalsoreducingsynthesisofaldosterone.Therefore,itblockseffects

mediatedbyangiotensinIIandaldosterone,includingvasoconstrictionofboth

arteriesand

veins,retentionofsodiumandwaterbythekidneyandremodellingeffects

(includingpathologicalcardiachypertrophyanddegenerativerenalchanges).

Revised:July2013

AN:00196/2013

Page4of5

Benazeprilhydrochloridecauseslong-lastinginhibitionofplasmaACEactivity,

withmorethan95%inhibitionatpeakeffectandsignificantactivity(>80%in

dogs)persisting24hoursafterdosing.

Benazeprilhydrochloridereducesthebloodpressureandvolumeloadonthe

heartindogswithcongestiveheartfailure.

5.2Pharmacokineticparticulars

Afteroraladministrationofbenazeprilhydrochloride,peaklevelsofbenazepril

areattainedrapidly(T

0.5hourindogs)anddeclinequicklyastheactive

substanceispartiallymetabolisedbyliverenzymestobenazeprilat.The

systemicbioavailabilityisincomplete(~13%indogs)duetoincomplete

absorption(38%indogs)andfirstpassmetabolism.

Indogs,peakbenazeprilatconcentrations(C

of37.6ng/mlafteradoseof

0.5mg/kgbenazeprilhydrochloride)areachievedwithaT

of1.25hours.

Benazeprilatconcentrationsdeclinebiphasically:theinitialfastphase(t

=1.7

hoursindogs)representseliminationoffreedrug,whiletheterminalphase

=19hoursindogs)reflectsthereleaseofbenazeprilatthatwasboundto

ACE,mainlyinthetissues.Benazeprilandbenazeprilatareextensivelybound

toplasmaproteins(85-90%),andintissuesarefoundmainlyintheliverand

kidney.

Thereisnosignificantdifferenceinthepharmacokineticsofbenazeprilatwhen

benazeprilhydrochlorideisadministeredtofedorfasteddogs.Repeated

administrationofbenazeprilhydrochlorideleadstoslightbioaccumulationof

benazeprilat(R=1.47indogswith0.5mg/kg),steadystatebeingachieved

withinafewdays(4daysindogs).

Benazeprilatisexcreted54%viathebiliaryand46%viatheurinaryroutein

dogs.Theclearanceofbenazeprilatisnotaffectedindogswithimpairedrenal

functionandthereforenoadjustmentofbenazeprilhydrochloridedoseis

requiredincasesofrenalinsufficiency.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Pregelatinizedstarch

Croscarmellosesodium

Castoroil,hydrogenated

Beefflavour201627

6.2Incompatibilities

Noneknown

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years

Revised:July2013

AN:00196/2013

Page5of5

Shelflifeafterfirstopeningtheimmediatepackaging:48hours.Anydividedtablet

portionremainingafter48hoursshouldbediscarded.

6.4Specialprecautionsforstorage

Donotstoreabove25

C.

Storeinadryplace.

Dividedtabletsshouldbestoredintheblisterpack.

Theblisterpackshouldbeinsertedbackintothecardboardbox.

6.5Natureandcompositionofimmediatepackaging

Aluminium/aluminiumblisterpackscontaining14tabletspackedinacardboard

boxwithapackageleaflet.BenazecareFlavour20mgtabletsaresuppliedin

packsof14,28,56or140tablets.Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

AnimalcareLtd

10GreatNorthWay

YorkBusinessPark

NetherPoppleton

York

YO266RB

8. MARKETINGAUTHORISATIONNUMBER

Vm 10347/4022

9. DATEOFFIRSTAUTHORISATION

Date:24August2011

10.DATEOFREVISIONOFTHETEXT

Date:July2013

Approved:26/07/2013

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Europe -DG Health and Food Safety

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

26-9-2018

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Active substance: pimobendan / benazepril) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6321 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2804/T/11

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

17-9-2018

Agenda:  Agenda - CHMP agenda of the 17-20 September 2018 meeting

Agenda: Agenda - CHMP agenda of the 17-20 September 2018 meeting

Europe - EMA - European Medicines Agency

4-9-2018

Agenda:  Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda: Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda of CHMP written procedure*20-23 August 2018

Europe - EMA - European Medicines Agency