Benazecare 5

Main information

  • Trade name:
  • Benazecare 5
  • Pharmaceutical form:
  • Film coated tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Benazecare 5
    Austria
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0264/001
  • Authorization date:
  • 28-10-2011
  • EU code:
  • UK/V/0264/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:May2012

AN:00040/2012

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BenazecareFlavour5mgTabletsforDogsandCats.

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Benazeprilhydrochloride5mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Beigeoblongtabletwithbreaklineonbothsides.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogsandcats.

4.2 Indicationsforuse,specifyingthetargetspecies

Dogs

Treatmentofcongestiveheartfailureindogs.

Cats

Reductionofproteinuriaassociatedwithchronickidneydisease.

4.3 Contraindications

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyofthe

excipients.

Donotuseincasesofhypotension,hypovolaemia,hyponatraemiaoracute

renalfailure.

Donotuseincasesofcardiacoutputfailureduetoaorticorpulmonary

stenosis.

Donotuseduringpregnancyorlactation(section4.7).

4.4 Specialwarningsforeachtargetspecies

None.

Revised:May2012

AN:00040/2012

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4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Noevidenceofrenaltoxicityoftheveterinarymedicinalproducthas

beenobserved(indogsorcats)duringclinicaltrials,however,asis

routineincasesofchronickidneydisease,itisrecommendedto

monitorplasmacreatinine,ureaanderythrocytecountsduringtherapy.

Theefficacyandsafetyofbenazeprilhydrochloridehasnotbeen

establishedindogsandcatsbelow2.5kgbodyweight.

ii. Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Washhandsafteruse.

Incaseofaccidentaloralingestion,seekmedicaladviceimmediately

andshowthelabelorthepackageleaflettothephysician.

Pregnantwomenshouldtakespecialcaretoavoidaccidentaloral

exposurebecauseangiotensinconvertingenzyme(ACE)inhibitors

havebeenfoundtoaffecttheunbornchildduringpregnancyin

humans.

4.6 Adversereactions(frequencyandseriousness)

Indouble-blindclinicaltrialsindogswithcongestiveheartfailure,benazepril

hydrochloridewaswelltoleratedwithanincidenceofadversereactionslower

thanobservedinplacebotreateddogs.

Asmallnumberofdogsmayexhibittransientvomiting,incoordinationorsigns

offatigue.

Incatsanddogswithchronickidneydisease,benazeprilhydrochloridemay

increaseplasmacreatinineconcentrationsatthestartoftherapy.Amoderate

increaseinplasmacreatinineconcentrationsfollowingadministrationofACE

inhibitorsiscompatiblewiththereductioninglomerularhypertensioninduced

bytheseagents,andisthereforenotnecessarilyareasontostoptherapyin

theabsenceofothersigns.

Benazeprilhydrochloridemayincreasefoodconsumptionandbodyweightin

cats.

Emesis,anorexia,dehydration,lethargyanddiarrhoeahavebeenreportedin

rareoccasionsincats.

4.7Useduringpregnancy,lactationorlay

Donotuseduringpregnancyorlactation.Thesafetyofbenazepril

hydrochloridehasnotbeenestablishedinbreeding,pregnantorlactatingdogs

andcats.Benazeprilhydrochloridereducedovary/oviductweightsincats

whenadministereddailyat10mg/kgbodyweightfor52weeks.Embryotoxic

Revised:May2012

AN:00040/2012

Page3of7

effects(foetalurinarytractmalformation)wereseenintrialswithlaboratory

animals(rats)atmaternallynon-toxicdoses.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Indogswithcongestiveheartfailure,benazeprilhydrochloridehasbeengiven

incombinationwithdigoxin,diuretics,pimobendanandanti-arrhythmic

veterinarymedicinalproductswithoutdemonstrableadverseinteractions.

Inhumans,thecombinationofACEinhibitorsandNon-SteroidalAnti-

InflammatoryDrugs(NSAIDs)canleadtoreducedanti-hypertensiveefficacy

orimpairedrenalfunction.Thecombinationofbenazeprilhydrochlorideand

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

diuretics),anaestheticsorsedativesmayleadtoadditivehypotensiveeffects.

Therefore,concurrentuseofNSAIDsorothermedicationswithahypotensive

effectshouldbeconsideredwithcare.Renalfunctionandsignsof

hypotension(lethargy,weaknessetc)shouldbemonitoredcloselyandtreated

asnecessary.

Interactions with potassiumpreservingdiureticslikespironolactone,

triamtereneoramiloridecannotberuledout.Itisrecommendedtomonitor

plasmapotassiumlevelswhenusingbenazeprilhydrochlorideincombination

withapotassiumsparingdiureticbecauseoftheriskofhyperkalaemia.

4.9 Amountstobeadministeredandadministrationroute

BenazecareFlavour5mgtabletsshouldbegivenorallyoncedaily,withor

withoutfood.Thedurationoftreatmentisunlimited.

Dogs

BenazecareFlavour5mgtabletsshouldbeadministeredorallyataminimum

doseof0.25mg(range0.25-0.5)benazeprilhydrochloride/kgbodyweight

oncedaily,accordingtothefollowingtable:

BENAZECARE

FLAVOUR5mg

Weightofdog

(kg) Standard

Dose Double

Dose

5 –10

>10 –20 0.5tablet

1tablet 1tablet

2tablets

Thedosemaybedoubled,stilladministeredoncedaily,toaminimumdoseof

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

veterinarysurgeon.

Cats

BenazecareFlavour5mgtabletsshouldbeadministeredorallyataminimum

doseof0.5mg(range0.5-1.0)benazeprilhydrochloride/kgbodyweightonce

dailyaccordingtothefollowingtable:

Revised:May2012

AN:00040/2012

Page4of7

Weightofcat

(kg) BENAZACAREFLAVOUR5mg

2.5 –5

0.5tablet

>5-10 1tablet

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Benazeprilhydrochloridereducederythrocytecountsinnormalcatswhen

dosedat10mg/kgbodyweightoncedailyfor12monthsandinnormaldogs

whendosedat150mg/kgbodyweightoncedailyfor12months,butthiseffect

wasnotobservedattherecommendeddoseduringclinicaltrialsincatsor

dogs.

Transientreversiblehypotensionmayoccurincasesofaccidentaloverdose.

Therapyshouldconsistofintravenousinfusionofwarmisotonicsaline.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:ACEInhibitors,plain.

ATCvetcode:QC09AA07

5.1 Pharmacodynamicproperties

Benazeprilhydrochlorideisaprodrughydrolysedinvivotoitsactive

metabolite,benazeprilat.Benazeprilatisahighlypotentandselectiveinhibitor

ofACE,thuspreventingtheconversionofinactiveangiotensinItoactive

angiotensinIIandtherebyalsoreducingsynthesisofaldosterone.Therefore,it

blockseffectsmediatedbyangiotensinIIandaldosterone,including

vasoconstrictionofbotharteriesandveins,retentionofsodiumandwaterby

thekidneyandremodellingeffects(includingpathologicalcardiachypertrophy

anddegenerativerenalchanges).

Benazeprilhydrochloridecauseslong-lastinginhibitionofplasmaACEactivity

indogsandcats,withmorethan95%inhibitionatpeakeffectandsignificant

activity(>80%indogsand>90%incats)persisting24hoursafterdosing.

Benazeprilhydrochloridereducesthebloodpressureandvolumeloadonthe

heartindogswithcongestiveheartfailure.

Incatswithexperimentalrenalinsufficiency,benazeprilhydrochloride

normalizedtheelevatedglomerularcapillarypressureandreducedthe

systemicbloodpressure.

Reductioninglomerularhypertensionmayretardtheprogressionofkidney

diseasebyinhibitionoffurtherdamagetothekidneys.Placebocontrolled

clinicalfieldstudiesincatswithchronickidneydisease(CKD)have

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AN:00040/2012

Page5of7

demonstratedthatbenazeprilhydrochloridesignificantlyreducedlevelsof

urineproteinandurineproteintocreatinineratio(UPC);thiseffectisprobably

mediatedviareducedglomerularhypertensionandbeneficialeffectsonthe

glomerularbasementmembrane.

NoeffectofbenazeprilhydrochlorideonsurvivalincatswithCKDhasbeen

shown,butbenazeprilhydrochlorideincreasedtheappetiteofthecats,

particularlyinmoreadvancedcases.

5.2 Pharmacokineticparticulars

Afteroraladministrationofbenazeprilhydrochloride,peaklevelsofbenazepril

areattainedrapidly(T

0.5hourindogsandwithin2hoursincats)and

declinequicklyastheactivesubstanceispartiallymetabolisedbyliver

enzymestobenazeprilat.Thesystemicbioavailabilityisincomplete(~13%in

dogs)duetoincompleteabsorption(38%indogs,<30%incats)andfirstpass

metabolism.

Indogs,peakbenazeprilatconcentrations(C

of37.6ng/mlafteradoseof

0.5mg/kgbenazeprilhydrochloride)areachievedwithaT

of1.25hours.

Incats,peakbenazeprilatconcentrations(C

of77.0ng/mlafteradoseof

0.5mg/kgbenazeprilhydrochloride)areachievedwithaT

of2hours.

Benazeprilatconcentrationsdeclinebiphasically:theinitialfastphase(t

=1.7

hoursindogsandt

=2.4hoursincats)representseliminationoffreedrug,

whiletheterminalphase(t

=19hoursindogsandt

=29hoursincats)

reflectsthereleaseofbenazeprilatthatwasboundtoACE,mainlyinthe

tissues.Benazeprilandbenazeprilatareextensivelyboundtoplasmaproteins

(85-90%),andintissuesarefoundmainlyintheliverandkidney.

Thereisnosignificantdifferenceinthepharmacokineticsofbenazeprilatwhen

benazeprilhydrochlorideisadministeredtofedorfasteddogs.Repeated

administrationofbenazeprilhydrochlorideleadstoslightbioaccumulationof

benazeprilat(R=1.47indogsandR=1.36incatswith0.5mg/kg),steadystate

beingachievedwithinafewdays(4daysindogs).

Benazeprilatisexcreted54%viathebiliaryand46%viatheurinaryroutein

dogsand85%viathebiliaryand15%viatheurinaryrouteincats.The

clearanceofbenazeprilatisnotaffectedindogsorcatswithimpairedrenal

functionandthereforenoadjustmentofbenazeprilhydrochloridedoseis

requiredineitherspeciesincasesofrenalinsufficiency.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Pregelatinizedstarch

Croscarmellosesodium

Castoroil,hydrogenated

Beefflavour201627

Revised:May2012

AN:00040/2012

Page6of7

6.2Incompatibilities

Noneknown

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelflifeafterfirstopeningtheimmediatepackaging:48hours.Anydivided

tabletportionremainingafter48hoursshouldbediscarded.

6.4Specialprecautionsforstorage

Donotstoreabove25

C.

Storeinadryplace.

Dividedtabletsshouldbestoredintheblisterpack.Theblisterpackshouldbe

insertedbackintothecardboardbox.

6.5Natureandcompositionofimmediatepackaging

Aluminium/aluminiumblisterpackscontaining14tablets,packedina

cardboardboxwithapackageleaflet.BenazecareFlavour5mgtabletsare

suppliedinpacksof14,28,56or140tablets.Notallpacksizesmaybe

marketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

AnimalcareLtd

CommonRoad

Dunnington

York,YO195RU

UK

+44(0)1904487687

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm 10347/4021

VPA10778/003/001

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Date:24thAugust2011

Revised:May2012

AN:00040/2012

Page7of7

10. DATEOFREVISIONOFTHETEXT

Date:May2012

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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