Banacep 5

Main information

  • Trade name:
  • Banacep 5
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Banacep 5
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • benazepril
  • Therapeutic area:
  • Cats, Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0180/001
  • Authorization date:
  • 02-12-2012
  • EU code:
  • FR/V/0180/001
  • Last update:
  • 09-08-2016

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

PARTI.B.2.PROPOSALFORINMEDIATEANDPACKAGE

LEAFLET

PACKAGELEAFLET

1.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AND OF THE MANUFACTURING AUTHORISATION HOLDER

RESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

Marketingauthorisationholderandmanufacturer

LaboratoriosCalier,S.A.

Barcelonès,26(PladelRamassà)

LesFranquesesdelVallès(Barcelona)

SPAIN

2.NAMEOFTHEVETERINARYMEDICINALPRODUCT

BANACEP ®

vet 5 mg film-coated tablet for dogs and cats

(BE,DK,DE,EL,ES,FI,IT,NL,PL,PT,SW,UK)

Benazeprilhydrochloride

BANACEP ® vet5film-coatedtabletfordogsandcats[FR]

3.STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHER

INGREDIENT(S)

Eachdivisibletabletcontains:

Benazepril........................................4.6mg

(equivalenttoBenazeprilHydrochloride5mg)

Excipients:

Titaniumdioxide(E171)..................1.929mg

Ironoxideyellow(E172).................0.117mg

Ironoxidered(E172)......................0.014mg

Ironoxideblack(E172)..................0.004mg

4.INDICATION(S)

Banacepvet5mgor5belongstoagroupofmedicinescalledAngiotensin

ConvertingEnzyme(ACE)inhibitors.Itisprescribedbytheveterinarysurgeon

forthetreatmentofcongestiveheartfailureindogsandforreductionof

proteinuriaassociatedwithchronickidneydiseaseincats.

5.CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotheactivesubstancebenazepril

hydrochlorideortoanyingredientofthetablets.

Donotuseincasesofhypotension(lowbloodpressure),hypovolemia(low

bloodvolume)oracuterenalfailure.

Donotuseincasesofcardiacoutputfailureduetoaorticorpulmonary

stenosis.

Donotuseinpregnantorlactatingdogsorcatsbecausethesafetyof

benazeprilhydrochloridehasnotbeenestablishedduringpregnancyor

lactationinthesespecies.

6.ADVERSEREACTIONS

Somedogswithcongestiveheartfailuremayexhibitvomitingorfatigueduring

treatment.

Indogsandcatswithchronickidneydiseasetheremaybeamoderateincrease

inlevelsofcreatinine,anindicatorofkidneyfunction,intheblood.Thisislikely

duetotheeffectofthemedicationinreducingthebloodpressurewithinthe

kidneyandisthereforenotnecessarilyareasonfortreatmenttobestopped,

unlesstheanimalisshowingotheradversereactions..

Theproductmayincreasefoodconsumptionandbodyweightincats.

Vomiting,poorappetite,dehydration,lethargyanddiarrhoeahavebeen

reportedonrareoccasionsincats.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,

pleaseinformyourveterinarysurgeon.

7.TARGETSPECIES

Dogsandcats

8.DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Theproductshouldbegivenorallyoncedaily,withorwithoutfood.Theduration

oftreatmentisunlimited.

.

Indogstheproductshouldbeadministeredorallyataminimumdoseof0.25

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

accordingtothefollowingtable:

Weightofdog(kg) BanacepVet5mgFilm-

CoatedTablets

Standard

dose Doubledose

5-10 0.5tablet 1tablet

10-20 1tablet 2tablets

Indogswithcongestiveheartfailure,thedosemaybedoubled,still

administeredoncedaily,toaminimumdoseof0.5mg(range0.5-1.0)

benazeprilhydrochloride/kgbodyweightifjudgednecessaryandadvisedbythe

veterinarysurgeon.Alwaysfollowthedosinginstructionsgivenbytheveterinary

surgeon.

Incatstheproductshouldbeadministeredorallyataminimumdoseof0.5mg

(range0.5-1.0)benazeprilhydrochloride/kgbodyweightoncedailyaccordingto

thefollowingtable:

Weightofcat(kg) BanacepVet5mgFilm-

CoatedTablets

2.5 –5 0.5tablet

>5-10 1tablet

9.ADVICEONCORRECTADMINISTRATION

None

10.WITHDRAWALPERIOD

Notapplicable

11.SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren

Donotstoreabove25°C.Storeinadryplace.

Returnanyhalvedtablettotheblisterpackandusewithin1day.Theblister

packshouldbeinsertedbackintothecardboardbox.

DonotuseaftertheexpirydatestatedonthecartonafterEXP

12. SPECIALWARNING(S)

Specialwarningsfordogsandcats

Theefficacyandsafetyoftheproducthasnotbeenestablishedindogsand

catsbelow2.5kgbodyweight.

Specialprecautionsforuseinanimals

Incasesofchronickidneydisease,yourveterinarianwillcheckthehydration

statusofyourpetbeforestartingtherapy,andmayrecommendthatregular

bloodtestsarecarriedoutduringtherapyinordertomonitorplasmacreatinine

concentrationsandblooderythrocytecounts.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Washhandsafteruse.

Incaseofaccidentaloralingestion,seekmedicaladviceimmediatelyandshow

thelabelorthepackageleaflettothephysician.

Pregnantwomenshouldtakespecialcaretoavoidaccidentaloralexposure

becauseACEinhibitorshavebeenfoundtoaffecttheunbornchildduring

pregnancyinhumans.

Useduringpregnancy,lactation

Donotuseduringpregnancyorlactation.Thesafetyoftheproducthasnot

beenestablishedinbreeding,pregnantorlactatingdogsorcats.

Interactions

Informtheveterinarysurgeoniftheanimalistaking,orhasrecentlytaken,any

othermedicines.

Indogswithcongestiveheartfailure,theproducthasbeengivenincombination

withdigoxin,diuretics,pimobendanandanti-arrhythmicproductswithout

evidenceofassociatedadversereactions.

Inhumans,thecombinationofACEinhibitorsandNSAIDs(Non-SteroidalAnti-

InflammatoryDrugs)canleadtoreducedanti-hypertensiveefficacyorimpaired

kidneyfunction.Thecombinationoftheproductandotheranti-hypertensive

agents(e.g.calciumchannelblockers, -blockersordiuretics),anaestheticsor

sedativesmayleadtoadditivehypotensiveeffects.Therefore,concurrentuseof

NSAIDsorothermedicationswithahypotensiveeffectshouldbeconsidered

withcare.

Yourveterinarysurgeonmayrecommendtocloselymonitorkidneyfunctionand

forsignsofhypotension(lethargy,weaknessetc)andtreattheseifnecessary.

Interactionswithpotassium-preservingdiureticslikespironolactone,triamterene

oramiloridecannotberuledout.Yourveterinarysurgeonmayrecommendto

monitorplasmapotassiumconcentrationswhenusingtheproductin

combinationwithapotassium-sparingdiureticbecauseoftheriskof

hyperkalaemia(highbloodpotassium).

Overdose

Transientreversiblehypotension(lowbloodpressure)mayoccurincasesof

accidentaloverdose.Therapyshouldconsistofintravenousinfusionofwarm

isotonicsaline.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSED

PRODUCTORWASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15.OTHERINFORMATION

Benazeprilhydrochlorideisaprodrughydrolysedinvivotoitsactivemetabolite,

benazeprilat.

Benazeprilatisahighlypotentandselectiveinhibitoroftheangiotensin

convertingenzyme(ACE),thuspreventingtheconversionofinactive

angiotensinItoactiveangiotensinIIandtherebyalsoreducingsynthesisof

aldosterone.Therefore,itblockseffectsmediatedbyangiotensinIIand

aldosterone,includingvasoconstrictionofbotharteriesandveins,retentionof

sodiumandwaterbythekidneyandremodelingeffects(includingpathological

cardiachypertrophyanddegenerativerenalchanges).

Banacepvet5mgcauseslong-lastinginhibitionofplasmaACEactivityindogs

andcats,withmorethan95%inhibitionatpeakeffectandsignificantactivity

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

Banacepvet5mgreducesthebloodpressureandvolumeloadontheheartin

dogswithcongestiveheartfailure.

Incatswithexperimentalrenalinsufficiency,Banacepvet5mgnormalizedthe

elevatedglomerularcapillarypressureandreducedthesystemicblood

pressure.Reductioninglomerularhypertensionmayretardtheprogressionof

kidneydiseasebyinhibitionoffurtherdamagetothekidneys.Inaclinicaltrialin

catswithchronickidneydisease,Banacepvet5mgsignificantlyreduced

proteinlossintheurine;thiseffectisprobablymediatedviareducedglomerular

hypertensionandbeneficialeffectsontheglomerularbasementmembrane.

Banacepvet5mgalsoincreasedtheappetiteofthecats,particularlyinmore

advancedcases.

IncontrastwithotherACEinhibitors,benazeprilatisexcretedequallybyboth

biliaryandurinaryroutesindogsand85%viathebiliaryand15%viathe

urinaryrouteincats,andthereforenoadjustmentofthedoseofBanacepvet5

mgisnecessaryinthetreatmentofcaseswithrenalinsufficiency.

Boxwith14or140tablets

Notallpacksizemaybemarketed.

Foranimaltreatmentonly –tobesuppliedonlyonveterinaryprescription.

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