BANACEP vet 20 mg Film-coated tablets for dogs

Main information

  • Trade name:
  • BANACEP vet 20 mg Film-coated tablets for dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BANACEP vet 20 mg Film-coated tablets for dogs
    Netherlands
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0180/002
  • Authorization date:
  • 02-12-2012
  • EU code:
  • FR/V/0180/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT:

BANACEPvet20mgfilm-coatedtabletfordogs

[BE,EL,DE,ES,IT,NL,PL,PT,UK]

BANACEPvet20film-coatedtabletfordogs[FR]

2.QUALITATIVEANDQUANTITATIVECOMPOSITION:

Eachdivisibletabletcontains:

Activesubstance:

Benazepril.........................................18.42mg

(equivalenttoBenazeprilHydrochloride20mg)

Excipients:

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

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

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

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

Forafulllistofexcipients,seesection6.1

3.PHARMACEUTICALFORM:

Film-coatedtablets

Beigeoblongbiconvex film-coateddivisibletablets.Thetabletscanbedividedinto

equalhalves.

4.CLINICALPARTICULARS:

4.1Targetspecies:

Dogs

4.2Indicationsforuse,specifyingtargetspecies:

Indogsweighingmorethan20kgbw:Treatmentofcongestiveheartfailure.

4.3.Contraindications:

DonotuseincasesofknownhypersensitivitytoACEinhibitorsortoanyingredient

oftheproduct.

Donotuseinanydogthathasevidenceofcardiacoutputfailure,forexample,dueto

aorticstenosis.

Seealsosection4.7.

4.4Specialwarningsforeachtargetspecies

None

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Noevidenceofrenaltoxicitytobenazeprilhasbeenobservedindogs.However,as

isroutineincasesofchronicrenalinsufficiency,itisrecommendedtomonitorplasma

creatinineandureaduringtherapy.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Pregnantwomenshouldtakespecialcaretoavoidaccidentaloralexposure,

becauseACEinhibitorshavebeenfoundtoaffecttheunbornchildduringpregnancy

inhumans.

Washhandsafteruse.

Incaseofaccidentalingestionbychildrenseekmedicaladviceimmediatelyand

showthelabeltothedoctor.

4.6Adversereactions(frequencyandseriousness):

Atthestartofthetreatment,adecreaseofthebloodpressureandatransient

increaseofplasmaticconcentrationsofcreatininemayoccur.

Onrareoccasions,transientsignsofhypotension,suchaslethargyandataxiamay

occur.

4.7Useduringpregnancylactationorlay

LaboratorystudiesinratshaveshownembryotoxiceffectsofBenazeprilatnon

maternotoxicdoses(urinarysystemabnormalitiesinfoetus).

Safetyofthisproducthasnotbeentestedinpregnantorlactatingbitches.

Donotuseinpregnantorlactatingfemales.

Donotuseinbreedingdogs.

4.8Interactionwithothermedicamentsandotherformsofinteraction:

Concomitantadministrationofpotassiumsparingdiureticsmaybeconsidered.Itis

thenrecommendedtoregularlymonitorpotassiumplasmalevels.

Thecombinationofthisproductwithotheranti-hypertensiveagents(e.g.calcium

channelblockers,bblockersordiuretics)anaestheticsorsedativesmayleadto

additivehypotensiveeffects.Inman,thecombinationofACEinhibitorsandNSAIDs

canleadtoreducedanti-hypertensiveefficacyorimpairedrenalfunction.Therefore

theconcurrentuseofNSAIDsormedicationswithhypotensiveeffectshouldbe

consideredwithcare.

4.9Amountstobeadministeredandadministrationroute:

Thedoseis0.23mgbenazepril/kgbwperday,correspondingto0.25mgof

Benazeprilhydrochloride/kgbwperday.Itshouldbegivenorallyoncedaily,withor

withoutfood.Itcorrespondsto1/2tabletper20to40kgand1tabletfordogsof

morethan40kggivenaccordingtothefollowingregime:

Weightofdog(kg) Numberoftablets

20-40 1/2tablet

40-80 1tablet

Dosagemaybedoubled,stilladministeredoncedaily,ifjudgedclinicallynecessary

andadvisedbytheveterinarysurgeon.

Returnanyhalvedtablettotheblisterpackandusewithin1day.Theblisterpack

shouldbeinsertedbackintothecarboardbox.

4.10Overdose(symptoms,emergencyprocedures,antidotes):

Transientreversiblesignsofhypotensionmayoccurincasesofaccidentaloverdose.

Symptomatictreatmentconsistsofintravenousinfusionofwarmisotonicsaline.

4.11Withdrawalperiod:

Notapplicable

5 PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:ACEinhibitors,benazepril

ATCvetcode:QC09AA07

5.1Pharmacodynamicproperties

Benazeprilhydrochlorideisaprodrughydrolysedinvivotobenazeprilat.Thisactive

metaboliteinhibitsangiotensinconvertingenzyme(ACE),thuspreventingthe

conversionofinactiveangiotensinIintoactiveangiotensinII.Therefore,

benazeprilateinhibitsalleffectsinducedbyangiotensinII,inparticular,

vasoconstrictionofbotharteriesandveinsandretentionofsodiumandwaterbythe

kidney.Benazeprilhydrochloridecauseslong-lastinginhibitionofplasmaACEin

dogs,withsignificantinhibitionpersistingfor24hoursafterasingledose.

Indogswithcardiacinsufficiency,benazeprilhydrochloridereducestheperipheral

resistance,bloodpressureofleftventricleandvolumeloadontheheart.

5.2.Pharmacokineticparticulars

Afteroraladministration,benazeprilisrapidlyabsorbedfromthegastrointestinal

tract.Onepartofabsorbedbenazeprilishydrolyzedbyhepaticenzymestotheactive

substance,benazeprilat;unchangedbenazeprilandhydrophilicmetabolitesaccount

fortheremainder.Theabsolutesystemicbioavailability,calculatedfororalbenazepril

versusintravenousbenazeprilisabout9%.Peakbenazeprilatconcentrationsare

achievedwithinabout2hours,bothinfastingandfedsituations.

Benazeprilandbenazeprilatareextensivelyboundtoplasmaproteins.Repeated

administrationleadstoslightaccumulationofbenazeprilatinplasma,steadystate

beingachievedinlessthan4days.

Indogs,themajorpartofbenazeprilatisrapidlyeliminated,anditisexcretedequally

viahepaticandurinaryroutes.

Aftertheadministrationofasingledoseoftheproduct(0.23mgbenazepril/kgb.w.),

peakbenazeprilatconcentrations(C

of40.9ng/ml)wereachievedwithinabout1.5

h(T

of1.5h),withAUCof320.5ng/ml.handahalf-life(t

)of12.4h.

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Ironoxideyellow(E-172)

Ironoxidered(E-172)

Ironoxideblack(E-172

Titaniumdioxide(E-171)

Cellulosemicrocrystalline

Lactosemonohydrate

Povidone

Maizestarch

Silicacolloidalanhydrous

Magnesiumstearate

Hypromellose

Macrogol8000

6.2Incompatibilities

Notapplicable

6.3Shelf-life

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeofdivisionsofthetablets:24hours

See4.9forstorageprecautionsoftheremaininghalf-tablet.

6.4Specialprecautionsforstorage:

Donotstoreabove25°C.

Storeinadryplace

Protectfromlight

6.5Natureandcompositionofimmediatepackaging:

BlistermadeofclearfilmofPVC/PE/PVDCandaluminiumfilmcontaining14tablets.

Boxwith:

-1blister(14tablets)

-2blisters(28tablets)

-4blisters(56tablets)

-10blisters(140tablets)

Notallpacksizemaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7.MARKETINGAUTHORISATIONHOLDER

LaboratoriosCalier,S.A.

Barcelonès,26(PladelRamassà)

LesFranquesesdelValles(Barcelona)

SPAIN

8.MARKETINGAUTHORISATIONNUMBER(S)

9.DATEOFTHEFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10.DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Tobesuppliedonlyonveterinaryprescription.

Administrationbyaveterinarysurgeonorundertheirdirectresponsibility.

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