Actikor 20 mg Film-coated Tablets for Dogs

Main information

  • Trade name:
  • Actikor 20 mg Film-coated Tablets for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Actikor 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:
  • NL/V/0151/002
  • Authorization date:
  • 29-09-2011
  • EU code:
  • NL/V/0151/002
  • Last update:
  • 09-08-2016

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

PACKAGINGLEAFLETFOR:

BE :Actikor20mgcomprimésenrobéspourchiens/filmomhuldetablettenvoor

honden

DE :Actikor20mgFilmtablettenfürHunde

DK :Actikor20mgfilmovertruknetablettertilhunde

FI :Actikor20mgkalvopäällysteisettabletitkoiralle/filmdrageradetabletterför

hundar

FR :Actikor20mgcomprimépelliculépourchiens

IE :Actikor20mgfilm-coatedtabletsfordogs

NL :Actikor20mgfilmomhuldetablettenvoorhonden

PL :Actikor20mgtabletkipowlekanedlapsów

SE :Actikor20mgfilmdrageradetabletterförhundar

UK :Actikor20mgFilm-coatedTabletsforDogs

1.NAMEANDADDRESSOFTHRMARKETINGAUTHORISATIONHOLDERANDOFTHE

MANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCHRELEASE

Marketingauthorizationholder:

EcupharNV

Legeweg157-i

8020Oostkamp

Belgium

Manufacturerforbatchrelease:

EcupharNV

Legeweg157-i

8020Oostkamp

Belgium

or

AccordHealthcareLimited

SageHouse,319,PinnerRoad,NorthHarrow,MiddlesexHA14HF,

UnitedKingdom

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BE :Actikor20mgcomprimésenrobéspourchiens/filmomhuldetablettenvoorhonden

DE :Actikor20mgFilmtablettenfürHunde

DK :Actikor20mgfilmovertruknetablettertilhunde

FI :Actikor20mgkalvopäällysteisettabletitkoiralle/filmdrageradetabletterförhundar

FR :Actikor20mgcomprimépelliculépourchiens

IE :Actikor20mgfilm-coatedtabletsfordogs

NL :Actikor20mgfilmomhuldetablettenvoorhonden

PL :Actikor20mgtabletkipowlekanedlapsów

SE :Actikor20mgfilmdrageradetabletterförhundar

UK :Actikor20mgFilm-coatedTabletsforDogs

BenazeprilHydrochloride

3. STATEMENTOFTHEACTIVESUBSTANCEANDOTHERINGREDIENT

Eachfilm-coatedtabletcontainsbenazepril18.4mg(equivalentto20mgofbenazeprilhydrochloride)

4. INDICATION

Dogsweighingmorethan20kg:

Treatmentofcongestiveheartfailureassociatedwith,inparticular,dilatedcardiomyopathyormitral

insufficiency

5. CONTRAINDICATION

Donotuseinanydogthathasevidenceofcardiacoutputfailureforexampleduetoaorticstenosis.

DonotuseincasesofhypersensitivitytobenazeprilortoanyotherACEinhibitorsortoanyofthe

excipient(s).

Foruseinpregnant,lactatingandbreedinganimals,pleasereferSection12.

6. ADVERSEREACTIONS

Atthestartofthetreatment,adecreaseofthebloodpressureandatransientincreaseofplasma tic

concentrationsofcreatininemayoccur.Inrarecasesfatigueordrowsinessmaybeobservedandtransient

signsofhypotension,suchaslethargyandataxiamayoccur.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES:

Dog

8. DOSAGEFOREACHSPECIES,ROUTEANDMETHODOFADMINISTRATION

Fororaluse

Thetherapeuticoraldoseis0.25mgbenazeprilhydrochloride/kgbodyweightoncedaily,withorwithout

foodaccordingtothefollowingdoseregime:

Dogsweighing5-10kg:½Actikor5mgtablet

Dogsweighing11-20kg:1Actikor5mgtablet.

Dogsweighing21-40kg:½Actikor20mgtablet

Dogsweighing41-80kg:1Actikor20mgtablet.

Thedosemaybedoubled(0.5mgbenazeprilhydrochloride/kgbodyweight)stilladministeredoncedaily,

ifjudgedclinicallynecessaryandadvisedbytheveterinarysurgeon.

Incaseofusinghalvedtablets:Returnanyremaininghalftablettotheopenedblisterpocketandstoreit

below30°C.Usetheremaininghalftabletforthenextadministration.

9.ADVICEONCORRECTADMINISTRATION

Foranimaluse.

Fororaladministration.

Particularcareshouldbetakenwithregardtotheaccuracyofdosing.Pleasecarefullyfollowthe

instructionsoftheveterinarian.

10. WITHDRAWALPERIOD

NotApplicable

11.SPECIALSTORAGEPRECAUTION

Donotstoreabove30°C.

Incaseofusinghalvedtablets:Returnanyremaininghalftablettotheopenedblisterpocket.Usethe

remaininghalftabletforthenextadministration.

Donotuseaftertheexpirydatesatedontheblisterandcartonafter“EXP”.

12. SPECIALWARNING

Precautionsforuseinanimals:

Noevidenceofrenaltoxicityhasbeenobservedindogsduringclinicaltrials.Asisroutineincasesofrenal

insufficiency,itisrecommendedtomonitorplasmacreatinineandureaduringtherapy.

Useduringpregnancyandlactation:

Studiesinlaboratoryanimals(rats)haveshownembryotoxiceffectsofbenazeprilatnon-maternotoxic

doses(malformationsofthefoetalurinarysystem).Benazepriladministeredtocatsatadailydoseof10

mg/kgfor52weeksresultedinthereductionofovary/oviductweights.InhumansACEinhibitorshave

beenfoundtobeteratogenicduringpregnancy.

InhumansACEinhibitorshavebeenfoundtobeteratogenicduringpregnancy.

Donotuseinbreeding,pregnantorlactatingdogsasthesafetyoftheproductintheseanimalshasnot

beentested.

Interaction:

Noneknownindogs

Indogswithheartfailure,Benazeprilhydrochloridehasbeengivenincombinationwithdigoxin,diuretics

andanti-arrythmicdrugswithoutdemonstrableadverseinteractions.Inhuman,thecombinationofACE

inhibitorsandNSAIDscanleadtoreducedanti-hypertensiveefficacyorimpairedrenalfunction.The

combinationofActikortabletandotheranti-hypertensiveagents(e.g.calciumchannelblockers,  -

blockersordiuretics),anaestheticsorsedativesmayleadtoadditivehypotensiveeffects.Therefore

concurrentuseofNSAIDsorothermedicationswithahypotensiveeffectshouldbeconsideredwithcare.

Renalfunctionandsignsofhypotension(lethargy,weaknessetc)shouldbecloselymonitoredandtreated

asnecessary.

Interactionswithpotassiumpreservingdiureticslikespironolactone,triamtereneoramiloridecannotbe

ruledout.Itisrecommendedtomonitorplasmapotassiumlevelswhenusingbenazeprilincombination

withapotassiumsparingdiureticaslifethreateningreactionsareapossibility.

Overdose:

Innormaldogs,overdosageupto200-foldofbenazeprilhydrochloridewasasymptomatic.Transient

reversiblehypotensionmayoccurincasesofaccidentaloverdosage.Therapyshouldconsistof

intravenousinfusionofwarmisotonicsaline.

UserWarnings:

ACEinhibitorshavebeenfoundtoaffecttheunbornchildduringpregnancyinhumans.Pregnantwomen

shouldtakespecialcaretoavoidaccidentalexposure,includinghand-to-mouthcontact.

Washhandsafteruse.

Benazeprilmaycausehypotensionafteroralingestion.

Keepoutofreachandsightofchildren.

Incaseofaccidentalingestion,particularlybychildren,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalornationalrequirements.

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.Thesemeasuresshouldhelp

toprotecttheenvironment.

14. DATEONWHICHTHEPACKAGINGLEAFLETWASLASTAPPROVED

Tobecompletednationally

15. OTHERINFORMATION

Tabletsarepresentedinaluminiumfoilblisterpacksof14,28,56,84and140tablets

Notallpacksizesmaybemarketed.

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