Actikor 5 mg Film-coated Tablets for Dogs

Main information

  • Trade name:
  • Benazeprilhydrochlorid Accord 5 mg Filmtabletten für Hunde
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Benazeprilhydrochlorid Accord 5 mg Filmtabletten für Hunde
    Germany
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0151/001
  • Authorization date:
  • 29-09-2011
  • EU code:
  • NL/V/0151/001
  • Last update:
  • 09-08-2016

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

PACKAGINGLEAFLETFOR:

BE :Actikor5mgcomprimésenrobéspourchiens/filmomhuldetablettenvoorhonden

DE :Actikor5mgFilmtablettenfürHunde

DK :Actikor5mgfilmovertruknetablettertilhunde

FI :Actikor5mgkalvopäällysteisettabletitkoiralle/filmdrageradetabletterför

hundar

FR :Actikor5mgcomprimépelliculépourchiens

IE :Actikor5mgfilm-coatedtabletsfordogs

NL :Actikor5mgfilmomhuldetablettenvoorhonden

PL :Actikor5mgtabletkipowlekanedlapsów

SE :Actikor5mgfilmdrageradetabletterförhundar

UK :Actikor5mgFilm-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 :Actikor5mgcomprimésenrobéspourchiens/filmomhuldetablettenvoorhonden

DE :Actikor5mgFilmtablettenfürHunde

DK :Actikor5mgfilmovertruknetablettertilhunde

FI :Actikor5mgkalvopäällysteisettabletitkoiralle/filmdrageradetabletterförhundar

FR :Actikor5mgcomprimépelliculépourchiens

IE :Actikor5mgfilm-coatedtabletsfordogs

NL :Actikor5mgfilmomhuldetablettenvoorhonden

PL :Actikor5mgtabletkipowlekanedlapsów

SE :Actikor5mgfilmdrageradetabletterförhundar

UK :Actikor5mgFilm-coatedTabletsforDogs

BenazeprilHydrochloride

3. STATEMENTOFTHEACTIVESUBSTANCEANDOTHERINGREDIENT

Eachfilm-coatedtabletcontainsbenazepril4.6mg(equivalentto5mgofbenazeprilhydrochloride)

4. INDICATION

Dogsweighingmorethan5kg:

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)stilladministeredonce

daily,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.

4-12-2018

FDA Approves Pexion for Treating Noise Aversion in Dogs

FDA Approves Pexion for Treating Noise Aversion in Dogs

The U.S. Food and Drug Administration announced today that its Center for Veterinary Medicine has approved Pexion (imepitoin tablets) to treat noise aversion in dogs. Dogs with noise aversion are sensitive to loud noises such as fireworks, street/traffic noises, and gun shots.

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

21-2-2017

Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets

Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets

Takeda Pharma A/S recalls a batch of Pamol® in packs of 300 film-coated tablets after the discovery of Ibumetin 600 mg containing ibuprofen in some packs. Both types of medicine are used for the treatment of mild pain, but they work in different ways and may cause different adverse reactions.

Danish Medicines Agency