Clavudale 500mg

Main information

  • Trade name:
  • Clavudale 500mg
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Clavudale 500mg
    Austria
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • amoxicillin and enzyme inhibitor
  • Therapeutic area:
  • Cats, Dogs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0373/003
  • Authorization date:
  • 01-05-2012
  • EU code:
  • UK/V/0373/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:March2011

AN:01855/2009

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Clavudale500mgtabletfordogs(UK,Ireland,France,Austria,Belgium,CzechRepublic,

Greece,Hungary,Iceland,Luxembourg,Norway,Poland,Portugal,SlovakRepublic)

Clavudale400mg/100mgtabletfordogs(Germany,Netherlands,Denmark,Spain,Finland,

Sweden)

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

ActiveSubstances:

Amoxicillin(asamoxicillintrihydrate) 400mg

Clavulanicacid(aspotassiumclavulanate) 100mg

Excipients:

Erythrosine(E127)7.5mg

Forafulllistofexcipientsseesection6.1.

3.PHARMACEUTICALFORM

Tablet.

Pinkoblongscoredtablets.

Thetabletcanbedividedintoequalhalves.

4.CLINICALPARTICULARS

4.1Targetspecies

Dogs

4.2Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofbacterialinfectionssusceptibletoamoxicillinincombinationwith

clavulanicacidwhereclinicalexperienceand/orsensitivitytestingindicatestheproductasthe

drugofchoice.

Usesinclude:

Skininfections(includingdeepandsuperficialpyodermas)associatedwithStaphylococci

andStreptococci;

Infectionsoftheoralcavity(mucousmembrane)associatedwithClostridia,Corynebacteria,

Staphylococci,Streptococci,Bacteroidesspp.andPasteurellae.;

UrinarytractinfectionsassociatedwithStaphylococci,Streptococci,Escherichiacoliand

Proteusspp;

RespiratorytractinfectionsassociatedwithStaphylococci,StreptococciandPasteurellae;

GastrointestinalinfectionsassociatedwithEscherichiacoliandProteusspp.

Revised:March2011

AN:01855/2009

4.3Contraindications

Donotuseinrabbits,guineapigs,hamstersandgerbils.

Donotuseinanimalswithknownhypersensitivitytopenicillinorsubstancesoftheβ-lactam

group.

Donotuseinanimalswitheitheroliguriaoranuriaassociatedwithrenaldysfunction.

Donotuseincasesofknownresistancetothecombinationofamoxicillinandclavulanicacid.

4.4Specialwarningsforeachtargetspecies

Noneknown.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Cautionisadvisedontheuseoftheproductinsmallherbivoresotherthanthoselistedin4.3.

Inanimalswithhepaticandrenaldysfunction,thedosingregimenshouldbecarefully

evaluated.

Useoftheproductshouldbebasedonsusceptibilitytestingandshouldtakeintoaccount

officialnationalandregionalpolicieswithrespecttotheuseofbroadspectrumantibiotics.Do

notuseincasesofbacteriasensitivetonarrowspectrumpenicillinsortoamoxicillinasa

singlesubstance.UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmay

increasetheprevalenceofbacteriaresistanttoamoxicillinandclavulanicacid,andmay

decreasetheeffectivenessoftreatmentwithotherβ-lactams,duetothepotentialforcross

resistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,

inhalation,ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocross-reactions

tocephalosporinsandviceversa.Allergicreactionstothesesubstancesmayoccasionallybe

serious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvised

nottoworkwithsuchpreparations.

Handlethisproductwithgreatcaretoavoidexposure,takingallrecommended

precautions.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshouldseek

medicaladviceandshowthedoctorthiswarning.Swellingoftheface,lipsoreyesor

difficultywithbreathingaremoreserioussymptomsandrequireurgentmedical

attention.

Washhandsafteruse.

Revised:March2011

AN:01855/2009

4.6Adversereactions(frequencyandseriousness)

Mildgastrointestinalsigns(diarrhoea,andvomiting)mayoccurafteradministrationofthe

product.

Allergicreactions(skinreactions,anaphylaxis),blooddyscrasiaandcolitismayoccasionally

occur.Inthesecases,discontinueadministrationandgivesymptomatictreatment.

4.7Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandmicehavenotproducedanyevidenceofteratogenicor

foetotoxiceffects.Nostudieshavebeenconductedinpregnantorlactatingdogs.Useonly

accordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Bacteriostaticantibiotics(e.g.chloramphenicol,macrolides,sulfonamidesandtetracyclines)

mayinhibittheantibacterialeffectsofpenicillins.

Thepotentialforallergiccross-reactivitywithotherpenicillinsshouldbeconsidered.

Penicillinsmayincreasetheeffectofaminoglycosides.

4.9Amountstobeadministeredandadministrationroute

Fororaladministrationonly.Thedosagerateis10mgamoxicillin/2.5mgclavulanicacid/kg

bodyweighttwicedaily.Thetabletsmaybeaddedtoalittlefood.

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyaspossibleto

avoidunder-dosing.

Thefollowingtableisintendedasaguidetodispensingtheproductatthestandarddoserate

of10mgamoxicillin/2.5mgclavulanicacid/kgtwicedaily.

Bodyweight

(kg) Numberoftabletstwice

daily

>30to≤40 1

>40to≤60

>60to≤80 2

Inrefractorycasesthedosemaybedoubledto20mgamoxicillin/5mgclavulanicacid/kg

bodyweighttwicedaily.

Durationoftherapy:

Routinecasesinvolvingallindications:

Themajorityofroutinecasesrespondtobetween5and7daysoftherapy.Lackofeffectafter

5-7daysoftreatmentnecessitatesrenewedexamination.

Chronicorrefractorycases:

Inchroniccases,longercoursesofantibacterialtherapymayberequired.Insuch

circumstances overalltreatmentlengthisattheclinician’sdiscretion,butmustbelongenough

toensurecompleteresolutionofthebacterialdisease.

Revised:March2011

AN:01855/2009

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Mildgastrointestinalsymptoms(diarrhoea,andvomiting)mayoccurmorefrequentlyafter

overdoseoftheproduct.

4.11Withdrawalperiod

Notapplicable

5. PHARMACOLOGICALPROPERTIES

ATCvetcode:QJ01CR02

Pharmacotherapeuticgroup:Beta-lactamantibacterials,penicillins.

5.1Pharmacodynamicproperties

Amoxicillinisanaminobenzylpenicillinfromtheβ-lactampenicillinfamilywhichprevents

bacterialcellwallformationbyinterferingwiththefinalstepofpeptidoglycansynthesis.

Clavulanicacidisanirreversibleinhibitorofintracellularandextr acellularβ-lactamaseswhich

protectsamoxicillinfrominactivationbymanyβ-lactamases.

Amoxicillinincombinationwithclavulanicacidhasawiderangeofactivitywhichincludes

β-lactamaseproducingstrainsofbothGram-positiveandGram-negativeaerobes,facultative

anaerobesandobligateanaerobes,including:

Gram-positiveswithgoodsusceptibility:Clostridiumspp.Corynebacteriumspp.

Staphylococcusspp.Streptococcusspp.

Gram-negativeswithgoodsusceptibility:Pasteurellaspp.Bacteroidesspp.Proteus

mirabilis.

Gram-negativeswithvariablesusceptibility:Escherichiacoli,Klebsiellaspp.

Bordetellabronchiseptica.

ResistantbacterialspeciesincludePseudomonasaeruginosa,Enterobacterspp.and

methicillin-resistantStaphylococcusaureus.

Susceptibilityandresistancepatternscanvarywithgeographicalareaandbacterialstrain,

andmaychangeovertime.

Revised:March2011

AN:01855/2009

5.2Pharmacokineticparticulars

Aftertheoraladministrationtodogsoftherecommendeddoseof10mgamoxicillin/2.5mg

clavulanicacid/kgweightthefollowingparameterswereobserved:medianT

of1.5hours

foramoxicillinandof1.0hoursforclavulanicacid.

Amoxicilliniswell-absorbedfollowingoraladministration.Indogsthesystemicbioavailability

is60-70%.Amoxicillin(pKa2.8)hasarelativelysmallapparentdistributionvolume,alow

plasmaproteinbinding(34%indogs)andashortterminalhalf-lifeduetoactivetubular

excretionviathekidneys.Followingabsorptionthehighestconcentrationsarefoundinthe

kidneys(urine)andthebileandtheninliver,lungs,heartandspleen.Thedistributionof

amoxicillintothecerebrospinalfluidislowunlessthemeningesareinflamed.

Clavulanicacid(pKa2.7)isalsowell-absorbedfollowingoraladministration.Thepenetration

tothecerebrospinalfluidispoor.Theplasmaproteinbindingisapproximately25%andthe

eliminationhalf-lifeisshort.Clavulanicacidismainlyeliminatedbyrenalexcretion

(unchangedinurine).

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Erythrosine(E127)

Silica,ColloidalAnhydrous

MagnesiumStearate

SodiumStarchGlycolate(TypeA)

Cellulose,Microcrystalline

6.2Incompatibilities

Notapplicable

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:4years

Shelflifeafterfirstopeningtheimmediatepackaging:12hours

Anydividedtabletportionsremainingafter12hoursshouldbediscarded.

6.4.Specialprecautionsforstorage

Donotstoreabove25ºC.

Dividedtabletsshouldbestoredintheblisterpack.

Revised:March2011

AN:01855/2009

6.5 Natureandcompositionofimmediatepackaging

BlisterpacksconsistingoforientatedPolyamide/Aluminium/Polyvinylchloridefilm,heat

sealedwithaluminiumfoil(20µm)instripsof6tablets.Cartonscontaining12or24tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7.MARKETINGAUTHORISATIONHOLDER

DechraLimited,

DechraHouse,

JamageIndustrialEstate,

TalkePits,

Stoke-on-Trent,

Staffordshire,

ST71XW,

UK.

Tel:01782771100

Fax:01782773366

8.MARKETINGAUTHORISATIONNUMBER

Vm10434/4053

9.DATEOFFIRSTAUTHORISATION

8January2010

10.DATEOFREVISIONOFTHETEXT

March2011