Clavudale 250 mg

Main information

  • Trade name:
  • Clavudale 250 mg
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Clavudale 250 mg
    Austria
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0373/002
  • Authorization date:
  • 01-05-2012
  • EU code:
  • UK/V/0373/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:March2011

AN:01854/2009

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Clavudale250mgtabletfordogs(UK,Ireland,France,Austria,Belgium,Czech

Republic,Greece,Hungary,Iceland,Luxembourg,Norway,Poland,Portugal,Slovak

Republic)

Clavudale200mg/50mgtabletfordogs(Germany,Netherlands,Denmark,Spain,

Finland,Sweden)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstances:

Amoxicillin(asamoxicillintrihydrate) 200mg

Clavulanicacid(aspotassiumclavulanate) 50mg

Excipients:

Erythrosine(E127)3.75mg

Forafulllistofexcipientsseesection6.1.

3. PHARMACEUTICALFORM

Tablet.

Pinkoblongscoredtablets.

Thetabletcanbedividedintoequalhalves.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofbacterialinfectionssusceptibletoamoxicillinincombinationwith

clavulanicacidwhereclinicalexperienceand/orsensitivitytestingindicatestheproduct

asthedrugofchoice.

Usesinclude:

Skininfections(includingdeepandsuperficialpyodermas)associatedwith

StaphylococciandStreptococci;

Infectionsoftheoralcavity(mucousmembrane)associatedwithClostridia,

Corynebacteria,Staphylococci,Streptococci,Bacteroidesspp.andPasteurellae.;

UrinarytractinfectionsassociatedwithStaphylococci,Streptococci,Escherichiacoli

andProteusspp;

RespiratorytractinfectionsassociatedwithStaphylococci,Streptococciand

Pasteurellae;

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GastrointestinalinfectionsassociatedwithEscherichiacoliandProteusspp.

Revised:March2011

AN:01854/2009

4.3 Contraindications

Donotuseinrabbits,guineapigs,hamstersandgerbils.

Donotuseinanimalswithknownhypersensitivitytopenicillinorsubstancesoftheβ-

lactamgroup.

Donotuseinanimalswitheitheroliguriaoranuriaassociatedwithrenaldysfunction.

Donotuseincasesofknownresistancetothecombinationofamoxicillinand

clavulanicacid.

4.4 Specialwarningsforeachtargetspecies

Noneknown.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Cautionisadvisedontheuseoftheproductinsmallherbivoresotherthanthose

listedin4.3.

Inanimalswithhepaticandrenaldysfunction,thedosingregimenshouldbe

carefullyevaluated.

Useoftheproductshouldbebasedonsusceptibilitytestingandshouldtakeinto

accountofficialnationalandregionalpolicieswithrespecttotheuseofbroad

spectrumantibiotics.Donotuseincasesofbacteriasensitivetonarrowspectrum

penicillinsortoamoxicillinasasinglesubstance.Useoftheproductdeviating

fromtheinstructionsgivenintheSPCmayincreasetheprevalenceofbacteria

resistanttoamoxicillinandclavulanicacid,andmaydecreasetheeffectivenessof

treatmentwithotherβ-lactamantibiotics,duetothepotentialforcrossresistance.

ii.Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)following

injection,inhalation,ingestionorskincontact.Hypersensitivitytopenicillinsmay

leadtocross-reactionstocephalosporinsandviceversa.Allergicreactionsto

thesesubstancesmayoccasionallybeserious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeen

advisednottoworkwithsuchpreparations.

Handlethisproductwithgreatcaretoavoidexposure,takingall

recommendedprecautions.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshould

seekmedicaladviceandshowthedoctorthiswarning.Swellingoftheface,

lipsoreyesordifficultywithbreathingaremoreserioussymptomsand

requireurgentmedicalattention.

Washhandsafteruse.

Revised:March2011

AN:01854/2009

4.6 Adversereactions(frequencyandseriousness)

Mildgastrointestinalsigns(diarrhoea,andvomiting)mayoccurafteradministrationof

theproduct.

Allergicreactions(skinreactions,anaphylaxis),blooddyscrasiaandcolitismay

occasionallyoccur.Inthesecases,discontinueadministrationandgivesymptomatic

treatment.

4.7 Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandmicehavenotproducedanyevidenceofteratogenicor

foetotoxiceffects.Nostudieshavebeenconductedinpregnantorlactatingdogs.Use

onlyaccordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Bacteriostaticantibiotics(e.g.chloramphenicol,macrolides,sulfonamidesand

tetracyclines)mayinhibittheantibacterialeffectsofpenicillins.

Thepotentialforallergiccross-reactivitywithotherpenicillinsshouldbeconsidered.

Penicillinsmayincreasetheeffectofaminoglycosides.

4.9 Amountstobeadministeredandadministrationroute

Fororaladministrationonly.Thedosagerateis10mgamoxicillin/2.5mgclavulanic

acid/kgbodyweighttwicedaily.Thetabletsmaybeaddedtoalittlefood.

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunder-dosing.

Thefollowingtableisintendedasaguidetodispensingtheproductatthestandard

doserateof10mgamoxicillin/2.5mgclavulanicacid/kgtwicedaily.

Bodyweight(kg) Numberoftabletstwicedaily

>8to≤10 ½

>10to≤20 1

>20to≤30 1½

>30to≤40 2

Inrefractorycasesthedosemaybedoubledto20mgamoxicillin/5mgclavulanic

acid/kgbodyweighttwicedaily.

Durationoftherapy:

Routinecasesinvolvingallindications:

Themajorityofroutinecasesrespondtobetween5and7daysoftherapy.Lackof

effectafter5-7daysoftreatmentnecessitatesrenewedexamination.

Chronicorrefractorycases:

Inchroniccases,longercoursesofantibacterialtherapymayberequired.Insuch

circu mstances,overalltreatmentlengthisattheclinician’sdiscretion,butmustbelong

enoughtoensurecompleteresolutionofthebacterialdisease.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Revised:March2011

AN:01854/2009

Mildgastrointestinalsymptoms(diarrhoea,andvomiting)mayoccurmorefrequently

afteroverdoseoftheproduct.

Revised:March2011

AN:01854/2009

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

ATCvetcode:QJ01CR02

Pharmacotherapeuticgroup:Beta-lactamantibacterials,penicillins.

5.1 Pharmacodynamicproperties

Amoxicillinisanaminobenzylpenicillinfromthe β-lactampenicillinfamilywhich

preventsbacterialcellwallformationbyinterferingwiththefinalstepofpeptidoglycan

synthesis.

Clavulanicacidisanirreversibleinhibitorofintracellularandextracellularβ-lactamases

whichprotectsamoxicillin frominactivationbymanyβ-lactamases.

Amoxicillinincombinationwithclavulanicacidhasawiderangeofactivitywhich

includesβ-lactamaseproducingstrainsofbothGram-positiveandGram-negative

aerobes,facultativeanaerobesandobligateanaerobes,including:

Gram-positiveswithgoodsusceptibility:Clostridiumspp.Corynebacteriumspp.

Staphylococcusspp.Streptococcusspp.

Gram-negativeswithgoodsusceptibility:Pasteurellaspp.Bacteroidesspp.

Proteusmirabilis.

Gram-negativeswithvariablesusceptibility:Escherichiacoli,Klebsiellaspp.

Bordetellabronchiseptica.

ResistantbacterialspeciesincludePseudomonasaeruginosa,Enterobacterspp.and

methicillin-resistantStaphylococcusaureus.

Susceptibilityandresistancepatternscanvarywithgeographicalareaandbacterial

strain,andmaychangeovertime.

Revised:March2011

AN:01854/2009

5.2 Pharmacokineticparticulars

Aftertheoraladministrationtodogsoftherecommendeddoseof10mgamoxicillin/

2.5mgclavulanicacid/kgweightthefollowingparameterswereobserved:median

of1.5hoursforamoxicillinandof1.0hoursforclavulanicacid.

Amoxicilliniswell-absorbedfollowingoraladministration.Indogsthesystemic

bioavailabilityis60-70%.Amoxicillin(pKa2.8)hasarelativelysmallapparent

distributionvolume,alowplasmaproteinbinding(34%indogs)andashortterminal

half-lifeduetoactivetubularexcretionviathekidneys.Followingabsorptionthehighest

concentrationsarefoundinthekidneys(urine)andthebileandtheninliver,lungs,

heartandspleen.Thedistributionofamoxicillintothecerebrospinalfluidislowunless

themeningesareinflamed.

Clavulanicacid(pKa2.7)isalsowell-absorbedfollowingoraladministration.The

penetrationtothecerebrospinalfluidispoor.Theplasmaproteinbindingis

approximately25%andtheeliminationhalf-lifeisshort.Clavulanicacidismainly

eliminatedbyrenalexcretion(unchangedinurine).

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Erythrosine(E127)

Silica,ColloidalAnhydrous

MagnesiumStearate

SodiumStarchGlycolate(TypeA)

Cellulose,Microcrystalline

6.2 Incompatibilities

Notapplicable.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:4years

Shelflifeafterfirstopeningtheimmediatepackaging:12hours

Anydividedtabletportionsremainingafter12hoursshouldbediscarded.

6.4. Specialprecautionsforstorage

Donotstoreabove25ºC.

Dividedtabletsshouldbestoredintheblisterpack.

6.5 Natureandcompositionofimmediatepackaging

BlisterpacksconsistingoforientatedPolyamide/Aluminium/Polyvinylchloridefilm,

heatsealedwithaluminiumfoil(20µm)instripsof6tablets.Cartonscontaining12or

24tablets.

Revised:March2011

AN:01854/2009

Notallpacksizesmaybemarketed.

Revised:March2011

AN:01854/2009

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

DechraLimited,

DechraHouse,

JamageIndustrialEstate,

TalkePits,

Stoke-on-Trent,

Staffordshire,

ST71XW,

UK.

Tel:01782771100

Fax:01782773366

8. MARKETINGAUTHORISATIONNUMBER

Vm10434/4051

9.DATEOFFIRSTAUTHORISATION

8January2010

10. DATEOFREVISIONOFTHETEXT

March2011