Kesium

Main information

  • Trade name:
  • Kesium 500 mg Chewable Tablets for dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Kesium 500 mg Chewable Tablets for dogs
    Ireland
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0225/004
  • Authorization date:
  • 22-06-2011
  • EU code:
  • FR/V/0225/004
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CZ,DK,DE,IT,FI,SE,AT,BE,NL,LUX:Kesium400mg/100mgChewabletabletsfor

dogs

UK,IE,FR,EL,PL,HU,RO,PT,ES:Kesium500mgChewabletabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Amoxicillin(asamoxicillintrihydrate) 400.00mg

Clavulanicacid(aspotassiumclavulanate) 100.00mg

Excipient(s):

Forafulllistofexcipients,seesection6.1

3.PHARMACEUTICALFORM

Chewabletablet

Oblongscoredbeigetablet.Thetabletscanbedividedintoequalhalves

4.CLINICALPARTICULARS

4.1.TargetSpecies:

Dogs

4.2.IndicationsforUse,SpecifyingtheTargetSpecies:

Forthetreatmentofthefollowinginfectionscausedby 

lactamaseproducingstrainsof

bacteriasensitivetoamoxicillinincombinationwithclavulanicacidandwhereclinical

experienceand/orsensitivitytestingindicatestheproductasthedrugofchoice:

- Skininfections(includingsuperficialanddeeppyodermas)associatedwith

Staphylococcusspp.

- UrinarytractinfectionsassociatedwithStaphylococcusspp,Streptococcusspp,

EscherichiacoliandProteusmirabilis.

- RespiratorytractinfectionsassociatedwithStaphylococcusspp,Streptococcussppand

Pasteurellaspp.

- DigestivetractinfectionsassociatedwithEscherichiacoli.

- Infectionsoftheoralcavity(mucousmembrane)associatedwithPasteurellaspp,

Streptococcusspp,Escherichiacoli.

4.3.Contraindications

Donotuseinanimalswithknownhypersensitivitytopenicillinsorothersusbstancesofthe β-

lactamgrouportoanyexcipients.

Donotuseinanimalswithseriousdysfunctionofthekidneysaccompaniedbyanuriaand

oliguria.

Donotadministertogerbils,guineapigs,hamsters,rabbitsandchinchillas.Donotusein

horsesandruminatinganimals.

Donotusewhereresistancetothiscombinationisknowntooccur.

4.4.SpecialWarningsforeachtargetspecies

Noneknown.

4.5.SpecialPrecautionsforUse

i)Specialprecautionsforuseinanimals

Official,nationalandregionalantimicrobialpolicieswithrespecttotheuseofbroad-spectrum

antibioticsshouldbetakenintoaccount.

Donotuseincaseofbacteriasensitivetonarrowspectrumpenicillinsortoamoxicillinas

singlesubstance.

Itisadvisedthatuponinitiatingtherapyappropriatesensitivitytestingisperformedandthat

therapyiscontinuedonlyaftersusceptibilitytothecombinationhasbeenestablished.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasethe

prevalenceofbacteriaresistanttotheamoxicillin/clavulanate,andmaydecreasethe

effectivenessoftreatmentwithbeta-lactamantibiotics

Inanimalswithhepaticandrenaldysfunction,thedosingregimenshouldbecarefully

evaluatedandtheuseoftheproductbasedonarisk/benefitevaluationbytheveterinary

surgeon.

Cautionisadvisedintheuseinsmallherbivoresotherthanthoseinthesection4.3.

Thepotentialforallergiccross-reactionswithotherpenicillinderivatesandcephalosporins

shouldbeconsidered

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,

inhalation,ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocross-

reactionstocephalosporinsandviceversa.Allergicreactionstothesesubstancesmay

occasionallybeserious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvisednotto

workwithsuchpreparations.

Handlethisproductwithgreatcaretoavoidexposure,takingallrecommendedprecautions.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedical

adviceandshowthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultywith

breathingaremoreserioussymptomsandrequireurgentmedicalattention.

Washhandsafteruse.

4.6.AdverseReactions(FrequencyandSeriousness)

Mildgastrointestinalsigns(diarrhoea,andvomiting)mayoccurafteradministrationofthe

product.Treatmentmaybediscontinueddependingontheseverityoftheundesirableeffects

andabenefit/riskevaluationbytheveterinarysurgeon.

Allergicreactions(skinreactions,anaphylaxis)mayoccasionallyoccur.Inthesecases,

administrationshouldbediscontinuedandasymptomatictreatmentgiven.

4.7.UseduringPregnancy,LactationorLay

Laboratorystudiesinratsandmicehavenotproducedanyevidenceofteratogenic,

foetotoxicormaternotoxiceffects.

Inpregnantandlactatinganimals,useonlyaccordingtothebenefit/riskassessmentbythe

responsibleveterinarian.

4.8.InteractionwithotherMedicinalProductsandOtherFormsofInteraction

Chloramphenicol,macrolides,sulfonamidesandtetracyclinesmayinhibittheantibacterial

effectofpenicillinsbecauseoftherapidonsetofbacteriostaticaction.

Penicillinsmayincreasetheeffectofaminoglycosides.

4.9.AmountstobeAdministeredandAdministration

Therecommendeddoseoftheproductis10mgamoxicillin/2.5mgclavulanicacidperkg

bodyweighttwiceadaybytheoralrouteindogs,i.e.1tabletper40kgbodyweightevery

12h,accordingtothefollowingtable:

Bodyweight

(kg) Numberoftabletsperday

(twicedaily)

>20.1to30.0 ≤ ½

>30.1to40.0 ≤

1

>40.1to60.0 ≤ 1½

>60.1to80.0 ≤ 2

Inrefractorycasesthedosemaybedoubledto20mgofamoxicillin/5mgclavulanicacid/kg

bodyweighttwicedaily,attheclinician’sdiscretion.

Thechewabletabletsareflavouredandareacceptedbyamajorityofdogs.Thechewable

tabletscanbeadministereddirectlyintothemouthoftheanimalsoraddedtoasmall

quantityoffood.

Durationoftherapy

Themajorityofroutinecasesrespondto5 –7daysoftherapy.

Inchroniccases,alongercaseoftherapyisrecommended.Insuchcircumstancesoverall

treatmentlengthmustbeattheclinician’sdiscretion,butshouldbelongenoughtoensure

completeresolutionofthebacterialdisease.

Toensurethecorrectdosage,bodyweightshouldbedeterminedasaccuratelyaspossible

toavoidunder-dosing.

4.10.Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Incaseofoverdosediarrhoea,allergicreactionsorfurthersymptomslikecentralnervous

excitationmanifestationsorcrampscouldappear.Symptomatictreatmentshouldbeinitiated

whennecessary.

4.11.WithdrawalPeriod(s)

Notapplicable.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Beta-lactamantibacterials,penicillins

ATCvetcode:QJ01CR02

5.1.Pharmacodynamicproperties

Amoxicillinisabeta-lactamantibioticanditsstructurecontainsthebeta-lactamringand

thiazolidineringcommontoallpenicillins.Amoxicillinshowsactivityagainstsusceptible

Gram-positivebacteriaandGram-negativebacteria.

Beta-lactamantibioticspreventthebacterialcellwallfromformingbyinterferingwiththefinal

stageofpeptidoglycansynthesis.Theyinhibittheactivityoftranspeptidaseenzymes,which

catalysecross-linkageoftheglycopeptidepolymerunitsthatformthecellwall.Theyexerta

bactericidalactionbutcauselysisofgrowingcellsonly.

Clavulanicacidisoneofthenaturallyoccurringmetabolitesofthestreptomycete

Streptomycesclavuligerus.Ithasastructuralsimilaritytothepenicillinnucleus,including

possessionofabeta-lactamring.Clavulanicacidisabeta-lactamaseinhibitoractinginitially

competitivelybutultimatelyirreversibly.Clavulanicacidwillpenetratethebacterialcellwall

bindingtobothextracellularandintracellularbeta-lactamases.

Amoxicillinissusceptibletobreakdownby 

-lactamaseandthereforecombinationwithan

effectiveß-lactamaseinhibitor(clavulanicacid)extendstherangeofbacteriaagainstwhichit

isactivetoinclude 

-lactamaseproducingspecies.

Invitropotentiatedamoxicillinisactiveagainstawiderangeofclinicallyimportantaerobic

andanaerobicbacteriaincluding:

Gram-positive:

Staphylococcusspp.(including 

-lactamaseproducingstrains)

Streptococcusspp

Gram-negative:

Escherichiacoli(includingmost 

-lactamaseproducingstrains)

Pasteurellaspp

Proteusspp

ResistanceisshownamongEnterobacterspp,Pseudomonasaeruginosaandmethicillin-

resistantStaphylococcusaureus.

DogsandcatsdiagnosedwithPseudomonasinfectionsshouldnotbetreatedwiththis

antibioticcombination.

AtrendinresistanceofE.coliisreported.

5.2.Pharmacokineticparticulars

Afteroraladministrationindogs,amoxicillinandclavulanicacidarerapidlyabsorbed.

Amoxicillin(pKa2.8)hasarelativelysmallapparentdistributionvolume,alowplasma

proteinbinding(34%indogs)andashortterminalhalf-lifeduetoactivetubularexcretionvia

thekidneys.Followingabsorptionthehighestconcentrationsarefoundinthekidneys(urine)

andthebileandtheninliver,lungs,heartandspleen.Thedistributionofamoxicillintothe

cerebrospinalfluidislowunlessthemeningesareinflamed.

Clavulanicacid(pKa2.7)isalsowell-absorbedfollowingoraladministration.Thepenetration

tothecerebrospinalfluidispoor.Theplasmaproteinbindingisapproximately25%andthe

eliminationhalf-lifeisshort.Clavulanicacidismainlyeliminatedbyrenalexcretion

(unchangedinurine).

Aftersingleoraladministrationof17mg/kgamoxicillinand4.3mg/kgclavulanicacidindogs:

- Themaximalplasmaconcentration(Cmax)ofamoxicillin(8.6µg/mL)wasobserved

1.5hourfollowingadministration.

- Themaximalplasmaconcentration(Cmax)ofclavulanicacid(4.9µg/mL)was

observed54minutesfollowingadministration.

6.PHARMACEUTICALPARTICULARS

6.1.ListofExcipient(s):

Pigliverpowder

Yeast

Crospovidone(typeIA)

PovidoneK25

Hypromellose

Microcrystallinecellulose

Silica,colloidalanhydrous

Magnesiumstearate

6.2.Incompatibilities

Notapplicable.

6.3.Shelf-Life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

30months

Anydividedtabletportionsremainingafter12hoursshouldbediscarded

6.4.SpecialPrecautionsforStorage

Donotstoreabove25

C.

Dividedtabletsshouldbestoredintheblisterpack

6.5.NatureandCompositionofImmediatePackaging

(PA-AL-PVC –aluminiumheatsealed)containing6tabletsperblister

Cardboardboxwith1blisterof6tablets

Cardboardboxwith2blistersof6tablets

Cardboardboxwith4blistersof6tablets

Cardboardboxwith6blistersof6tablets

Cardboardboxwith8blistersof6tablets

Cardboardboxwith10blistersof6tablets

Cardboardboxwith12blistersof6tablets

Cardboardboxwith14blistersof6tablets

Cardboardboxwith16blistersof6tablets

Cardboardboxwith40blistersof6tablets

Notallpacksizesmaybemarketed

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements

7.MARKETINGAUTHORISATIONHOLDER

SOGEVAL

RoutedeMayenne

ZoneIndustrielledesTouches

53000LAVAL

France

Tel:33243495151

Fax:33243539700

E-mail: sogeval@sogeval.fr

8. MARKETINGAUTHORISATIONNUMBER

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Tobecompletedinaccordancewithnationalrequirements

3-12-2018

PMS-Amoxicillin (2018-12-03)

PMS-Amoxicillin (2018-12-03)

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1-12-2018

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3-8-2018

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Unauthorized prescription antibiotic drugs seized from Gigi's Market in Ottawa, ON, may pose serious health risks

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