Kesium 625 mg chewable tablets for dogs

Main information

  • Trade name:
  • Kesium 625 mg chewable tablets for dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Kesium 625 mg chewable tablets for dogs
    Italy
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0225/005
  • Authorization date:
  • 24-04-2013
  • EU code:
  • FR/V/0225/005
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

D209_ Kesium625 mg

VeterinaryMedicinalProduct

CZ,DK,DE,IT,FI,SE,AT,BE,NL,LUX:

Kesium500mg/125mgChewabletabletsfordogs

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

Kesium625mgChewabletabletsfordogs

PARTIB

PharmaceuticalForm

ChewableTablet

D209_ Kesium625 mg

TABLEOFCONTENT

SUMMARYOFTHEPRODUCTCHARACTERISTICS............................3

A –LABELLING.....................................................................10

A –LABELLING–“OUTERPACKAGE”..............................11

A –LABELLING–BLISTER..................................................14

B –PACKAGELEAFLET.......................................................16

D209_ Kesium625 mg

VeterinaryMedicinalProduct

CZ,DK,DE,IT,FI,SE,AT,BE,NL,LUX:

Kesium500mg/125mgChewabletabletsfordogs

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

Kesium625mgChewabletabletsfordogs

PARTIB

SUMMARYOFTHEPRODUCTCHARACTERISTICS

PharmaceuticalForm

ChewableTablet

D209_ Kesium625 mg

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CZ,DK,DE,IT,FI,SE,AT,BE,NL,LUX:Kesium500mg/125mgChewabletabletsfordogs

UK,IE,FR,EL,PL,HU,RO,PT,ES:Kesium625mgChewabletabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Amoxicillin(asamoxicillintrihydrate) 500.00mg

Clavulanicacid(aspotassiumclavulanate) 125.00mg

Excipient(s):

Forafulllistofexcipients,seesection6.1

3.PHARMACEUTICALFORM

Chewabletablet

Clover-shapedscoredbeigetablet.Thetabletscanbedividedintofourequalparts.

4.CLINICALPARTICULARS

4.1.TargetSpecies:

Dogs

4.2.IndicationsforUse,SpecifyingtheTargetSpecies:

Forthetreatmentofthefollowinginfectionscausedby 

lactamaseproducingstrainsofbacteria

sensitivetoamoxicillinincombinationwithclavulanicacidandwhereclinicalexperienceand/or

sensitivitytestingindicatestheproductasthedrugofchoice:

- Skininfections(includingsuperficialanddeeppyodermas)associatedwithStaphylococcus

spp.

- UrinarytractinfectionsassociatedwithStaphylococcusspp,Streptococcusspp,Escherichia

coliandProteusmirabilis.

- RespiratorytractinfectionsassociatedwithStaphylococcusspp,Streptococcussppand

Pasteurellaspp.

- DigestivetractinfectionsassociatedwithEscherichiacoli.

- Infectionsoftheoralcavity(mucousmembrane)associatedwithPasteurellaspp,

Streptococcusspp,Escherichiacoli.

4.3.Contraindications

Donotuseinanimalswithknownhypersensitivitytopenicillinsorothersubstancesofthe β-lactam

grouportoanyexcipients.

Donotuseinanimalswithseriousdysfunctionofthekidneysaccompaniedbyanuriaandoliguria.

D209_ Kesium625 mg

Donotadministertogerbils,guineapigs,hamsters,rabbitsandchinchillas.Donotuseinhorses

andruminatinganimals.

Donotusewhereresistancetothiscombinationisknowntooccur.

4.4.SpecialWarningsforeachtargetspecies

Noneknown.

4.5.SpecialPrecautionsforUse

i)Specialprecautionsforuseinanimals

Official,nationalandregionalantimicrobialpolicieswithrespecttotheuseofbroad-spectrum

antibioticsshouldbetakenintoaccount.

Donotuseincaseofbacteriasensitivetonarrowspectrumpenicillinsortoamoxicillinassingle

substance.

Itisadvisedthatuponinitiatingtherapyappropriatesensitivitytestingisperformedandthattherapy

iscontinuedonlyaftersusceptibilitytothecombinationhasbeenestablished.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistanttotheamoxicillin/clavulanate,andmaydecreasetheeffectivenessoftreatment

withbeta-lactamantibiotics

Inanimalswithhepaticandrenaldysfunction,thedosingregimenshouldbecarefullyevaluated

andtheuseoftheproductbasedonarisk/benefitevaluationbytheveterinarysurgeon.

Cautionisadvisedintheuseinsmallherbivoresotherthanthoseinthesection4.3.

Thepotentialforallergiccross-reactionswithotherpenicillinderivatesandcephalosporinsshould

beconsidered

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,inhalation,

ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocross-reactionsto

cephalosporinsandviceversa.Allergicreactionstothesesubstancesmayoccasionallybe

serious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvisednottowork

withsuchpreparations.

Handlethisproductwithgreatcaretoavoidexposure,takingallrecommendedprecautions.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedicaladvice

andshowthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultywithbreathingare

moreserioussymptomsandrequireurgentmedicalattention.

Washhandsafteruse.

4.6.AdverseReactions(FrequencyandSeriousness)

Mildgastrointestinalsigns(diarrhoea,andvomiting)mayoccurafteradministrationoftheproduct.

Treatmentmaybediscontinueddependingontheseverityoftheundesirableeffectsanda

benefit/riskevaluationbytheveterinarysurgeon.

D209_ Kesium625 mg

Allergicreactions(skinreactions,anaphylaxis)mayoccasionallyoccur.Inthesecases,

administrationshouldbediscontinuedandasymptomatictreatmentgiven.

4.7.UseduringPregnancy,LactationorLay

Laboratorystudiesinratsandmicehavenotproducedanyevidenceofteratogenic,foetotoxicor

maternotoxiceffects.

Thesafetyoftheproducthasnotbeenassessedinpregnantandlactatingbitches.

Inpregnantandlactatinganimals,useonlyaccordingtothebenefit/riskassessmentbythe

responsibleveterinarian.

4.8.InteractionwithotherMedicinalProductsandOtherFormsofInteraction

Chloramphenicol,macrolides,sulfonamidesandtetracyclinesmayinhibittheantibacterialeffectof

penicillinsbecauseoftherapidonsetofbacteriostaticaction.

Penicillinsmayincreasetheeffectofaminoglycosides.

4.9.AmountstobeAdministeredandAdministrationroute(s)

Oralroute

Therecommendeddoseoftheproductis10mgamoxicillin/2.5mgclavulanicacidperkgbody

weighttwiceadaybytheoralrouteindogs,i.e.1tabletper50kgbodyweightevery12h,

accordingtothefollowingtable:

Bodyweight

(kg) Numberoftabletstobe

administeredtwicedaily

>9to12.5 ¼

12.6to20 Usethe250mg

20.1to25 ½

25.1to37.5 ¾

37.6to50 1

50.1to62.5 1¼

62.6to75 1½

Inrefractorycasesthedosemaybedoubledto20mgofamoxicillin/5mgclavulanicacid/kg

bodyweighttwicedaily,attheclinician’sdiscretion.

Thechewabletabletsareflavouredandareacceptedbyamajorityofdogs.Thechewabletablets

canbeadministereddirectlyintothemouthoftheanimalsoraddedtoasmallquantityoffood.

Durationoftherapy

Themajorityofroutinecasesrespondto5 –7daysoftherapy.

Inchroniccases,alongercaseoftherapyisrecommended.Insuchcircumstancesoverall

treatmentlengthmustbeattheclinician’sdiscretion,butshouldbelongenoughtoensure

completeresolutionofthebacterialdisease.

Toensurethecorrectdosage,bodyweightshouldbedeterminedasaccuratelyaspossibleto

avoidunder-dosing.

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

D209_ Kesium625 mg

Incaseofoverdosediarrhoea,allergicreactionsorfurthersymptomslikecentralnervous

excitationmanifestationsorcrampscouldappear.Symptomatictreatmentshouldbeinitiatedwhen

necessary.

4.11.WithdrawalPeriod(s)

Notapplicable.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Beta-lactamantibacterials,penicillins

ATCvetcode:QJ01CR02

5.1.Pharmacodynamicproperties

Amoxicillinisabeta-lactamantibioticanditsstructurecontainsthebeta-lactamringand

thiazolidineringcommontoallpenicillins.AmoxicillinshowsactivityagainstsusceptibleGram-

positivebacteriaandGram-negativebacteria.

Beta-lactamantibioticspreventthebacterialcellwallfromformingbyinterferingwiththefinalstage

ofpeptidoglycansynthesis.Theyinhibittheactivityoftranspeptidaseenzymes,whichcatalyse

cross-linkageoftheglycopeptidepolymerunitsthatformthecellwall.Theyexertabactericidal

actionbutcauselysisofgrowingcellsonly.

ClavulanicacidisoneofthenaturallyoccurringmetabolitesofthestreptomyceteStreptomyces

clavuligerus.Ithasastructuralsimilaritytothepenicillinnucleus,includingpossessionofabeta-

lactamring.Clavulanicacidisabeta-lactamaseinhibitoractinginitiallycompetitivelybutultimately

irreversibly.Clavulanicacidwillpenetratethebacterialcellwallbindingtobothextracellularand

intracellularbeta-lactamases.

Amoxicillinissusceptibletobreakdownby 

-lactamaseandthereforecombinationwithaneffective

ß-lactamaseinhibitor(clavulanicacid)extendstherangeofbacteriaagainstwhichitisactiveto

include 

-lactamaseproducingspecies.

Invitropotentiatedamoxicillinisactiveagainstawiderangeofclinicallyimportantaerobicand

anaerobicbacteriaincluding:

Gram-positive:

Staphylococcusspp.(including 

-lactamaseproducingstrains)

Streptococcusspp

Gram-negative:

Escherichiacoli(includingmost 

-lactamaseproducingstrains)

Pasteurellaspp

Proteusspp

ResistanceisshownamongEnterobacterspp,Pseudomonasaeruginosaandmethicillin-resistant

Staphylococcusaureus.

DogsdiagnosedwithPseudomonasinfectionsshouldnotbetreatedwiththisantibiotic

combination.

AtrendinresistanceofE.coliisreported.

D209_ Kesium625 mg

5.2.Pharmacokineticparticulars

Afteroraladministrationindogs,amoxicillinandclavulanicacidarerapidlyabsorbed.Amoxicillin

(pKa2.8)hasarelativelysmallapparentdistributionvolume,alowplasmaproteinbinding(34%in

dogs)andashortterminalhalf-lifeduetoactivetubularexcretionviathekidneys.Following

absorptionthehighestconcentrationsarefoundinthekidneys(urine)andthebileandtheninliver,

lungs,heartandspleen.Thedistributionofamoxicillintothecerebrospinalfluidislowunlessthe

meningesareinflamed.

Clavulanicacid(pKa2.7)isalsowell-absorbedfollowingoraladministration.Thepenetrationto

thecerebrospinalfluidispoor.Theplasmaproteinbindingisapproximately25%andthe

eliminationhalf-lifeisshort.Clavulanicacidismainlyeliminatedbyrenalexcretion(unchangedin

urine).

Aftersingleoraladministrationof17mg/kgamoxicillinand4.3mg/kgclavulanicacidindogs:

- Themaximalplasmaconcentration(Cmax)ofamoxicillin(8.6µg/mL)wasobserved1.5

hourfollowingadministration.

- Themaximalplasmaconcentration(Cmax)ofclavulanicacid(4.9µg/mL)wasobserved54

minutesfollowingadministration.

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:

24months

Anydividedtabletportionsremainingafter36hoursshouldbediscarded

6.4.SpecialPrecautionsforStorage

Donotstoreabove25

C.

Dividedtabletsshouldbestoredintheblisterpack

6.5.NatureandCompositionofImmediatePackaging

(PA-AL-PVC –aluminiumheatsealed)containing6tabletsperblister

Cardboardboxof6tablets

Cardboardboxof12tablets

D209_ Kesium625 mg

Cardboardboxof96tablets

Cardboardboxof144tablets

Cardboardboxof240tablets

Notallpacksizesmaybemarketed

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements

7.MARKETINGAUTHORISATIONHOLDER

SOGEVAL

200avenuedeMayenne

ZoneIndustrielledesTouches

53000LAVAL

France

Tel:33243495151

Fax:33243539700

E-mail: sogeval@sogeval.fr

8. MARKETINGAUTHORISATIONNUMBER

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Tobecompletedinaccordancewithnationalrequirements

D209_ Kesium625 mg

VeterinaryMedicinalProduct

CZ,DK,DE,IT,FI,SE,AT,BE,NL,LUX:

Kesium500mg/125mgChewabletabletsfordogs

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

Kesium625mgChewabletabletsfordogs

PARTIB

A-LABELLING

PharmaceuticalForm

ChewableTablet

D209_ Kesium625 mg

VeterinaryMedicinalproduct

CZ,DK,DE,IT,FI,SE,AT,BE,NL,LUX:

Kesium500mg/125mgChewabletabletsfordogs

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

Kesium625mgChewabletabletsfordogs

PARTIB

A –LABELLING–“OUTERPACKAGE”

Pharmaceuticalform

ChewableTablet

D209_ Kesium625 mg

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CZ,DK,DE,IT,FI,SE,AT,BE,NL,LUX:Kesium500mg/125mgChewabletabletsfordogs

UK,IE,FR,EL,PL,HU,RO,PT,ES:Kesium625mgChewabletabletsfordogs

Amoxicillin(asamoxicillintrihydrate)

Clavulanicacid(aspotassiumclavulanate)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachtabletcontains:

Activesubstance:

Amoxicillin(asamoxicillintrihydrate) 500.00mg

Clavulanicacid(aspotassiumclavulanate) 125.00mg

3. PHARMACEUTICALFORM

Chewabletablet

Clover-shapedscoredbeigetablet.Thetabletcanbedividedintofourequalparts.

4. PACKAGESIZE

Cardboardboxof6tablets

Cardboardboxof12tablets

Cardboardboxof96tablets

Cardboardboxof144tablets

Cardboardboxof240tablets

5. TARGETSPECIES

Dogs

6. INDICATION(S)

7. METHODANDROUTE(S)OFADMINISTRATION

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Notapplicable.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10.EXPIRYDATE

EXP{month/year}

Anydividedtabletportionsremainingafter36hoursshouldbediscarded

11.SPECIALSTORAGECONDITIONS

Donotstoreabove25

C.

D209_ Kesium625 mg

Dividedtabletsshouldbestoredintheblisterpack

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription

14. THEWORDS“KEEPOUTOFTHESIGHTANDREACHOFCHILDREN”

Keepoutofthesightandreachofchildren

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

SOGEVAL

200avenuedeMayenne

ZoneIndustrielledesTouches

53000LAVAL

France

Tel:33243495151

Fax:33243539700

E-mail: sogeval@sogeval.fr

16.MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch:

D209_ Kesium625 mg

VeterinaryMedicinalproduct

CZ,DK,DE,IT,FI,SE,AT,BE,NL,LUX:

Kesium500mg/125mgChewabletabletsfordogs

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

Kesium625mgChewabletabletsfordogs

PARTIB

A –LABELLING–BLISTER

Pharmaceuticalform

ChewableTablet

D209_ Kesium625 mg

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CZ,DK,DE,IT,FI,SE,AT,BE,NL,LUX:Kesium500mg/125mgChewabletabletsfordogs

UK,IE,FR,EL,PL,HU,RO,PT,ES:Kesium625mgChewabletabletsfordogs

Amoxicillin(asamoxicillintrihydrate)

Clavulanicacid(aspotassiumclavulanate)

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

SOGEVAL

3. EXPIRYDATE

EXP{month/year}

4. BATCHNUMBER

Batch:

5. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly

D209_ Kesium625 mg

VeterinaryMedicinalproduct

CZ,DK,DE,IT,FI,SE,AT,BE,NL,LUX:

Kesium500mg/125mgChewabletabletsfordogs

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

Kesium625mgChewabletabletsfordogs

PARTIB

B –PACKAGELEAFLET

Pharmaceuticalform

ChewableTablet

D209_ Kesium625 mg

PACKAGELEAFLET

CZ,DK,DE,IT,FI,SE,AT,BE,NL,LUX:

Kesium500mg/125mgChewabletabletsfordogs

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

Kesium625mgChewabletabletsfordogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOFTHE

MANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCHRELEASE,

IFDIFFERENT

Marketingauthorisationholder:

SOGEVAL

200avenuedeMayenne

ZoneIndustrielledesTouches

53000LAVAL

FRANCE

Tel:33243495151

Fax:33243539700

E-mail: sogeval@sogeval.fr

Manufacturerforthebatchrelease:

SOGEVAL

200avenuedeMayenne

ZoneIndustrielledesTouches

53000LAVAL

FRANCE

Tel:33243495151

Fax:33243539700

E-mail: sogeval@sogeval.fr SOGEVAL

ZoneAutoroutière

53950LOUVERNE

FRANCE

Tel:33243495151

Fax:33243539700

E-mail: sogeval@sogeval.fr

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CZ,DK,DE,IT,FI,SE,AT,BE,NL,LUX:Kesium500mg/125mgChewabletabletsfordogs

UK,IE,FR,EL,PL,HU,RO,PT,ES:Kesium625mgChewabletabletsfordogs

Amoxicillin(asamoxicillintrihydrate)

Clavulanicacid(aspotassiumclavulanate)

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachtabletcontains:

Activesubstance:

Amoxicillin(asamoxicillintrihydrate) 500.00mg

Clavulanicacid(aspotassiumclavulanate) 125.00mg

Chewabletablet

Clover-shapedscoredbeigetablet.Thetabletcanbedividedintofourequalparts.

D209_ Kesium625 mg

4. INDICATION(S)

Forthetreatmentofthefollowinginfectionscausedby 

lactamaseproducingstrainsofbacteria

sensitivetoamoxicillinincombinationwithclavulanicacidandwhereclinicalexperienceand/or

sensitivitytestingindicatestheproductasthedrugofchoice:

- Skininfections(includingsuperficialanddeeppyodermas)associatedwithStaphylococcus

spp.

- UrinarytractinfectionsassociatedwithStaphylococcusspp,Streptococcusspp,Escherichia

coliandProteusmirabilis.

- RespiratorytractinfectionsassociatedwithStaphylococcusspp,Streptococcussppand

Pasteurellaspp.

- DigestivetractinfectionsassociatedwithEscherichiacoli.

- Infectionsoftheoralcavity(mucousmembrane)associatedwithPasteurellaspp,

Streptococcusspp,Escherichiacoli.

5. CONTRAINDICATIONS

Donotuseinanimalswithknownhypersensitivitytopenicillinsorothersubstancesofthe β-lactam

grouportoanyexcipients.

Donotuseinanimalswithseriousdysfunctionofthekidneysaccompaniedbyanuriaandoliguria.

Donotadministertogerbils,guineapigs,hamsters,rabbitsandchinchillas.Donotuseinhorses

andruminatinganimals.

Donotusewhereresistancetothiscombinationisknowntooccur.

6. ADVERSEREACTIONS

Mildgastrointestinalsigns(diarrhoea,andvomiting)mayoccurafteradministrationoftheproduct.

Treatmentmaybediscontinueddependingontheseverityoftheundesirableeffectsanda

benefit/riskevaluationbytheveterinarysurgeon.

Allergicreactions(skinreactions,anaphylaxis)mayoccasionallyoccur.Inthesecases,

administrationshouldbediscontinuedandasymptomatictreatmentgiven.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Dogs

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Oralroute

Therecommendeddoseoftheproductis10mgamoxicillin/2.5mgclavulanicacidperkgbody

weighttwiceadaybytheoralrouteindogs,i.e.1tabletper50kgbodyweightevery12h,

accordingtothefollowingtable:

D209_ Kesium625 mg

Bodyweight

(kg) Numberoftabletstobe

administeredtwicedaily

>9to12.5 ¼

12.6to20 Usethe250mg

20.1to25 ½

25.1to37.5 ¾

37.6to50 1

50.1to62.5 1¼

62.6to75 1½

Inrefractorycasesthedosemaybedoubledto20mgofamoxicillin/5mgclavulanicacid/kg

bodyweighttwicedaily,attheclinician’sdiscretion.

Durationoftherapy

Themajorityofroutinecasesrespondto5 –7daysoftherapy.

Inchroniccases,alongercaseoftherapyisrecommended.Insuchcircumstancesoverall

treatmentlengthmustbeattheclinician’sdiscretion,butshouldbelongenoughtoensure

completeresolutionofthebacterialdisease.

Toensurethecorrectdosage,bodyweightshouldbedeterminedasaccuratelyaspossibleto

avoidunder-dosing.

9. ADVICEONCORRECTADMINISTRATION

Thechewabletabletsareflavouredandareacceptedbyamajorityofdogs.Thechewabletablets

canbeadministereddirectlyintothemouthoftheanimalsoraddedtoasmallquantityoffood.

10.WITHDRAWALPERIOD

Notapplicable.

11.SPECIALSTORAGEPRECAUTIONS

Keepoutofthesightandreachofchildren.

Donotstoreabove25

C.

Dividedtabletsshouldbestoredintheblisterpack

Anydividedtabletportionsremainingafter36hoursshouldbediscarded

Donotuseaftertheexpirydatestatedontheblisterandthecarton.

12.SPECIALWARNING(S)

i)Specialprecautionsforuseinanimals

Official,nationalandregionalantimicrobialpolicieswithrespecttotheuseofbroad-spectrum

antibioticsshouldbetakenintoaccount.

Donotuseincaseofbacteriasensitivetonarrowspectrumpenicillinsortoamoxicillinassingle

substance.

Itisadvisedthatuponinitiatingtherapyappropriatesensitivitytestingisperformedandthattherapy

iscontinuedonlyaftersusceptibilitytothecombinationhasbeenestablished.

D209_ Kesium625 mg

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistanttotheamoxicillin/clavulanate,andmaydecreasetheeffectivenessoftreatment

withbeta-lactamantibiotics

Inanimalswithhepaticandrenaldysfunction,thedosingregimenshouldbecarefullyevaluated

andtheuseoftheproductbasedonarisk/benefitevaluationbytheveterinarysurgeon.

Cautionisadvisedintheuseinsmallherbivoresotherthanthoseinthesection

“Contraindications”.

Thepotentialforallergiccross-reactionswithotherpenicillinderivatesandcephalosporinsshould

beconsidered

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,inhalation,

ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocross-reactionsto

cephalosporinsandviceversa.Allergicreactionstothesesubstancesmayoccasionallybe

serious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvisednottowork

withsuchpreparations.

Handlethisproductwithgreatcaretoavoidexposure,takingallrecommendedprecautions.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedicaladvice

andshowthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultywithbreathingare

moreserioussymptomsandrequireurgentmedicalattention.

Washhandsafteruse.

Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandmicehavenotproducedanyevidenceofteratogenic,foetotoxicor

maternotoxiceffects.

Thesafetyoftheproducthasnotbeenassessedinpregnantandlactatingbitches.

Inpregnantandlactatinganimals,useonlyaccordingtothebenefit/riskassessmentbythe

responsibleveterinarian.

Interactionwithothermedicinalproductsandotherformsofinteraction

Chloramphenicol,macrolides,sulfonamidesandtetracyclinesmayinhibittheantibacterialeffectof

penicillinsbecauseoftherapidonsetofbacteriostaticaction.

Penicillinsmayincreasetheeffectofaminoglycosides.

Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Incaseofoverdosediarrhoea,allergicreactionsorfurthersymptomslikecentralnervous

excitationmanifestationsorcrampscouldappear.Symptomatictreatmentshouldbeinitiatedwhen

necessary.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

D209_ Kesium625 mg

15.OTHERINFORMATION

Packsizes:

Cardboardboxof6tablets

Cardboardboxof12tablets

Cardboardboxof96tablets

Cardboardboxof144tablets

Cardboardboxof240tablets

Notallpacksizesmaybemarketed.

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocalrepresentative

ofthemarketingauthorisationholder.

Localrepresentative: