Kesium

Main information

  • Trade name:
  • Kesium 625mg Chewable Tablets for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Kesium 625mg 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/0225/005
  • 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

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9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

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