Kesium 50

Main information

  • Trade name:
  • Kesium 50
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Kesium 50
    Austria
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0225/001
  • Authorization date:
  • 22-06-2011
  • EU code:
  • FR/V/0225/001
  • 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:Kesium40mg/10mgChewabletabletsforcats

anddogs

UK,IE,FR,EL,PL,HU,RO,PT,ES:Kesium50mgChewabletabletsforcatsanddogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Amoxicillin(asamoxicillintrihydrate) 40.00mg

Clavulanicacid(aspotassiumclavulanate) 10.00mg

Excipient(s):

Forafulllistofexcipients,seesection6.1

3.PHARMACEUTICALFORM

Chewabletablet

Oblongscoredbeigetablet. Thetabletscanbedividedintoequalhalves

4.CLINICALPARTICULARS

4.1.TargetSpecies:

Catsanddogs

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

bodyweighttwiceadaybytheoralrouteindogsandcats,i.e.1tabletper4kgbodyweight

every12h,accordingtothefollowingtable:

Bodyweight

(kg) Numberoftabletsperday

(twicedaily)

>1.0to2.0≤

½

>2.0to4.0≤ 1

>4.0to6.0≤ 1½

>6.0to8.0≤ 2

Inrefractorycasesthedosemaybedoubledto20mgofamoxicillin/5mgclavulanicacid/kg

bodyweighttwicedaily,attheclinician’sdiscretion.

Thechewabletabletsareflavouredandareacceptedbyamajorityofcatsanddogs.The

chewabletabletscanbeadministereddirectlyintothemouthoftheanimalsoraddedtoa

smallquantityoffood.

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

Afteroraladministrationindogsandcats,amoxicillinandclavulanicacidarerapidly

absorbed.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).

Aftersingleoraladministrationof13mg/kgamoxicillinand3.15mg/kgclavulanicacidin

cats:

- Themaximalplasmaconcentration(Cmax)ofamoxicillin(9.3µg/mL)wasobserved2

hoursfollowingadministration.

- Themaximalplasmaconcentration(Cmax)ofclavulanicacid(4.1µg/mL)was

observed50minutesfollowingadministration

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(typeA)

PovidoneK25

Hypromellose

Microcrystallinecellulose

Silica,colloidalanhydrous

Magnesiumstearate

6.2.Incompatibilities

Notapplicable.

6.3.Shelf-Life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

24months

Anydividedtabletportionsremainingafter12hoursshouldbediscarded

6.4.SpecialPrecautionsforStorage

Donotstoreabove25

C.

Dividedtabletsshouldbestoredintheblisterpack

6.5.NatureandCompositionofImmediatePackaging

(PA-AL-PVC –aluminiumheatsealed)containing10tabletsperblister

Cardboardboxwith1blisterof10tablets

Cardboardboxwith2blistersof10tablets

Cardboardboxwith4blistersof10tablets

Cardboardboxwith6blistersof10tablets

Cardboardboxwith8blistersof10tablets

Cardboardboxwith10blistersof10tablets

Cardboardboxwith24blistersof10tablets

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

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31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

FDA - U.S. Food and Drug Administration

18-5-2018

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

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

Health Canada has seized four unauthorized drugs from Gigi’s Market, 23 Montreal Road, Ottawa, ON. The products (Ampicillin, Kamox, Medampi and Medomox) are labelled to contain antibiotic drugs (ampicillin or amoxicillin) that can only be dispensed by a healthcare professional to a patient with a valid prescription. The products listed below have not been evaluated by Health Canada for safety, effectiveness or quality and may pose serious health risks.

Health Canada

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

19-9-2018

Targretin (Eisai GmbH)

Targretin (Eisai GmbH)

Targretin (Active substance: bexarotene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6098 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/326/T/50

Europe -DG Health and Food Safety

27-8-2018

Beromun (BELPHARMA s.a.)

Beromun (BELPHARMA s.a.)

Beromun (Active substance: Tasonermin (Tumor Necrosis Factor alfa-1a)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5699 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/206/T/40

Europe -DG Health and Food Safety

7-8-2018

ACMD meeting statement, Meeting 40, 12 April 2018

ACMD meeting statement, Meeting 40, 12 April 2018

Advisory Committee on Medical Devices meeting statement

Therapeutic Goods Administration - Australia

11-6-2018

Zydelig (Gilead Sciences Ireland UC)

Zydelig (Gilead Sciences Ireland UC)

Zydelig (Active substance: idelalisib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3765 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3843/T/40

Europe -DG Health and Food Safety

4-6-2018

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Active substance: apixaban) - Centralised - 2-Monthly update - Commission Decision (2018)3616 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2148/II/50

Europe -DG Health and Food Safety

16-5-2018

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Active substance: corifollitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3049 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1106/T/40

Europe -DG Health and Food Safety