Kesium 500

Main information

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

Documents

Localization

  • Available in:
  • Kesium 500 mg Chewable Tablets for Cats and Dogs
    United Kingdom
  • 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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14-4-2018

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

AMA Wholesale Inc. (Distributor/Re-seller), is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. FDA analysis found the product to be tainted with undeclared tadalafil. Tadalafil is an active ingredient in a FDA-approved prescription drug that is used for erectile dysfunction.

FDA - U.S. Food and Drug Administration

28-3-2018

Public Notification: Rhino 69 Extreme 50000 contains hidden drug ingredient

Public Notification: Rhino 69 Extreme 50000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Rhino 69 Extreme 50000, a product promoted and sold for sexual enhancement on various websites, including www.bonanza.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

14-12-2017

Marmex Corp Issues Voluntary Nationwide Recall Of Blue Pearl All Natural Male Enhancement Supplement, Due To Undeclared Sildenafil

Marmex Corp Issues Voluntary Nationwide Recall Of Blue Pearl All Natural Male Enhancement Supplement, Due To Undeclared Sildenafil

Orange, CA, Marmex Corp is voluntarily recalling All lots of Blue Pearl All Natural Male Enhancement Supplement, 500mg to the consumer level. FDA analysis has found the products to contain sildenafil.

FDA - U.S. Food and Drug Administration

25-9-2017

Global operation against illegal medicines

Global operation against illegal medicines

A global operation against illegal medicines has been completed. 123 countries participated, and the operation resulted in 354 arrests or further investigations and the suspension of more than 3,500 websites.

Danish Medicines Agency

19-6-2015

Global operation against illicit medicines completed

Global operation against illicit medicines completed

A global medicine operation results in 156 arrests and shutdown of more than 2,400 websites.

Danish Medicines Agency

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

20-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more:  https://go.usa.gov/xP

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xP

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xPAtn  #MedicalDevice #FDA pic.twitter.com/6e064UQ2wg

FDA - U.S. Food and Drug Administration

25-7-2018

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist.  https://go.usa.gov/xUEPn  #MedicalDevices

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist. https://go.usa.gov/xUEPn  #MedicalDevices

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist. https://go.usa.gov/xUEPn  #MedicalDevices

FDA - U.S. Food and Drug Administration

29-5-2018

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Active substance: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine) - Transfer of orphan designation - Commission Decision (2018)3402 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/185/14/T/01

Europe -DG Health and Food Safety