Combisyn Tablets 50mg

Main information

  • Trade name:
  • Combisyn Tablets 50mg
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Combisyn Tablets 50mg
    France
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0197/001
  • Authorization date:
  • 24-11-2011
  • EU code:
  • UK/V/0197/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:November2011

AN:01186/2011

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Combisyn250mgTabletsforDogs(RMSUK)

Clavobay250mgTabletsforDogs(inCMSAT,BE,FR,IS,IT,NL,NO,PT

exceptDK,SEandES.

ClavobayVet200mg/50mgTabletsforDogs(SE)

Clavubay250mgTabletsforDogs(ES)

Clavobayvet250mgTabletsforDogs(DK)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveSubstance:

Amoxicillin(asamoxicillintrihydrate) 200mg

Clavulanicacid(asPotassiumclavulanate) 50mg

Excipients:

CarmoisineLake(E122) 1.225mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Tablet.

Roundpinkbiconvextabletwithascorelineand250embossedonopposing

faces.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofthefollowinginfectionscausedby 

lactamaseproducingstrains

ofbacteriasensitivetoamoxicillinincombinationwithclavulanicacid:

Skininfections(includingsuperficialanddeeppyodermas)causedby

susceptibleStaphylococci

UrinarytractinfectioncausedbysusceptibleStaphylococciorEscherichia

coli

RespiratoryinfectionscausedbysusceptibleStaphylococci

Revised:November2011

AN:01186/2011

Page2of6

EnteritiscausedbysusceptibleEscherichiacoli

Itisrecommendedtocarryoutsuitabletestsforsensitivitytestingwhen

initiatingthetreatment.Thetreatmentshouldonlyproceedifsensitivityis

proventothecombination.

4.3 Contraindications

Donotuseinanimalswithknowncasesofhypersensitivitytopenicillinorother

substancesofthebeta-lactamgroup.

Donotuseinrabbits,guineapigs,hamstersorgerbils.

Donotuseinanimalswithseriousdysfunctionofthekidneysaccompaniedby

anuriaandoliguria.

Donotusewhereresistancetothiscombinationisknowntooccur.

4.4 SpecialWarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteria

resistanttoamoxicillin/clavulanicacid.

Inanimalswithhepaticandrenalfailure,thedosingregimenshouldbe

carefullyevaluated.

Useoftheproductshouldbebasedonsusceptibilitytestingandtakeinto

accountofficialandlocalantimicrobialpolicies.Narrowspectrum

antibacterialtherapyshouldbeusedforfirstlinetreatmentwhere

susceptibilitytestingsuggestslikelyefficacyofthisapproach.

Cautionisadvisedintheuseinsmallherbivoresotherthanthosein4.3.

Donotadministertohorsesandruminatinganimals.

ii.Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)

followinginjection,inhalation,ingestionorskincontact.Hypersensitivityto

penicillinsmayleadtocross-reactionstocephalosporinsandviceversa.

Allergicreactionstothesesubstancesmayoccasionallybeserious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhave

beenadvisednottoworkwithsuchpreparations.

Handlethisproductwithgreatcaretoavoidexposure,takingall

recommendedprecautions.

Revised:November2011

AN:01186/2011

Page3of6

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,you

shouldseekmedicaladviceandshowthedoctorthiswarning.Swellingof

theface,lipsoreyesordifficultywithbreathingaremoreserioussymptoms

andrequireurgentmedicalattention.

Washhandsafteruse.

4.6 Adversereactions(frequencyandseriousness)

NoneKnown

4.7 Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshavenotproducedanyevidenceofteratogenic,

effects.Useonlyaccordingtothebenefit/riskassessmentbytheresponsible

veterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Chloramphenicol,macrolides,sulfonamidesandtetracyclinesmayinhibitthe

antibacterialeffectofpenicillinsbecauseoftherapidonsetofbacteriostatic

action.

Thepotentialforallergiccross-reactivitywithotherpenicillinsshouldbe

considered.

Penicillinsmayincreasetheeffectofaminoglycosides.

4.9 Amountstobeadministeredandadministrationroute

Administrationisviatheoralroute.Thedosagerateis12.5mgcombined

actives/kgbodyweighttwicedaily.Thetabletsmaybecrushedandaddedtoa

littlefood.

Thefollowingtableisintendedasaguidetodispensingtheproductatthe

standarddoserateof12.5mgofcombinedactives/kgtwicedaily.

Bodyweight(kg) Numberoftabletstwicedaily

19-20 1

21-30 1,5

31-40 2

41-50 2,5

Morethan50 3

Durationoftherapy:

Routinecasesinvolvingallindications:Themajorityofcasesrespondto

between5and7daystherapy.

Chronicorrefractorycases:Inthesecaseswherethereisconsiderabletissue

damage,alongercourseoftherapymayberequiredinthatitallowssufficient

timefordamagedtissuetorepair.

Revised:November2011

AN:01186/2011

Page4of6

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theproductisofaloworderoftoxicityandiswelltoleratedbytheoralroute.

Inatolerancestudyatesteddoseof3timestherecommendeddoseof12.5mg

ofthecombinedactivesadministeredtwicedailyfor8daysdidnotdemonstrate

adverseeffects.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Beta-lactamantibacterials,penicillins

ATCVetCode:QJ01CR02

5.1 Pharmacodynamicproperties

Amoxicillinisabeta-lactamantibioticanditsstructurecontainsthebeta-lactam

ringandthiazolidineringcommontoallpenicillins.Amoxicillinshowsactivity

againstsusceptibleGram-positivebacteriaandGram-negativebacteria.

Beta-lactamantibioticspreventthebacterialcellwallfromformingbyinterfering

withthefinalstageofpeptidoglycansynthesis.Theyinhibittheactivityof

transpeptidaseenzymes,whichcatalysecross-linkageoftheglycopeptide

polymerunitsthatformthecellwall.Theyexertabactericidalactionbutcause

lysisofgrowingcellsonly.

Clavulanicacidisoneofthenaturallyoccurringmetabolitesofthe

streptomyceteStreptomycesclavuligerus.Ithasastructuralsimilaritytothe

penicillinnucleus,includingpossessionofabeta-lactamring.Clavulanicacid

isabeta-lactamaseinhibitoractinginitiallycompetitivelybutultimately

irreversibly.Clavulanicacidwillpenetratethebacterialcellwallbindingtoboth

extracellularandintracellularbeta-lactamases.

Amoxicillinissusceptibletobreakdownby 

-lactamaseandtherefore

combinationwithaneffectiveß-lactamaseinhibitor(clavulanicacid)extends

therangeofbacteriaagainstwhichitisactivetoinclude 

-lactamaseproducing

species.

Invitropotentiatedamoxicillinisactiveagainstawiderangeofclinically

importantaerobicandanaerobicbacteriaincluding:

Revised:November2011

AN:01186/2011

Page5of6

Gram-positive:

Staphylococci(including 

-lactamaseproducingstrains)

Clostridia

Streptococci

Gram-negative:

Escherichiacoli(includingmost 

-lactamaseproducingstrains)

Campylobacterspp

Pasteurellae

Proteusspp

ResistanceisshownamongEnterobacterspp,Pseudomonasaeruginosaand

methicillin-resistant Staphylococcus aureus. Dogs diagnosed with

pseudomonasinfectionsshouldnotbetreatedwiththisantibioticcombination.

AtrendinresistanceofE.coliisreported.

5.2 Pharmacokineticproperties

Amoxicilliniswell-absorbedfollowingoraladministration.Indogsthesystemic

bioavailabilityis60-70%.Amoxicillin(pKa2.8)hasarelativelysmallapparent

distributionvolume,alowplasmaproteinbinding(34%indogs)andashort

terminalhalf-lifeduetoactivetubularexcretionviathekidneys.Following

absorptionthehighestconcentrationsarefoundinthekidneys(urine)andthe

bileandtheninliver,lungs,heartandspleen.Thedistributionofamoxicillinto

thecerebrospinalfluidislowunlessthemeningesareinflamed.

Clavulanicacid(pK12.7)isalsowell-absorbedfollowingoraladministration.

Thepenetrationtothecerebrospinalfluidispoor.Theplasmaproteinbinding

isapproximately25%andtheeliminationhalf-lifeisshort.Clavulanicacidis

heavilyeliminatedbyrenalexcretion(unchangedinurine).

Afteroraladministrationoftherecommendeddoseof12.5mgcombined

actives/kgtodogs,thefollowingparameterswereobserved:Cmaxof6.30+/-

0.45µg/ml,Tmaxof1.98+/-0.135handAUCof23.38+/-1.39µg/ml.hfor

amoxicillinandCmaxof0.87+/-0.1µg/ml,Tmaxof1.57+/-0.177hrsandAUC

of1.56+/-0.24mg/ml.hforclavulanicacid.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

CarmosineLake(E122)

SodiumStarchGlycollate

CopovidoneK24-36

MagnesiumStearate

MicrocrystallineCellulose

CalciumCarbonate

HeavyMagnesiumcarbonate

RoastBeefFlav-o-lok

Revised:November2011

AN:01186/2011

Page6of6

6.2 Incompatibilities

Notapplicable.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

Blisterpacks:2years

Tubs:6months

6.4 Specialprecautionsforstorage

Donotstoreabove25

C.Storeintheoriginalpackageinordertoprotectfrom

moisture.

6.5 Natureandcompositionofimmediatepackaging

Theproductissuppliedinhigh-densitypolyethylenetubswithapolyethylene

screwcaplidcontaining100and250tablets.Asachetofdesiccantisincluded

ineachcontainer.Theproductisalsopresentedinpacksof4,10and50

blisterstrips(aluminium-aluminium)eachcontaining5tabletsperstrip.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordance

withnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited

StationWorks

Newry

Co.Down,BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER

Vm 02000/4225

9. RENEWALOFTHEAUTHORISATION

February2009

10. DATEOFREVISIONOFTHETEXT

November2011

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