Clavaseptin 62.5 mg Palatable Tablets for Dogs and Cats

Main information

  • Trade name:
  • Clavaseptin 62.5 mg Palatable Tablets for Dogs and Cats
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Clavaseptin 62.5 mg Palatable Tablets for Dogs and Cats
    Romania
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0209/004
  • Authorization date:
  • 23-01-2013
  • EU code:
  • UK/V/0209/004
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:April2013

AN:00043/2012

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Name Countries

Clavaseptin62.5mgPalatabletabletsfordogs

andcats Belgium, Bulgaria, Cyprus,

Greece, Czech Republic,

Hungary, Ireland, Latvia,

Lithuania,Netherlands,Poland,

Romania,Slovakia,Slovenia,

UK,Portugal,Spain

ClavaseptinP62.5mgTabletsfordogsandcats France,Luxembourg

Clavaseptin62.5mg –Tabletsfordogsandcats Austria,Germany,Italy

Clavaseptin50mg/12.5mgTabletsfordogsand

cats Denmark, Finland, Sweden,

Norway

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Onetabletcontains:

Activeingredients:

Amoxicillin(asamoxicillintrihydrate)……………….……………..……….50.000mg

Clavulanicacid(aspotassiumclavulanate)…………………………..…

12.500mg

Excipients

Brownironoxide(E172)………………………………….…..…….….. 0.120mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet.

Beigescoredtabletthatcanbedividedintohalves.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogsandcats

4.2 Indicationsforuse,specifyingthetargetspecies

Indogs:treatmentoradjunctivetreatmentofperiodontalinfectionscausedby

bacteriasusceptibletoamoxicillinincombinationwithclavulanicacidi.e.Pasteurella

spp,StreptococcussppandEscherichiacoli.

Incats:treatmentofskininfections(includingwoundsandabscesses)causedby

bacteriasusceptibletoamoxicillinincombinationwithclavulanicacidi.e.Pasteurella

spp,Staphylococcusspp,StreptococcussppandEscherichiacoli.

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4.3 Contraindications

Donotuseinanimalswithknownhypersensitivitytopenicillinsorothersubstances

oftheβ-lactamgroup.

Donotadministertogerbils,guineapigs,hamsters,rabbitsandchinchillas.

4.4 Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Inadditiontosection4.3contraindications:

Inanimalswithimpairedliverandkidneyfunction,theuseoftheproductshouldbe

subjecttoarisk/benefitevaluationbytheveterinarysurgeonandtheposology

evaluatedcarefully.

Cautionisadvisedintheuseinsmallherbivoresotherthanthosein4.3.

Useoftheproductshouldbebasedonsusceptibilitytesting.

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistantto

amoxicillin/clavulanicacid.Useoftheproductshouldtakeintoaccountofficialand

localantimicrobialpolicies.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)following

injection,inhalation,ingestionorskincontact.Hypersensitivitytopenicillinsmaylead

tocrossreactionstocephalosporinsandviceversa.Allergicreactionstothese

substancesmayoccasionallybeserious.

1. Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeen

advisednottoworkwithsuchpreparations.

2. Handlethisproductwithgreatcaretoavoidexposure,takingallrecommended

precautions.

3. Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshould

seekmedicaladviceandshowthedoctorthiswarning.

Swellingoftheface,lipsoreyesordifficultybreathingaremoreserious

symptomsandrequireurgentmedicalattention.

Washhandsafterhandlingthetablets.

4.6Adversereactions(frequencyandseriousness)

Vomitinganddiarrhoeamaybeobserved.Treatmentmaybediscontinueddepending

ontheseverityoftheundesirableeffectsandabenefit/riskevaluationbythe

veterinarysurgeon.

Hypersensitivityreactions(allergicskinreactions,anaphylaxis)maybeobserved.In

thesecases,administrationshouldbediscontinuedandasymptomatictreatment

given.

4.7Useduringpregnancy,lactationorlay

Thesafetyoftheproducthasnotbeenestablishedduringpregnancyandlactation.

Laboratorystudiesinratshavenotproducedanyevidenceofteratogenic,foetotoxic

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ormaternotoxiceffects.Usetheproductonlyaccordingtothebenefit/risk

assessmentbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Thebactericidalactivityofamoxicillinmaybereducedbythesimultaneoususeof

bacteriostaticsubstancessuchasmacrolides,tetracyclines,sulfonamidesand

chloramphenicol.

4.9 Amountstobeadministeredandadministrationroute

Therecommendeddoseoftheproductis10mgamoxicillin/2.5mgclavulanicacid

perkgbodyweighttwiceadaybytheoralrouteindogsandcats,i.e.1tabletper5

kgbodyweightevery12h,accordingtothefollowingtable:

Bodyweight(kg) Numberoftabletstwicedaily

[1.0-2.5] ½

[2.6-5.0] 1

[5.1-7.5] 1½

[7.6-10.0] 2

Insevereinfections,thedosemaybedoubledto20mgamoxicillin/5mgclavulanic

acid/kgbodyweighttwicedaily.

Durationoftreatment:

-7daysforthetreatmentofperiodontalinfectionsindogs.

-7daysforthetreatmentofskininfectionsincats(includingwoundsand

abscesses).Theclinicalstatusofanimalsshouldbere-evaluatedafter7daysand

thetreatmentprolongedforafurther7daysifnecessary.Severecasesofskin

infectionmayrequireanevenlongerdurationoftreatmentandthisshouldbeatthe

discretionoftheresponsibleveterinarian.

Toensurethecorrectdosage,bodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunder-dosing.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Atthreetimestherecommendeddoseforaperiodof28days,adecreasein

cholesterolvaluesandepisodesofvomitingwereobservedincatsanddiarrhoea

wasobservedindogs.Intheeventofanoverdosesymptomatictreatmentisadvised.

4.11Withdrawalperiod(s)

Notapplicable.

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5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:anti-infectiveforsystemicuse;amoxicillinandenzyme

inhibitor.

ATCVetcode:QJ01CR02

5.1Pharmacodynamicproperties

Amoxicillinisanaminobenzylpenicillinfromtheβ-lactampenicillinfamilywhich

preventsthebacterialcellwallformationbyinterferingwiththefinalstepof

peptidoglycansynthesis.

Clavulanicacidisanirreversibleinhibitorofintracellularandextracellularβ-

lactamaseswhichprotectsamoxicillinfrominactivationbymanyβ-lactamases.

Amoxicillin/clavulanatehasawiderangeofactivitywhichin cludesβ-lactamase

producingstrainsofbothGram-positiveandGram-negativeaerobes,facultative

anaerobesandobligateanaerobes.

Amoxicillin/clavulanicacidbreakpoints(NCCLS/2002):

Staphylococci:sensitive:MIC<4/2µg/ml,resistant:MIC>8/4µg/ml

Otherorganisms:sensitive:MIC<8/4µg/ml,resistant:MIC>32/16µg/ml

IndogperiodontalinfectionsinEurope(isolatesoftheyear2002fromFrance,

GermanyandBelgium)amoxicillin/clavulanicacidcombinationinaratio2/1showed

thefollowingdataonsensitivity:

Streptococcusspp.:MIC

:0.4/0.2µg/ml,

Pasteurellaceae:MIC

:0.4/0.2µg/ml,

Escherichiacoli:MIC

:5.3/2.6µg/ml,

IncatskininfectionsincludingwoundsandabscessesinEurope(isolatesoftheyear

2002fromFrance,GermanyandBelgium)amoxicillin/clavulanicacidcombinationin

aratio2/1showedthefollowingdataonsensitivity:

Pasteurellaceae:MIC

:0.66/0.3µg/ml,

Staphylococcaceae:MIC

:0.4/0.2µg/ml,

Streptococcaceae:MIC

:0.4/0.2µg/ml,

Escherichiacoli:MIC

:7.0/3.5µg/ml,

Only1.5%ofallisolatedstrainswereresistant.

Resistance toβ-lactamantibioticsismainlymediatedbyβ-lactamaseswhich

hydrolyzeantibioticssuchasamoxicillin.

Susceptibilityandresistancepatternscanvarywithgeographicalareaandbacterial

strain,andmaychangeovertime.

5.2 Pharmacokineticparticulars

Afteroraladministrationattherecommendeddoseindogsandcats,theabsorption

ofamoxicillinandclavulanicacidisfast.Indogs,themaximumplasmaconcentration

ofamoxicillinof8.5µg/mlisreachedin1.4handthemaximumplasmaconcentration

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ofclavulanicacidof0.9µg/mlisreachedin0.9h.Halflifeis1hourindogsforboth

substances.

Incats,themaximumplasmaconcentrationofamoxicillinof6.6µg/mlisreachedin

1.8handthemaximumplasmaconcentrationofclavulanicacidof3.7µg/mlis

reachedin0.75h.Halflifeis1to2hoursincatsforbothsubstances.

Eliminationisalsofast.12%oftheamoxicillinand17%ofclavulanicacidis

excretedintheurine.Theremainderisexcretedasinactivemetabolites.

Afterrepeatedoraladministrationoftherecommendeddoseindogsandcats,there

isnoaccumulationofamoxicillinorclavulanicacidandthesteadystateisreached

rapidlyafterfirstadministration.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

BrownironoxideE172

Crospovidone

PovidoneK25

Silicondioxide

Microcrystallinecellulose

Liveraroma

Yeastaroma,

Magnesiumstearate

Hypromellose

6.2Incompatibilities

Noneknown

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelflifeafterfirstopeningtheimmediatepackaging:12hours.

6.4.Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalpackage.

Returnanyhalvedtabletstotheopenedstrip-packandusewithin12hours.

6.5Natureandcompositionofimmediatepackaging

Aluminium/aluminiumstrippackwith10tablets/strip

Cardboardbox:Packsizesof10,100,250and500tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

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7. MARKETINGAUTHORISATIONHOLDER

VetoquinolUKLtd

VetoquinolHouse

GreatSlade

BuckinghamIndustrialPark

Buckinghamshire

MK181PA

8. MARKETINGAUTHORISATIONNUMBER

Vm08007/4135

9. DATEOFFIRSTAUTHORISATION

17April2013

10. DATEOFREVISIONOFTHETEXT

April2013

Approved: 17/04/2013

7-9-2018

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