Clavudale 250 mg

Main information

  • Trade name:
  • Clavudale 250 mg
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Clavudale 250 mg
    Portugal
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0373/002
  • Authorization date:
  • 01-05-2012
  • EU code:
  • UK/V/0373/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:March2011

AN:01854/2009

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Clavudale250mgtabletfordogs(UK,Ireland,France,Austria,Belgium,Czech

Republic,Greece,Hungary,Iceland,Luxembourg,Norway,Poland,Portugal,Slovak

Republic)

Clavudale200mg/50mgtabletfordogs(Germany,Netherlands,Denmark,Spain,

Finland,Sweden)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstances:

Amoxicillin(asamoxicillintrihydrate) 200mg

Clavulanicacid(aspotassiumclavulanate) 50mg

Excipients:

Erythrosine(E127)3.75mg

Forafulllistofexcipientsseesection6.1.

3. PHARMACEUTICALFORM

Tablet.

Pinkoblongscoredtablets.

Thetabletcanbedividedintoequalhalves.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofbacterialinfectionssusceptibletoamoxicillinincombinationwith

clavulanicacidwhereclinicalexperienceand/orsensitivitytestingindicatestheproduct

asthedrugofchoice.

Usesinclude:

Skininfections(includingdeepandsuperficialpyodermas)associatedwith

StaphylococciandStreptococci;

Infectionsoftheoralcavity(mucousmembrane)associatedwithClostridia,

Corynebacteria,Staphylococci,Streptococci,Bacteroidesspp.andPasteurellae.;

UrinarytractinfectionsassociatedwithStaphylococci,Streptococci,Escherichiacoli

andProteusspp;

RespiratorytractinfectionsassociatedwithStaphylococci,Streptococciand

Pasteurellae;

Revised:March2011

AN:01854/2009

GastrointestinalinfectionsassociatedwithEscherichiacoliandProteusspp.

Revised:March2011

AN:01854/2009

4.3 Contraindications

Donotuseinrabbits,guineapigs,hamstersandgerbils.

Donotuseinanimalswithknownhypersensitivitytopenicillinorsubstancesoftheβ-

lactamgroup.

Donotuseinanimalswitheitheroliguriaoranuriaassociatedwithrenaldysfunction.

Donotuseincasesofknownresistancetothecombinationofamoxicillinand

clavulanicacid.

4.4 Specialwarningsforeachtargetspecies

Noneknown.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Cautionisadvisedontheuseoftheproductinsmallherbivoresotherthanthose

listedin4.3.

Inanimalswithhepaticandrenaldysfunction,thedosingregimenshouldbe

carefullyevaluated.

Useoftheproductshouldbebasedonsusceptibilitytestingandshouldtakeinto

accountofficialnationalandregionalpolicieswithrespecttotheuseofbroad

spectrumantibiotics.Donotuseincasesofbacteriasensitivetonarrowspectrum

penicillinsortoamoxicillinasasinglesubstance.Useoftheproductdeviating

fromtheinstructionsgivenintheSPCmayincreasetheprevalenceofbacteria

resistanttoamoxicillinandclavulanicacid,andmaydecreasetheeffectivenessof

treatmentwithotherβ-lactamantibiotics,duetothepotentialforcrossresistance.

ii.Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)following

injection,inhalation,ingestionorskincontact.Hypersensitivitytopenicillinsmay

leadtocross-reactionstocephalosporinsandviceversa.Allergicreactionsto

thesesubstancesmayoccasionallybeserious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeen

advisednottoworkwithsuchpreparations.

Handlethisproductwithgreatcaretoavoidexposure,takingall

recommendedprecautions.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshould

seekmedicaladviceandshowthedoctorthiswarning.Swellingoftheface,

lipsoreyesordifficultywithbreathingaremoreserioussymptomsand

requireurgentmedicalattention.

Washhandsafteruse.

Revised:March2011

AN:01854/2009

4.6 Adversereactions(frequencyandseriousness)

Mildgastrointestinalsigns(diarrhoea,andvomiting)mayoccurafteradministrationof

theproduct.

Allergicreactions(skinreactions,anaphylaxis),blooddyscrasiaandcolitismay

occasionallyoccur.Inthesecases,discontinueadministrationandgivesymptomatic

treatment.

4.7 Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandmicehavenotproducedanyevidenceofteratogenicor

foetotoxiceffects.Nostudieshavebeenconductedinpregnantorlactatingdogs.Use

onlyaccordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Bacteriostaticantibiotics(e.g.chloramphenicol,macrolides,sulfonamidesand

tetracyclines)mayinhibittheantibacterialeffectsofpenicillins.

Thepotentialforallergiccross-reactivitywithotherpenicillinsshouldbeconsidered.

Penicillinsmayincreasetheeffectofaminoglycosides.

4.9 Amountstobeadministeredandadministrationroute

Fororaladministrationonly.Thedosagerateis10mgamoxicillin/2.5mgclavulanic

acid/kgbodyweighttwicedaily.Thetabletsmaybeaddedtoalittlefood.

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunder-dosing.

Thefollowingtableisintendedasaguidetodispensingtheproductatthestandard

doserateof10mgamoxicillin/2.5mgclavulanicacid/kgtwicedaily.

Bodyweight(kg) Numberoftabletstwicedaily

>8to≤10 ½

>10to≤20 1

>20to≤30 1½

>30to≤40 2

Inrefractorycasesthedosemaybedoubledto20mgamoxicillin/5mgclavulanic

acid/kgbodyweighttwicedaily.

Durationoftherapy:

Routinecasesinvolvingallindications:

Themajorityofroutinecasesrespondtobetween5and7daysoftherapy.Lackof

effectafter5-7daysoftreatmentnecessitatesrenewedexamination.

Chronicorrefractorycases:

Inchroniccases,longercoursesofantibacterialtherapymayberequired.Insuch

circu mstances,overalltreatmentlengthisattheclinician’sdiscretion,butmustbelong

enoughtoensurecompleteresolutionofthebacterialdisease.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Revised:March2011

AN:01854/2009

Mildgastrointestinalsymptoms(diarrhoea,andvomiting)mayoccurmorefrequently

afteroverdoseoftheproduct.

Revised:March2011

AN:01854/2009

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

ATCvetcode:QJ01CR02

Pharmacotherapeuticgroup:Beta-lactamantibacterials,penicillins.

5.1 Pharmacodynamicproperties

Amoxicillinisanaminobenzylpenicillinfromthe β-lactampenicillinfamilywhich

preventsbacterialcellwallformationbyinterferingwiththefinalstepofpeptidoglycan

synthesis.

Clavulanicacidisanirreversibleinhibitorofintracellularandextracellularβ-lactamases

whichprotectsamoxicillin frominactivationbymanyβ-lactamases.

Amoxicillinincombinationwithclavulanicacidhasawiderangeofactivitywhich

includesβ-lactamaseproducingstrainsofbothGram-positiveandGram-negative

aerobes,facultativeanaerobesandobligateanaerobes,including:

Gram-positiveswithgoodsusceptibility:Clostridiumspp.Corynebacteriumspp.

Staphylococcusspp.Streptococcusspp..

Gram-negativeswithgoodsusceptibility:Pasteurellaspp.Bacteroidesspp.

Proteusmirabilis.

Gram-negativeswithvariablesusceptibility:Escherichiacoli,Klebsiellaspp.

Bordetellabronchiseptica.

ResistantbacterialspeciesincludePseudomonasaeruginosa,Enterobacterspp.and

methicillin-resistantStaphylococcusaureus.

Susceptibilityandresistancepatternscanvarywithgeographicalareaandbacterial

strain,andmaychangeovertime.

Revised:March2011

AN:01854/2009

5.2 Pharmacokineticparticulars

Aftertheoraladministrationtodogsoftherecommendeddoseof10mgamoxicillin/

2.5mgclavulanicacid/kgweightthefollowingparameterswereobserved:median

of1.5hoursforamoxicillinandof1.0hoursforclavulanicacid.

Amoxicilliniswell-absorbedfollowingoraladministration.Indogsthesystemic

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

distributionvolume,alowplasmaproteinbinding(34%indogs)andashortterminal

half-lifeduetoactivetubularexcretionviathekidneys.Followingabsorptionthehighest

concentrationsarefoundinthekidneys(urine)andthebileandtheninliver,lungs,

heartandspleen.Thedistributionofamoxicillintothecerebrospinalfluidislowunless

themeningesareinflamed.

Clavulanicacid(pKa2.7)isalsowell-absorbedfollowingoraladministration.The

penetrationtothecerebrospinalfluidispoor.Theplasmaproteinbindingis

approximately25%andtheeliminationhalf-lifeisshort.Clavulanicacidismainly

eliminatedbyrenalexcretion(unchangedinurine).

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Erythrosine(E127)

Silica,ColloidalAnhydrous

MagnesiumStearate

SodiumStarchGlycolate(TypeA)

Cellulose,Microcrystalline

6.2 Incompatibilities

Notapplicable.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:4years

Shelflifeafterfirstopeningtheimmediatepackaging:12hours

Anydividedtabletportionsremainingafter12hoursshouldbediscarded.

6.4. Specialprecautionsforstorage

Donotstoreabove25ºC.

Dividedtabletsshouldbestoredintheblisterpack.

6.5 Natureandcompositionofimmediatepackaging

BlisterpacksconsistingoforientatedPolyamide/Aluminium/Polyvinylchloridefilm,

heatsealedwithaluminiumfoil(20µm)instripsof6tablets.Cartonscontaining12or

24tablets.

Revised:March2011

AN:01854/2009

Notallpacksizesmaybemarketed.

Revised:March2011

AN:01854/2009

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

DechraLimited,

DechraHouse,

JamageIndustrialEstate,

TalkePits,

Stoke-on-Trent,

Staffordshire,

ST71XW,

UK.

Tel:01782771100

Fax:01782773366

8. MARKETINGAUTHORISATIONNUMBER

Vm10434/4051

9.DATEOFFIRSTAUTHORISATION

8January2010

10. DATEOFREVISIONOFTHETEXT

March2011

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Published on: Mon, 26 Nov 2018 The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous c...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

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

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

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

18-4-2018

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Active substance: Adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene) - Orphan designation - Commission Decision (2018)2403 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/255/17

Europe -DG Health and Food Safety