Noroclav Palatable Tablets 500mg

Main information

  • Trade name:
  • Noroclav Palatable Tablets 500mg
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Noroclav Palatable Tablets 500mg
    Austria
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ampicillin and enzyme inhibitor
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0248/001
  • Authorization date:
  • 16-02-2011
  • EU code:
  • UK/V/0248/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:May2011

AN:00894/2010

SUMMARYOFPRODUCTCHARACTERISTICS

1. NameoftheVeterinaryMedicinalProduct

Noroclav500mgPalatableTabletsforDogs

NoroclavTablets400mg/100mgforDogs(Sweden)

NoroclavComprimés400mg/100mgpourChiens(France)

2. QualitativeandQuantitativeComposition

Eachtabletcontains:

ActiveIngredients:

Amoxicillin(asamoxicillintrihydrate) 400mg

Clavulanicacid(aspotassiumclavulanate) 100mg

ColouringAgent:

CarmoisineLake(E122)

Forafulllistofexcipients,seeSection6.1.

3. PharmaceuticalForm

Tablet.Pinkdivisiblecirculartabletwithscorelineononefaceandfigure500

embossedonopposingface.Thetabletcanbedividedintoequalhalves.

4. ClinicalParticulars

4.1 TargetSpecies:

Dogs

4.2 IndicationsforUse,SpecifyingtheTargetSpecies:

Treatmentofthefollowinginfectionscausedbybeta-lactamaseproducingstrainsof

bacteriasensitivetoamoxicillinincombinationwithclavulanicacid:

-Skininfections(includingsuperficialanddeeppyodermas)causedby

susceptibleStaphylococci.

-UrinarytractinfectionscausedbysusceptibleStaphylococciorEscherichiacoli.

-RespiratoryinfectionscausedbysusceptibleStaphylococci.

-EnteritiscausedbysusceptibleEscherichiacoli.

Itisrecommendedtocarryoutsuitabletestsforsensitivitywheninitiatingthe

treatment.Thetreatmentshouldonlyproceedifsensitivityisproventothe

combination.

Revised:May2011

AN:00894/2010

4.3 Contraindications:

Donotuseinanimalswithknowncasesofhypersensitivitytopenicillinsorother

substancesofthebeta-lactamgroup.

Donotuseinrabbits,guineapigs,hamstersorgerbils.

Donotuseinanimalswithseriousdysfunctionofkidneysaccompaniedbyanuriaor

oliguria.

Donotusewhereresistancetothecombinationisknowntooccur

4.4 Specialwarningsforeachtargetspecies

None.

4.5 SpecialPrecautionsforUse:

(i)Specialprecautionsforuseinanimals:

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistant

toamoxicillin/clavulanicacid.

Inanimalswithhepaticandrenalfailure,thedosingregimenshouldbecarefully

evaluated.

Useoftheproductshouldbebasedonsusceptibilitytestingandtakeintoaccount

officialandlocalantimicrobialpolicies.Narrowspectrumantibacterialtherapy

shouldbeusedforfirstlinetreatmentwheresusceptibilitytestingsuggestslikely

efficacyofthisapproach.

Cautionisadvisedintheuseinsmallherbivoresotherthanthosein4.3.

Donotadministertohorsesandruminatinganimals.

(ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals:

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)following

injection,inhalation,ingestionorskincontact.Hypersensitivitytopenicillinsmay

leadtocrossreactionstocephalosporinsandviceversa.Allergicreactionstothese

substancesmayoccasionallybeserious.

Handlethisproductwithgreatcaretoavoidexposure,takingallrecommended

precautions.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshouldseek

medicaladviceandshowthepackageleafletorthelabeltothephysician.Swelling

oftheface,lipsoreyesordifficultywithbreathingaremoreserioussymptomsand

requireurgentmedicalattention.

Washhandsafteruse.

4.6 Adversereactions(frequencyandseriousness):

Hypersensitivityunrelatedtodosecanoccurwiththeseagents.

Gastrointestinalsymptoms(diarrhoea,vomiting)mayoccurafteradministrationof

theproduct.

Allergicreactions(e.g.skinreactions,anaphylaxia)mayoccasionallyoccur.

Incaseofoccurrenceofallergicreaction,thetreatmentshouldbewithdrawn.

Revised:May2011

AN:00894/2010

4.7 UseDuringPregnancy,LactationorLay:

Studiesinlaboratoryanimalshavenotproducedanyevidenceofteratogenic

effects.Useonlyaccordingtotherisk/benefitassessmentbytheresponsible

veterinarian.

4.8 InteractionswithOtherMedicinalProductsandOtherFormsofInteraction:

Chloramphenicol,macrolides,sulfonamidesandtetracyclinesmayinhibitthe

antibacterialeffectofpenicillinbecauseoftherapidonsetofbacteriostaticaction.

Thepotentialforallergiccross-reactivitywithotherpenicillinsshouldbeconsidered.

Penicillinsmayincreasetheeffectsofaminoglycoside.

4.9 AmountstobeAdministeredandAdministration:

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Administrationisviatheoralroute.Thedosagerateis12.5mgcombined

actives/kgbodyweighttwicedaily.Thetabletsmaybecrushedandaddedtoalittle

food.

Thefollowingtableisintendedasaguidetodispensingtheproductatthestandard

doserateof12.5mg/kgtwicedaily.

Bodyweight(kg) Numberoftablets(500mg)perdosetwice

daily

20kg ½

40kg 1

60kg 1½

80kg 2

Durationoftherapy:

Routinecasesinvolvingallindications:Themajorityofcasesrespondtobetween5

and7daystherapy.

Chronicorrefractorycases:Inthesecaseswherethereisconsiderabletissue

damage,alongercourseoftherapymayberequiredinthatitallowssufficienttime

fordamagedtissuetorepair.

4.10Overdose(Symptoms,EmergencyProcedures,Antidotes)ifnecessary:

Noadverseeffectshavebeenreportedafterthedailyadministrationof3timesthe

recommendeddosefor8days,andafterthedailyadministrationofthe

recommendeddosefor21days.

4.11WithholdPeriod(s):

Notapplicable

Revised:May2011

AN:00894/2010

5. PharmacologicalProperties

Pharmacotherapeuticgroup:Anti-infectiveforsystemicuse:amoxicillinand

enzymeinhibitor.

ATCvetcode:QJ01CR02

5.1 Pharmacodynamicproperties:

Amoxicillinisabeta-lactamantibioticanditsstructurecontainsthebeta-lactamring

andthiazolidineringcommontoallpenicillins.Amoxicillinshowsexcellentactivity

againstsusceptibleGram-positivebacteriaandGram-negativebacteria.

Beta-lactamantibioticspreventthebacterialcellwallfromformingbyinterfering

withthefinalstageofpeptidoglycansynthesis.Theyinhibittheactivityof

transpeptidaseenzymes,whichcatalysecross-linkageoftheglycopeptidepolymer

unitsthatformthecellwall.Theyexertabactericidalactionbutcauselysisof

growingcellsonly.

Clavulanicacidisoneofthenaturallyoccurringmetabolitesofthestreptomycete

Streptomycesclavuligerus.Ithasastructuralsimilaritytothepenicillinnucleus,

includingpossessionofabeta-lactamring.Clavulanicacidisabeta-lactamase

inhibitoractinginitiallycompetitivelybutultimatelyirreversibly.Clavulanicacidwill

penetratethebacterialcellwallbindingtobothextracellularandintracellularbeta-

lactamases.

Amoxicillinissusceptibletobreakdownby 

-lactamaseandthereforecombination

withaneffectiveß-lactamaseinhibitor(clavulanicacid)extendstherangeof

bacteriaagainstwhichitisactivetoinclude 

-lactamaseproducingspecies.

Invitropotentiatedamoxicillinisactiveagainstawiderangeofclinicallyimportant

aerobicandanaerobicbacteriaincluding:

Gram-positive:Staphylococci(including β-lactamaseproducingstrains),Clostridia,

Streptococci.

Gram-negative:Escherichiacoli (includingmostβ-lactamaseproducingstrains),

Campylobacterspp,Pasteurellae,Proteusspp.

ResistanceisshownamongEnterobacterspp,Pseudomonasaeruginosaand

methicillin-resistantStaphylococcusaureus.DogsdiagnosedwithPseudomonas

infectionsshouldnotbetreatedwiththisantibioticcombination.Atrendin

resistanceofE.coliisreported.

Revised:May2011

AN:00894/2010

5.2 Pharmacokineticproperties:

Amoxicilliniswell-absorbedfollowingoraladministration.Indogsthesystemic

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

distributionvolume,alowplasmaproteinbinding(34%indogs)andashortterminal

half-lifeduetoactivetubularexcretionviathekidneys.Followingabsorptionthe

highestconcentrationsarefoundinthekidneys(urine)andthebileandtheninliver,

lungs,heartandspleen.Thedistributionofamoxicillintothecerebrospinalfluidis

lowunlessthemeningesareinflamed.

Clavulanicacid(pKa2.7)isalsowell-absorbedfollowingoraladministration.The

penetrationtothecerebrospinalfluidispoor.Theplasmaproteinbindingis

approximately25%andtheeliminationhalf-lifeisshort.Clavulanicacidisheavily

eliminatedbyrenalexcretion(unchangedinurine).

Afteroraladministrationofthe50mgpresentationattherecommendeddoseof

12.5mgcombinedactives/kgtodogs,thefollowingparameterswereobserved:

Cmaxof6.30+/-0.45µg/ml,Tmaxof1.98+/-0.135handAUCof23.38+/-1.39

µg/ml.hforamoxicillinandCmaxof0.87+/-0.1µg/ml,Tmaxof1.57+/-0.177hrs

andAUCof1.56+/-0.24mg/ml.hforclavulanicacid.

6. PharmaceuticalParticulars

6.1 ListofExcipient(s)

SodiumStarchGlycolate(typeA)

Copovidone

MagnesiumStearate

Cellulose,microcrystalline

SiliconDioxide

CalciumCarbonate

MagnesiumCarbonate,heavy

RoastBeefFlavour

LakeCarmosine(E122)

6.2 Incompatibilities

Notapplicable.

6.3 Shelf-Life:

Shelf-lifeofveterinaryproductaspackagedforsale:2years.

Shelflifeafterfirstopeningtheimmediatepackaging:24hours.

Anydividedtabletportionremainingafter24hoursshouldbediscarded.

6.4 SpecialPrecautionsforStorage:

Donotstoreabove25

C.Storeinadryplace.Dividedtabletsshouldbestoredin

theblisterpack.

Revised:May2011

AN:00894/2010

6.5 NatureandCompositionofImmediatePackaging:

Theproductispresentedasfollows:

Aluminium/aluminiumblisterstrips,eachcontaining5tablets.Cartonsof10,20,25

and100tablets.Notallpacksizesmaybemarketed.

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinaryMedicinalProducts

orWasteMaterialsDerivedfromtheUseofSuchProductsifappropriate:

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MarketingAuthorisationHolder

NorbrookLaboratoriesLimited

StationWorks

Newry

CountyDown

BT356JP

NorthernIreland

8. MarketingAuthorisationNumber

Vm02000/4259

9. DateofFirstAuthorisation

26April2006

10. DateofRevisionofText

May2011

ProhibitionofSale,Supplyand/orUse

NotApplicable.

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