Noroclav Tablets 250mg

Main information

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

Documents

Localization

  • Available in:
  • Noroclav Tablets 250mg
    Italy
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0195/002
  • Authorization date:
  • 24-11-2011
  • EU code:
  • UK/V/0195/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:November2011

AN:01183/2011

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Noroclav50mgTabletsforDogsandCats(RMSUK)

Noroclav50mgTabletsforDogsandCats(inCMSAT,BE,IS,IT,NL,NO,PT,

ES,IEexceptSE,FRandDK)

NoroclavVet40mg/10mgTabletsforDogsandCats(SE)

Noroclav50mgTabletsforDogsandCats(FR)

NoroclavVet50mgTabletsforDogsandCats(DK)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Pertablet:

ActiveIngredients:

Amoxicillin(asamoxicillintrihydrate) 40mg

Clavulanicacid(asPotassiumclavulanate) 10mg

Excipients:

CarmoisineLake(E122) 0.245mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Tablet.

Roundpinkbiconvextabletwithascorelineand50embossedonopposingfaces.

4. CLINICALPARTICULARS

4.1 TargetSpecies

Dogsandcats.

4.2 IndicationsforUse,SpecifyingtheTargetSpecies

Treatmentofthefollowinginfectionscausedby 

lactamaseproducingstrainsof

bacteriasensitivetoamoxicillinincombinationwithclavulanicacid:

Skininfections(includingsuperficialanddeeppyodermas)causedby

susceptibleStaphylococci.

UrinarytractinfectionscausedbysusceptibleStaphylococciorEscherichia

coli.

RespiratoryinfectionscausedbysusceptibleStaphylococci.

Revised:November2011

AN:01183/2011

Page2of7

EnteritiscausedbysusceptibleEscherichiacoli.

Itisrecommendedtocarryoutsuitabletestsforsensitivitytestingwheninitiating

thetreatment.Thetreatmentshouldonlyproceedifsensitivityisproventothe

combination.

4.3 Contraindications

Donotuseinanimalswithknownhypersensitivitytopenicillinorothersubstances

ofthebeta-lactamgroup.

Donotuseinrabbits,guineapigs,hamstersorgerbils.

Donotuseinanimalswithseriousdysfunctionofthekidneysaccompaniedby

anuriaandoliguria.

Donotusewhereresistancetothiscombinationisknowntooccur.

Donotadministertohorsesandruminatinganimals.

4.4 SpecialWarningsforEachTargetSpecies

None.

4.5 SpecialPrecautionsforUse

i. Specialprecautionsforuseinanimals

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteria

resistanttoamoxicillin/clavulanicacid.

Inanimalswithhepaticandrenalfailure,thedosingregimenshouldbe

carefullyevaluated.

Useoftheproductshouldbebasedonsusceptibilitytestingandtakeinto

accountofficialandlocalantimicrobialpolicies.Narrowspectrumantibacterial

therapyshouldbeusedforfirstlinetreatmentwheresusceptibilitytesting

suggestslikelyefficacyofthisapproach.

Cautionisadvisedintheuseinsmallherbivoresotherthanthosein4.3.

DogsandcatsdiagnosedwithPseudomonasinfectionsshouldnotbetreated

withthisantibioticcombination.

ii.Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)following

injection,inhalation,ingestionorskincontact.Hypersensitivitytopenicillins

mayleadtocross-reactionstocephalosporinsandviceversa.Allergic

reactionstothesesubstancesmayoccasionallybeserious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeen

advisednottoworkwithsuchpreparations.

Handlethisproductwithgreatcaretoavoidexposure,takingallrecommended

precautions.

Revised:November2011

AN:01183/2011

Page3of7

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshould

seekmedicaladviceandshowthedoctorthiswarning.Swellingoftheface,

lipsoreyesordifficultywithbreathingaremoreserioussymptomsandrequire

urgentmedicalattention.

Washhandsafteruse.

4.6 AdverseReactions(FrequencyandSeriousness)

Hypersensitivityreactionsunrelatedtodosecanoccurwiththeseagents.

Gastrointestinalsymptoms(diarrhoea,vomiting)mayoccurafteradministrationof

theproduct.

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

Incaseofoccurrenceofallergicreaction,thetreatmentshouldbewithdrawn.

4.7 UseDuringPregnancy,LactationorLay

Studiesinlaboratoryanimalshavenotproducedanyevidenceofteratogenic

effects.Useonlyaccordingtothebenefit/riskassessmentbytheresponsible

veterinarian.

4.8 InteractionwithotherMedicinalProductsandOtherFormsofInteraction

Chloramphenicol,macrolides,sulfonamidesandtetracyclinesmayinhibitthe

antibacterialeffectofpenicillinsbecauseoftherapidonsetofbacteriostaticaction.

Thepotentialforallergiccross-reactivitywithotherpenicillinsshouldbe

considered.

Penicillinsmayincreasetheeffectofaminoglycosides.

4.9 AmountstobeAdministeredandAdministration

Administrationisviatheoralroute.Thedosagerateis12.5mgcombined

actives/kgbodyweighttwicedaily.Thetabletsmaybecrushedandaddedtoa

littlefood.

Thefollowingtableisintendedasaguidetodispensingtheproductatthe

standarddoserateof12.5mgofcombinedactivesperkgtwicedaily.

Bodyweight Numberoftabletstwicedaily

1-2 ½

3-4 1

5-6 1,5

7-8 2

9-10 2,5

11-12 3

13-14 3,5

15-16 4

17-18 4,5

Revised:November2011

AN:01183/2011

Page4of7

Durationoftherapy

Acutecases:5to7daysoftreatment.

Ifnoimprovementisobservedafter5to7days,thediagnosisshouldbere-

assessed.

Chronicorrefractorycases:Inthesecaseswherethereisconsiderabletissue

damage,alongercourseoftherapymayberequiredsothatitallowssufficient

timefordamagedtissuetorepair.

Ifnoimprovementisobservedaftertwoweeks,thediagnosisshouldbere-

assessed.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theproductisofaloworderoftoxicityandiswelltoleratedbytheoralroute.

Inatolerancestudyindogsatesteddoseof3timestherecommendeddoseof

12.5mgofthecombinedactivesadministeredtwicedailyfor8daysdidnot

demonstrateadverseeffects.

Inatolerancestudyincatsatesteddoseof3timestherecommendeddoseof

12.5mgofthecombinedactivesadministeredtwicedailyfor15daysdidnot

demonstrateadverseeffects.

4.11WithdrawalPeriod(s)

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.

Clavulanicacidisoneofthenaturallyoccurringmetabolitesofthestreptomycete

Streptomycesclavuligerus.Ithasastructuralsimilaritytothepenicillinnucleus,

includingpossessionofabeta-lactamring.Clavulanicacidisabeta-lactamase

inhibitoractinginitiallycompetitivelybutultimatelyirreversibly.Clavulanicacidwill

penetratethebacterialcellwallbindingtobothextracellularandintracellularbeta-

lactamases.

Revised:November2011

AN:01183/2011

Page5of7

Amoxicillinissusceptibletobreakdownby 

-lactamaseandthereforecombination

withaneffectiveß-lactamaseinhibitor(clavulanicacid)extendstherangeof

bacteriaagainstwhichitisactivetoinclude 

-lactamaseproducingspecies.

Invitropotentiatedamoxicillinisactiveagainstawiderangeofclinicallyimportant

aerobicandanaerobicbacteriaincluding:

Gram-positive:

Staphylococci(including 

-lactamaseproducingstrains)

Clostridia

Streptococci

Gram-negative:

Escherichiacoli(includingmost 

-lactamaseproducingstrains)

Campylobacterspp

Pasteurellae

Proteusspp

ResistanceisshownamongEnterobacterspp,Pseudomonasaeruginosaand

methicillin-resistantStaphylococcusaureus.AtrendinresistanceofE.coliis

reported.

5.2 Pharmacokineticproperties

Amoxicilliniswell-absorbedfollowingoraladministration.Indogsthesystemic

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

distributionvolume,alowplasmaproteinbinding(34%indogs)andashort

terminalhalf-lifeduetoactivetubularexcretionviathekidneys.Following

absorptionthehighestconcentrationsarefoundinthekidneys(urine)andthebile

andtheninliver,lungs,heartandspleen.Thedistributionofamoxicillintothe

cerebrospinalfluidislowunlessthemeningesareinflamed.

Clavulanicacid(pK12.7)isalsowell-absorbedfollowingoraladministration.The

penetrationtothecerebrospinalfluidispoor.Theplasmaproteinbindingis

approximately25%andtheeliminationhalf-lifeisshort.Clavulanicacidisheavily

eliminatedbyrenalexcretion(unchangedinurine).

Afteroraladministrationoftherecommendeddoseof12.5mgcombinedactives/kg

todogs,thefollowingparameterswereobserved:Cmaxof6.30+/-0.45µg/ml,

Tmaxof1.98+/-0.135handAUCof23.38+/-1.39µg/ml.hforamoxicillinand

Cmaxof0.87+/-0.1µg/ml,Tmaxof1.57+/-0.177hrsandAUCof1.56+/-

0.24mg/ml.hforclavulanicacid.

Afteroraladministrationoftherecommendeddoseof12.5mgcombinedactives/kg

tocats,thefollowingparameterswereobserved:Cmaxof7.12+/-1.460µg/ml,

Tmaxof2.69+/-0.561handAUCof33.54+/-7.335µg/ml.hforamoxicillinand

Cmaxof1.67+/-0.381µg/ml,Tmaxof1.83+/-0.227handAUCof7.03+/-1.493

µg/ml.hforclavulanicacid.

Revised:November2011

AN:01183/2011

Page6of7

6. PHARMACEUTICALPARTICULARS

6.1 ListofExcipient(s)

CarmosineLake(E122)

SodiumStarchGlycollate

CopovidoneK24-36

MagnesiumStearate

MicrocrystallineCellulose

CalciumCarbonate

HeavyMagnesiumcarbonate

RoastBeefFlav-o-lok

6.2 Incompatibilities

Notapplicable.

6.3 Shelf-Life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

2years(blisterpacks),6months(tubs).

6.4 SpecialPrecautionsforStorage

Donotstoreabove25

C.Storeintheoriginalpackageinordertoprotectfrom

moisture.

6.5 NatureandCompositionofImmediatePackaging

Theproductissuppliedinhigh-densitypolyethylenetubswithapolypropylene

screwcaplidcontaining100tabletsandinhigh-densitypolyethylenetubswitha

polyethylenescrewcaplidcontaining500tablets.Asachetofdesiccantis

includedineachcontainer.Theproductisalsopresentedinpackscontaining2,

10and50blisterstrips(aluminium-aluminium)eachcontaining10tabletsperstrip.

Notallpacksizesmaybemarketed.

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinaryMedicinalProducts

orWasteMaterialsDerivedFromtheUseofSuchProducts,ifappropriate

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewith

nationalrequirements.

Revised:November2011

AN:01183/2011

Page7of7

7. NAMEORCORPORATENAMEANDADDRESSORREGISTEREDPLACEOF

BUSINESSOFTHEMARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited

StationWorks

CamloughRoad

Newry

Co.Down

BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER

Vm

02000/4211

9. RENEWALOFTHEAUTHORISATION

Date:25 th

February2009

10. DATEOFREVISIONOFTHETEXT

Date:November2011

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