Orbax Oral Suspension 3%

Main information

  • Trade name:
  • Orbax Oral Suspension 3%
  • Pharmaceutical form:
  • Oral suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Orbax Oral Suspension 3%
    Austria
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Orbifloxacin
  • Therapeutic area:
  • Cats, Dogs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0254/001
  • Authorization date:
  • 21-04-2011
  • EU code:
  • UK/V/0254/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:October2012

AN:00697/2012

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Noroclav500mgPalatableTabletsforDogs

NoroclavTablets400mg/100mgforDogs(Sweden)

NoroclavComprimés400mg/100mgpourChiens(France)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

ActiveIngredients:

Amoxicillin(asamoxicillintrihydrate) 400mg

Clavulanicacid(aspotassiumclavulanate) 100mg

ColouringAgent:

CarmoisineLake(E122) 2.45mg

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:October2012

AN:00697/2012

4.3 Contraindications

Donotuseinanimalswithknowncasesofhypersensitivitytopenicillinsorother

substancesofthebeta-lactamgroup.

Donotuseinrabbits,guineapigs,hamstersorgerbils.

Donotuseinanimalswithseriousdysfunctionofkidneysaccompaniedbyanuriaor

oliguria.

Donotusewhereresistancetothecombinationisknowntooccur

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)following

injection,inhalation,ingestionorskincontact.Hypersensitivitytopenicillins

mayleadtocrossreactionstocephalosporinsandviceversa.Allergic

reactionstothesesubstancesmayoccasionallybeserious.

Handlethisproductwithgreatcaretoavoidexposure,takingall

recommendedprecautions.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshould

seekmedicaladviceandshowthepackageleafletorthelabeltothe

physician.Swellingoftheface,lipsoreyesordifficultywithbreathingare

moreserioussymptomsandrequireurgentmedicalattention.

Washhandsafteruse.

4.6 Adversereactions(frequencyandseriousness)

Hypersensitivityunrelatedtodosecanoccurwiththeseagents.

Gastrointestinalsymptoms(diarrhoea,vomiting)mayoccurafteradministrationof

theproduct.

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

Incaseofoccurrenceofallergicreaction,thetreatmentshouldbewithdrawn.

Revised:October2012

AN:00697/2012

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:October2012

AN:00697/2012

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(in cludingβ-lactamaseproducingstrains),Clostridia,

Streptococci.

Gram-negative:Escherichiacoli (includingmostβ-lactamaseproducingstrains),

Campylobacterspp,Pasteurellae,Proteusspp.

ResistanceisshownamongEnterobacterspp,Pseudomonasaeruginosaand

methicillin-resistantStaphylococcusaureus.DogsdiagnosedwithPseudomonas

infectionsshouldnotbetreatedwiththisantibioticcombination.Atrendin

resistanceofE.coliisreported.

Revised:October2012

AN:00697/2012

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:October2012

AN:00697/2012

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

Vm

02000/4259

9. DATEOFFIRSTAUTHORISATION

Date:26April2006

10. DATEOFREVISIONOFTEXT

Date:October2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

NotApplicable

APPROVED29/11/12