Nisamox Injection

Main information

  • Trade name:
  • Nisamox Injection
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Nisamox Injection
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0199/001
  • Authorization date:
  • 17-08-2011
  • EU code:
  • UK/V/0199/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:September2012

AN:00536/2012

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NisamoxSuspensionforInjection(Belgium&UK)

NisamoxSuspensionforInjection(Portugal)

Nisamox175mgSuspensionforInjection(Spain)

NisinjectSuspensionforInjection(Italy)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Each1mlsupplies:

ActiveSubstance:

Amoxicillin(asAmoxicillintrihydrate) 140mg

Clavulanicacid(asPotassiumclavulanate) 35mg

Excipients:

Butylatedhydroxyanisole(E320)0.08mg

Butylatedhydroxytoluene(E321)0.08mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Suspensionforinjection.

Anoff-whitetocreamoilysuspension.

4. CLINICALPARTICULARS

4.1Targetspecies

CattleandDogs.

4.2Indicationsforuse,specifyingthetargetspecies

Incattle:

Respiratoryinfections

Softtissueinfections(e.g.joint/navelill,abscessesetc.)

InDogs:

Respiratorytractinfections,urinarytractinfections,skinandsofttissue

infections(e.g.abscesses,pyoderma,analsacculitisandgingivitis.).

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4.3Contraindications

Donotuseinanimalswithknownhypersensitivitytopenicillinorother

substancesofthebeta-lactamgroup.

Donotuseinanimalswithseriousdysfunctionofkidneysaccompaniedby

anuriaoroliguria.

Donotuseinrabbits,guineapigs,hamstersorgerbils.

Theuseoftheproductiscontra-indicatedwhereresistancetothe

combinationofpenicillinsorothersubstancesofthebeta-lactamgroupis

knowntooccur.

4.4SpecialWarningsforeachtargetspecies

Clavulanicacidismoisturesensitive.Itisveryimportanttherefore,thata

completelydryneedleandsyringeisusedwhenextractingsuspensionfor

injectioninordertoavoidcontaminatingtheremainingcontentsofthevial

withdropsofwater.

Contaminationwillresultinobviousbeadsofdark,browndiscolouration

correspondingtotheintroducedwaterdroplets.Suspensionaffectedin

thiswayshouldnotbeusedasitmayhavesignificantlyreducedpotency.

Shakebeforeuse.

4.5Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Thisproductdoesnotcontainanantimicrobialpreservative.

Incaseoftheoccurrenceofallergicreaction,thetreatmentshouldbe

withdrawn.

Inappropriateuseoftheproductmayincreasetheprevalenceof

bacteriaresistanttoamoxycillin/clavulanicacidandtoother

substancesofthebeta-lactamgroup.

Inanimalswithhepaticandrenalfailurethedosageregimeshouldbe

carefullyevaluated.

Useoftheproductshouldbebasedonsusceptibilitytestingand

takingintoaccountofficialandlocalantimicrobialpolicies.

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Narrowspectrumantibacterialtherapyshouldbeusedforfirstline

treatmentwheresusceptibilitytestingsuggeststhelikelyefficacyof

thisapproach.

Cautionisadvisedintheuseinsmallherbivoresotherthanthosein

4.3.

ii.Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproductstoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)

following injection, inhalation, ingestion or skin contact.

Hypersensitivitytopenicillinsmayleadtocross-reactionsto

cephalosporinsandviceversa.Allergicreactionstothese

substancesmayoccasionallybeserious.

Donothandlethisproductifyouknowyouaresensitised,orifyou

havebeenadvisednottoworkwithsuchpreparations.

Incaseofaccidentalcontactwitheyes,rinseimmediatelywithplenty

ofwater.

Handlethisproductwithgreatcaretoavoidexposure,takingall

recommendedprecautions.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,you

shouldseekmedicaladviceandshowthedoctorthiswarning.

Swellingoftheface,lipsoreyesordifficultywithbreathingaremore

serioussymptomsandrequireurgentmedicalattention.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Diarrhoea,vomitingandsweatingmayrarelyoccurafteradministrationof

theproduct.Hypersensitivityreactionsunrelatedtodosecanoccurwith

theseagents.Allergicreactions(e.g.,skinreactions,anaphylaxis)may

occasionallyoccur.

Localtissuereactionsatthesiteofinjectionmayoccurfollowing

administration.Thesereactionsaregenerallyofmildtomoderateswelling

and/orhardnessandcanpersistforupto2weeksfollowingadministration

attherecommendeddoserateintherumporlegmusclesand4daysafter

administrationattherecommendeddoserateintheneckmuscles.Pain

oninjectionmayoccasionallyoccur.Useoftheproductmayoccasionally

resultinpainoritchingoninjectionand/orlocaltissuereaction.

4.7Useduringpregnancy,lactationorlay

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Studiesinlaboratoryanimalshavenotproducedanyevidenceof

teratogeniceffects.Useonlyaccordingtothebenefit/riskassessmentby

theresponsibleveterinarysurgeon.

Thesafetyoftheproducthasnotbeenassessedinpregnantandlactating

cowsorbitches.

4.8Interactionwithothermedicinalproductsandotherformsof

interaction

Thebactericidaleffectofamoxicillinisneutralizedbysimultaneoususeof

bacteriostaticactingpharmaceuticals(macrolides,sulfonamidesand

tetracyclines).

Thepotentialforallergiccross-reactivitywithotherpenicillinsshouldbe

considered.Penicillinsmayincreasetheeffectsofaminoglycosides.

4.9Amountstobeadministeredandadministrationroute

Theproductisindicatedforintramuscularadministrationtocattleand

subcutaneousadministrationtodogs.

Therecommendeddosagerateof8.75mg/kgbodyweight[7mg/kg

bodyweightamoxicillinand1.75mg/kgbodyweightofclavulanicacid](1ml

per20kgbodyweight)oncedailyfor3-5days.Shakethevialwellbefore

use.Useacompletelydrysterileneedleandsyringe.Swabtheseptum

beforeremovingeachdose.

Themaximumvolumeadministeredatthesiteofinjectionshouldnot

exceed10ml.

Seealsosection4.5(i)

4.10Overdose(symptoms,emergencyprocedures,antidotes),if

necessary

InCattle,theproductiswelltoleratedupto2timestherecommendeddose

administeredforupto5days.

Studiesincattleatthenormaldoserateandtwicethenormaldoserate

haveshowntransientanddosedependentmuscledamageattheinjection

site resulting in increased Creatine kinase and Aspartate

Aminotransferaselevels.Injectionsitereactionstendedtobedose

dependentandwerefullyresolvedby2weeksafteradministrationtothe

legandrumpand4daysafteradministrationtotheneckevenattwicethe

recommendeddoserate.Nootherclinicallysignificantabnormalitieswere

detected.

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Theproductiswelltoleratedupto3timestherecommendeddose

administeredforupto6daysfordogs,however,indogs,reactionsatthe

injectionsitemayoccurat3timestherecommendeddoserateafter2

weeks.

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4.11Withdrawalperiod

Meatandoffal:42days

Milk60hours(5milkings)

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antimicrobial

ATCVetCode:QJ01CR02

5.1Pharmacodynamicproperties

ModeofAction

Amoxicillinisabeta-lactamantibioticanditsstructurecontainsthebeta

lactamringandthiazolidineringcommontoallpenicillins.Amoxicillin

showsactivityagainstsusceptibleGrampositiveandGramnegative

bacteria.

Beta-lactamantibioticspreventthebacterialcellwallfromformingby

interferingwiththefinalstageofpeptidoglycansynthesis.Theyinhibitthe

activityoftranspeptidaseenzymeswhichcatalysecross-linkageofthe

glycopeptidepolymerunitsthatformthecellwall.Theyexertabactericidal

actionbutcauselysisofgrowingcellsonly.

Clavulanicacidisoneofthenaturallyoccurringmetabolitesofthe

streptomyceteStreptomycesclavuligerus.Ithasastructuralsimilarityto

thepenicillinnucleusincludingpossessionofabeta-lactamring.

Clavulanicacidisabeta-lactamaseinhibitoractinginitiallycompetitively

butultimatelyirreversibly.

Clavulanicacidwillpenetratethebacterialcellwallbindingtoboth

extracellularandintracellularbeta-lactamases.

Amoxicillinissusceptibletobreakdownbyß-lactamasesproducedby

somebacterialspecies,andthereforecombinationwithaneffectiveß-

lactamaseinhibitor(clavulanicacid)extendstherangeofbacteriaagainst

whichitisactivetoincludeß-lactamaseproducingspecies.

Invitropotentiatedamoxicillinisactiveagainstawiderangeofclinically

importantbacteriaincluding:

Grampositive:

Staphylococci(includingbeta-lactamaseproducingstrains)

Streptococci

Corynebacterium

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Clostridia

Gramnegative:

Escherichiacoli

Campylobacterspp

Klebsiellaspp

Proteusspp

Pasteurellaspp

Bacteroides(includingbeta-lactamaseproducingstrains)

Haemophilusspp.

Anotherpossiblemodeofresistancetobeta-lactamantibioticscanbe

associatedwithchromosomalmutationsinbacteriaresultingin

modificationofthepenicillinbindingproteins(PBPs)ormodificationofthe

cellularpermeabilityto 

-lactamantibioticsbytheirnaturesuch

chromosomalmutationstendtoberelativelyslowindevelopmentprimarily

byverticaltransmission.AtrendinresistanceofE.coliisreported.

5.2Pharmacokineticproperties

After intramuscular administration to cattle and subcutaneous

administrationtodogs,amoxicillinandclavulanicacidarewellabsorbed

anddistributedinthetissues.Theprinciplerouteofeliminationof

amoxicillinandclavulanicacidisintheurine.

Afterintramuscularadministrationoftheproductattherecommendeddose

oncedailyforfiveconsecutivedaysthefollowingparameterswere

observed.

Cmaxof1.69µg/ml,Tmaxof2.67h,AUCof30.59µg/ml.handt½of15.22

hrforamoxicillinandCmaxof0.94µg/ml,Tmaxof1.3h,AUCof3.123

µg/ml.handt½of1.71hforclavulanicacid.

Aftersubcutaneousadministrationofthemaximumrecommendeddoseto

dogs,thefollowingparameterswereobserved:Cmaxof8.66μg/ml,Tmax

of1.78handAUCof50.98μg/ml.hforamoxixillin.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

PropyleneGlycolDicaprylate/Dicaprate

Butylatedhydroxyanisole

Butylatedhydroxytoluene

6.2Incompatibilities

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Donotmixwithotherveterinarymedicinalproducts.

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6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:1year

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.

Onceavialhasbeenbroachedthecontentsshouldbeusedwithin28

days.

Discardunusedmaterial.

6.5Natureandcompositionofimmediatepackaging

TheproductwillbesuppliedinclearcolourlesstypeIIglassvialsof50ml

and100ml,completewithnitrylbungsandaluminiumcaps.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited

StationWorks

Newry

Co.Down,BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER

Vm:

02000/4227

9. DATEOFRENEWALOFAUTHORISATION

Date:28April2009

10.DATEOFREVISIONOFTHETEXT

Date:September2012