Multishield DC Intramammary Suspension

Main information

  • Trade name:
  • Multishield DC Intramammary Suspension
  • Pharmaceutical form:
  • Intramammary suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Multishield DC Intramammary Suspension
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • lactam antibacterials, penicillins, combinations with other antibacterials
  • Therapeutic area:
  • Cattle Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • IE/V/0277/001
  • Authorization date:
  • 21-12-2012
  • EU code:
  • IE/V/0277/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SummaryofProductCharacteristics

1NAMEOFTHEVETERINARYMEDICINALPRODUCT

MultishieldDCIntramammarySuspensionforCows.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each4.5gintramammarysyringecontains

ActiveSubstances:

Neomycin 70000IU

(correspondingtoNeomycinSulphate 100mg)

Penethamate 77.2mg

(correspondingtoPenethamateHydriodide 100mg)

Benzylpenicillin 227.2mg

(correspondingtoProcaineBenzylpenicillin 400mg)

Excipients:

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Intramammarysuspension.

Asmooth,offwhite,oilysuspension.

4CLINICALPARTICULARS

4.1TargetSpecies

Cows(atdryoff).

4.2Indicationsforuse,specifyingthetargetspecies

Incowsatdryingoff:

Treatmentofsubclinicalmastitiscausedbybovinemastitisorganismssensitivetothecombinationofactive

substances,penicillinandneomycin,andaspartofstrategyforthepreventionofnewinfectionsoccurringduringthe

dryperiod.

4.3Contraindications

Donotuseinlactatingcows.

Donotuseinanimalswhichareknowntobehypersensitiveto -lactamantibiotics,cephalosporinantibiotics,

neomycinorotheraminoglycosideantibioticsortoiodine.

Donotuseincowswithclinicalmastitis.

4.4Specialwarningsforeachtargetspecies

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4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfromtheanimal.Ifthisisnot

possible,therapyshouldbebasedonlocal(regional,farmlevel)epidemiologicalinformationaboutsusceptibilityofthe

targetbacteria.

Official,nationalandregionalantimicrobialpoliciesshouldbetakenintoaccountwhentheproductisused

Thetherapeuticefficacyoftheproductisonlyestablishedagainstpathogensthataresensitivetotheactivesubstances.

Seriousacutemastitis[potentiallylethal]duetopathogenslikePseudomonasaeruginosa,canoccurafterdryingoff

despitepreventivetreatment.Goodasepticpracticesshouldbethoroughlyrespectedinordertoreducethatrisk;cows

shouldbehousedinahygienicpaddockfarfromthemilkingparlourandregularlycheckedforseveraldaysafter

dryingoff.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Operatorsshouldavoidcontactwiththispreparationasoccasionallyskinallergymayoccur.

Penicillinsandcephalosporinsmaycausesensitisationfollowinginjection,inhalation,ingestionorskincontact.

Sensitivitytopenicillinsmayleadtocrosssensitivitytocephalosporinsandviceversa.Allergicreactionstothese

substancesmayoccasionallybeserious.

Donothandlethisproductifyouknowthatyouaresensitisedorifyouhavebeenadvisednottoworkwithsuch

preparations.

Ifyoudevelopsymptomssuchasaskinrashfollowingexposure,seekmedicaladviceandshowthiswarningtothe

doctor.Swellingoftheface,lipsoreyes,ordifficultywithbreathingaremoreserioussymptomsandrequireurgent

medicalattention.

4.6Adversereactions(frequencyandseriousness)

Allergicreactions(allergicskinreactions,anaphylaxis).

Penicillinsmaycausehypersensitivityfollowingadministration.Allergicreactionstothesesubstancesmay

occasionallybeserious.

4.7Useduringpregnancy,lactationorlay

Theproductisnotrecommendedforuseinlactatingcows,exceptatthedryingoffstage.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Nodataavailable.

4.9Amountstobeadministeredandadministrationroute

100mgofneomycinsulphate,100mgofPenethamateHydriodideand400mgofProcaineBenzylpenicillinintoeach

quarter.

Singleintramammaryadministration

Thecontentsofonesyringeshouldbeinfusedintoeachquarterviatheteatcanalimmediatelyafterthefinalmilkingof

alactation.

Beforeinstillation,theuddershouldbemilkedoutcompletely.Theteatanditsorificeshouldbethoroughlycleaned

anddisinfectedwithacleaningtowel.Careshouldbetakentoavoidcontaminationoftheinjectornozzle.Gentlyinsert

thecontentofonesyringeintoeachquarter.Dispersetheproductbygentlemassageoftheteatandudder.Thesyringe

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4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosingmayinvalidatethestatedmilkandmeatwithdrawaltimes.

4.11WithdrawalPeriod(s)

MeatandOffal:28days.

Milk:96hourspostcalvingincowswithadryperiodofmorethan50days.

50daysplus96hoursaftertreatmentfromcowswithadryperiodof50daysorless.

5PHARMACOLOGICALorIMMUNOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Combinationofantibacterialsforintramammaryuse,

Beta-lactamantibacterialswithotherantibacterials.

ATCvetCode:QJ51RC

5.1Pharmacodynamicproperties

Theproductcontainsanaminoglycoside(neomycinsulphate)andtwopenicillinderivatives(procainebenzylpenicillin

andpenethamatehydriodide).

Aminoglycosidesdisturbthepermeabilityofthebacterialcellmembranebyaneffectexertedduringcellwall

development.Oncetheaminoglycosidehasenteredthecell,itbindstoreceptorsontheribosome,inducingmisreading

ofthegeneticcode.Neomycinincommonwithotheraminoglycosideshasactivitypredominantlyagainstgram

negativeorganisms.

Neomycinhasbeenshowntohavesynergisticactivitywith-lactamantibioticsagainstGrampositivebacteria.

Penicillinshaveatime-dependent,bacteriocidaleffectbyinterferingwithmicrobialcellwallsynthesis. Theyinhibit

theactivityoftranspeptidaseenzymeswhichcatalysecrosslinkageoftheglycopeptidepolymerunitsthatformthecell

wall.BothProcainebenzylpenicillinandPenethamatehydroiodidearehydrolysedintheuddertoreleasefree

penicillin.

BovinemastitisorganismswhichcanbetreatedwiththeproductincludesensitiveisolatesofStaphylococcusaureus,

Streptococcusagalactiae,Streptococcusuberis,othersensitiveStreptococcusspp,Arcanobacteriumpyogenesand

sensitiveisolatesofE.coli.

Penicillinresistanceduetotheproductionofpenicillinaseisawell-recognisedfeatureofsomeStaphylococcusspp

isolateshoweverreportedresistancelevelsvaryconsiderablybetweengeographicalareas.Theprevalenceofresistance

againstneomycinremainslowinthosespecies.

5.2Pharmacokineticproperties

PenethamatehydriodideisanesterofbenzylpenicillinwhichisrapidlyhydrolysedatpH7.3toliberatefreepenicillin

whichquicklydistributesthroughouttheuddertissue.

Procainebenzylpenicillinisacomplex,sparinglysolubleorganicsaltofbenzylpenicillinanditsuse,incombination

withaslow-releasebase,isintendedtodelayreleaseoftheactivepenicillinmoietyatthesiteofadministrationandso

giverisetoaprolongeddurationofaction.

Neomycinisapoorlylipidsoluble,basicaminoglycosidethatshowsahighdegreeofbindingtouddertissueandhas

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Liquidparaffin

Aluminiumdi/tristearate.

6.2Incompatibilities

Noneknown.

6.3Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Syringesareforsingleuseonly.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Donotrefrigerateorfreeze

6.5Natureandcompositionofimmediatepackaging

Lowdensitypolyethyleneintramammarysyringe,containing4.5gintramammarysuspension.

Syringespackedincartonsof24syringesorbucketsof120syringes.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwastematerials

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproductshouldbe

disposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

CrossVetpharmGroupLtd.,

BroomhillRoad

Tallaght

Dublin24.

Ireland

8MARKETINGAUTHORISATIONNUMBER(S)

VPA10960/074/001

9DATEOFTHEFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

January2013

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