ADVOCIN 180

Main information

  • Trade name:
  • ADVOCIN 180
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ADVOCIN 180
    Malta
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • danofloxacine
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0126/001
  • Authorization date:
  • 13-02-2012
  • EU code:
  • FR/V/0126/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. Nameoftheveterinarymedicinalproduct

ADVOCIN180,180mg/ml,SolutionforInjectionforCattle

2. Qualitativeandquantitativecomposition

1mlcontains

Activesubstance:

Danofloxacin 180.00mg

(Equivalentto228.4mgDanofloxacin

mesylate)

Excipients:

Phenol 2.50mg

Monothioglycerol 5.00mg

Excipientqsp 1ml

Forafulllistofexcipients,seesection6.1

3. Pharmaceuticalform

Solutionforinjection.Mediumyellowtoambersolution.

4. Clinicalparticulars

4.1.Targetspecies

Cattle

4.2.Indicationsforuse,specifyingthetargetspecies

Incattle:TreatmentofbovinerespiratorydiseasecausedbyMannheimia

haemolytica,PasteurellamultocidaandHistophilussomnisensitiveto

danofloxacin.Forthetreatmentofacutebovinemastitiscausedby

Escherichiacolisensitivetodanofloxacin.

Inneo-natalcalves:TreatmentofentericinfectionscausedbyEscherichiacoli

sensitivetodanofloxacin.

4.3.Contraindications

Donotuseincasesofknownhypersensitivitytotheactiveingredient,toother

(fluoro)quinolonesortoanyingredientsoftheproduct.

Donotuseincaseswherethepathogeninvolvedisresistanttoother

fluoroquinolones(crossresistance)

4.4.Specialwarningsforeachtargetspecies

Thesafetyoftheproducthasnotbeenassessedinbreedingbulls.

4.5.Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Useoffluoroquinolonesshouldbebasedonsusceptibilitytestingandtakeinto

accountofficialandlocalantimicrobialusepolicies.Itisprudenttoreserve

fluoroquinolonesforthetreatmentofclinicalconditionswhichhaveresponded

poorlytootherclassesofantimicrobials.Efficacyagainstgrampositivestrains

hasnotbeenestablished.

Forfluoroquinolonesasaclass,over-dosageatmultiplesoftherecommended

dosehasbeenshowntoinduceerosionofarticularcartilage.Careshouldbe

takentodoseaccuratelyand theproductshouldbeusedwithcautionin

animalswithjointdiseaseorcartilagegrowthdisorders.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmay

increasetheprevalenceofbacteriaresistanttothefluoroquinolonesandmay

decreasetheeffectivenessoftreatmentwithotherquinolonesduetothe

potentialforcrossresistance

ii)Specialprecautionstobetakenbythepersonadministeringthe

medicinalproductstoanimals

Personswithknownhypersensitivityto(fluoro)quinolonesshouldavoidcontact

withtheproduct.

Careshouldbetakentoavoidaccidentalselfinjection,itcaninduceaslight

irritation.

Incaseofaccidentalselfinjection,seekmedicaladviceandshowthepackage

leafletorthelabeltothephysician.

Incaseofcontactwithskinoreyes,rinsewithplentyofwater.

Washhandsafteruse.

Donoteat,drinkorsmokeduringapplication.

iii)Otherprecautions

4.6.Adversereactions(frequencyandseriousness)

Inveryrarecasesinsensitiveanimals,immediateordelayedanaphylactic

shockmayoccuraftertheinjection.

Subcutaneousinjectionoftheproductinducesamoderateinflammatory

responseinthetissuearoundtheinjectionsite.Theresultantlesionsmay

persistforupto30days.

4.7.Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshaveshownadverseeffectsonreproduction.At

highdosesinrats(100to200mg/kg/day),increaseinfoetaldelayed

ossificationandindilatationofthecerebralventricleswereobserved.Dams

givenhighdoseproducedfewerlivepupsperlitterandpupweightand

survivalwereadverselyaffected.Thesafetyoftheproducthasnotbeen

assessedinpregnantcows.Theuseoftheproductisnotrecommendedfor

cowsduringpregnancy.

4.8.Interactionwithothermedicinalproductsandotherformsof

interaction

Noneknown

4.9.Amount(s)tobeadministeredandadministrationroute

6mg/kgbodyweight(1ml/30kgbodyweight)asasingleinjectionbythe

subcutaneousorintravenousroute.

Ifclinicalsignsofrespiratoryorentericdiseasepersist48hoursafterthefirst

injection,anadditionaldoseat6mg/kgbodyweightmaybeadministered.

Itisrecommendedtotreatanimalsintheearlystagesofdiseaseandto

evaluatetheresponsetotreatmentwithin48hours.

Forthetreatmentofacutebovinemastitis,theproductshouldbeadministered

at6mg/kgbodyweight(1ml/30kgbodyweight)asasingleinjectionbythe

subcutaneousorintravenousroute.Theclinicalsignsshouldbemonitored

carefullyandsupportivetherapyshouldbegivenasappropriate.Ifclinical

signsofacutebovinemastitispersist36-48hoursafterthefirstinjection,the

antibiotictreatmentstrategyshouldbereviewed.Itisrecommendedtotreat

animalsintheearlystagesofdiseaseandtoevaluatetheresponseto

treatmentwithin36-48hours.

Fortreatmentofcattleweighingmorethan450kg,dividethesubcutaneous

dosesothatnomorethan15mlareinjectedatonesite.

Whendosingalargenumberofanimalsfromasinglevial,theuseofan

automaticsyringeisrecommendedtoavoidexcessivebroachingoftherubber

stopper.

4.10.Overdose(symptoms,emergencyprocedures,antidotes),if

necessary

Atdosesofthreetimesthetherapeuticdose(18mg/kgbw),erythemaofthe

nasalandocularmucosaewasinducedandfoodintakewasreduced.At

evenhigherdosesandprolongedexposure,therewasdamagetothe

cartilageinthejointsandsomeanimalsdisplayedparesis,

ataxiaornystagmus.

4.11.Withdrawalperiod(s)

Meatandoffal: 8days

Milk: 4days

5. Pharmacologicalproperties

Pharmacotherapeuticgroup:Fluoroquinolones,

ATCvetcode:QJ01MA92

5.1.Pharmacodynamicproperties

Danofloxacinisasyntheticfluoroquinoloneantimicrobialagentthatpossesses

potentinvitroactivityagainstMannheimiahaemolytica,Pasteurellamultocida,

HistophilussomniandEscherichiacoli,thebacterialpathogensmost

commonlyassociatedwithbovinerespiratory,entericdiseaseandacute

bovinemastitis.

Theantimicrobialactivityofdanofloxacinisbasedupontheinhibitionof

microbialDNAgyraseandtopoisomeraseIV.Theinhibitoryeffectisonthe

secondstepoftheenzymaticprocess,uncouplingthebreakageandreunion

functions.Danofloxacin,incommonwithotherfluoroquinolones,producesa

stablecomplexbetweentheenzymeandDNA.Thisresultsinthecessation

ofDNAreplicationandtranscription.Thebactericidaleffectisalsoobserved

onbacteriainthestationarygrowthphase.

Althoughthereisthepossibilityforcrossresistancedevelopingwithinany

classofantimicrobialbecauseofthespecificmodeofactionof

fluoroquinolonescrossresistancewithothermajorantibioticswhichactonthe

cellwalloronproteinsynthesisisunlikelytooccur.

Danofloxacinisefficaciousinthetreatmentoffieldcasesofacutemastitiswith

aGramnegativebacterialaetiology.

5.2.Pharmacokineticparticulars

Theproductisrapidlyandextensivelyabsorbedfromthesiteofsubcutaneous

injection,bioavailabilityisaround90%.Danofloxacinisonlypoorly

metabolisedandsubsequentlyeliminatedviaboththerenalandhepatic

routes.Adifferenceineliminationkineticsisobservedbetweenpre-ruminant

animals(half-lifeof12hours)andruminantanimals(half-lifeof4hours).High

drugconcentrationsinlung,entericandlymphatictissuesareobserved.

Followingasinglesubcutaneousadministrationat6mg/kgbodyweight,peak

plasmaandtissueconcentrationsareachievedwithinonetotwohoursafter

treatment,withconcentrationsinlungandenterictissuesapproximatelyfour

timesgreaterthaninplasma.Thedoseselectedfortheproductwasbased

ontheoptimisationoftheconcentrationdependentbactericidalactivityof

danofloxacinagainstrespiratoryandentericpathogens.

Themeanmilkconcentrationsofdanofloxacinwere4.61and0.2µg/mlatthe

8and24hourmilking,respectively,followingasinglesubcutaneousinjection.

6. Pharmaceuticalparticulars

6.1.Listofexcipients

Phenol

Monothioglycerol

PovidoneK15

2-pyrrolidone

Magnesiumoxide

Hydrochloricacid

Sodiumhydroxide

Waterforinjection

6.2.Incompatibilities

Noneknown

6.3.Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningoftheimmediatepackaging:28days.

6.4.Specialprecautionsforstorage

Storeintheoriginalpackaginginordertoprotectfromlight.

Donotfreeze.

6.5.Natureandcompositionofimmediatepackaging

NatureofPrimaryPackaging

TypeIamberglassvial

Chlorobutylrubberstopper

Aluminiumoversealwithpolypropylenecover

MarketPresentations

Boxcontainingone50mlvial

Boxcontainingone100mlvial

Boxcontainingone250mlvial

6.6.Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts,if

appropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfrom

suchveterinarymedicinalproductsshouldbedisposedofinaccordancewith

localrequirements.

7. Marketingauthorisationholder

PfizerLtd

RamsgateRoad

Sandwich

Kent

CT139NJ

8. Marketingauthorisationnumber(s)

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