Cobactan DC

Main information

  • Trade name:
  • Cobactan DC
  • Pharmaceutical form:
  • Intramammary ointment
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Cobactan DC
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • cefquinome
  • Therapeutic area:
  • Cattle Non Lactating

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0148/001
  • Authorization date:
  • 11-10-2011
  • EU code:
  • FR/V/0148/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NameoftheproductinFR:CobactanDC

NameoftheproductinUK/IE:CephaguardDC150mgintramammaryointment

AllotherCMS:CobactanDC150mgintramammaryointment

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Each3gpre-filledsyringecontains:

Activesubstance

Cefquinome(assulphate):150.0mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Intramammaryointment

Homogeneousoff-whiteoilyointment

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle(drycows)

4.2 Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofsubclinicalmastitisatdryingoffandthepreventionofnewbacterial

infectionsoftheudderduringthedryperiodinthedairycowcausedbythefollowing

cefquinomesensitiveorganisms:Streptococcusuberis,Streptococcusdysgalactiae,

Streptococcusagalactiae,Staphylococcusaureus,coagulasenegativestaphylococci.

4.3 Contraindications

Nottobeadministeredtoanimalswhichareknowntobehypersensitivetocephalosporin

antibioticsorotherβ-lactamantibiotics.

Nottobeadministeredtocowswithclinicalmastitis.

Andseesection4.7.

4.4 Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfromthe

animal.Ifitisnotpossible,therapyshouldbebasedonlocal(regional,farmlevel)

epidemiologicalinformationaboutsusceptibilityofthetargetbacteria

Donotusethecleaningtowelonteatswithlesions.

Incaseoferroneoususeduringlactationthemilkshouldbediscardedfor35days.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,

inhalation,ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocrosssensitivity

tocephalosporinandviceversa.Allergicreactionstothesesubstancesmayoccasionallybe

serious.

Donothandlethisproductifyouknowyouaresensitisedtopenicillinsorcephalosporins,orif

youhavebeenadvisednottoworkwithsuchpreparations.

Handlethisproductwithgreatcaretoavoidexposure.Useimperviousgloveswhenhandling

andadministeringtheproduct.Washexposedskinafteruse.

Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshouldseekmedical

adviceandshowtheDoctorthiswarning.Swellingoftheface,lipsandeyesordifficultyin

breathingaremoreserioussymptomsandrequireurgentmedicalattention.Personsdeveloping

areactionaftercontactwiththeproductshouldavoidhandlingtheproduct(andother

cephalosporinandpenicillincontainingproducts)infuture.

Washhandsafterusingthetowelsandwearprotectiveglovesifskinirritationduetoisopropyl

alcoholisknownorsuspected.Avoidcontactwitheyesbecauseisopropylalcoholcancauseeye

irritation.

4..6Adversereactions(frequencyandseriousness)

Noneknown.

4.7 Useduringpregnancy,lactationorlay

Thereisnoevidenceofreproductivetoxicity(incl.teratogenicity)incattle.Laboratorystudies

inratsandrabbitshavenotshownanyteratogenic,foetotoxicormaternotoxiceffects.

Theproductisintendedforuseduringpregnancy.Intheclinicaltrials,noadverseeffectsonthe

foetuswereobserved.

Donotuseduringlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Seepoint5.1withregardtocross-resistanceinthecephalosporingroup.

Theneutralizingeffectofbacteriostaticactingpharmaceuticals(macrolides,sulfonamidesand

tetracyclines)onbactericidaleffectofcefquinonehasnotbeenevaluatedyet.Thereforethereis

noinformationaboutthesafetyandefficacyofthiskindofassociation.

4.9 Amountstobeadministeredandadministrationroute

Singleintramammaryadministration.

150mgcefquinome,i.e.thecontentofonesyringeshouldbeinstilledgentlyintotheteatof

eachquarter,immediatelyafterthelastmilking.

Beforeinstillation,theuddershouldbemilkedoutcompletely.Theteatanditsorificeshouldbe

thoroughlycleanedanddisinfectedwiththecleaningtowelprovided.Careshouldbetakento

avoidcontaminationoftheinjectornozzle.Gentlyinserteitherabout5mmorthetotallengthof

thenozzleandinstillthecontentofonesyringeintoeachquarter.Dispersetheproductbygentle

massageoftheteatandudder.

Thesyringemustonlybeusedonce.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Notrelevant.

4.11Withdrawalperiods

Meatandoffal:2days

Milk:1dayaftercalvingwhendryperiodismorethan5weeks

36daysaftertreatmentwhendryperiodis5weeksorless

5. PHARMACOLOGICALPROPERTIES

Activeingredient:cefquinome.

Pharmacotherapeuticgroup: cephalosporinsandrelatedsubstances.

ATCvetcode:QJ51DA92.

Substancegroup:antibacterialsforintramammaryuse.

5.1 Pharmacodynamicproperties

Theantibacterialdrugcefquinomeisabroadspectrumcephalosporinofthefourthgeneration

whichactsbyinhibitionofcellwallsynthesis.Itisbactericidalandischaracterisedbyitsbroad

therapeuticspectrumofactivityandahighstabilityagainstpenicillinasesandbeta-lactamases.

InvitroactivityhasbeendemonstratedagainstcommonGrampositiveandGramnegative

bacteriaincludingEscherichiacoli,Citrobacterspp.,Klebsiellaspp.,Pasteurellaspp.,Proteus

spp.,Salmonellaspp.,Serratiamarcescens,Arcanobacteriumpyogenes,Corynebacteriumspp.,

Staphylococcusaureus,coagulasenegativeStaphylococci,Streptococcusdysgalactiae,

Streptococcusagalactiae,Streptococcusuberis,Streptococcusbovis.

Followingbacterialspecies:Staphylococcusaureus,coagulasenegativeStaphylococci,

Streptococcusuberis,StreptococcusdysgalactiaeandStreptococcusagalactiaeisolatedfroma

fieldstudyconductedbetween2000and2002inGermany,France,Belgiumandthe

NetherlandsprovedtobesusceptibletocefquinomewithMICvaluesbetween≤0.008µg/ml

and2.0µg/ml.

AnoverviewoftheMIC

ofeachbacterialpathogenispresentedinthetablebelow:

Bacterialspeciesisolated MIC

90 (µg/ml)

Staphylococcusaureus 0.5

coagulasenegativeStaphylococci 0.5

Streptococcusuberis 0.063

Streptococcusdysgalactiae ≤0.008

Streptococcusagalactiae 0.032

Cefquinomeasafourthgenerationcephalosporincombineshighcellularpenetrationandβ-

lactamasestability . Incontrasttocephalosporinsofpreviousgenerations,cefquinomeisnot

hydrolysedbychromosomally–encodedcephalosporinasesoftheAmp-Ctypeorbyplasmid

mediatedcephalosporinasesofsomeenterobacterialspecies.However,someextendedspectrum

beta-lactamases(ESBL)canhydrolysecefquinomeandcephalosporinsofothergenerations.

Thepotentialforresistancedevelopmentagainstcefquinomeisratherlow.High-levelresistance

tocefquinomewouldrequirethecoincidenceoftwogeneticmodifications,i.e.hyperproduction

ofspecificβ-lactamasesaswellasdecreasedmembranepermeability.

Nocross-resistancehasbeendescribedforthemechanismofalterationofpenicillinbinding

proteinencounteredinGrampositivebacteria.Resistanceduetochangesinmembrane

permeabilitymightresultincross-resistance.

5.2 Pharmacokineticparticulars

Resorptionofcefquinomefromtheuddertothesystemiccirculationisinsignificant.The

cefquinomeconcentrationsreachapeakinthedryuddersecretionsafter7to14daysand

slowlydecreaseduringthedryperiod.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Silicacolloidalhydrophobic,

Liquidparaffin

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

Pre-filledsyringeconsistingof:

- barrelmadefromhighdensitypolyethylene(HDPE)

- plungermadefromlowdensitypolyethylene(LDPE)

- capmadefromlowdensitypolyethylene(LDPE)

Boxof1sachetof4applicatorsand4cleaningtowels.

Boxof5sachetsof4applicatorsand20cleaningtowels.

Boxof15sachetsof4applicatorsand60cleaningtowels.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

Virbac

1èreavenue,2065M,L.I.D.06516Carros,France

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

25/03/2004

10 DATEOFREVISIONOFTHETEXT

February2009

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

None.

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