Cobactan 2.5%

Main information

  • Trade name:
  • Cobactan 2.5%
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Cobactan 2.5%
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • cefquinome
  • Therapeutic area:
  • Cattle Food, Pigs Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0130/001
  • Authorization date:
  • 23-09-2011
  • EU code:
  • UK/V/0130/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:April2012

AN:01965/2011

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

COBACTAN2.5%w/vsuspensionforinjectionforcattleandpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlsuspensionforinjectioncontains:

Activesubstance:

Cefquinome(assulfate)25mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Suspensionforinjection

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattleandpigs

4.2 Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofbacterialinfectionsincattleandpigscausedbythe

GrampositiveandGramnegativemicroorganismssensitiveto

cefquinome.

Cattle:

RespiratorydiseasecausedbyPasteurellamultocidaandMannheimia

haemolytica

Digitaldermatitis,infectiousbulbarnecrosisandacuteinterdigital

necrobacillosis(foulinthefoot)

AcuteE.colimastitiswithsignsofsystemicinvolvement

Calves:

E.colisepticaemiaincalves

Pigs:

Forthetreatmentofbacterialinfectionsofthelungsandrespiratorytract

causedbyPasteurellamultocida,Haemophilusparasuis,Actinobacillus

pleuropneumoniae,Streptococcussuisandothercefquinome-sensitive

organisms

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Mastitis-Metritis-Agalactiasyndrome(MMA)withinvolvementofE.coli,

Staphylococcusspp.,Streptococcusspp.andothercefquinome

sensitiveorganisms

Piglets:

ReductionofmortalityincasesofmeningitiscausedbyStreptococcus

suis.

Forthetreatmentof:

ArthritiscausedbyStreptococcusssp.,E.coliandothercefquinome-

sensitiveorganisms.

Epidermitis(mildormoderatelesions)causedbyStaphylococcus

hyicus.

4.3 Contraindications

DonotuseCobactan2.5%inanimals,whichareknowntobe

hypersensitivetoß-lactamantibiotics.

Donotadministertoanimalslessthan1.25kgbodyweight.

Donotuseinpoultry(includingeggs)duetoriskofspreadof

antimicrobialresistancetohumans.

4.4Specialwarnings<foreachanimaltargetspecies>

None

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Cobactan2.5%selectsforresistantstrainssuchasbacteria

carryingextendedspectrumbetalactamases(ESBL)whichmay

constitutearisktohumanhealthifthesestrainsdisseminateto

humanse.g.viafood.Forthisreason,Cobactan2.5%shouldbe

reservedforthetreatmentofclinicalconditionswhichhave

respondedpoorly,orareexpectedtorespondpoorly(refersto

veryacutecaseswhentreatmentmustbeinitiatedwithout

bacteriologicaldiagnosis),tofirstlinetreatment.Official,national

andregionalantimicrobialpoliciesshouldbetakenintoaccount

whentheproductisused.Increaseduse,includinguseofthe

productdeviatingfromtheinstructionsgivenintheSPC,may

increasetheprevalenceofsuchresistance.Wheneverpossible,

Cobactan2.5%shouldonlybeusedbasedonsusceptibility

testing.

Cobactan2.5%isintendedfortreatmentofindividualanimals.Do

notusefordiseasepreventionorasapartofherdhealth

programmes.Treatmentofgroupsofanimalsshouldbestrictly

restrictedtoongoingdiseaseoutbreaksaccordingtothe

approvedconditionsofuse.

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UserWarnings

1.Donothandlethisveterinarymedicinalproductifyouknowyouare

sensitized,orifyouhavebeenadvisednottoworkwithsuch

preparation.

2.Handlethisveterinarymedicinalproductwithgreatcaretoavoid

exposure,takingallrecommendedprecautions.

3.Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,you

shouldseekmedicaladviceandshowthedoctorthiswarning.

Swellingoftheface,lipsoreyesordifficultywithbreathing,aremore

serioussymptomsandrequireurgentmedicalattention.

4.Cephalosporinsmaycausehypersensitivity(allergy)following

injection,inhalation,ingestionorskincontact.Hypersensitivityto

penicillinsmayleadtocrosssensitivitytocephalosporinsandvice

versa.Allergicreactionstothesesubstancesmayoccasionallybe

serious.

4.6 Adversereactions(frequencyandseriousness)

Useoftheveterinarymedicinalproductmayresultinlocalizedtissue

reaction.Tissuelesionsarerepaired15daysafterthelast

administrationoftheveterinarymedicinalproduct.

Hypersensitivityreactionstocephalosporinsoccurrarely.

4.7Useduringpregnancyandlactation

Thereisnoavailableinformationindicatingreproductivetoxicityincattle

orpigs.Inreproductiontoxicitystudiesinlaboratoryanimalscefquinome

didnotrevealanyeffectonreproductionorteratogenicpotential.

Useonlyaccordinglytothebenefit/riskassessmentbytheresponsible

veterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsof

interaction

Itisknownthatacrosssensitivitytocephalosporinexistsforbacteria

sensitivetothecephalosporingroup.

Duetoundesirablepharmacodynamicinteraction,donotapply

cefquinomesimultaneouslywithpharmaceuticalsacting

bacteriostatically.

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4.9 Amountstobeadministeredandadministrationroute

SpeciesIndication

Dosage Frequency

Cattle Respiratorydisease

causedbyPasteurella

multocidaand

M.haemolytica 1mgcefquinome/kg

bw(2ml/50kgbw) Oncedailyfor3or

5consecutivedays

Digitaldermatitis,

infectiousbulbar

necrosisandacute

interdigital

necrobacillosis(foulin

thefoot)

AcuteE.colimastitis

withsignsofsystemic

involvement 1mgcefquinome/kg

bw(2ml/50kgbw) Oncedailyfor2

consecutivedays

Calves E.colisepticaemia 2mgcefquinome/kg

bw(4ml/50kgbw) Oncedailyfor3or

5consecutivedays

Pigs

Respiratorydisease 2mgcefquinome/kg

bw(2ml/25kgbw) Oncedailyfor3

consecutivedays.

MMA 2mgcefquinome/kg

bw(2ml/25kgbw) Oncedailyfor2

consecutivedays.

Piglets

Meningitis

Arthritis

Epidermitis 2mgcefquinome/kg

bw(2ml/25kgbw) Oncedailyfor5

consecutivedays

Alltreatmentstobegivenbyintramuscularinjection.Studieshave

indicatedtheadvisabilityofgivingsecondandsubsequentinjectionsat

adifferentinjectionsite.Thepreferredinjectionsiteisinmusculartissue

inthemidneck'

Toensureacorrectdosage,bodyweightshouldbedeterminedas

accuratelyaspossibletoavoidunderdosing.

Shakethevialwellbeforeusing.

Theveterinarymedicinalproductdoesnotcontainanantimicrobial

preservative.Swabtheseptumbeforeremovingeachdose.Useadry

sterileneedleandsyringe.Anappropriatelygraduatedsyringemustbe

usedtoallowaccurateadministrationoftherequireddosevolume.This

isparticularlyimportantwheninjectingsmallvolumes,forexamplewhen

treatingpiglets.Thecapmaybesafelypuncturedupto25times.The

50mlvialshouldbeusedfortreatingsmallpiglets.Whentreatinggroups

ofanimals,useadraw-offneedle.

4.10Overdose(symptoms,emergencyprocedures,antidotes),if

necessary

Overdosesof20mg/kg/dayincattleand10mg/kg/dayinpigsand

pigletshavebeenwelltolerated.

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4.11Withdrawalperiods

Species Product WithdrawalPeriod

Cattle Meatandoffal 5days

Cattle Milk 24hours

Pigs Meatandoffal 3days

5. PHARMACOLOGICALPROPERTIES

Pharmaceuticgroup:Cephalosporinsandrelatedsubstances

ATCvetcode:QJ01DE90

Theantibacterialdrugcefquinomeisabroad-spectrumcephalosporinof

thefourth-generationwhichactsbyinhibitionofthecellwallsynthesis.It

isbactericidalandischaracterizedbyitsbroadtherapeuticspectrumof

activityandahighstabilityagainstpenicillinasesandbeta-lactamases.

5.1Pharmacodynamicproperties

InvitroactivityhasbeendemonstratedagainstcommonGrampositive

andGramnegativebacteriaincludingEscherichiacoli,Citrobacterspp.,

Klebsiellaspp.,Mannheimiahaemolytica,Pasteurellamultocida,

Proteusspp.,Salmonellaspp.,Serratiamarcescens,Haemophilus

somnus,Arcanobacteriumpyogenes,Bacillusspp.,Corynebacterium

spp.,Staphylococcusspp.,Streptococcusspp.,Bacteroidesspp.,

Clostridiumspp.,Fusobacteriumspp.,Prevotellaspp.,Actinobacillus

spp.andErysipelothrixrhusiopathiae.

Bacterialstrainswereisolatedbetween1999and2002fromcattleand

pigspresentingdiseasescorrespondingtotargetindicationsin

Germany,France,TheNetherlandsandUnitedKingdom.Froma

sampleofmorethan350isolates,97.7%werefoundtobesusceptible

tocefquinome(resistancebreakpointof4µg/mL).Thesesusceptible

strainshadMIClevelsrangingfrom<0.004to2µg/mL.

Investigationswhichhavebeendonebetween2000and2004on304

MannheimiahaemolyticaandPasteurellamultocidaisolateshave

shownasusceptibilityrateof100%withaMICof

0.008to0.125

g/ml(limitingconcentrationforsusceptibility:2

g/ml).

Cefquinomeasafourthgenerationcephalosporincombineshigh

cellular penetration and ß-lactamase stability. In contrast to

cephalosporinsofpreviousgenerations,cefquinomeisnothydrolysed

bychromosomally –encodedcephalosporinasesoftheAmp-Ctypeorby

plasmidmediatedcephalosporinasesofsomeenterobacterialspecies.

However,someExtendedSpectrumbeta-lactamases(ESBL)can

hydrolysecefquinomeandcephalosporinsofothergenerations.The

potentialforresistancedevelopmentagainstcefquinomeisratherlow.

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High-levelresistancetocefquinomewouldrequirethecoincidenceof

twogeneticmodifications,i.e.hyperproductionofspecificß-lactamases

aswellasdecreasedmembranepermeability.

5.2Pharmacokineticparticulars

Incattlepeakserumconcentrationsofabout2µg/mlarereachedwithin

1.5-2hoursafterintramuscularorsubcutaneousadministrationatthe

doseof1mg/kg.Cefquinomehasarelativelyshorthalf-life(2.5hours),

is<5%proteinboundandexcretedunchangedintheurine.

Cefquinomeisnotabsorbedafteroraladministration.

Inpigsorpiglets,at2mg/kgdosage,maximumserumconcentrationsof

around5µg/mlaremeasuredwithin15to60minutesafter

intramuscularinjection.Theaveragehalf-lifeisabout9hours.

Cefquinomebindspoorlytoplasmaproteinsandthereforepenetrates

intothecerebrospinalfluid(CSF)andthesynovialfluidinpigs.The

concentrationprofileissimilarbetweenthesynovialfluidandthe

plasma.TheconcentrationsreachedintheCSF12hoursafter

treatmentaresimilartothoseinplasma.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Ethyloleate

6.2Incompatibilities

Noneknown

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2

years

Shelf-lifeafterfirstopeningoftheimmediatepackaging:28days

6.4.Specialprecautionsforstorage

Donotstoreabove25°C.Protectfromlight.

6.5Natureandcompositionofimmediatepackaging

Cartoncontainingone50mlor100mlcolourlessglassbottle,typeII

withagreyepichlorhydrinerubberstopper,fluoropolymercoated,typeI

closureandsealedwithaluminumcaps.

Notallpacksizesmaybemarketed.

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6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialshouldbe

disposedofinaccordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

Marketingauthorisationholder:

IntervetInternationalB.V.

WimdeKörverstraat35

5831ANBoxmeer

TheNetherlands

Representedby:

IntervetUKLtd.

WaltonManor

Walton

MiltonKeynes

MK77AJ

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm 01708/4452

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHE

AUTHORISATION

Date:08November1993

10. DATEOFREVISIONOFTHETEXT

Date:April2012