Kepravin Dry Cow 250mg Intramammary Suspension

Main information

  • Trade name:
  • Cepravin dry cow 250 mg
  • Pharmaceutical form:
  • Intramammary suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Cepravin dry cow 250 mg
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • cefalonium
  • Therapeutic area:
  • Cattle Lactating

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0343/001
  • Authorization date:
  • 25-07-2012
  • EU code:
  • UK/V/0343/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:September2012

AN:00840/2011

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

UK:KepravineDryCow250mgIntramammarySuspension

AT,CY,DE,EE,LT,LV,MT,NL:CepravinDryCow250mgIntramammarySuspension

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachintramammarysyringewith3gsuspensioncontains:

Activesubstance:

Cefalonium(ascefaloniumdihydrate) 0.25g

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Intramammarysuspension.

Whitetocreamcolouredsuspension.

4. CLINICALPARTICULARS

4.1Targetspecies

Dairycattle(cowsatdryingoff).

4.2Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofsubclinicalmastitisatdrying-offandthepreventionofnewbacterial

infectionsoftheuddercausedbyStaphylococcusaureus,Streptococcusagalactiae,

Streptococcusdysgalactiae,Streptococcusuberis,Arcanobacteriumpyogenes,

EscherichiacoliandKlebsiellaspp.duringthenon-lactatingperiodofcows.

4.3Contraindications

Nottobeadministeredtoanimalswhichareknowntobehypersensitiveto

cephalosporinantibioticsandotherβ-lactamantibiotics.

Pleaserefertosection4.7

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4.4Specialwarnings

None.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Donotbendthenozzle.

Donotcontaminatethenozzle.

Useoftheproductshouldbebasedonsusceptibilitytestingandshouldtakeinto

accountofficialandlocalantimicrobialpolicies.Increaseduse,includinguseofthe

productdeviatingfromtheinstructionsgivenintheSPC,mayincreasetheprevalenceof

bacteriaresistanttocefalonium.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandsafteruse.

Penicillinandcephalosporinsmaycausesensitisation(allergy)followinginjection,

inhalation,ingestionorskincontact.Sensitivitytopenicillinmayleadtocross-sensitivity

tocephalosporinandviceversa.Allergicreactionstothesesubstancesmay

occasionallybeserious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvised

nottoworkwithsuchpreparations.

Handlethisproductwithgreatcaretoavoidexposure,takingallrecommended

precautions.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrashyoushouldseek

medicaladviceandshowtheDoctorthiswarning.Swellingoftheface,lipsoreyesor

breathingdifficultiesaremoreserioussymptomsandrequireurgentmedicalattention.

4.6Adversereactions(frequencyandseriousness)

Noneknown

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4.7Useduringpregnancy,lactationorlay

Intendedforuseduringthelasttrimesterofpregnancyoncethelactatingcowhasbeen

driedoff.Thereisnoadversetreatmenteffectonthefoetus.

Nottobeusedinlactatingcows.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

Forintramammaryuse.

Thecontentofonesyringeshouldbeinfusedintotheteatcanalofeachquarter

immediatelyafterthelastmilkingofthelactation.Beforeinfusion,theteatshouldbe

thoroughlycleanedanddisinfectedwiththecleaningtowelprovided.Avoid

contaminationofthenozzleafterremovingthecap.

Option1:Forshortnozzleintramammaryadministration:holdthebarrelofthe

syringeandthebaseofthecapinonehandandtwistoffthesmallupperpartofthecap

abovetheindentmark(thebaseportionofthecapremainsonthesyringe).Takecare

nottocontaminatetheshortexposedpartofthenozzle.

Option2:Forfullnozzleintramammaryadministration:removethecapfullyby

holdingthebarrelofthesyringefirmlyinonehandandwiththethumbpushupandalong

thelengthofthecapuntilthecapclicksoff.Takecarenottocontaminatethenozzle.

Insertthenozzleintotheteatcanalandapplysteadypressureonthesyringeplunger

untilthefulldosehasbeendelivered.Holdingtheendoftheteatwithonehand,gently

massageupwardswiththeothertoaiddispersionoftheantibioticintothequarter.

Finallyimmersetheteatsinateatdip.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Repeateddosesincattleonthreeconsecutivedaysdidnotdemonstrateorproduceany

adverseeffects.

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4.11Withdrawalperiod(s)

Meatandoffal:

21days

Milk:

oIntervaltreatment- calving≥54days:withdrawalperiod=96hoursaftercalving.

oIntervaltreatment-calving<54days:withdrawalperiod=54daysplus96hours

aftertreatment,ensuringthatatleast7completemilkingsarediscarded.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Cephalosporinsandrelatedsubstances

ATCvetcode:QJ51DB90

5.1Pharmacodynamicproperties

Theproductisalong-actingintramammarysuspensioncontainingcefaloniumdihydrate,

asemi-syntheticcephalosporinantibiotic.Itisformulatedtogivepersistentantibiotic

levelsinthedryudder.

Cefaloniumisanantibacterialdrugofthecephalosporingroupwhichactsbyinhibition

ofcellwallsynthesis(bactericidalmodeofaction).Itischaracterisedbyitsbroad

therapeuticspectrumofactivityandahighstabilityagainstbeta-lactamases.

Cefaloniumisactiveagainst:Corynebacteriumbovis,Staphylococcusaureus,

Streptococcusagalactiae,Streptococcusdysgalactiae,Streptococcusuberis,

Escherichiacoli,Klebsiellaspp.andArcanobacteriumpyogenes.

MICdatawasgeneratedforGram-positiveandGram-negativeisolatesovertheperiod

2000to2006.Particularregardwaspaidtothefollowingmastitispathogens:

Staphylococcusaureus,Streptococcusagalactiae,Streptococcusdysgalactiae,

Streptococcusuberis,Escherichiacoli,Klebsiellaspp.andArcanobacterium

pyogenes.AnoverviewoftheMIC

90 values

ofthesebacterialmastitispathogensis

presentedinthetablebelow:

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Table1:Summaryofsusceptibilitydataforcefaloniumagainstmastitisisolatesfrom

theperiod2000to2006

Organism YearofIsolation n MICrange

(µg/mL) MIC

90

(µg/mL)

Staphylococcus

aureus 2000 –2006 120 ≤0.03–0.125 0.125

Streptococcus

agalactiae 2004-2005 11 0.0078 –0.0156 0.0156

Streptococcus

dysgalactiae 2000-2006 123 0.00375 –0.06 0.0078

Streptococcus

uberis 2000-2005 1200.00375 –0.125 0.06

Arcanobacteriu

mpyogenes 2000-2006 38 0.03 –0.125 0.125

Escherichiacoli 2000 –2006

64 0.5 –4

2

Klebsiellaspp. 2000 –2006

64 1-4 2

.CattletreatedwithCepravinDryCowhavelowersomaticcellcountsaftercalving.

5.2Pharmacokineticparticulars

Pharmacokineticsofcefaloniuminthetargetspecieshasbeeninvestigatedfollowing

intramammaryadministrationinseveralstudies.Thepresenceofcefaloniumand/orits

biologicallyactivemetaboliteswasdetectedinurineandserum.

Cefaloniumisextensivelybutslowlyabsorbedfromtheudderandexcretedprimarilyin

theurine.Between7and13%oftheactivesubstanceiseliminatedinurineoneachof

thefirstthreedayspostdosingwhilstdailyexcretioninfaecesis<1%overthesame

period.

Meanbloodconcentrationremainsfairlyconstantduringapproximately10daysafter

dosingwhichisconsistentwithslowbutprolongedabsorptionofcefaloniumfromthe

udder.

Thelongtermpersistenceofcefaloniuminthedryudderwasexaminedoveratime

spanof10weeksafterinfusion.Efficientlevelsofcefaloniuminuddersecretaremained

upto10weeksafterinfusion.

6. PHARMACEUTICALPARTICULARS

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6.1Listofexcipients

Aluminiumdistearate

Liquidparaffin

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelflifeoftheveterinarymedicalproductaspackagedforsale:3years

6.4.Specialprecautionsforstorage

Donotstoreabove30

C

Donotfreeze

6.5Natureandcompositionofimmediatepackaging

Singledose3gwhitepolyethylenesyringeswitharedpolyethylenedualpush-fitcap.

Boxesof20intramammarysyringeswithcleaningtowels.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

IntervetUKLimited

WaltonManor

Walton

MiltonKeynes

Buckinghamshire

MK77AJ

8. MARKETINGAUTHORISATIONNUMBER

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AN:00840/2011

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Vm01708/4587

9. DATEOFFIRSTAUTHORISATION

24September2012

10 DATEOFREVISIONOFTHETEXT

September2012