Kenocidin

Main information

  • Trade name:
  • Kenocidin
  • Pharmaceutical form:
  • liquid dilution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Kenocidin
    Hungary
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Chlorhexidine
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0378/001
  • Authorization date:
  • 24-11-2010
  • EU code:
  • UK/V/0378/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:April2011

AN:01767/2009

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ForallCMSsexceptSpain

Kenocidin

Chlorhexidinedigluconate5mg/g,Teatdipsolutionforcattle(dairy)

ForSpain

Kenocidin

5mg/g,Teatdipsolutionforcattle(dairy)

Chlorhexidinedigluconate

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Qualitativecomposition

Activesubstance:

Chlorhexidinedigluconate

(Equivalenttochlorhexidine

Excipients:

PatentBlueV(E131)

OtherConstituents:

Glycerol

Allantoin

Forafulllistofexcipients,seesection

Quantitativecomposition

5.0mg/g

2.815mg/g)

0.03mg/g

51mg/g

1mg/g

3. PHARMACEUTICALFORM

TeatDipSolution

BlueViscousLiquid

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle(dairy).

4.2 Indicationsforuse,specifyingthetargetspecies

Teatdisinfectionasapartofapreventionstrategyformastitisinlactatingdairy

cows.

Forthemaintenanceofgoodteatskinandteatendcondition.

4.3 Contraindications

Donotuseincaseofknownhypersensitivitytochlorhexidineoranyofthe

excipients.

Revised:April2011

AN:01767/2009

4.4 Specialwarningsforeachtargetspecies

Ensureudderandteatsarecleananddrybeforethenextmilking.

4.5 Specialprecautionsforuse

i.Specialprecautionsforuseinanimals

Forexternaluseonly.

Allowproducttodrybeforeexposingthecowstowet(rainy),coldorwindy

conditions.

Ifthetemperatureisbelowfreezing,allowteatstoairdrybeforeletting

cowsoutside.

Useforthetreatmentofteatswithcutaneouslesionsmaydelaythewound

healingprocess.Itisrecommendedtodiscontinuethetreatmentuntilthe

lesionsarehealed.Thepresenceoforganicmatter(pus,blood,etc.)may

limittheactionofthedisinfectantchlorhexidine.

Ifsignsofdiseaseappear,consultaveterinarysurgeon.

ii.Specialprecautionsforthepersonadministeringtheveterinarymedicinal

producttoanimals

Avoidcontactwitheyes.Ifsplashedintheeye,rinsewithcleanrunning

waterandseekmedicaladvice.

Incaseofingestion,drinklargequantitiesofwaterandseekmedical

attentionimmediately.

Keepawayfromfoodandanimalfeed.

Washhandsafteruse.

Peoplewithknownhypersensitivitytochlorhexidineshouldavoidcontact

withtheveterinarymedicinalproduct.

iii.

Otherprecautions

None

4.6 Adversereactions(frequencyandseriousness)

Noneknown

4.7 Useduringpregnancy,lactationorlay

Canbeusedduringpregnancyandlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amount(s)tobeadministeredandadministrationroute

Theproductisreadytouseasapost-milkingteatdip,applieduptotwotimesper

day.

Revised:April2011

AN:01767/2009

Useatleast5mlpercowperapplication.

Diptheteatsimmediatelyaftermilkingeachcow.Ensurethattheteatis

completelycoveredtothreequartersofitslength.

Thedipcupshouldbereplenishedasnecessary.

Ifacommondipcupisusedforapplication,afreshsolutionshouldalwaysbe

usedateachmilking.Thedipcupshouldbeemptied,cleanedandrinsedafter

eachmilkingsessionorwhenthecupbecomescontaminatedduringmilking.Do

notpourtheremainingsolutionfromthedipcupbackintotheoriginalcontainer.

Donotusetheproductforcleaningand/orsanitizingmilkingequipment.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Notapplicable.Thisveterinarymedicinalproductisfortopicalapplication,

significantabsorptiondoesnotoccur.

4.11Withdrawalperiod(s)

MeatandOffal:Zerodays.

Milk:Zerohours

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:

Dermatologicals,antiseptic,disinfectantbasedonchlorhexidine

ATCVetCode:

QD08AC02

5.1 Pharmacodynamicproperties

Chlorhexidineisabisbiguanideantiseptic.Chlorhexidinehasabroad-spectrumof

activity.Itiscapableofrapidlyandcompletelykillingoncontactpracticallyall

vegetativebacteria.Chlorhexidinehasamycostaticactivityaswellandprevents

theoutgrowthofbacterialspores.

Chlorhexidinecausescellwalldisruption.Thisleadstomodification,orloss,of

permeabilityanddamage.Leakageofintracellularconstituentsoccursasa

consequenceofcelldeath.Releaseofcellconstituentsoccursatverylow

concentrations.Highconcentrationsofchlorhexidinecausecoagulationof

intracellularconstituents.Duetoelectrostaticinteractionwiththeacid

phospholipids,theprimarysiteofactionisthecytoplasmicmembrane.

Allspeciesofvegetativebacteriaaresusceptibletothisactionofchlorhexidine

andthereisnodocumentedresistancemechanisminthefield.

Chlorhexidineisanantiseptic.KENOCIDINhasbeentestedaccordingto

EuropeanStandardsEN1656(fieldconditions)againstStaphylococcusaureus,

Pseudomonasaeruginosa,Proteusvulgaris,Enterococcushirae,E.coli,S.

agalactiae,S.dysgalactiae,S.uberis,Corynebacteriumbovis,Streptococcus

bovis,Klebsiella,Citrobacter,Enterobacter.

Revised:April2011

AN:01767/2009

5.2 Pharmacokineticparticulars

Chlorhexidineisnotsignificantlyabsorbedthroughtheskinaftertopical

applicationandthereforenosystemicpharmacokineticactivityisindicated.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

PatentBlueV(E131)

Glycerol

Allantoin

IsopropylAlcohol

MacrogolStearate

Guar

MintOil,PartlyDementholised

CitricAcidMonohydrate

SodiumHydroxyde30%Solution

Water,Purified

6.2 Incompatibilities

Chlorhexidinecanbeinactivatedbyanionicandnonionicsurfactants(egsoaps,

evennatural)orinorganicanions,sodonotmixwithtapwater,otherchemicals,

disinfectantsandotherproductsfortheteatanduddercare

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:18months

Shelflifeafterfirstopeningtheimmediatepackaging:6months

6.4 Specialprecautionsforstorage

Keepcontainertightlyclosed

Protectfromfrost

Iftheveterinarymedicinalproducthasfrozen,thawinawarmplaceandshake

wellbeforeuse

Protectfromlight.

6.5 Natureandcompositionofimmediatepackaging

1litrewhitehigh-densitypolyethylenemultidosecontainers(HDPE)withHDPE

screw-capsando-ringseals.

5,10,20,25,60and200*litre,blueHDPEmultidosecontainerswithHDPEscrew-

capsando-ringseals.Theoversealonthe200litrespresentationisred.

Notallpacksizesmaybemarketed.

*The200litremultidosecontainershouldnotbereturnedforre-filling.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts,ifappropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

Revised:April2011

AN:01767/2009

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.Theproductshouldnotenterwatercoursesasthismaybe

dangerousforfishandotheraquaticorganisms.

UKOnly:Todisposeofunusedproducttolandyoumusthaveanauthorisation

undertheGroundwaterRegulations1998.

7 MARKETINGAUTHORISATIONHOLDER

CIDLINESN.V.

Waterpoortstraat2

8900Ieper

Belgium

8. MARKETINGAUTHORISATIONNUMBER

Vm22136/4002

9. DATEOFFIRSTAUTHORISATION

5November2009

10. DATEOFREVISIONOFTHETEXT

April2011

17-1-2013

Danish Pharmacovigilance Update, 15 November 2012

Danish Pharmacovigilance Update, 15 November 2012

In this issue of Danish Pharmacovigilance Update: Chlorhexidine and the risk of anaphylactic reaction.

Danish Medicines Agency

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