Kenocidin SD 5mg/g chlorhexidine, Teat dip/Teat spray solution for cattle (dairy)

Main information

  • Trade name:
  • Kenocidin SD 5mg/g chlorhexidine, Teat dip/Teat spray solution for cattle (dairy)
  • Pharmaceutical form:
  • liquid dilution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Kenocidin SD 5mg/g chlorhexidine, Teat dip/Teat spray solution for cattle (dairy)
    Romania
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0390/001
  • Authorization date:
  • 20-04-2011
  • EU code:
  • UK/V/0390/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:July2011

AN:00516/2010

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ForallCMSsexceptSpain

KenocidinSPRAYANDDIP

Chlorhexidinedigluconate5mg/g,TeatDip/TeatSpraysolutionforcattle(dairy)

ForSpain

KenocidinSPRAYYBAÑO

5mg/g,Teatdip/TeatSpraysolutionforcattle(dairy)

Chlorhexidinedigluconate

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Qualitativecomposition

Activesubstance:

Chlorhexidinedigluconate

(Aschlorhexidine

Excipients:

PatentBlueV(E131)

OtherConstituents:

Glycerol

Allantoin

Forafulllistofexcipients,seesection

Quantitativecomposition

5.0mg/g

2.815mg/g)

0.03mg/g

60mg/g

1mg/g

3. PHARMACEUTICALFORM

TeatDip/TeatSpraySolution

BlueLiquidSolution

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle(dairy).

4.2 Indicationsforuse,specifyingthetargetspecies

Teatdisinfectionasapartofapreventionstrategyformastitisinlactatingdairy

cows.

Forthemaintenanceofgoodteatskinandteatendcondition.

Revised:July2011

AN:00516/2010

4.3 Contraindications

Donotuseincasesofknownhypersensitivitytochlorhexidineoranyofthe

excipients.

4.4 Specialwarningsforeachtargetspecies

Ensureudderandteatsarecleananddrybeforethenextmilking.

4.5 Specialprecautionsforuse

i.Specialprecautionsforuseinanimals

Ifsignsofdiseaseappear,orpersist,consultaveterinarysurgeon.

Forexternaluseonly.

Allowproducttodrybeforeexposingthecowstowet(rainy),coldorwindy

conditions.

Ifthetemperatureisbelowfreezing,allowteatstoairdrybeforeletting

cowsoutside.

Useforthetreatmentofteatswithcutaneouslesionsmaydelaythewound

healingprocess.Itisrecommendedtodiscontinuethetreatmentuntilthe

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

limittheactionofthedisinfectantchlorhexidine.

ii.Specialprecautionsforthepersonadministeringtheveterinarymedicinal

producttoanimals

Avoidcontactwitheyes.Ifsplashedintheeye,rinsewithcleanrunning

waterandseekmedicaladvice.

Incaseofingestion,drinklargequantitiesofwaterandseekmedical

attentionimmediately.

Keepawayfromfoodandanimalfeed.

Washhandsafteruse.

Whentheproductisusedasaspray,avoidworkinginspraymist.

Peoplewithknownhypersensitivitytochlorhexidineshouldavoidcontact

withtheproduct.

iii.

Otherprecautions

None

4.6 Adversereactions(frequencyandseriousness)

Noneknown.

4.7 Useduringpregnancy,lactationorlay

Canbeusedduringpregnancyandlactation.

Revised:July2011

AN:00516/2010

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amount(s)tobeadministeredandadministrationroute

Theproductisreadytouseasapost-milkingteatdiporspray,applieduptotwo

timesperday.

Useatleast5mlpercowperapplication.

Diptheteatsimmediatelyaftermilkingeachcow.Ensurethattheteatis

completelycoveredtothreequartersofitslength.Alternatively,spraytheentire

surfaceofeachteatimmediatelyaftermilking.

Thedipcuporsprayershouldbereplenishedasnecessary.

Ifacommondipcuporsprayerisusedforapplication,afreshsolutionshould

alwaysbeusedateachmilking.Thedipcuporsprayershouldbeemptied,

cleanedandrinsedaftereachmilkingsessionorwhenthecuporsprayer

becomescontaminatedduringmilking.Donotpourtheremainingsolutionfrom

thedipcuporsprayerbackintotheoriginalcontainer.Donotusetheproductfor

cleaningand/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-spectrum

efficacy.Itiscapableofrapidlyandcompletelykillingoncontactpracticallyall

vegetativebacteria.Chlorhexidinehasamycostaticactivityaswellandprevents

theoutgrowthofbacterialspores.

Chlorhexidinecausescellwalldisruption.Thisleadstomodification,orloss,of

permeabilityanddamage.Leakageofintracellularconstituentsoccursasa

consequenceofcelldeath.Releaseofcellconstituentsoccursatverylow

concentrations.Highconcentrationsofchlorhexidinecausecoagulationof

intracellularconstituents.Duetoelectrostaticinteractionwiththeacid

phospholipids,theprimarysiteofactionisthecytoplasmicmembrane.

Revised:July2011

AN:00516/2010

Allspeciesofvegetativebacteriaaresusceptibletothisactionofchlorhexidine

andthereisnodocumentedresistancemechanism.

Chlorhexidineisanantiseptic.KENOCIDINSPRAYANDDIPhasbeentested

accordingtoEuropeanStandardsEN1656(fieldconditions)against

Staphylococcus aureus, Pseudomonas aeruginosa, Proteus vulgaris,

Enterococcushirae,E.coli,S.agalactiae,S.dysgalactiae,S.uberis,

Corynebacterium bovis, Streptococcus bovis, Klebsiella, Citrobacter,

Enterobacter.

5.2 Pharmacokineticproperties

Chlorhexidineisnotsignificantlyabsorbedthroughtheskinaftertopical

applicationandthereforenosystemicpharmacokineticactivityisindicated.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

PatentBlueV(E131)

Glycerol

Allantoin

IsopropylAlcohol

MacrogolStearate

MintOil,PartlyDementholised

CitricAcidMonohydrate

SodiumHydroxyde30%Solution

Water,Purified

6.2 Incompatibilities

Chlorhexidinecanbeinactivatedbyanionicandnonionicsurfactants(egsoaps,

evennatural)orinorganicanions,sodonotmixwithtapwater,otherchemicals,

disinfectantsandotherproductsfortheteatanduddercare.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:18months

Shelflifeafterfirstopeningtheimmediatepackaging:6months

Revised:July2011

AN:00516/2010

6.4 Specialprecautionsforstorage

Keepcontainertightlyclosed.

Protectfromfrost

Iftheveterinarymedicinalproducthasfrozen,thawinawarmplaceandshake

wellbeforeuse

Protectfromlight

6.5 Natureandcompositionofimmediatepackaging

1litrewhitehigh-densitypolyethylenemultidosecontainers(HDPE)withHDPE

screwcapsando-ringseals.

5,10,20,25,60and200*litre,blueHDPEmultidosecontainersanddrumswith

HDPEscrewcapsando-ringseals.Theoversealonthe200litrepresentationis

red.

Notallpacksizesmaybemarketed.

*The200litrecontainershouldnotbereturnedforre-filling.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts,ifappropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.Theproductshouldnotenterwatercoursesasthismaybe

dangerousforfishandotheraquaticorganisms.

7 MARKETINGAUTHORISATIONHOLDER

CIDLINESN.V.

Waterpoortstraat2

8900Ieper

Belgium

8. MARKETINGAUTHORISATIONNUMBERS

UK:Vm22136/4003

IE:VPAnumber:10792/004/001

9. DATEOFFIRSTAUTHORISATION

17November2009

10. DATEOFREVISIONOFTHETEXT

July2011