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

Main information

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

Documents

Localization

  • Available in:
  • Kenocidin SD
    Germany
  • 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

13-12-2018

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Published on: Wed, 12 Dec 2018 Studies evaluating the safety and efficacy of lactic and acetic acids to reduce microbiological surface contamination on pork carcasses pre‐chill and pork meat cuts post‐chill were assessed. Lactic acid treatments consisted of 2–5% solutions at temperatures of up to 80°C applied to carcasses by spraying or up to 55°C applied on cuts by spraying or dipping. Acetic acid treatments consisted of 2–4% solutions at temperatures of up to 40°C applied on carcasses by spraying or o...

Europe - EFSA - European Food Safety Authority Publications

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