Suredip

Main information

  • Trade name:
  • Suredip Concentrate
  • Pharmaceutical form:
  • Teat dip concentrate
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Suredip Concentrate
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Cattle Lactating, Goats Lactating, Sheep Lactating

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0161/001
  • Authorization date:
  • 15-12-2011
  • EU code:
  • UK/V/0161/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:December2011

AN:01307/2011

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

UK:SUREDIP3.7%CONCENTRATEforTeatDiporTeatSpray

Eire:HEXAGUARD3.7%CONCENTRATEforTeatDiporTeatSpray

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveIngredient:

Chlorhexidinegluconatesolution(20%Ph.Eur)toprovideconcentrationof

Chlorhexidinegluconate3.70%w/v.

Otherconstituents:Fulllistofexcipientsisgivenin6.1

1.LanolinCompound

2.Glycerol

3.Alcohol6molethoxylate:3molepropoxylate

4.Ethyleneoxide/propyleneoxideblockco-polymer

5.PatentblueV(dye –E131)

6.Waterdeionised

3. PHARMACEUTICALFORM

ConcentrateforTeatDiporTeatSpraysolution

Requiresdilutionbeforeuse

4. CLINICALPARTICULARS

Thisproductcontainschlorhexidinegluconateasabiocide.Theagentisa

bactericidaldisinfectantwhichbelongstothebiquanidinegroupof

cationicsurfactantsthatactbydisruptingcellularmatter.

Theemollientsaidinteatcareandhealth.

4.1 Targetspecies

Pregnantandlactatingdairycows,sheepandgoats

4.2 Indicationsforuse,specifyingthetargetspecies

Whenusedasateatdip/teatsprayisanaidinthepreventionofthe

spreadofmastitisinlactatingdairycattle,sheepandgoats.

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4.3 Contraindications

None

4.4 Specialwarningsforeachtargetspecies

Forexternaluseonly.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Washanddryuddersandteatsbeforenextmilking.Emptyteatdipping

beakersaftereachmilkingandwashbeforereuse.

Ifsignsofdiseasepersistorappearconsultyourveterinarysurgeon.

ii. Specialprecautionsforthepersonadministeringtheveterinarymedicinal

producttoanimals

Avoidcontactwitheyes.Ifsplashedintheeye,rinsewithcleanrunning

waterandseekmedicaladvice.

Incaseofingestionseekmedicaladviceimmediately.

Whenusedasaspray,avoidworkinginaspraymist.

Keepawayfromanimalfeed.

Washhandsafteruse.

iii.

Otherprecautions

None.

4.6 Adversereactions(frequencyandseriousness)

SkinsensitivitytoChlorhexidineisrareandnosuspectedadverse

reactionshavebeenreportedsofar.

4.7 Useduringpregnancy,lactationorlay

Foruseinpregnantandlactatingcows,sheepandgoats.Theproductis

amedicinaldisinfectantforexternalapplicationasanaidagainstmastitis.

4.8 Interactionwithothermedicinalproductsandotherformsof

interaction

Donotuseinconjunctionwithanyothertreatmentfordisinfectionof

teats/udders –notcompatiblewithiodinebasedteatdips.

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4.9

Amount(s)tobeadministeredandadministrationroute

SuredipConcentrateisapreparationthatshouldbedilutedpriorto

use.

TeatDipping

Makeupastocksolutiondailybydiluting1partofSuredip(Hexaguard)

Concentratewith4partsofwater.Thestocksolutionwillcontain7400

ppmchlorhexidinegluconate.

Fillthedippingbeakerstwothirds(2/3)fullandapplytotheteatsofthe

lactatingcows,sheeporgoatsimmediatelyaftermilking.Thedipping

beakersshouldbeemptiedaftereachmilkingandwashedbeforereuse.

Replenishdippingbeakersaftereachmilking.

TeatSpraying

Makeastocksolutiondailybydiluting1partofSuredip(Hexaguard)

Concentrateto4partsofwater.Immediatelyafterthemilkingofcows,

sheepandgoatsspraytheentiresurfaceofeachteat.Thestocksolution

willcontain7400ppmchlorhexidinegluconate.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),if

necessary

Notapplicable –externalteatsurfacetreatmentonly.

4.11 Withdrawalperiod(s)

MeatandMilk:Zerodays

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:

VeterinaryDisinfectant:Dermatologicals:

Antisepticsanddisinfectants:Chlorhexidine

ATCVetCode:QD08AC02

5.1 Pharmacodynamicproperties

Theactiveingredientisadisinfectantwithbactericidalactivityagainst

mostbacteria.Thepostmilkingtopicalapplicationofthe(diluted)product

totheteatsoflactatingcows,sheepandgoatspreventstheingressof

pathogenicorganismsintothestreakcanaloftheteatandtherebyaidsin

thepreventionofthespreadofmastitisfrominfectedquarterstonon-

infectedquarters.

5.2 Pharmacokineticproperties

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WorkdonebytheInstituteforAnimalHealth,Compton,Newbury,UKin

1991demonstratesthatpostmilkingtopicalapplicationoftheproductto

theteatsoflactatingcows,resultedintheabsorptionintomilkofalevelof

theactiveingredientnotexceeding10ppb.

6.

PHARMACEUTICALPARTICULARS

Suredip(Hexaguard)Concentrateisapreparationthatshouldbediluted

priortousewhichcontainschlorhexidinegluconateandemollientsasan

aidinthepreventionofthespreadofmastitisinlactatingdairycattle,

sheepandgoats.

6.1 Listofexcipients

Glycerol(CASNo.56-81-5),

WatersolubleLanolincompound(CASNo.61790-81-6),

PatentblueV(dye –E131),

polymericnon-ionicsurfactants:Alcohol6moleethoxylate:3mole

propoxylate(CASNo.68154-97-2)andEthyleneoxide/propyleneoxide

blockcopolymer(CASNo.90003-11-6)

6.2 Incompatibilities

Chlorhexidinegluconateisincompatiblewithsoapsorwashingupliquids

oranionicsurfactants.Donotmixwithsodiumhypochloritesolutionsor

alkalinemixtures.

Donotmixwithiodinebasedteatdips.

6.3 Shelflife

Twoyears

6.4 Specialprecautionsforstorage

Storeoutofthereachandsightofchildren.

Donotstoreabove25°C.

Protectfromfrost.

Protectfromdirectsunlight.

6.5 Natureandcompositionofimmediatepackaging

SuredipConcentrateispackedin:

1.5litreliquidteatdipinblowmouldedhighdensitypolyethylene

jerricanstylecontainerscompletewithtamperevidentscrewcap

2.20,25and45Lliquidteatdipinanaturalsquare/roundhigh

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densitypolythenecontainerwithscrewcap(tamperevident)

closure.

3.200Lliquidteatdipinacylindricalpolyethylenecontainerwith

combinationbung.

6.6 Specialprecautionsforthedisposalofunusedveterinary

medicinalproductorwastematerialsderivedfromtheuseofsuch

products,ifappropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfrom

suchveterinarymedicinalproductsshouldbedisposedofinaccordance

withlocalrequirements.

Harmfultofish.Donotcontaminatepondsorditcheswiththisproductor

usedcontainer.

7. MARKETINGAUTHORISATIONHOLDER

GEAFarmTechnologies(UK)Ltd

WylyeWorks

WateryLane

Bishopstrow

Warminster

Wiltshire

BA129HT

8. MARKETINGAUTHORISATIONNUMBER(S)

UK: Vm 01808/4013Eire:VPA10844/4/1

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHE

AUTHORISATION

Date:1 st

August2002

10. DATEOFREVISIONOFTHETEXT

Date:December2011

Conditionsofsale,supplyand/oruse:

Inaccordancewithnationalrequirements.