Bovidip 2% w/v Concentrate for Dip or Spray Solution

Main information

  • Trade name:
  • Bovidip 2% w/v Concentrate for Dip or Spray Solution
  • Pharmaceutical form:
  • Teat dip concentrate
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Bovidip 2% w/v Concentrate for Dip or Spray Solution
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Tars
  • Therapeutic area:
  • Cattle Females

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0331/001
  • Authorization date:
  • 07-01-2011
  • EU code:
  • UK/V/0331/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:November2012

AN.01679/2011

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Bovidip2%w/vConcentrateforTeatDiporSpraySolution

forcows.

2 QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:iodine,2%w/v

2gper100mlasavailableiodine(concentrate).

25mgper5mldoseasavailableiodine(ready-to-use

solution).

Excipients

Emollients: glycerol,10%w/v

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

ConcentrateforTeatDiporSpraySolution.

ClearBrownLiquid.

4. CLINICALPARTICULARS

4.1 Targetspecies

Bovine.

4.2 Indicationsforuse,specifyingthetargetspecies

Teatdisinfectionasanaidinthepreventionofmastitisinlactatingdairycows.

4.3 Contra-indications

Donotuseincasesofknownhypersensitivitytoiodine,ortoanyofthe

excipients.

Donotmixwithotherchemicals.

4.4 Specialwarningsforeachtargetspecies

Priortomilking,washteatswithanudderwashsolutionanddrywitha

disposablepapertowel.

Discardanyproductthatbecomescontaminated.

Revised:November2012

AN.01679/2011

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4.5 Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Allowproducttodrybeforeexposingthecowstowet(rainy),coldorwindy

conditions.

Useininjuredteatsmaydelaythewound-healingprocess.Itis

recommendedthattreatmentbediscontinueduntilteatlesionshave

resolved.

Ifsignsofdiseasepersistorappear,consultaveterinarysurgeon.

ii)Specialprecautionsforthepersonadministeringtheveterinarymedicinal

producttoanimals

Careshouldbetakenavoideyecontact.Incaseofeyecontact,flushthe

eyeswithcopiousamountsofwaterandseekmedicaladvice.

Incaseofingestion,drinklargequantitiesofwaterandobtainmedical

attentionassoonaspossible.

Whenusedasspray,avoidworkinginspraymist.

Washhandsafteruse.

Personswithiodineallergyshouldwearglovesandmask.

iii)Otherprecautions

None.

4.6 Adversereactions

Noneknown.

4.7. Useduringpregnancy,lactationorlay

Indicatedforuseduringpregnancyandlactation.

4.8.Interactionwithothermedicinalproductsandotherformsofinteraction

Theuseofthisproductinthespecifiedmanner(topicalantiseptic)hasno

knowninteractionswithothermedicamentsornutrition.

4.9.Amountstobeadministeredandadministrationroute

Dilutebeforeuse.Prepareafreshsolutiondaily.DiluteonepartofBovidip2%

w/vConcentrateforTeatDiporSpraySolutionwiththreepartsofcleanwater

andmixwell.Alwayscleanthedipcuporspraycontainerafteruse.

Amountstobeadministered:about5mlpercowperapplication.

Administrationroute:

oDipping:Dipeachteatimmediatelyaftermilkinginateatdipcup

containingdilutedproduct.Dipthefulllengthoftheteatsandreplenish

thedipcupasnecessary.

oSpraying:Spraytheentiresurfaceoftheteatsaftereachmilking.

Revised:November2012

AN.01679/2011

Page3of5

4.10.Overdose

Notapplicable.Theproductisfortopicalapplication.Significantabsorption

doesnotoccur.

4.11.Withdrawalperiods

Meat:Zerodays.

Milk:Zerohours.

5. PHARMACOLOGICALPROPERTIES

PharmacotherapeuticGroup:Productsforteatsandudders:Disinfectants

ATCVetCode:QG52A

5.1.Pharmacodynamicproperties

Iodinesolutionsreactwiththeorganicmatterofbacteriaandvirusestorender

themharmless.Themechanismofkillappearstobeduetoanoxidative-

reductivereaction,involvingvariouscellwallconstituents,whichare

irreversiblytransformed.Thesulphydryllinkages,inbacterialcellwall

components,arespecificallytargetedbyiodine.

Bovidip2%w/vConcentrateforTeatDiporSpraySolutionisbactericidal(EN

1040andEN1656)against:

Pseudomonasaeruginosa

Staphylococcusaureus

Enterococcushirae

Proteusvulgaris

5.2. Pharmacokineticparticulars

Literaturesuggeststhatabsorptionofiodinethroughtheskiniswellbelow

levelswhichwouldleadtopharmacokineticactivityinthebody.

6. PHARMACEUTICALPARTICULARS

6.1. Listofexcipients

WaterPurified

Glycerol

Macrogollaurylether

Poloxamer

Sodiumiodide

Citricacidmonohydrate

Sodiumhydroxide

Revised:November2012

AN.01679/2011

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6.2.Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmust

notbemixedwithotherveterinarymedicinalproducts.

6.3.Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:18months.

Shelflifeafterfirstopeningtheimmediatepackaging:6months.

Shelflifeafterdilutionaccordingtodirections:1day.

6.4.Specialprecautionsforstorage

Storeuprightinthetightlyclosedoriginalcontainer.

Donotstoreabove25°C.

Protectfromfrost.

Iftheproducthasfrozen,thawinawarmplaceandshakewellbeforeuse.For

thelargerpacksizes,theproductshouldberolledsufficientlytomixthe

solution.Undernocircumstancesshouldanattemptbemadetoshakethe60

or200litrepacks.

Protectfromlight.

6.5.Natureandcompositionofimmediatepackaging

High-densitypolyethylene5,10,20,60or200litrecansclosedwithhigh-

densitypolyethylenescrewcaps,securedwithasealingring.

The200litrecontainershouldnotbereturnedforre-filling.

Notallpacksizesmaybemarketed.

6.6.Specialprecautionsforthedisposalofunusedveterinarymedicinal

productsorwastematerialsderivedfromtheuseofsuchproducts,if

appropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

DeLavalInternationalAb

Industriepark-Drongen10

B-9031Gent

Belgium

8. MARKETINGAUTHORISATIONNUMBERS

UK: Vm17140/4008

Ireland: 10827/003/001

Revised:November2012

AN.01679/2011

Page5of5

9. DATEOFTHEFIRSTAUTHORISATION

09July2007

10. DATEOFREVISIONOFTHETEXT

November2012

5-7-2018

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Europe - EMA - European Medicines Agency