BRAUNODERM COLOURED

Main information

  • Trade name:
  • BRAUNODERM COLOURED
  • Dosage:
  • 1 %w/v
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BRAUNODERM COLOURED
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0179/025/001
  • Authorization date:
  • 05-06-1986
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BraunodermColouredIsopropylAlcohol500mg/gandIodinatedPovidone10mg/gCutaneousSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveIngredients:

100.0gsolutioncontains:

50.0gIsopropylAlcohol

1.0gIodinatedPovidone,withacontentof10%availableiodine

Excipients:

SunsetYellow(E110)0.075%w/w

Ponceau4R(E124)0.05%w/w

BrilliantBlackBN(E151)0.0015%w/w

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cutaneoussolution

Clear,brownsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asatopicalantisepticfordisinfectionofintactskin.

4.2Posologyandmethodofadministration

ApplyundilutedBraunodermcolouredtotheskinareatobedisinfectedandspreadwithsterileswab.Wettheskinto

betreatedcompletelyandthenletdry.

4.3Contraindications

Useinpatientswithhypersensitivitytoiodineortheotherexcipients.

Beforeandafterradio-iodine-therapy(untilcompletehealing).

4.4Specialwarningsandprecautionsforuse

Shouldevidenceoflocalirritationorsensitivityoccur,useoftheproductshouldcease.Ifnoimprovementoccurs,the

doctorshouldbeconsulted.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

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4.6Pregnancyandlactation

Caremustbetakeninthecaseofpregnantwomenandinfantsuptotheageof6months,aswellaspatientssuffering

fromnoninfectednodularstrumaeorlatenthyperthyreosis.

4.7Effectsonabilitytodriveandusemachines

Notrelevant.

4.8Undesirableeffects

Allergicreactions.

4.9Overdose

Becausethepreparationisonlyappliedlocally,nooverdosecanresult.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:

Dermatologicals,otherAntisepticsandDisinfectants,ATCCode:D08AX.

Alcoholicsolutionswithiodinatedpovidonecombinetheadvantagesoffastantimicrobialactionduetothealcohol

withabroadspectrumofactivityduetoiodine.

Althoughalcoholsarestudiedextensivelyasagroup,theirmodeofactionisnotclearlyunderstood.Themostplausible

explanationfortheantimicrobialactionofalcoholsisdenaturingofproteins.

5.2Pharmacokineticproperties

Alcoholiciodinatedpovidone-preparationsareusedasdisinfectantsforskin,thatmeansonlyforlocalapplication.

Iodineandisopropylalcoholarepoorlyabsorbedthroughintactskin.Afterapplicationthepreparationevaporates

readilyfromskinsurfaceandthereforeasystemicactionofsuchapreparationisunlikely.

Incaseofsystemicaction,e.g.afteraccidentaloraluptake,apartofisopropylalcoholismetabolisedslowlyby

oxidationtoacetoneandtheremainderisexcretedunchangedbythekidneysandthelungs.

Afteraccidentaloraluptakeiodinatedpovidone-preparations(whichareconvertedtoiodide)andiodidesaretrappedby

thethyroidglandafterresorption.Excessiodidesareexcretedmainlyintheurine,withsmalleramountsappearingin

thefaeces,salivaandsweat.Theycrosstheplacentalbarrierandareexcretedinbreastmilk.

5.3Preclinicalsafetydata

Applicationofisopropylalcoholtotheskinmaycausedrynessandirritation.Thelethaldosebymouthisreportedto

be250ml,buteven20mlproducetoxicsymptomslikeketoacidosisandketonuriaduetothemajormetabolite

acetone.Inhalationofisopropylalcoholvapourhasbeenreportedtoproducecoma.

Duetotheverygoodlocaltoleranceofiodinatedpovidone-preparationsaccidentaloraluptakedoesnotcausethesame

severecorrosiveeffectsaswrittenfornoncomplexediodine-preparations.

Thetoxicityofiodinatedpovidoneismainlydefinedfromtheintakeofiodineasiodideanditseffectonthethyroid.

Thethyroidissensitivetoanexcessofiodine.Goitreandhypothyroidism(ascanoccurwithiodinedeficiency)aswell

ashyperthyroidismcanresultfromthis.

Thenormaldailyrequirementrangesfrom100to300micrograms,quantitiesof500microgramsto1mgdaily

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production,butatstillhigherdoses,productiondecreases(Wolff-Chaikoffeffect).Thefallinthyroidhormone

productionisnormallytransient,adaptationoccurringonrepeatedadministration.Alackofadaptationmayproducea

chronicinhibitionofthyroidhormonesynthesisleadingtogoitreandhypothyroidismincertaincases.Congenital

goitreandhypothyroidismhavefollowedmaternalingestion.Neonateshavebeenaffectedfollowingmaternal

applicationofiodinatedpovidoneaswellasfollowingdirectapplicationtotheneonate.

Excessiodinemayalsoinducehyperthyroidism(Iod-Basedowphenomenon).Elderlysubjectsandthosewithnodular

goitreshavebeenfoundtobeatgreatestrisk.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Potassiumiodide

Purifiedwater

Sodiumdihydrogenphosphatedihydrate

SunsetyellowFCF(E110,C.I.15985)

Ponceau4R(E124,C.I.16255)

BrilliantblackBN(E151,C.I.28440)

6.2Incompatibilities

Iodinereactswithmercurycompoundsformingstronglycausticmercurousiodide.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.

6.5Natureandcontentsofcontainer

150ml,500ml,1000ml:Bottleofpolyethylene,closedwithascrewcapofpolypropylene.

5l:Bottleofpolyethylene,closedwithasealandascrewcapofpolyethylene.

Bottlesmaybeaccompaniedbyamechanicalpump-spray-head.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

B.BraunMedicalLimited

3NaasRoadIndustrialPark

NaasRoad

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8MARKETINGAUTHORISATIONNUMBER

PA179/25/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:5June1986

Dateoflastrenewal:5June2006

10DATEOFREVISIONOFTHETEXT

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