BRAUNODERM NON-COLOURED

Main information

  • Trade name:
  • BRAUNODERM NON-COLOURED
  • Dosage:
  • 500/ 10 mg/ g
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0179/025/002
  • Authorization date:
  • 08-04-1987
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BraunodermNon-Coloured,IsopropylAlcohol500mg/gandIodinatedPovidone10mg/gCutaneousSolution.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Activeingredients:

100gsolutioncontains:

50.0gIsopropylAlcoholPh.Eur.

1.0gIodinatedPovidonePh.Eur.,withacontentof10%availableiodine.

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Cutaneoussolution.

Clear,brownsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asatopicalantisepticfordisinfectionofintactskin.

4.2Posologyandmethodofadministration

ApplyundilutedBraunodermnon-colouredtotheskinareatobedisinfectedandspreadwithsterileswab.Wettheskin

tobetreatedcompletelyandthenletdry.

4.3Contraindications

Useinpatientswithhypersensitivitytoiodineortheotherexcipients.

Beforeandafterradio-iodine-therapy(untilcompletehealing).

4.4Specialwarningsandprecautionsforuse

Nonestated.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Iodinereactswithmercurycompoundsformingstronglycausticmercurousiodide.

4.6Pregnancyandlactation

Caremustbetakeninthecaseofpregnantwomenandinfantsuptotheageof6months,aswellaspatientssuffering

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4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Allergicreactions.

4.9Overdose

Becausethepreparationisonlyappliedlocally,nooverdosecanresult.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Alcoholicsolutionswithpovidone,iodinatedcombinetheadvantagesoffastantimicrobialactionduetothealcohol

withabroadspectrumofactivityduetoiodine.

Althoughalcoholsarestudiedextensivelyasagroup,theirmodeofactionisnotclearlyunderstood.Themostplausible

explanationfortheantimicrobialactionofalcoholsisdenaturingofproteins.

5.2Pharmacokineticproperties

Alcoholicpovidone,iodinatedpreparationsareusedasdisinfectantsforskin(thatmeansonlyforlocalapplication).

Iodineandisopropylalcoholarepoorlyabsorbedthroughintactskin.Afterapplicationthepreparationevaporates

readilyfromskinsurfaceandthereforeasystemicactionofsuchapreparationisunlikely.

Incaseofsystemicaction,e.g.afteraccidentaloraluptake,apartofisopropylalcoholismetabolisedslowlyby

oxidationtoacetoneandtheremainderisexcretedunchangedbythekidneysandthelungs.

Afteraccidentaloraluptakepovidone,iodinatedpreparations(whichareconvertedtoiodide)andiodidesaretrapped

bythethyroidglandafterresorption.Excessiodidesareexcretedmainlyintheurine,withsmalleramountsappearing

inthefaeces,salivaandsweat.Theycrosstheplacentabarrierandareexcretedinbreastmilk.

5.3Preclinicalsafetydata

Applicationofisopropylalcoholtotheskinmaycausedrynessandirritation.Thelethaldosebymouthisreportedto

be250mL,buteven20mLproducetoxicsymptomslikeketonacidosisandketonuriaduetothemajormetabolite

acetone.Inhalationofisopropylalcoholvapourhasbeenreportedtoproducecoma.

Duetotheverygoodlocaltoleranceofpovidone,iodinatedpreparationsaccidentaloraluptakedoesnotcausethesame

severecorrosiveeffectsaswrittenfornotcomplexediodinepreparations.

Thetoxicityofpovidone,iodinatedismainlydefinedfromtheintakeofiodineasiodideanditseffectonthethyroid:

Thethyroidissensitivetoanexcessofiodine.Goitreandhypothyroidism(ascanoccurwithiodinedeficiency)aswell

ashyperthyroidismcanresultfromthis.

Thenormaldailyrequirementrangesfrom100to300micrograms,quantitiesof500microgramsto1mgdaily

probablyhavenoeffectsonthyroidfunctioninmostcases.Largerdosescauseaninitialriseinthyroidhormone

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

productionisnormallytransient,adaptationoccurringonrepeatedadministration.Alackofadaptationmayproducea

chronicinhibitionofthyroidhormonesynthesisleadingtogoitreandhypothyroidismincertaincases.Congenital

goitreandhypothyroidismhavefollowedmaternalingestion.Neonateshavebeenaffectedfollowingmaternal

applicationofpovidone,iodinatedaswellasfollowingdirectapplicationtotheneonate.

Excessiodinemayalsoinducehyperthyroidism(Iod-Basedowphenomenon).Elderlysubjectsandthosewithnodular

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Potassiumiodide

Sodiumdihydrogenphosphatedihydrate

Purifiedwater

6.2Incompatibilities

Iodinereactswithmercurycompoundsformingstronglycausticmercurousiodide.

6.3ShelfLife

Shelflifeofthemedicinalproductaspackedforsale

2years

In-useshelf-life:12months

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

150ml,500ml,1000ml: Bottleofpolyethylene(HDPE),closedwithascrewcapofpolypropylene.

5l: Bottleofpolyethylene(HDPE),closedwithasealandascrewcapofpolyethylene.

Bottledmaybeaccompaniedbyamechanicalpump-spray-head.Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

B.BraunMedicalLimited

3NaasRoadIndustrialPark

NaasRoad

Dublin12

8MARKETINGAUTHORISATIONNUMBER

PA0179/025/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 08April1987

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10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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