BRAUNOSAN

Main information

  • Trade name:
  • BRAUNOSAN Cutaneous Solution 7.5 %w/w
  • Dosage:
  • 7.5 %w/w
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BRAUNOSAN Cutaneous Solution 7.5 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0179/026/002
  • Authorization date:
  • 05-06-1986
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Braunosan75mg/gCutaneousSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveIngredient:

100gsolutioncontain:

7.5gIodinatedPovidone,withacontentof10%availableiodine.

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cutaneoussolution

Clear,brown,aqueoussolution

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asatopicalantisepticfordisinfectionofintactskin.

4.2Posologyandmethodofadministration

Applytotheaffectedarea.

4.3Contraindications

Hypersensitivitytoiodineoranyoftheotherexcipients.

Usebeforeradio-iodinetherapy.

4.4Specialwarningsandprecautionsforuse

Shouldevidenceoflocalirritationorsensitivityoccur,useoftheproductshouldcease.

Ifnoimprovementoccurs,thedoctorshouldbeconsulted.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Iodinereactswithmercurycompoundsformingstronglycausticmercurousiodide.

4.6Pregnancyandlactation

Irish Medicines Board

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4.7Effectsonabilitytodriveandusemachines

Noneapplicable.

4.8Undesirableeffects

Allergicreactionsareveryrare,eveniniodinesensitivepatients.

4.9Overdose

Becausethepreparationisonlyappliedlocally,nooverdosecanresult.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:AntisepticsandDisinfectants–Iodineproducts,ATCcode:D08AG02.

Iodinatedpovidone(povidoneiodine)isaniodophorusedfordisinfectionandantisepsismainlyforthetreatmentof

contaminatedwoundsandpre-operativedisinfectionoftheskinandmucousmembranes.

Iodophorsareloosecomplexesofiodineandcomplexingpolymers.Solutionsofpovidoneiodinegraduallyrelease

iodine.Povidoneiodineisthuslesstoxicthanpreparationsofuncomplexediodine.

5.2Pharmacokineticproperties

Iodineispoorlyabsorbedwhenappliedtotheskin.Afteraccidentaloraluptakepovidoneiodine-preparations(which

areconvertedtoiodide)andiodidesaretrappedbythethyroidglandafterresorption.Excessiodidesareexcreted

mainlyintheurine,withsmalleramountsappearinginthefaeces,saliva,andsweat.Theycrosstheplacentalbarrier

andareexcretedinbreastmilk.

5.3Preclinicalsafetydata

Attention:DuetoitscontentofstronglyfoaminganionicdetergentsaccidentaloraluptakeofBraunosan involvesthe

acuteriskofsuffocationbyaspirationoflather.

Ingeneral,accidentaloraluptakeofpovidoneiodinepreparationsdoesnotcausethesameseverecorrosiveeffectsas

writtenfornoncomplexediodinepreparationsasaresultoftheverygoodlocaltolerance.Thetoxicityofpovidone

iodineismainlydefinedfromtheintakeofiodineasiodideanditseffectonthethyroid.

Thethyroidissensitivetoanexcessofiodine.Goitreandhypothyroidism(ascanoccurwithiodinedeficiency)aswell

ashyperthyroidismcanresultfromthis.

Thenormaldailyrequirementrangesfrom100to300microgram,quantitiesof500microgramto1mgdailyprobably

havenoeffectsonthyroidfunctioninmostcases.Largerdosescauseaninitialriseinthyroidhormoneproduction,but

atstillhigherdoses,productiondecreases(Wolff-Chaikoffeffect).Thefallinthyroidhormoneproductionisnormally

transient,adaptationoccurringonrepeatedadministration.Alackofadaptationmayproduceachronicinhibitionof

thyroidhormonesynthesisleadingtogoitreandhypothyroidismincertaincases.Congenitalgoitreandhypothyroidism

havefollowedmaternalingestion.Neonateshavebeenaffectedfollowingmaternalapplicationofpovidoneiodineas

wellasfollowingdirectapplicationtotheneonate.

Excessiodinemayalsoinducehyperthyroidism(Iod-Basedowphenomena).Elderlysubjectsandthosewithnodular

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Purifiedwater

Ammoniumparethsulfate

Povidone

Macrogol15glycerylisostearate

Sodiumdihydrogenphosphatedihydrate

Perfume

Sodiumhydroxide(forpH-adjustment)

6.2Incompatibilities

Iodinereactswithmercurycompoundsformingstronglycausticmercurousiodide.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.

6.5Natureandcontentsofcontainer

500ml,1000ml: Bottleofpolyethylene,closedwithascrewcapofpolyethylene.

5l: Bottleofpolyethylene,closedwithasealandascrewcapofpolyethylene.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

B.BraunMedicalLimited

3NaasRoadIndustrialPark

NaasRoad

Dublin12

8MARKETINGAUTHORISATIONNUMBER

PA179/26/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:05June1986

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10DATEOFREVISIONOFTHETEXT

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