BRAUNOVIDON

Main information

  • Trade name:
  • BRAUNOVIDON Ointment 10 %w/ w
  • Dosage:
  • 10 %w/ w
  • Pharmaceutical form:
  • Ointment
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BRAUNOVIDON Ointment 10 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0179/024/001
  • Authorization date:
  • 05-06-1986
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Braunovidon100mg/gOintment

2QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveIngredient

100gointmentcontain:

10gIodinatedPovidonewithacontentof10%availableiodine.

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Ointment

Lighttomediumbrownointment.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asatopicalantisepticfordisinfectionofintactskin.

4.2Posologyandmethodofadministration

Applytoaffectedarea.

4.3Contraindications

Hypersensitivitytoiodineoranyoftheotherexcipients.

Usebeforeradio-iodinetherapy.

4.4Specialwarningsandprecautionsforuse

Shouldevidenceoflocalirritationorsensitivityoccur,useoftheproductshouldcease.

Ifnoimprovementoccurs,thedoctorshouldbeconsulted.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Iodinereactswithmercurycompoundsformingstronglycausticmercurousiodide.

4.6Pregnancyandlactation

Caremustbetakeninthecaseofpregnantwomenandinfantsuptotheageof6months,aswellaspatientssuffering

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4.7Effectsonabilitytodriveandusemachines

Notrelevant.

4.8Undesirableeffects

Allergicreactionsareveryrare,eveniniodinesensitivepatients.

4.9Overdose

Becausethepreparationisonlyappliedlocally,nooverdosecanresult.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:AntisepticsandDisinfectants–Iodineproducts,ATCcode:D08AG02.

Iodinatedpovidone(povidoneiodine)isaniodophoreusedfordisinfectionandantisepsismainlyforthetreatmentof

contaminatedwoundsandpre-operativedisinfectionoftheskinandmucousmembranes.

Iodophoresareloosecomplexesofiodineandcomplexingpolymers.Solutionsofpovidoneiodinegraduallyrelease

iodine.Povidoneiodineisthuslesstoxicthanpreparationsofuncomplexediodine.

5.2Pharmacokineticproperties

Iodineispoorlyabsorbedwhenappliedtotheskin.Afteraccidentaloraluptakepovidoneiodine-preparations(which

areconvertedtoiodide)andiodidesaretrappedbythethyroidglandafterresorption.Excessiodidesareexcreted

mainlyintheurine,withsmalleramountsappearinginthefaeces,saliva,andsweat.Theycrosstheplacentalbarrier

andareexcretedinbreastmilk.

5.3Preclinicalsafetydata

Duetotheverygoodlocaltoleranceofpovidoneiodine-preparationsaccidentaloraluptakedoesnotcausethesame

severecorrosiveeffectsaswrittenfornoncomplexediodine-preparations.Thetoxicityismainlydefinedfromthe

intakeofiodineasiodideanditseffectonthethyroid.

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

Macrogol400

Macrogol4000

Purifiedwater

Sodiumhydrogencarbonate

6.2Incompatibilities

Iodinereactswithmercurycompoundsformingstronglycausticmercurousiodide.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

Polyfoiltubeswithaninnerlayerofpolyethyleneandscrewcapsofpolypropylenewithcontentsof20g,100g,and

250g.

Jarsofpolypropylenewithscrewcapsofpolypropylenewithcontentof250g.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

B.BraunMedicalLimited

3NaasRoadIndustrialPark

NaasRoad

Dublin12

8MARKETINGAUTHORISATIONNUMBER

PA179/24/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:05June1986

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10DATEOFREVISIONOFTHETEXT

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