BRAUNOL 7.5 %w/v Cutaneous Solution

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
POVIDONE-IODINE
Available from:
B. Braun Medical Limited
INN (International Name):
POVIDONE-IODINE
Dosage:
7.5 %w/v
Pharmaceutical form:
Cutaneous Solution
Prescription type:
Product not subject to medical prescription
Authorization status:
Withdrawn
Authorization number:
PA0179/027/001
Authorization date:
0000-00-00

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Braunol75mg/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

Caremustbetakeninthecaseofpregnantwomenandinfantsuptotheageof6months.

4.7Effectsonabilitytodriveandusemachines

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 10/01/2007 CRN 2031833 page number: 1

4.8Undesirableeffects

Allergicreactionsareveryrare,eveniniodinesensitivepatients.

4.9Overdose

Becausethepreparationisonlyappliedlocally,nooverdosecanresult.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:AntisepticsandDisinfectants–Iodineproducts,ATCcode:D08AG02.

Iodinatedpovidone(povidoneiodine)isaniodophorusedfordisinfectionandantisepsis.Iodophorsareloose

complexesofiodineandcomplexingpolymers.Solutionsofpovidoneiodinegraduallyreleaseiodine.Povidoneiodine

isthuslesstoxicthanpreparationsofuncomplexediodine.

5.2Pharmacokineticproperties

Iodineispoorlyabsorbedwhenappliedtotheskin.Afteraccidentaloraluptakepovidoneiodine-preparations(which

areconvertedtoiodide)andiodidesaretrappedbythethyroidglandafterresorption.Excessiodidesareexcreted

mainlyintheurine,withsmalleramountsappearinginthefaeces,salivaandsweat.Theycrosstheplacentalbarrierand

areexcretedinbreastmilk.

5.3Preclinicalsafetydata

Duetotheverygoodlocaltoleranceofpovidoneiodine-preparationsaccidentaloraluptakedoesnotcausethesame

severecorrosiveeffectsaswrittenfornoncomplexediodine-preparations.

Thetoxicityofpovidoneiodineismainlydefinedfromtheintakeofiodineasiodideanditseffectonthethyroid.

Thethyroidissensitivetoanexcessofiodine.Goitreandhypothyroidism(ascanoccurwithiodinedeficiency)aswell

ashyperthyroidismcanresultfromthis.

Thenormaldailyrequirementrangesfrom100to300micrograms,quantitiesof500microgramsto1mgdaily

probablyhavenoeffectsonthyroidfunctioninmostcases.Largerdosescauseaninitialriseinthyroidhormone

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

productionisnormallytransient,adaptationoccurringonrepeatedadministration.Alackofadaptationmayproducea

chronicinhibitionofthyroidhormonesynthesisleadingtogoitreandhypothyroidismincertaincases.Congenital

goitreandhypothyroidismhavefollowedmaternalingestion.Neonateshavebeenaffectedfollowingmaternal

applicationofpovidoneiodineaswellasfollowingdirectapplicationtotheneonate.

Excessiodinemayalsoinducehyperthyroidism(Iod-Basedowphenomenon).Elderlysubjectsandthosewithnodular

goitreshavebeenfoundtobeatgreatestrisk.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Purifiedwater

Sodiumdihydrogenphosphatedihydrate

Nonoxinol9

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 10/01/2007 CRN 2031833 page number: 2

6.2Incompatibilities

Iodinereactswithmercurycompoundsformingstronglycausticmercurousiodide.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.

6.5Natureandcontentsofcontainer

500ml,1000ml: Bottleofpolyethylene,closedwithascrewcapofpolypropylene.

5l: Bottleofpolyethylene,closedwithasealandascrewcapofpolyethylene.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

B.BraunMedicalLimited

3NaasRoadIndustrialPark

NaasRoad

Dublin12

8MARKETINGAUTHORISATIONNUMBER

PA179/27/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:05June1986

Dateoflastrenewal:05June2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 10/01/2007 CRN 2031833 page number: 3

Similar products

Search alerts related to this product

View documents history

Share this information