BETADINE ANTISEPTIC TULLE

Main information

  • Trade name:
  • BETADINE ANTISEPTIC TULLE
  • Dosage:
  • 10 %w/ w
  • Pharmaceutical form:
  • Impregnated Dressing
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BETADINE ANTISEPTIC TULLE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1175/002/015
  • Authorization date:
  • 08-06-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PA1175/002/015

CaseNo:2037610

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

TransferredfromPA0696/002/005.

MedlockMedicalLtd

TubitonHouse,MedlockStreet,Oldham,OL13HS,England

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

BetadineAntisepticTulle250mgImpregnatedDressing

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom08/06/2007.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 12/06/2007 CRN 2037610 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BetadineAntisepticTulle250mgImpregnatedDressing

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachdressingisimpregnatedwith2.5gofgelcontaining250mgpovidoneiodineequivalentto10%w/w.

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Impregnateddressing.

10x10cmgauzedressingimpregnatedwithagoldenbrowngel.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asanantisepticdressingforthemanagementofcutaneoustraumaticlesionsandulcers.

4.2Posologyandmethodofadministration

Fortopicaluseonly.

Applyasrequiredtotheaffectedarea,coverwithgauzeorcottonwoolandabandage.

4.3Contraindications

Hypersensitivitytoiodine,polyvinylpyrrolidineortoanyexcipient.Historyofabnormalthyroidfunctionorgoitre(in

particularnodularcolloidgoitre,endemicgoitreandHashimoto’sthyroiditis).Useinchildrenundertwoyearsofage.

Regularuseshouldbeavoidedinpatientsonconcurrentlithiumtherapy.

4.4Specialwarningsandprecautionsforuse

Useofthispreparationmayinterferewithtestsofthyroidfunction.Iodineisabsorbedthroughburnsandbrokenskin

andtoalesserextentthroughintactskinandmayleadtotoxiclevelsofiodineinthebloodparticularlyinpatientswith

renalinsufficiency.Ifusedforlongperiodsthyroidfunctiontestsshouldbeperformed.

BetadineAntisepticTullecanpermanentlydiscolourwhitegoldjewelleryanditisrecommendedthatthistypeof

Irish Medicines Board

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Usewithconcurrentlithiumtherapyhasbeenshowntoexhibitadditivehypothyroidiceffects.Absorptionofiodine

frompovidoneiodinethrougheitherintactskinorbrokenskinmayinterferewiththyroidfunctiontests.Contamination

withpovidoneiodineofseveraltypesoftestsforthedetectionofoccultbloodinfaecesorbloodinurinemayproduce

false-positiveresults.

4.6Pregnancyandlactation

Iodinefreelycrossestheplacentaandissecretedinbreastmilk.Thyroidfunctiondisordershavebeenreportedinthe

offspringofmothersexposedtopharmacologicaldosesofiodine.Povidoneiodineshouldnotbeusedregularlyduring

pregnancyunlessthereisnoalternativetreatmentavailable.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Localirritation,skinburnsandsensitivityreactionshavebeenreportedrarely.Anaphylacticreactions,anaphylactoid

reactionsandanaphylacticshockhavebeenreporteduncommonlywithproductscontainingpovidone-iodineor

povidone.

Excessiodinecanproducegoitreandhypothyroidismorhyperthyroidism.Sucheffectshaveoccasionallybeenseen

withextensiveorprolongeduseofpovidoneiodine.Othereffectsthathavebeenreportedaremetabolicacidosisand

acuterenalfailure.

4.9Overdose

Duetothenatureofthisproduct,overdoseishighlyunlikely.However,deliberateoraccidentalingestionoflarge

quantitiesofpovidoneiodinewillresultinhighbloodlevelsofiodineandgastrointestinaltoxicityincludingvomiting

anddiarrhoea.Symptomaticandsupportivetreatmentshouldbestartedwithspecialattentiontomonitoringelectrolyte

balance,renalfunction,thyroidfunctionandliverfunction.Iodinecanberemovedbydialysis.

5PHARMACOLOGICALPROPERTIES

D08AG02-Antisepticsanddisinfectants

5.1Pharmacodynamicproperties

Povidoneiodineisacomplexofiodine,whichretainsthebroadspectrumgermicidalactivityoftheelementaliodine

withoutitsdisadvantages.Thegermicidalactivityismaintainedinthepresenceofblood,pus,serumandnecrotic

tissue.Itisthereforesuitableforuseasabroadspectrumtopicalantisepticforthepreventionofinfectioninminor

cuts,smallareasofburnsandtreatmentofbacterialskininfectionsandpyodermas,includinginfectioni.e.decubitus

andvenousulcers.

5.2Pharmacokineticproperties

Atthelevelofiodinereleasedfromthepovidoneiodinecomplexinthispresentation,littlesystemicabsorptionwould

beexpected.

5.3Preclinicalsafetydata

Irish Medicines Board

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Macrogol400

Macrogol4000

Macrogol6000

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

Eachdressingisforsingleuseonly.Useimmediatelyafteropening.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

6.5Natureandcontentsofcontainer

Each10x10cmgauzedressingisimpregnatedwithatleast2.5gofgel.

Thedressingisplacedbetweentwopolyethyleneprotectivefilmsandenclosedinapolyethylene/paperlaminate

sachet.Tensachetsarecontainedinanoutercarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

MedlockMedicalLtd

TubitonHouse

MedlockStreet

Oldham

OL13HS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA1175/2/15

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:16 th

February1992

Dateoflastrenewal:16 th

Irish Medicines Board

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10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 12/06/2007 CRN 2037610 page number: 5