BETADINE ANTISEPTIC SWAB

Main information

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

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1175/002/016
  • Authorization date:
  • 11-02-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BetadineAntisepticSwab

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcottonswabcontains1gofsolution,eachmlofthesolutioncontains10%w/vpovidoneiodine,whichcontains3

partspermillionoffreeiodine.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Swabimpregnatedwithacutaneoussolution.

Sachetcontainingafolded100%surgicalgradecottonswabimpregnatedwithacleargoldenbrowniodinatedsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asanantisepticforcleansingandpreparationofsites.

4.2Posologyandmethodofadministration

Fortopicaluseonly.

Swabareathoroughly.Useswabonceonly.Useasrequired.

4.3Contraindications

Useinpatientswithaknownhypersensitivitytoiodine.Useinchildrenunder2yearsofage.Useinpatientswith

thyroiddisorders.

4.4Specialwarningsandprecautionsforuse

Useofthispreparationmayinterferewithtestsofthyroidfunction.Specialcautionisneededwhenregularapplications

tobrokenskinaremadeinpatientswithpre-existingrenalinsufficiency.Regularuseshouldbeavoidedinpatientson

concurrentlithiumtherapy.Ifusedforprolongedperiods,thyroidfunctiontestsshouldbepreformed.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

Regularuseshouldbeavoidedinpregnantorlactatingwomenasabsorbediodinecancrosstheplacentalbarrierand

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 20/07/2006 CRN 2025767 page number: 1

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Localskinreactionscanoccur.Applicationtolargewoundsorsevereburns,canproducesystemicadverseeffectssuch

asmetabolicacidosis,hypernatraemiaandimpairmentofrenalfunction.

4.9Overdose

Duetothenatureofthisproduct,overdoseishighlyunlikely.However,excessiodinecanproducegoitreand

hypothyroidismorhyperthyroidism.Systemicabsorptionofiodineafterrepeatedapplicationsofpovidoneiodineto

largeareasofwoundsorburnsmayleadtoanumberofadverseeffects:metallictasteinmouth,increasedsalivation,

burningorpaininthethroatormouth,irritation,swellingoftheeyes,pulmonaryoedema,skinreactions,

gastrointestinalupsetanddiarrhoea,metabolicacidosis,hypernatraemia,renalimpairment.Inthecaseofaccidental

ingestionoflargequantitiesofBetadine,symptomaticandsupportivetreatmentshouldbeprovidedwithspecial

attentiontoelectrolytebalanceandrenalandthyroidfunction.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Povidoneiodineisacomplexofiodine,whichretainsthebroadspectrumgermicidalactivityoftheelementaliodine

withoutitsdisadvantages.Thegermicidalactivityismaintainedinthepresenceofblood,pus,serumandnecrotic

tissue.Itisthereforesuitableforuseasabroadspectrumtopicalantisepticforthepreventionofinfectioninminorcuts,

smallareasofburnsandtreatmentofbacterialskininfectionsandpyodermas,includinginfectioni.e.decubitusand

venousulcers.

5.2Pharmacokineticproperties

Atthelevelsofiodinereleasedfromthepovidoneiodinecomplexinthispresentation,littlesystemicabsorptionwould

beexpected.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Purifiedwater.

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 20/07/2006 CRN 2025767 page number: 2

6.4Specialprecautionsforstorage

Donotstoreabove30ºC.

6.5Natureandcontentsofcontainer

Paper/polyethylenefoilsachetcontainingoneswab.100sachets(20stripsof5)arecontainedinacarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Notapplicable.

7MARKETINGAUTHORISATIONHOLDER

MedlockMedicalLtd.

TubitonHouse

MedlockSt.

Oldham

Lancashire

OL13HS

England

8MARKETINGAUTHORISATIONNUMBER

PA1175/2/16

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:08March1982

Dateoflastrenewal:08March2002

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 20/07/2006 CRN 2025767 page number: 3