BETADINE SWABSTICKS

Main information

  • Trade name:
  • BETADINE SWABSTICKS
  • Pharmaceutical form:
  • Cutaneous Stick
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BETADINE SWABSTICKS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1175/002/017
  • Authorization date:
  • 11-02-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BetadineSwabsticks

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlofimpregnatingsolutioncontains10%w/vpovidoneiodine,whichcontains3partspermillionfreeiodine.

Each3swabpacketwillcontain7.0gofsolution.

Each5swabpacketwillcontain14.0gofsolution.

Eachsingleswabpacketcontains2.33gofimpregnatingsolution.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Swabsticksimpregnatedwithacutaneoussolution.

Swabsticksimpregnatedwithanaqueousiodinecolouredsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asanantisepticforcleansingandpreparationprocedures.

4.2Posologyandmethodofadministration

Fortopicaluseonly.

Swabareathoroughly.Useswabonly.Useasrequired.

4.3Contraindications

Useinpatientswithaknownhypersensitivitytoiodine.Useinchildrenunder2yearsofage.Useinpatientswith

thyroiddisorders.

4.4Specialwarningsandprecautionsforuse

Useofthispreparationmayinterferewithtestsofthyroidfunction.Specialcautionisneededwhenregularapplications

tobrokenskinaremadeinpatientswithpre-existingrenalinsufficiency.Regularuseshouldbeavoidedinpatientson

concurrentlithiumtherapy.Ifusedforprolongedperiods,thyroidfunctiontestsshouldbeperformed.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

Regularuseshouldbeavoidedinpregnantorlactatingwomenasabsorbediodinecancrosstheplacentalbarrierand

Irish Medicines Board

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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

Atthelevelsofiodinereleasedfrothepovidoneiodinecomplexinthispresentation,littlesystemicabsorptionwould

beexpected.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerol

Sodiumhydroxide

IgepalCO360(nonylphenoxypoly(ethyleneoxy)ethanol)

Sodiumphosphatedried

Citricacidanhydrous

Purifiedwater

6.2Incompatibilities

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6.3ShelfLife

3years.

Useimmediatelyafteropening.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

6.5Natureandcontentsofcontainer

Cartonscontaining50individualpaper/polyethylenesachets.Rayon-tippedpolypropyleneswabsticks.Eachsachet

contains1,3or5swabsticks.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Notapplicable.

7MARKETINGAUTHORISATIONHOLDER

MedlockMedicalLtd.

TubitonHouse

MedlockSt.

Oldham

Lancashire

OL13HS

England

8MARKETINGAUTHORISATIONNUMBER

PA1175/2/17

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:08March1982

Dateoflastrenewal:08March2002

10DATEOFREVISIONOFTHETEXT

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