CHLORHEXIDINE ACETATE BP 0.02% W/V IRRIGATION SOLU

Main information

  • Trade name:
  • CHLORHEXIDINE ACETATE BP 0.02% W/V IRRIGATION SOLU
  • Dosage:
  • 0.02 %w/v
  • Pharmaceutical form:
  • Solution for Irrigation
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CHLORHEXIDINE ACETATE BP 0.02% W/V IRRIGATION SOLU
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/010/009A
  • Authorization date:
  • 01-04-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ChlorhexidineAcetateBP0.02%w/vIrrigationsolution.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance

ChlorhexidineAcetate.

QuantitativeComposition

Perlitre:ChlorhexidineAcetate0.2g

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Irrigationsolution.

Aclear,colourless,sterileaqueousirrigationsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asadisinfectantfortopicalirrigationofwoundsandburns.

Fordisinfectionofrespirators.

4.2Posologyandmethodofadministration

Dosage

Thedosageoftheproductisdeterminedbytheindividualpatient’srequirements.

Administration

Fortopicaluseonly.

4.3Contraindications

Thissolutionshouldnotcomeintocontactwiththebrainmeninges,perforatedeardrumoreyes.Thissolutionisnot

recommendedforbladder-irrigation.Useinpatientswithknownhypersensitivitytochlorhexidine.Thissolutionisnot

Irish Medicines Board

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Date Printed 15/11/2007 CRN 2043475 page number: 1

4.4Specialwarningsandprecautionsforuse

Thissolutionshouldnotbetakenorally.Thissolutionisnotforintravenousadministration.Accidentalingestion

shouldbetreatedwithastomachlavageconsistingofmilk,eggwhite,gelatineormildsoap.Idiosyncraticreactionsto

chlorhexidineacetateBPhavebeenreported.

Thisproductshouldonlybeusedinspecialistunitsfamiliarwiththeappropriateselectionofpatients.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

TheactionofchlorhexidineisreducedbyanalkalinepH,thepresenceoforganicmatter,anionicdetergentsand

tannins.Effectofchlorhexidinewillbeinactivatedoncontactwithsoap,blood.(FollowingSPCTravahex0.5%).

4.6Pregnancyandlactation

Thisproductshouldnotbeusedduringpregnancyunlessconsideredessentialbythephysician.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Veryoccasionallythefollowingreactionshavebeennotedwhenchlorhexidinecontainingirrigatingsolutionshave

beenusedintravesically,intravaginally,ortopicallyontraumatisedskin:hypotension,paraesthesia,dyspnoea,

tachycardia,coldsweat,generalisederythema,urticariaandlossofconsciousness.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Therapeuticgroup:B05D

ThissolutionisintendedforuseasanexternalirrigatingsolutionasaneffectivedisinfectantagainstGram-positiveand

Gram-negativebacteria.

5.2Pharmacokineticproperties

Giventhemethodforuseofthesolution,absorptionthroughtheskinisminimal,nosignificantlevelsbeingfoundin

blood.

5.3Preclinicalsafetydata

Irish Medicines Board

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Date Printed 15/11/2007 CRN 2043475 page number: 2

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

WaterforInjections

AceticAcid

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Unopened:2years.

Opened:Forsingle-useonly.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Storeintheoriginalcontainer.

6.5Natureandcontentsofcontainer

TheproductwillbesuppliedinHighDensityPolyethylenesingle-usecontainersofthefollowingsizes:100ml,500ml

and1000ml.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Donotuseunlesssolutionisclearandthecontainerisundamaged.

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd.,

CaxtonWay,

Thetford,

Norfolk,

IP243SE,

UnitedKingdom.

8MARKETINGAUTHORISATIONNUMBER

PA0167/010/009

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1 st

April1983

Dateoflastrenewal:1 st

Irish Medicines Board

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Date Printed 15/11/2007 CRN 2043475 page number: 3

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 15/11/2007 CRN 2043475 page number: 4