CHLORHEXIDINE ACETATE BP 0.05% IRRIGATION SOLUTION

Main information

  • Trade name:
  • CHLORHEXIDINE ACETATE BP 0.05% IRRIGATION SOLUTION
  • Dosage:
  • 0.05 %w/ v
  • Pharmaceutical form:
  • Solution for Irrigation
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CHLORHEXIDINE ACETATE BP 0.05% IRRIGATION SOLUTION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/010/012A
  • Authorization date:
  • 01-04-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0167/010/012A

CaseNo:2044438

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

BaxterHealthcareLimited

CaxtonWay,Thetford,NorfolkIP243SE,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

ChlorhexidineAcetateBP0.05%IrrigationSolution

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom01/04/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 05/07/2008 CRN 2044438 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ChlorhexidineAcetateBP0.05%w/vIrrigationsolution.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance

ChlorhexidineAcetate

QuantitativeComposition

ChlorhexidineAcetatePerlitre:0.5g

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Irrigationsolution.

Clearcolourless,sterile,aqueousirrigationsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asadisinfectantfortopicalirrigationofwoundsandburns.

Fordisinfectionofrespirators.

4.2Posologyandmethodofadministration

Dosage

Thedosageoftheproductisdeterminedbytheindividualpatient’srequirements.

Administration

Fortopicaluseonly.

4.3Contraindications

Thissolutionshouldnotcomeintocontactwiththebrainmeninges,perforatedeardrumoreyes.

Thissolutionisnotrecommendedforbladderirrigation.

Useinpatientswithknownhypersensitivitytochlorhexidine.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 05/07/2008 CRN 2044438 page number: 2

4.4Specialwarningsandprecautionsforuse

Thissolutionshouldnotbetakenorally.Thissolutionisnotforintravenousadministration.Accidentalingestion

shouldbetreatedwithastomachlavageconsistingofmilk,eggwhite,gelatineormildsoap.Idiosyncraticreactionsto

ChlorhexidineAcetateBPhavebeenreported.

Thisproductshouldonlybeusedinspecialistunitsfamiliarwiththeappropriateselectionofpatients.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Notapplicable.

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

Notapplicable.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

WaterforInjections

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 05/07/2008 CRN 2044438 page number: 3

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Unopened:2years.

Opened:Forsingle-useonly.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Storeintheoriginalcontainerinordertoprotectfromlight.

6.5Natureandcontentsofcontainer

TheproductwillbesuppliedinHighDensityPolyethyleneSingle-Usecontainersof1000ml.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Donotuseunlesssolutionisclearandthecontainerisundamaged.

Discardunusedportion.

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd.,

CaxtonWay,

Thetford,

Norfolk,

IP243SE,

UnitedKingdom.

8MARKETINGAUTHORISATIONNUMBER

PA0167/010/012

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1 st

April1983

Dateoflastrenewal:1 st

April2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 05/07/2008 CRN 2044438 page number: 4