CHLORHEXIDINE ACETATE 0.015% W/ V AND CETRIMIDE 0.1

Main information

  • Trade name:
  • CHLORHEXIDINE ACETATE 0.015% W/ V AND CETRIMIDE 0.1
  • Dosage:
  • .015/ .15 %w/ v
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CHLORHEXIDINE ACETATE 0.015% W/V AND CETRIMIDE 0.1
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/032/025A
  • 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)

PA0167/032/025A

CaseNo:1005077

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

BaxterHealthcareLimited

CaxtonWay,Thetford,NorfolkIP243SE,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Chlorhexidineacetate0.015%w/vandCetrimide0.15%w/vIrrigationsolution.

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom16/03/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 16/03/2009 CRN 1005077 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Chlorhexidineacetate0.015%w/vandCetrimide0.15%w/vIrrigationsolution.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachlitrecontains:

ChlorhexidineAcetate0.150g

Cetrimide1.5g

Excipients:ContainsSunsetYellow(E110)8mg/L

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Irrigationsolution

Aclear,yellow,sterile,nonpyrogenic,aqueousirrigationsolution.

pH5.0-6.5

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asadisinfectantfortopicalantibacterialirrigationofwoundsandburns,andsomebodycavitiessuchasthebladder.

Fordisinfectionofrespirators.

4.2Posologyandmethodofadministration

Dosage

Thedosageisdependentupontheage,weightandclinicalconditionofthepatient.

Administration

Topicalirrigation

4.3Contraindications

UseinpatientswithaknownhypersensitivitytoChlorhexidineorCetrimide.

Thissolutionshouldnotbeusedintheeye,intravenously,orallyintheauditorycanalornearmeninges,brainorspinal

cord.

4.4Specialwarningsandprecautionsforuse

Thisproductshouldonlybeusedinspecialistunitsfamiliarwiththeappropriateselectionofpatients.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 16/03/2009 CRN 1005077 page number: 2

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonespecified.

4.6Pregnancyandlactation

Nonestated.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Veryoccasionallythefollowingreactionshavebeennotedwhenchlorhexidinecontainingirrigatingsolutionshave

beenusedintravesically,intravaginallyortopicallyontraumatisedskin:Hypotension,paraesthesia,dysponea,

tachycardia,coldsweat,generalisederythema,urticariaandlossofconsciousness.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Notapplicable.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

SunsetYellow(E110)

AceticAcid(forpHadjustment)

WaterforInjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thismedicinalproductmustnotbemixedwithothermedicinalproducts.

6.3ShelfLife

Unopened:2years

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 16/03/2009 CRN 1005077 page number: 3

6.4Specialprecautionsforstorage

Donotstoreabove25 °

C.Storeintheoriginalpackageinordertoprotectfromlight.

6.5Natureandcontentsofcontainer

Highdensitypolyethylenecontainer.Theproductissuppliedina500mland1000mlvolumes.

Notallpacksizeswillbemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Donotuseunlesssolutionisclearandthecontainerisundamaged.Discardanyunusedportion.

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd,

CaxtonWay,

Thetford,

Norfolk,IP243SE,

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA0167/032/025

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 01April1983

Dateoflastrenewal: 01April2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 16/03/2009 CRN 1005077 page number: 4