CHLORHEXIDINE ACETATE

Main information

  • Trade name:
  • CHLORHEXIDINE ACETATE
  • Dosage:
  • 0.05 %w/ v
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CHLORHEXIDINE ACETATE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/010/016
  • Authorization date:
  • 30-09-1986
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ChlorhexidineAcetateBP0.05%w/v forIrrigation, 250 ml.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

ChlorhexidineAcetate0.05%w/v

3PHARMACEUTICALFORM

Cutaneousirrigation solution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asadisinfectantfortopicalirrigation ofwoundsorburns.

Fordisinfection ofrespirators.

4.2Posologyandmethodofadminstration

4.2.1.Dosage

Thedosageisdependantupon theage, weightand clinicalcondition ofthepatient

4.2.2.Administration

Fortopicaluseonly.

4.3Contraindications

Thissolution mustnotcomeinto contactwith thebrain meninges, perforated eardrumoreyes. Thissolution isnot

recommended forbladderirrigation.Usein patientswith known hypersensitivity to Chlorhexidine, notforusein

abdominalcavities, unlessundersupervision ofaspecialist.

4.4Special warningsandspecialprecautionsforuse

Thissolution should notbetakenorally.Thissolution isnotforintravenousadministration.Accidentalingestion

should betreated with astomach lavageconsisting ofmilk, egg white, gelatineormild soap.Idiosyncraticreactionsto

ChlorhexidineAcetateBPhavebeen reported.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Notapplicable.

4.6Pregnancyandlactation

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 18/11/2005 CRN 2016954 page number: 1

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Notapplicable.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Notapplicable.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinical safetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Waterforinjections

Aceticacid

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2 years

6.4Special precautionsforstorage

Do notstoreabove25 o

Protectsolution fromdirectsunlight.

6.5Natureandcontentsofcontainer

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 18/11/2005 CRN 2016954 page number: 2

6.6Instructionsforuseandhandling

Do notuseunlesssolution isclearand thecontainerisundamaged.

Discardany unused portion.

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd.

Caxton Way

Thetford

Norfolk

IP24 3SE

England

8MARKETINGAUTHORISATIONNUMBER

PA167/10/16

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:30 th

September1986

Dateoflastrenewal:30 th

September2001

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 18/11/2005 CRN 2016954 page number: 3