AIDEX FIRST AID ANTISEPTIC

Main information

  • Trade name:
  • AIDEX FIRST AID ANTISEPTIC
  • Dosage:
  • 0.1,0.1,1 %w/w
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AIDEX FIRST AID ANTISEPTIC
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0206/029/001
  • Authorization date:
  • 11-02-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0206/029/001

CaseNo:2043901

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

OvelleLimited

DundalkIndustrialEstate,Coe'sRoad,Dundalk,Co.Louth,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AidexFirstAidAntisepticCream,AminoacridineHydrochloride0.1%w/w,Benzocaine0.1%w/w,Phenoxyethanol1.0%w/w

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom11/02/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 12/04/2008 CRN 2043901 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AidexFirstAidAntisepticCream

AminoacridineHydrochloride0.1%w/w,

Benzocaine0.1%w/w,

Phenoxyethanol1.0%w/w.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

AminoacridineHydrochloride0.1%w/w,

Benzocaine0.1%w/w,

Phenoxyethanol1.0%w/w.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cream.

Apaleyellowcream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AidexCreamisacreamforthesymptomatictreatmentofminorabrasionsandscalds.

4.2Posologyandmethodofadministration

AidexCreamisappliedtopicallyandisforexternaluseonly.

4.3Contraindications

AidexCreamiscontra-indicatedinpatientswithaknownsensitivitytoitsingredients.

4.4Specialwarningsandprecautionsforuse

Noadverseeffectsreported.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noadverseeffectsreported.

4.6Pregnancyandlactation

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 12/04/2008 CRN 2043901 page number: 2

4.7Effectsonabilitytodriveandusemachines

Noadverseeffectsreported.

4.8Undesirableeffects

Nonereported.

4.9Overdose

Nospecialproceduresorantidoteislikelytobenecessary.Incaseofoveruse,washoffwithsoapandhotwater.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

AminacrineHydrochloride,

AminacrineHydrochloride(anacridinederivative)isnon-stainingandisusedforthetreatmentofwounds,burnsand

forskindisinfection.

Benzocaine,

Benzocaineisasurfaceanaestheticoftheestertypewithlowsystemictoxicity.

5.2Pharmacokineticproperties

Benzocaine,

Benzocaineisreadilyreleasedfromoilinwaterbases.Mostlocalanaestheticsarereadilyabsorbedthroughmucous

membranesandthroughdamagedskin.LocalanaestheticsareweakbasesandattissuepHcandiffusethrough

connectivetissueandcellularmembranestoreachthenervefibrewhereisolationcanoccur.

Anaestheticsoftheestertypearehydrolysedbyesterasesintheplasmaandtoalesserextentintheliver.

5.3Preclinicalsafetydata

Nofurtherinformationavailable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Emulsifyingwax,

Paraffin,softyellow,

Glycerol,

Purifiedwater.

6.2Incompatibilities

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 12/04/2008 CRN 2043901 page number: 3

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Keepcontainertightlyclosed.

Keepcontainerintheoutercarton.

6.5Natureandcontentsofcontainer

30galuminiumtubewithpolyethylenescrewcap.Eachtubeispackedincardboardcarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

OvelleLtd.,

DundalkIndustrialEstate,

Coe’sRd,

Dundalk,

Co.Louth.

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA206/29/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:11 th

February1993

Dateoflastrenewal:11 th

February2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 12/04/2008 CRN 2043901 page number: 4