GERMOLENE FIRST AID

Main information

  • Trade name:
  • GERMOLENE FIRST AID
  • Dosage:
  • 1.2/ 0.25 %w/ w
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GERMOLENE FIRST AID
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1447/048/001
  • Authorization date:
  • 16-10-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PPA1447/048/001

CaseNo:2068999

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

G&ALicensingLtd

Ballymurray,Co.Roscommon,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

GermoleneFirstAid1.2%w/w/0.25%w/wCream

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom16/10/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 23/10/2009 CRN 2068999 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

GermoleneFirstAid1.2%w/w/0.25%w/wCream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Phenol1.20%w/wandChlorhexidineDigluconateSolutiontogiveChlorhexidineDigluconate0.25%w/w

Alsocontainscetostearylalcohol.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cream

ProductimportedfromtheUK:

Apink,viscous,homogeneouscream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthetreatmentofminorskinirritations.

4.2Posologyandmethodofadministration

Applyasnecessaryaftercleansingforupto3days.

4.3Contraindications

Knownhypersensitivitytoanyoftheconstituents.

4.4Specialwarningsandprecautionsforuse

Ifsymptomspersistortheconditionworsens,consultyourdoctor.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Chlorhexidineisincompatiblewithanionicagents.

4.6Pregnancyandlactation

Althoughuseofthisproductisnotcontraindicatedduringpregnancyandlactation,aswithallmedicinesduring

Irish Medicines Board

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Date Printed 23/10/2009 CRN 2068999 page number: 2

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Rarelyirritancy,rashesandotherskinconditionsmayoccur.

4.9Overdose

RepeatedTopicalApplication

Frequentlyrepeatedtopicalapplicationonthesamesitecouldtheoreticallyleadtoskinirritation.However,sincethe

productisonlyintendedforminorskintrauma,extensiveexposureisunlikely.

AccidentalorDeliberateIngestion

Theproductwouldonlybeexpectedtobeharmfuliforallyingestedinverylargequantities.Thisisunlikelyduetothe

unpleasanttasteoftheproduct.Insuchacasetheprimaryconcernwouldbethephenolintakewhichcancausenausea,

vomiting,diarrhoeaandheadache.

Treatment

Gastriclavagewithwaterandcharcoal.Administrationofdemulcentssuchaseggwhiteormilkandsupportive

measures.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Phenol:Antisepticandlocalanaesthetic.

Chlorhexidinegluconate:Antiseptic.

5.2Pharmacokineticproperties

Theproducthasalocalactionwithminimalriskofsystemiceffects.

5.3Preclinicalsafetydata

Preclinicalsafetydataontheseactiveingredientsintheliterature,havenotrevealedanypertinentandconclusive

findingswhichareofrelevancetotherecommendeddosageanduseoftheproduct.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Cetostearylalcohol

Lightliquidparaffin

Polyoxyethylene-(21)-stearylether

Polyoxyethylene-(2)-stearylether

Dimeticone

MethylSalicylate

Sunsetyellow(E110)

Ponceau(E124)

Irish Medicines Board

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Date Printed 23/10/2009 CRN 2068999 page number: 3

6.2Incompatibilities

Chlorhexidineisincompatiblewithanionicagents.

6.3ShelfLife

Theshelflifeexpirydateofthisproductisthedateshownonthetubeandoutercartonoftheproductasmarketedin

thecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25’C.

6.5Natureandcontentsofcontainer

30galuminiumtubewithapolypropylenecapcontainedinanoverlabelledcarton.

6.6Specialprecautionsfordisposalandotherhandling

NoSpecialrequirements.

7ParallelProductAuthorisationHolder

G&ALicensingLtd

Ballymurray

Co.Roscommon

Ireland

8ParallelProductAuthorisationNumber

PPA1447/48/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:16 th

October2009

Irish Medicines Board

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Date Printed 23/10/2009 CRN 2068999 page number: 4