BATRAFEN

Main information

  • Trade name:
  • BATRAFEN Cutaneous Solution 10 %v/ v
  • Dosage:
  • 10 %v/ v
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BATRAFEN Cutaneous Solution 10 %v/v
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0540/032/006
  • Authorization date:
  • 09-01-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0540/032/006

CaseNo:2064842

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

sanofi-aventisIrelandLimited

CitywestBusinessCampus,Dublin24,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Batrafen1%w/vCutaneousSolution

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom10/07/2009until17/12/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 10/07/2009 CRN 2064842 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Batrafen1%w/vCutaneousSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains10mgciclopiroxolamineinanalcoholicaqueousbase.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

CutaneousSolution

Colourlesstofaintlyyellowsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Allfungalinfectionsoftheskinwhererapiddryingisanadvantage.

4.2Posologyandmethodofadministration

Batrafensolutionshouldbegentlyrubbedintotheinfectedareatwiceaday.

4.3Contraindications

Batrafensolutionshouldnotbeusedinpatientswithknownhypersensitivitytoanycomponent.Itshouldnotbe

appliedtotheeyesormucosa.Batrafenisnotrecommendedforuseduringpregnancyorinwomenwhoarebreast

feedinginfantsorinchildrenlessthansixyearsold.DonotapplyBatrafentoanopenwound.

4.4Specialwarningsandprecautionsforuse

Toavoidrelapsestreatmentshouldbecontinuedforonetotwoweeksafterdisappearanceofthesymptoms-usually

withintwoweeks.

Allpossiblyinfectedareasshouldbetreatedatthesametime.

Additionalhygienicmeasurese.g.sprinklingpowderintosocksorshoesshouldberecommended.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 10/07/2009 CRN 2064842 page number: 2

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Inrarecasestransientlocalreactionse.g.pruritisoraslightburningsensationmayoccur,asmayallergiccontact

dermatitis.Ifanyofthesereactionsaresevere,treatmentshouldbediscontinued.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Theactivesubstanceciclopiroxolamineisabroadspectrumantimycoticforthetopicaltreatmentofinfectionsdueto

superficialdermatophytes,candidaspeciesandothersensitivefungi.

5.2Pharmacokineticproperties

Fortopicaluse.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Macrogol400

2-Propanol

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

4years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 10/07/2009 CRN 2064842 page number: 3

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

sanofi-aventisIrelandLtd

CitywestBusinessCampus

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA540/32/6

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:18December1985

Dateoflastrenewal:18December2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 10/07/2009 CRN 2064842 page number: 4