BRASIVOL MEDIUM 52 %w/w Cutaneous Paste

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
ALUMINIUM OXIDE
Available from:
Stiefel Laboratories (U.K.) Ltd.
INN (International Name):
ALUMINIUM OXIDE
Dosage:
52 %w/w
Pharmaceutical form:
Cutaneous Paste
Authorization status:
Withdrawn
Authorization number:
PA0144/025/002
Authorization date:
2009-05-08

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BrasivolNo.2Medium

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Aluminiumoxide52.0%w/w.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

CutaneousPaste

Agreyish-bluemoderatelygrittycutaneouspastewithaslightperfume.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Brasivolisindicatedinthetreatmentofacnevulgaris.BrasivolNo.2Mediumeffectivelycleansesandremoves

debrisfromblockedporesandremovesexcesssebumfromtheskin,thusmaintainingpatencyoftheporeduct

openings.

4.2Posologyandmethodofadministration

TwogradesofBrasivolareavailable:BrasivolNo.1FineandBrasivolNo.2Medium.

TreatmentshouldnormallycommencewithBrasivolNo.1Fine.Theabrasivecleansingpasteshouldbeappliedto

wettedskinandrubbedgentlybutfirmlyovertheaffectedareawithacircularmotionfor15-20seconds,thenrinsed

offthoroughlywithwater.Thisroutinemayberepeatedtwoorthreetimesdaily,replacingordinarysoapandwater.

Inmoresevereconditions,aftertheuseofBrasivolNo.1Fineforseveralweeks,theskinmayrequiretheslightly

moreabrasiveactionofBrasivolNo.2Medium.

4.3Contraindications

Brasivoliscontra-indicatedinthepresenceofsuperficialvenulesandtelangiectasia(actinicsequelae).

4.4Specialwarningsandprecautionsforuse

CareshouldbetakentoavoidusingBrasivolNo.2Mediumclosetotheeyesormouth.Malepatientsusingan

electricrazorshouldshavebeforeapplyingBrasivolNo.2Medium.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 07/12/2006 CRN 2030898 page number: 1

4.6Pregnancyandlactation

TherearenorestrictionsontheuseofBrasivolNo.2Mediuminpregnancyorlactation.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Adegreeofdrynessandrednesswillbeseenduringthefirstfewdaysoftreatment.Over-enthusiasticuse,however,

cancauseirritationand,ifthisoccurs,treatmentshouldbeinterruptedforadayortwoandthenresumed.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

BrasivolNo.2Mediumaidsinthetreatmentofacnebyexertingadebradingeffectontheskinsurface,unblocking

thefollicle,thusallowingtheremovalofretainedsebumandpermittingthesebaceousglandstoreturntonormalsize

andactivity.VariousdegreesofabrasionaremadepossiblebytheprovisionoftwogradesofBrasivol.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerol

Macrogol

Stearicacid

Lauricacid

Myristicacid

1-(3-chloroallyl)-3,5,7triaza1-azoniadamantanechloride(Dowicil200)

Bentonite

Sodiumhydroxide

Sodiumlaurilsulfatesolution(30%)

PatentBlueVE131

PerfumeBV-2

Purifiedwater

6.2Incompatibilities

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 07/12/2006 CRN 2030898 page number: 2

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Nospecialprecautionsforstorage.

6.5Natureandcontentsofcontainer

Theproductispackagedinwhiteopaquelowdensitypolyethylenetubesof75g.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

StiefelLaboratories(UK)Ltd

HoltspurLane

WooburnGreen

HighWycombe

Buckinghamshire

HP100AU

8MARKETINGAUTHORISATIONNUMBER

PA144/25/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:10October1984

Dateoflastrenewal:10October2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 07/12/2006 CRN 2030898 page number: 3

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