BRASIVOL MEDIUM

Main information

  • Trade name:
  • BRASIVOL MEDIUM
  • Dosage:
  • 52 %w/w
  • Pharmaceutical form:
  • Cutaneous Paste
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BRASIVOL MEDIUM
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0144/025/002
  • Authorization date:
  • 01-10-1984
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

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

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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

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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

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