DIPROBASE OINTMENT

Main information

  • Trade name:
  • DIPROBASE OINTMENT
  • Dosage:
  • 5/95 %w/w
  • Pharmaceutical form:
  • Ointment
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIPROBASE OINTMENT
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1286/028/001
  • Authorization date:
  • 25-03-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DiprobaseOintment

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Ointment.

Smooth,uniformwhiteointment.

4CLINICALPARTICULARS

4.1TherapeuticIndications

DiprobaseOintmentisanemollient,moisturisingandprotectiveointmentforthefollow-uptreatmentwithtopical

steroidsorinspacingsuchtreatment.Itmayalsobeusedasdiluentfortopicalsteroids.DiprobaseOintmentis

recommendedforthesymptomatictreatmentofredinflamed,damaged,dryorchappedskin,theprotectionofrawskin

areasandasapre-bathingemollientfordry/eczematousskintoalleviatedryingareas.

4.2Posologyandmethodofadministration

AdultsandChildren:

Theointmentshouldbethinlyappliedtocovertheaffectedareacompletely,massaginggentlyandthoroughlyintothe

skin.Frequencyofapplicationshouldbeestablishedbythephysician.Generally,DiprobaseOintmentcanbeusedas

oftenasrequired.

4.3Contraindications

Hypersensitivitytoanyofthecomponentsoftheointmentisacontraindicationtoitsuse.

4.4Specialwarningsandprecautionsforuse

Nonestated.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonestated.

4.6Fertility,pregnancyandlactation

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 25/03/2011 CRN 2087762 page number: 1

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Skinreactionsincludingpruritus,rash,erythema,skinexfoliation,burningsensation,hypersensitivity,pain,dryskin

andbullousdermatitishavebeenreportedwithproductuse.

4.9Overdose

Nonestated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

DiprobaseOintmentcontainsnoactiveingredientsandhasnopharmacologicalaction.Theingredientshavean

emollientactionondryorchappedskin.

5.2Pharmacokineticproperties

Notapplicableduetotopicaladministrationanddirectactionontheskin.

5.3Preclinicalsafetydata

Notrelevant.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

WhiteSoftParaffin

LiquidParaffin

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

5years(tubepresentations)

3years(500gplasticjarwithscrewcap)

6.4Specialprecautionsforstorage

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 25/03/2011 CRN 2087762 page number: 2

6.5Natureandcontentsofcontainer

5g,50gand100g:Epoxylinedaluminiumtubeswithplasticcaps.

500g:Whitepolypropylenejarclosedwithawhitetamper-evidentlowdensitypolyethylenescrewcap.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewiththelocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

MerckSharp&DohmeIreland(HumanHealth)Limited

PelhamHouse

SouthCountyBusinessPark

Leopardstown

Dublin18

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA1286/028/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:5 th

October1983

Dateoflastrenewal:5 th

October2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 25/03/2011 CRN 2087762 page number: 3