DIPROBASE

Main information

  • Trade name:
  • DIPROBASE Cream
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1286/028/002
  • Authorization date:
  • 25-03-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DiprobaseCream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Excipientsinclude:Chlorocresol0.10%w/wandCetostearylAlcohol7.20%w/w

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Cream

Smoothuniformwhitecream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

DiprobaseCreamisanemollient,moisturisingandprotectivecreamforthefollow-uptreatmentwithtopical

steroidsorinspacingsuchtreatment.Itmayalsobeusedasdiluentfortopicalsteroids.DiprobaseCreamis

recommendedforthesymptomatictreatmentofredinflamed,damaged,dryorchappedskin,theprotectionof

rawskinareasandasapre-bathingemollientfordry/eczematousskintoalleviatedryingareas.

4.2Posologyandmethodofadministration

AdultsandChildren:

Thecreamshouldbeappliedtothedryskinareasasoftenasisrequiredandrubbedwellintotheskin.

4.3Contraindications

Therearenoabsolutecontraindicationstotheuseofthecreamotherthanhypersensitivitytoanyofthe

ingredients.

4.4Specialwarningsandprecautionsforuse

DiprobaseCreamcontainsChlorocresolwhichmaycauseallergicreactionsandCetostearylalcoholwhichmaycause

localskinreactions(e.g.contactdermatitis)

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonestated.

4.6Fertility,pregnancyandlactation

Irish Medicines Board

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

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

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

dryskinandbullousdermatitishavebeenreportedwithproductuse.

4.9Overdose

Nonestated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

DiprobaseCreamcontainsnoactiveingredientsandhasnopharmacologicalaction.Theingredientsprovide

emollient,moisturisingactionondryorchappedskin.

5.2Pharmacokineticproperties

Notapplicableduetotopicaladministrationanddirectactionontheskin.

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedin

othersectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Chlorocresol

MacrogolCetostearylether

Cetostearylalcohol

Liquidparaffin

Whitesoftparaffin

Phosphoricacid

Sodiumdihydrogenphosphate

Sodiumhydroxide

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

AluminiumTubes:5years

Irish Medicines Board

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

6.4Specialprecautionsforstorage

Storebelow25 o

6.5Natureandcontentsofcontainer

15g,50g,and100galuminiumepoxylinedmembranetubeswithplasticcaps.

A500gpolypropylenejarwithapolyethylenefollowerplateandapumpsystem.Thepumpsystemconsistsof

apolypropylenepumpcylinder,apolypropylenehead,apolypropylenepumpbodyandapolyethylenepiston

withaglassvalveandapolyethylenevalve.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewiththelocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

MerckSharp&DohmeIreland(HumanHealth)Limited

PelhamHouse

SouthCountyBusinessPark

Leopardstown

Dublin18

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA1286/028/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:5 th

October1983

Dateoflastrenewal:5 th

October2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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