DOVONEX

Main information

  • Trade name:
  • DOVONEX Cutaneous Solution 50 Microgram/ML
  • Dosage:
  • 50 Microgram/ML
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOVONEX Cutaneous Solution 50 Microgram/ML
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1328/023/003
  • Authorization date:
  • 26-01-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PPA1328/023/003

CaseNo:2034068

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrants

B&SHealthcare

Unit4,BradfieldRoad,Ruislip,Middlesex,HA40NU,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Dovonex50micrograms/mlScalpSolution

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjectto

thegeneralconditionsasmaybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom26/03/2007until25/01/2012.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 12/04/2007 CRN 2034068 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dovonex50micrograms/mlScalpSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmillilitreofsolutioncontains50microgramsofcalcipotriol(asthehydrate).

Excipient:Propyleneglycol(E1520)

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Scalpsolution.

ProductimportedfromGreeceandtheUK:

Clear,colourless,slightlyviscoussolutionwithanodourofmenthol.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Dovonex ®

ScalpSolutionisindicatedforthetopicaltreatmentofscalppsoriasis.

4.2Posologyandmethodofadministration

Adults:Dovonex ®

ScalpSolutionshouldbeappliedtwicedaily(morningandevening)totheaffected

areas.Maximumweeklydoseshouldnotexceed60ml.

WhenusedtogetherwithDovonex ®

CreamorOintment,thetotaldoseofcalcipotriolshouldnot

exceed5mginanyweek.

Children:ThereisnoexperienceoftheuseofDovonex ®

ScalpSolutioninchildren.

4.3Contraindications

Knownhypersensitivitytoanyoftheingredients.

Duetothecontentofcalcipotriol,Dovonex ®

iscontraindicatedinpatientswithknowndisordersofcalcium

metabolism.

4.4Specialwarningsandprecautionsforuse

Dovonex ®

Irish Medicines Board

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Date Printed 12/04/2007 CRN 2034068 page number: 2

useoftheproducttoavoidapplicationandaccidentaltransfertotheface.Handsmustbewashedafter

eachapplication.

UseofDovonex ®

shouldbeavoidedinpatientswithsevererenalfailureorseverehepaticdisorders.

Theriskofhypercalcaemiaisminimalwhenthedosagerecommendationsarefollowed.

Hypercalcaemiamayoccurifthemaximumweeklydose(60ml)isexceeded.However,serum

calciumisquicklynormalisedwhentreatmentisdiscontinued.

DuringDovonextreatmentphysiciansmaywishtoadvisepatientstolimitoravoidexcessiveexposuretoeithernatural

orartificialsunlight.TopicalcalcipotriolshouldbeusedwithUVradiationonlyifthephysicianandpatientconsider

thatthepotentialbenefitsoutweighthepotentialrisks(Seesection5.3)

Propyleneglycolmaycauseskinirritation.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

Standardreproductionstudiesinanimalshaveshownnoevidenceofdrugrelatedabnormality.Thereisnoexperience

ofuseinhumansinpregnancyandlactation,thereforeuseshouldbelimitedtothatconsideredessentialbythe

physician.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Verycommon>1/10

Common>1/100and<1/10

Uncommon>1/1,000and<1/100

Rare>1/10,000and<1/1,000

Veryrare<1/10,000

Themostfrequentlyreportedundesirableeffectsarevariousskinreactionsandinparticular

applicationsitereactions.Hypercalcaemiaandallergicreactionshavebeenreportedveryrarely.

BasedonclinicaldataforDovonex ®

ScalpSolutionundesirableeffectsoccurredinapproximately

25%ofthepatients.

Burningandstingingsensationareverycommon.Pruritus,skinirritation,dryskin,erythemaandrash

arecommon.Contactdermatitis,eczemaandaggravatedpsoriasisareuncommon.

Systemiceffectsaftertopicalusemayappearveryrarelycausinghypercalcaemiaorhypercalciuria,cf.

section4.4.

Post-marketdataonDovonex ®

cream,ointmentandscalpsolution

Transientchangesinskinpigmentation,transientphotosensitivityreactionsandhypersensitivity

reactionsincludingurticaria,angioedema,periorbitalorfacialoedemahavebeenreportedveryrarely.

Perioraldermatitismayoccurrarely.

Basedonpost-marketingdatathetotal'reportingrate'ofundesirableeffectisveryrarebeing

approximately1:10,000treatmentcourses.

TheundesirableeffectsarelistedbyMedDRASOCandtheindividualundesirableeffectsarelisted

Irish Medicines Board

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Date Printed 12/04/2007 CRN 2034068 page number: 3

Skinandsubcutaneoustissuedisorders:

Pruritus

Skinburningsensation

Skinstingingsensation

Skinirritation

Skindry

Erythema

Rash*

Eczema

ContactDermatitis

AggravatedPsoriasis

Skinhyperpigmentation

Skindepigmentation

Photosensitivityreaction

Urticaria

Facialoedema

Periorbitaloedema

Angioedema

*Varioustypesofrashreactionssuchasscaly,erythematous,maculo-papularandpustularhavebeen

reported

Metabolismandnutritiondisorders:

Hypercalcaemia

Hypercalciuria

4.9Overdose

Useabovetherecommendeddosemaycauseelevatedserumcalciumwhichshouldrapidlysubsidewhenthetreatment

isdiscontinued.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

CalcipotriolisavitaminDderivative.Invitrodatasuggestthatcalcipotriolinducesdifferentiationandsuppresses

proliferationofkeratinocytes.Thiseffectistheproposedbasisforitseffectinpsoriasis.

5.2Pharmacokineticproperties

Calcipotriolisonlyslightlyabsorbedfromtheskin.

5.3Preclinicalsafetydata

Theeffectonthecalciummetabolismisapproximately100timeslessthanthatofthehormonallyactiveformof

vitaminD

Irish Medicines Board

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wasappliedtopicallyforupto24monthsatdosesof3,10and30µg/kg/day(correspondingto9,30and90

g/m2/day).Thehigh-dosewasconsideredtobetheMaximumToleratedDosefordermaltreatmentofmicewith

calcipotriol.Survivalwasdecreasedat10and30 µ

g/kg/day,particularlyinthemales.Thereducedsurvivalwas

associatedwithanincreasedincidenceofobstructiveuropathy,mostprobablycausedbytreatment-relatedchangesin

theurinarycomposition.ThisisanexpectedeffectoftreatmentwithhighdosesofcalcipotriolorothervitaminD

analogues.Therewerenodermaleffectsandnodermalorsystemiccarcinogenicity.

Inastudywherealbinohairlessmicewererepeatedlyexposedtobothultraviolet(UV)radiationandtopicallyapplied

calcipotriolfor40weeksatthesamedoselevelsasinthedermalcarcinogenicitystudy,areductioninthetimerequired

forUVradiationtoinducetheformationofskintumourswasobserved(statisticallysignificantinmalesonly),

suggestingthatcalcipotriolmayenhancetheeffectofUVradiationininduceskintumours.Theclinicalrelevanceof

thesefindingsinunknown.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

hyprolose

isopropylalcohol

levomenthol

sodiumcitrate

propyleneglycol(E1520)

purifiedwater.

6.2Incompatibilities

Notapplicable

6.3ShelfLife

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

WhiteHDPEbottlesfittedwithanLDPEnozzleandblueHDPEscrewcap.

Packsize:30mland120ml

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerials

derivedfromsuchmedicinalproductandotherhandlingoftheproduct

Thealcoholbaseisflammable.

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackage

Irish Medicines Board

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Date Printed 12/04/2007 CRN 2034068 page number: 5

B&SHealthcare

Unit4

BradfieldRoad

Ruislip

Middlesex

HA40NU

UnitedKingdom

8ParallelProductAuthorisationNumber

PPA1328/23/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation26thJanuary2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 12/04/2007 CRN 2034068 page number: 6