DONA

Main information

  • Trade name:
  • DONA Powder for Oral Solution 1500 Milligram
  • Dosage:
  • 1500 Milligram
  • Pharmaceutical form:
  • Powder for Oral Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DONA Powder for Oral Solution 1500 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1328/133/001
  • Authorization date:
  • 12-02-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PPA1328/133/001

CaseNo:2074339

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

B&SHealthcare

Unit4,BradfieldRoad,Ruislip,Middlesex,HA40NU,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Dona1500mgPowderforOralSolution

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom12/02/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dona1500mgPowderforOralSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachsachetcontains

Crystallineglucosaminesulfate 1884mg

equivalentto:glucosaminesulfate 1500mg

sodiumchloride 384mg

Excipients:containsaspartame(E951)andsorbitol(E420)

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

PowderforOralSolution

ProductimportedfromtheItaly

Awhite,crystalline,odourlesspowder

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofthesymptomsofosteoarthritis,i.e.painandfunctionlimitation.

4.2Posologyandmethodofadministration

AdultsandtheElderly:

Thecontentsofonesachet(dissolvedinaglassofwater)shouldbetakenoncedaily,preferablyatmeals.

Pivotalproofofefficacyhasbeendemonstratedforperiodsofuptothreemonths,witharesidualeffectevidentfortwo

monthsafterdrugwithdrawal.Thesafetyandefficacyoftheproductwerealsoconfirmedinpivotalclinicaltrialsfor

treatmentuptothreeyears.Continuoustreatmentbeyond3yearscannotberecommendedasthesafetyhasnotbeen

establishedbeyondthisperiod.

Children:

Safetyandefficacyhasnotbeenestablishedinchildren,thereforenodosagerecommendationscanbemade.

4.3Contraindications

Hypersensitivitytoglucosamine.Thepowderfororalsolutioncontainsaspartameandisthereforecontraindicatedin

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4.4Specialwarningsandprecautionsforuse

Sinceglucosamineisobtainedfromshellfish,patientswhoareallergictoshellfishshouldexercisecautionintheuseof

theproduct.

Thismedicinalproductcontains151mgsodiumperdose.Tobetakenintoconsiderationbypatientsonacontrolled

sodiumdiet.

Cautionisadvisedintreatmentofpatientswithimpairedglucosetolerance.Closermonitoringofbloodsugarlevels

maybenecessaryindiabeticsatthebeginningoftreatment.

Nospecialstudieswereperformedinpatientswithrenalorhepaticinsufficiency.Thetoxicologicaland

pharmacokineticprofileoftheproductdoesnotindicatelimitationsforthesepatients.However,administrationto

patientswithseverehepaticorrenalinsufficiencyshouldbeundermedicalsupervision.

Thepowderfororalsolutioncontainssorbitol.Patientswithrarehereditaryproblemsoffructoseintoleranceshouldnot

takethispharmaceuticalform.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noformaldruginteractionstudieshavebeenperformed,however,thephysico-chemicalandpharmacokinetic

propertiesofglucosaminesulfatesuggestalowpotentialforinteractions.Thecompounddoesnotcompetefor

absorptionmechanismsand,afterabsorption,doesnotbindtoplasmaprotein,whileitsmetabolicfateasan

endogenoussubstanceincorporatedinproteoglycansordegradedindependentlyofthecytochromeenzymesystem,is

unlikelytogiverisetodruginteractions.

However,anincreasedeffectofwarfarinduringconcomitanttreatmentwithglucosaminehasbeenreportedinpost-

marketingexperience.Therefore,morefrequentmeasurementofthewarfarineffectmaybeconsidered.

Theoraladministrationofglucosaminesulphatecanenhancethegastrointestinalabsorptionoftetracyclines.

4.6Pregnancyandlactation

Inanimalstudies,nounfavourableeffectsonreproductivefunctionoronlactationweredemonstrated.Intheabsence

ofsuchstudiesinhumans,theuseofglucosaminesulfateduringpregnancyandlactationshouldbelimitedtocases

wherethebenefitsoutweighthepotentialrisks.Administrationduringthefirstthreemonthsofpregnancymustbe

avoided.

4.7Effectsonabilitytodriveandusemachines

NoeffectsontheCNSormotorsystemareknownthatmightimpairtheabilitytodriveorusemachines.

4.8Undesirableeffects

Themorecommonlyobservedundesirableeffectsafteroraladministrationarestomachpain,flatulence,constipation

anddiarrhoea.

Inthefollowingtable,adversereactionshavebeengroupedonthebasisof“InternationallyagreedOrderof

Importance”SystemOrganClass(SOC)MedDRAClassification.IneachSOC,undesirableeffectswereclassified

accordingtotheiroccurrencefrequency.Ineachfrequencyclasstheundesirableeffectsarereportedaccordingtoan

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*whichfrequencycannotbeestimatedbytheavailabledata

4.9Overdose

Nocasesofaccidentalorintentionaloverdoseareknown.Theanimalacuteandchronictoxicologicalstudiesindicate

thattoxiceffectsandsymptomsareunlikelytooccuratdosesupto200timesthetherapeuticdose.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Productforthetreatmentofosteoarthritis.

(Productforthemusculoskeletalsystem-ATCcode:M01AX05).

Glucosaminesulfate,theactiveingredientofDONA,isachemicallywelldefinedandpurecompoundandisthesaltof

thenaturalamino-monosaccharideglucosaminewhichisphysiologicallypresentinthehumanbody.

Themechanismofactionofglucosaminesulfateinosteoarthritisisunknown.However,glucosamineisanormal

constituentofthepolysaccharidechainsofcartilagematrixandsynovialfluidglucosaminoglycans.Invitroandinvivo

studieshaveshownthatglucosaminesulfatestimulatesthesynthesisofphysiologicalglycosaminoglycansand

proteoglycansbychondrocytesandofhya1uronicacidbysynoviocytes.

Glucosaminesulfatehasalsobeenshowntoinhibittheactivityofcartilage-destroyingenzymessuchascollagenase

andphospholipaseA2,aswellasthegenerationofothertissue-damagingsubstancessuchassuperoxideradicals,orthe

activityoflysosomalenzymes.Theseactivitiesmaycontributetothemildanti-inflammatoryeffectsobservedinvivo

inexperimentalmodels,includingsometypesofexperimentalarthritis.UnlikeNSAIDs,glucosaminesulfatedoesnot

inhibitthesynthesisofprostaglandins.

Noeffectsonthecardiovascularandrespiratorysystems,ontheCNS,ortheautonomicnervoussystem,havebeen

showninsafetypharmacologystudies.

Pivotalproofofefficacyhasbeendemonstratedinkneeosteoarthritis,andhasbeenpartlyreplicatedinosteoarthritisof

thespineandofotherjoints,includingthehip.Theefficacyofglucosaminesulfatehasnotbeenestablishedfor

osteoarthritisofthehand.

SystemOrganClass Very

common

≥1/10 Common

from ≥1/100

≤1/10 Uncommonfrom

≥1/1,000

≤1/100 Rarefrom

≥1/10,000

≤1/1,000 Veryrare

≤1/10,000 Unknown*

Immunesystem

disorders Allergic

reaction

Nervoussystem

disorders Headache

Somnolence

Eyedisorders Visual

disturbance

Gastrointestinal

disorders Diarrhoea

Constipation

Nausea

Flatulence

Stomachpain

Dyspepsia

Skinand

subcutaneoustissue

disorders Erythema

Pruritus

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AnalgesicsandNSAIDsmaybeusedconcomitantlywithglucosaminesulfate,eitherforrescueanalgesiaduring

possibleflaresofthedisease,orintheinitialperiodoftreatment,whenthesymptomaticeffectsofglucosaminesulfate

maybedelayedfor1-2weeks.Physicaltherapyprogramscanbeusedconcomitantlywithglucosaminesulfateinthe

overallmanagementofosteoarthritis.

5.2Pharmacokineticproperties

Thepharmacokineticpropertiesofglucosaminesulfatehavebeenstudiedintheratanddogusinguniformly 14

labelledglucosamine.Followingintravenousadministration,radiolabelledglucosaminedisappearsrapidlyfromblood

andisincorporatedintovarioustissues,inparticulartheliver,kidneyandthearticularcartilage.Inthelatter,the

radioactivityfromlabelledglucosamineremainsforaprolongedperiodoftime,withabiologicalhalflifeofabout70

hours.About50%oftheadministeredradioactivityisexhaledasCO

duringthe6daysfol1owingtheadministration,

30-40%isfoundintheurine,whereastheexcretionviathefaecesisonlyabout2%.

Afteroraladministration,radiolabelledglucosamineisrapidlyandalmostcompletelyabsorbed.Thesubsequent

pharmacokineticandmetabolicpatternsareconsistentwiththoseafterintravenousadministration.

Apharmacokineticstudyinmanwithsingledosesofradiolabelledglucosaminebyi.v.,i.m.ororalrouteconfirmedthe

analogyofthepharmacokineticpatternofglucosaminewiththatfoundinanimals.

Theabsolutebioavailabilityinmanafterasingleoraldoseofradiolabelledglucosaminewas25%,duetothefirst-pass

effectintheliverinwhichmorethan70%ofglucosamineismetabolised.Thegastrointestinalabsorptioniscloseto

90%,sinceonly11%oftheadministeredradioactivityisexcretedinfaeces.

Studiesinmanwerealsoperformedafteri.v.ororaladministrationofunlabelledglucosamineandglucosaminewas

assayedbyionexchangechromatographyinbloodandurine.Thisassaymethodhasaquantitationlimitinsufficientfor

soundpharmacokineticstudies.Nevertheless,theresultswereconsistentwiththoseobtainedwithradiolabelled

glucosamine.

5.3Preclinicalsafetydata

Thetoxicologicalstudiesperformedwithglucosaminesulfateindicatethelargesafetymarginofthedrug.

Thefollowingpreclinicalstudieswerecarriedout.Themaximumtesteddosesreportedherearethoseshowingnoor

minimaleffects,thesewerereversibleandtherewasnodetectabletargetorgantoxicity:

acutetoxicitystudiesinmiceandratsbyi.v.,i.m.andoralroute,withupto5000mg/kggivenbythe

oralroute;

subchronictoxicitystudiesof4weeksintherabbitbythei.v.routeupto80mg/kg,intheratbythe

oralrouteto240mg/kg,andinthedogbythei.v.routefor13weeksupto300mg/kg;

chronictoxicitystudiesof52weeksintheratwithoraldosesupto2700mg/kg,andof26weeksin

thedogwithoraldosesupto2149mg/kg;

embryotoxicitystudiesintheratandrabbitbytheoralrouteupto2500mg/kg,andfertilitystudiesin

theratbytheoralrouteupto2149mg/kg;

mutagenicpotentialstudiesinvitrouptoconcentrationof5000µg/mlandinvivouptotheoraldose

of1592mg/kgintheratand7160mg/kginthemouse.

Thedosesusedrepresentaverylargemultipleofthedailydosecurrentlyusedinhumantherapy,whichisaround20-

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Aspartame(E951)

Citricacid(anhydrous)(E330)

Sorbitol(E420)

Macrogol4000

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelflifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Over-labelledcartoncontainingoverlabelledsingledosesachets

Packsize:20sachets

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7ParallelProductAuthorisationHolder

B&SHealthcareLtd

Unit4

BradfieldRoad

Ruislip

MiddlesexHA40NU

UnitedKingdom

8ParallelProductAuthorisationNumber

PPA1328/133/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:12 th

February2010

Irish Medicines Board

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