DIORALYTE BLACKCURRANT

Main information

  • Trade name:
  • DIORALYTE BLACKCURRANT
  • Dosage:
  • 0.47/ 0.3/ 3 Grams
  • Pharmaceutical form:
  • Powder for Oral Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIORALYTE BLACKCURRANT
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1447/072/001
  • Authorization date:
  • 25-06-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DioralyteBlackcurrantPowderforOralSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachsachetcontains:

Exipients-Alsocontainsethanol

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Powderfororalsolution

ProductimportedfromUK:

White,homogeneous,granularpowderwithanodourandtasteofblackcurrant

4CLINICALPARTICULARS

4.1TherapeuticIndications

Intheoralcorrectionoffluidandelectrolytelossandinthemanagementofwaterydiarrhoea.

4.2Posologyandmethodofadministration

Thebasicunitofdosageisthecontentofasinglesachetreconstitutedin200ml(approximately7fluidounces)of

drinkingwater.Usefreshdrinkingwaterforadultsandchildren.Forinfantswheredrinkingwaterisunavailablethe

watershouldbefreshlyboiledandcooled.Thesolutionshouldbemadeupimmediatelybeforeuse.Ifrefrigerated,the

solutionmaybestoredforupto24hours,otherwiseanysolutionremaininganhourafterreconstitutionshouldbe

discarded.

Thesolutionmustnotbeboiledafterreconstitution.

Dailyintakemaybebasedonavolumeof150ml/kgbodyweightforinfantsand20-40mg/kgbodyweightforadults

andchildren.Areasonableapproximationis:

Infants–Onetooneandahalftimestheusualfeedvolume.Forinfantsunder12months,useonlyundermedical

advice.

Children–Onesachetaftereveryloosemotion.

Adultsincludingelderly–Oneortwosachetsaftereveryloosemotion.Moremayberequiredinitiallytoensureearly

SodiumChloridePh.Eur 0.47g

PotassiumChloridePh.Eur 0.30g

GlucosePh.Eur 3.56g

Irish Medicines Board

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Date Printed 26/10/2011 CRN 2107054 page number: 1

4.3Contraindications

Therearenoknowncontra-indicationstoDioralyte.

4.4Specialwarningsandprecautionsforuse

Speciallabellingrequirements.

Thesolutionmustnotbereconstitutedexceptwithwateratthevolumestated.

Solutionsofgreaterconcentrationmayresultinhypernatraemia.Thoseofgreaterdilutionmayresultin

inadequatereplacement.

Ifthereisnoimprovementwithin24-36hoursthephysicianshouldbeconsulted.

Forinfantsunder12monthsuseonlyonmedicaladvice.

Ifnauseaandvomitingarepresentwiththediarrhoea,smallbutfrequentamountsofdioralyteshouldbedrunk

atfirst.

Foruseintheelderlynospecificprecautionsarenecessary.However,careshouldbetakenwhenadministering

glucose-electrolytesolutionsincasesofsevererenalorhepaticimpairmentorotherconditionswherethe

normalelectrolytebalancemaybedistributed.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

None.

4.6Fertility,pregnancyandlactation

Dioralyteisnotcontra-indicatedinpregnancyorlactation.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Nonestated.

4.9Overdose

Intheeventofsignificantoverdose,serumelectrolytesshouldbeevaluatedassoonaspossible,appropriatestepstaken

tocorrectanyabnormalitiesandlevelsmonitoreduntilreturntonormallevelsisestablished.Thisisparticularly

importantintheveryyoungandincasesofseverehepaticorrenalfailure.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Dioralyteisanoralrehydrationtherapy.Thecombinationofelectrolytesstimulateswaterandelectrolyteabsorption

fromthegastro-intestinaltractandthereforepreventsdehydrationindiarrhoea.

5.2Pharmacokineticproperties

Sodiumandglucoseareactivelytransportedviathemembraneintotheenterocytes.Sodiumisthenextrudedintothe

intercellularspacesandtheresultingosmoticgradientcauseswaterandelectrolytestobedrawnfromthegutandthen

Irish Medicines Board

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Date Printed 26/10/2011 CRN 2107054 page number: 2

5.3Preclinicalsafetydata

None.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

SaccharinSodium

SiliconeDioxide

BlackcurrantFlavour(containingethanol)

6.2Incompatibilities

Notapplicable

6.3Shelflife

Theshelf-lifeexpirydateofthisproductisthedateshownonthecartonandsachetoftheproductonthemarketinthe

countryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Thereconstitutedsolutionshouldbeusedimmediatelybutmaybestoredforupto24hoursinarefrigeratorat2-8 o

6.5Natureandcontentsofcontainer

Overlabelledsachetcontainingblackcurrantpowderinanoverlabelledoutercarton

Packsize:6sachets

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Thesolutionshouldbepreparedimmediatelybeforeuse.Thecontentsofeachsachetshouldbedissolvedin200ml

(approximately7fluidounces)ofdrinking/cooledboiledwaterwhererelevant.Dioralyteshouldonlybepreparedwith

waterandtothevolumestated.

Thesolutionmustnotbeboiledafterreconstitution.

7PARALLELPRODUCTAUTHORISATIONHOLDER

G&ALicensingLimited

Ballymurray

Co.Roscommon

Ireland

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1447/72/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Irish Medicines Board

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Date Printed 26/10/2011 CRN 2107054 page number: 3

10DATEOFREVISIONOFTHETEXT Irish Medicines Board

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Date Printed 26/10/2011 CRN 2107054 page number: 4