0.18 % W/V SODIUM CHLORIDE AND 4 % W/V GLUCOSE INT

Main information

  • Trade name:
  • 0.18 % W/V SODIUM CHLORIDE AND 4 % W/V GLUCOSE INT
  • Dosage:
  • 500/1000 Millilitre
  • Pharmaceutical form:
  • Solution for Infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • 0.18 % W/V SODIUM CHLORIDE AND 4 % W/V GLUCOSE INT
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0179/003/006A
  • Authorization date:
  • 01-04-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0179/003/006A

CaseNo:2041821

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

B.BraunMedicalLimited

3NaasRoadIndustrialPark,Dublin12,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

0.18%w/vSodiumChlorideand4%w/vGlucoseIntravenousInfusionBPSolutionforinfusion,500mland1000ml

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom01/04/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/04/2008 CRN 2041821 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

0.18%w/vSodiumChlorideand4%w/vGlucoseIntravenousInfusionBP,SolutionforInfusion.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionforinfusion

Aclear,colourless,sterileandnon-pyrogenicaqueoussolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Foruseinprophylacticandreplacementtherapyrequiringtheuseofglucoseandsodiumchloride.

4.2Posologyandmethodofadministration

4.2.1Dosage

Inaccordancewithfluid,electrolyteandenergyrequirements:

Notmorethan40ml/kgbodyweightperday,correspondingto1.7gglucose/kgbodyweightperday.

Infusionanddroprate:

Notmorethan5mg/kgbodyweightperhour,correspondingto0.2gglucose/kgbodyweightperhour,ornotmore

Thesolutioncontainsper 500ml 1000ml

Sodiumchloride 0.90g 1.80g

AnhydrousGlucose 20.00g 40.00g

asGlucoseMonohydrate

Eachlitreprovides:

Electrolytes:

Sodium 31 mmol/l

Chloride 31 mmol/l

Calorificvalue: 668kJ/1=160kcal/1

Theoreticalosmolarity: 284 mOsm/l

Titrationacidity(topH7.4): <0.5mmol/l

Irish Medicines Board

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4.2.2Methodandrouteofadministration

Intravenousinfusion.

4.3Contraindications

0.18%w/vSodiumChlorideand4%w/vGlucoseIntravenousInfusionBP,solutionforInfusionshouldnotbeused

incasesof:

-Hyperhydrationstates.

-Hypotonicdehydrationwithhyponatraemia.

-Hypokalaemia.

-Impairedkidneyfunction.

Thiscontainercontainsasignificantvolumeofair.Toavoidriskofairembolism,thisproductmustnotbe

administeredbypressureinfusion.

4.4Specialwarningsandprecautionsforuse

0.18%w/vSodiumChlorideand4%w/vGlucoseIntravenousInfusionB.P.SolutionforInfusionshouldonlybe

administeredwithcautionincasesofinsulinrefractoryhyperglycaemianecessitatingtheadministrationofmorethan6

unitsofinsulin/hour.

Itisnecessarytomonitortheserumelectrolytesandwaterbalance.

Inpost-operativeandpost-traumaticconditionsandinconditionsofimpairedglucosetolerance:onlyadministerwith

monitoringofbloodglucoselevel.

Specialattentionshouldbepaidtoregularmonitoringoftheserumpotassiumconcentration.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thesolutionshouldnotbeadministeredthroughthesameinfusionequipmentsimultaneously,beforeorafteran

administrationofbloodbecauseofthepossibilityofpseudo-agglutination.

4.6Pregnancyandlactation

0.18%w/vSodiumChlorideand4%w/vGlucoseIntravenousInfusionBPSolutionforInfusioncanbeusedas

indicated.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Irish Medicines Board

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4.9Overdose

4.9.1Symptoms

Overdosemayresultinoverhydrationwithincreasedskintension,venouscongestion,oedema-possiblyalsolungor

brainoedema,hypokalaemiaandacid-baseimbalancesandhyperglycaemia.

Clinicalsymptomsofwaterintoxicationmayalsooccur,suchasnausea,vomiting,spasms.

4.9.2Emergencytreatment;antidotes

Immediatecessationofinfusion,administrationofdiureticswithcontinuousmonitoringofserumelectrolytes,

correctionofelectrolyteandacid-baseimbalances,administrationofinsulinifnecessary.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Thesolutioncontainsequimolarproportionsofsodiumandchloridecorrespondingtoonefifththephysiological

concentrationintheplasma.Inadditionthissolutionalsocontains4%(w/v)ofcarbohydrateintheformofglucose.

Thesolutionismainlyintendedtosupplyfreewaterincasesofdehydration.

5.2Pharmacokineticproperties

Thetotalsodiumcontentofthebodyisca.80mmol/kgofwhichca.97%isextracellularandca.3%intracellular.

Thedailyturnoverisca.100-180mmol(correspondingto1.5-2.5mmol/kgbodyweight).

Chlorideisexchangedforhydrogencarbonateinthetubulesystemandis,thus,involvedintheregulationoftheacid

basebalance.

Oninfusionglucoseisfirstdistributedintheintravascularspaceandthenistakenupintotheintracellularspace.

Inglycolysisglucoseismetabolizedtopyruvateortolactate.Lactatecanbepartiallyre-introducedintotheglucose

metabolism(Coricycle).Underaerobicconditionspyruvateiscompletelyoxidizedtocarbondioxideandwater.The

finalproductsofthecompleteoxidationofglucoseareeliminatedviathelungs(carbondioxide)andthekidneys

(water).

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothosealreadystatedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Waterforinjections

6.2Incompatibilities

Whenmixingwithothermedicamentsitshouldberememberedthat0.18%w/vSodiumChlorideand4%w/v

Irish Medicines Board

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6.3ShelfLife

Unopened:3years

Onceopened:Useimmediately.Discardanyunusedcontents.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Storeinoriginalcontainer.

6.5Natureandcontentsofcontainer

Containersoflow-densitypolyethylenewithintegralon-weldedclosureofthesamematerial.Theclosurecontainsa

rubberdisc.

Contents:500ml,1000ml.

6.6Specialprecautionsfordisposalandotherhandling

Single-dosecontainer.Discardunusedcontents.

Onlytobeusedifthesolutionisclear,freefromvisiblesolidparticlesandthecontaineroritsclosuredonotshow

visiblesignsofdamage.

7MARKETINGAUTHORISATIONHOLDER

B.BraunMedicalLimited

3NaasRoadIndustrialPark

Dublin12

8MARKETINGAUTHORISATIONNUMBER

PA179/3/6

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1983

Dateoflastrenewal:01April2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 08/04/2008 CRN 2041821 page number: 5