COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP

Main information

  • Trade name:
  • COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP
  • Dosage:
  • 500ml,1000 %v/v
  • Pharmaceutical form:
  • Solution for Infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0179/004/003A
  • Authorization date:
  • 01-04-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CompoundSodiumLactateIntravenousInfusionBP,SolutionforInfusion(Hartmann’sSolution).

2QUALITATIVEANDQUANTITATIVECOMPOSITION

1000mlofsolutioncontain

SodiumChloride 6.00g

SodiumLactateSolution(50%m/m) 6.24g

PotassiumChloride 0.40g

CalciumChlorideDihydrate 0.27g

3PHARMACEUTICALFORM

Solutionforinfusion

Aclear,colourless,sterileandnon-pyrogenicaqueoussolution.

Eachlitreprovides:

Electrolytes:

4CLINICALPARTICULARS

4.1TherapeuticIndications

Foruseinprophylacticandreplacementtherapyrequiringtheuseofsodiumchlorideandlactate,withminimum

amountsofcalciumandpotassium.

4.2Posologyandmethodofadministration

Recommendeddosage

ThedosageofCompoundSodiumLactateIntravenousInfusionBPdependsonage,weightandclinicalconditionof

thepatient.

Flowrate:upto5mlperkgbodyweightperhour,correspondingto1.7dropsperkgbodyweightperminute.

Childrenandtheelderly

Sodium 131 mmol/l

Potassium 5 mmol/l

Calcium 2 mmol/l

Chloride 111 mmol/l

Lactate 29 mmol/l

Theoreticalosmolarity: 278 mOsm/l

Titrationacidity:(topH7.4) <1 mmol/l

Irish Medicines Board

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Date Printed 05/11/2008 CRN 2058101 page number: 1

Routeofadministration

Intravenousinfusion.

4.3Contraindications

CompoundSodiumLactateIntravenousBPinfusionmustnotbeadministeredtopatientsinstatesofhyperhydration,

withcirculatoryoverload,respiratoryalkalosis,cardiacandliverdisease.

Thiscontainercontainsasignificantvolumeofair.Toavoidriskofairembolism,thisproductmustnotbe

administeredbypressureinfusion.

4.4Specialwarningsandprecautionsforuse

SpecialWarnings

CompoundSodiumLactateIntravenousInfusionBPshouldonlybeadministeredwithparticularcautioninthe

followingconditions:

Hypertonicdehydration,

Hyperkalaemia,

Hyperchloraemia,

Hypernatraemia,

Renalinsufficiencywithtendencytohyperkalaemia,

Disorderswhererestrictionofsodiumintakeisindicated,suchascardiacinsufficiency,generalisedoedema,

pulmonaryoedema,hypertension,clampsia,severerenalinsufficiency.

Specialprecautionsforuse

Itisnecessarytomonitortheserumelectrolytesandwaterbalance.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Pharmacologicalinteractionsarenotknown.

4.6Pregnancyandlactation

Compoundsodiumlactatemaybegivenifindicatedduringpregnancyandlactationbutshouldbeusedwithcautionin

toxaemiaofpregnancy.

4.7Effectsonabilitytodriveandusemachines

Notapplicable:Solutionforintravenousinfusion.

4.8Undesirableeffects

Irish Medicines Board

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Date Printed 05/11/2008 CRN 2058101 page number: 2

4.9Overdose

Symptoms:

Overdosemayresultinoverhydrationwithincreasedskintension,venouscongestion,oedema-possiblyalsolungor

brainoedema-,electrolyteandacid-baseimbalancesaswellasserumhyperosmolarity.

Emergencytreatment,antidotes

Cessationofinfusion,administrationofdiureticswithcontinuousmonitoringofserumelectrolytes,correctionof

electrolyteandacid-baseimbalances.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

CompoundSodiumLactateIntravenousInfusionBPhasasimilarelectrolytecompositionastheextracellularfluid,

withatotalcationcontentof138mmol/l.Itisusedforcorrectionofserumelectrolyteandacid-baseimbalances.

Electrolytesareadministeredinordertoachieveortomaintainanormalosmoticsituationinboththeextra-andthe

intracellularspace.

5.2Pharmacokineticproperties

AdministrationofCompoundSodiumLactateIntravenousInfusionBPdirectlyresultsinreplenishmentofthe

interstitialspacewhichamountstoabout2/3oftheextracellularspace.Only1/3oftheadministeredvolumestaysin

theintravascularspace.Thusthesolutionhasashorthaemodynamiceffect.

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothosealreadystatedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Waterforinjections.

6.2Incompatibilities

Drugscontainingoxalate,phosphate,orcarbonate/bicarbonatemaycauseprecipitationuponmixingwithCompound

SodiumLactateIntravenousInfusionBP.

Noothermedicamentorsubstanceshouldbeaddedtothefluidunlessknowntobecompatible.

6.3ShelfLife

Unopened:3years

Onceopened:Useimmediately.Discardanyunusedcontents.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

Irish Medicines Board

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Date Printed 05/11/2008 CRN 2058101 page number: 3

6.5Natureandcontentsofcontainer

Containersoflow-densitypolyethylenewithintegralon-weldedclosureofthesamematerial.Theclosurecontainsa

rubberdisc.

Contents:500ml,1000mlinpacksof10.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Single-dosecontainer.Discardunusedcontents.

Onlytobeusedifthesolutionisclear,freefromvisiblesolidparticlesandthecontaineroritsclosuredonotshow

visiblesignsofdamage.

7MARKETINGAUTHORISATIONHOLDER

B.BraunMedicalLimited

3NaasRoadIndustrialPark

Dublin12

8MARKETINGAUTHORISATIONNUMBER

PA0179/004/003A

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 01April1983

Dateoflastrenewal: 01April2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 05/11/2008 CRN 2058101 page number: 4