COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP (H

Main information

  • Trade name:
  • COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP (H
  • Pharmaceutical form:
  • Solution for Infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/055/001A
  • Authorization date:
  • 01-04-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CompoundSodiumLactateIntravenousInfusionBP,(Hartmann’sSolution)SolutionforInfusion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachlitreprovidesthefollowingconcentrationofelectrolytes:

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionforinfusion

Sterile,non-pyrogenic,clear,colourless,aqueoussolutionforinfusion.

4CLINICALPARTICULARS

4.1TherapeuticIndications

ForprophylacticandreplacementtherapyrequiringtheuseofSodiumChlorideandlactate,withminimalamountsof

calciumandpotassium.

4.2Posologyandmethodofadministration

4.2.1 Dosage

Thedosageisdependantupontheage,weightandclinicalconditionofthepatient.

4.2.2 Administration

Intravenous.

4.3Contraindications

4.3.1 Administrationincongestiveheartfailure,orinconditionsofsevereimpairmentofrenalfunction,orin

oedemawithsodiumretention.

SodiumChloride 6.0 g/l

SodiumLactate 3.22 g/l

PotassiumChloride 400 mg/l

CalciumChlorideDihydrate 270 mg/l

131mmol/l

5mmol/l

111mmol/l

Lactate 29mmol/l

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/04/2011 CRN 2098524 page number: 1

4.4Specialwarningsandprecautionsforuse

4.4.1 Administrationshouldbecarriedoutunderregularandcarefulsurveillance;plasmaelectrolytelevelsshouldbe

monitoredduringuse.

4.4.2 Thisfluidshouldbeadministeredwithgreatcaretopatientswithrenalinsufficiency.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

Thesafetyofthismedicinalproductforuseinhumanpregnancyhasnotbeenestablished.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Patientswithdoubtfulrenalfunctionmayresultinexcessivesodiumchlorideretention.Prolongedinfusionmaycause

thrombophlebitisextendingfromthesiteofinfusion.

Allergicreactionsoranaphylactic/anaphylactoidsymptomssuchaslocalisedorgeneralisedurticaria,skinrashand

erythemaanditching/pruritis,skinswelling,periorbitalfacialandorlaryngealoedema(Quincke’soedema);chest

tightness,chestpainwithtachycardiaorbradycardia;nasalcongestion,coughing,sneezing,bronchospasmand/or

difficultybreathinghavebeenreportedduringadministrationofLactatedRinger’sInjection,USP.

4.9Overdose

Discontinueifadversereactionoccurs.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Notapplicable.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

SodiumHydroxide(forpHadjustment)

LacticAcid(forpHadjustment)

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/04/2011 CRN 2098524 page number: 2

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thismedicinalproductmustnotbemixedwithothermedicinalproducts.

6.3Shelflife

Unopened:2years.

Theproductshouldbeusedimmediatelyafteropening.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Thesolutionissuppliedinaclear,collapsible,polyvinylchloride(Viaflex®)container,overwrappedwithhighdensity

polyethyleneandpolypropyleneandcontaining500mlor1000mlofsolution.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Forsingleuseonly.Discardanyunusedportion.

Useonlyifsolutionisclearwithoutvisibleparticlesandifthecontainerisundamaged.Solutionscontainingvisible

solidparticlesshouldnotbeused.

Donotreconnectpartiallyusedbags.

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd.

CaxtonWay

Thetford

Norfolk

IP243SE

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA167/55/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1983

Dateoflastrenewal:01April2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/04/2011 CRN 2098524 page number: 3