Compound Sodium Lactate Solution for Infusion BP

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium chloride; Potassium chloride; Calcium chloride dihydrate; Sodium lactate

Available from:

Baxter Holding B.V.

ATC code:

B05BB; B05BB01

INN (International Name):

Sodium chloride; Potassium chloride; Calcium chloride dihydrate; Sodium lactate

Dosage:

3.2 gram(s)

Pharmaceutical form:

Solution for infusion

Therapeutic area:

Solutions affecting the electrolyte balance; electrolytes

Authorization status:

Marketed

Authorization date:

2003-04-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
COMPOUND SODIUM LACTATE SOLUTION FOR INFUSION BP
Active substances: sodium chloride, potassium chloride, calcium
chloride dihydrate and
sodium Lactate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Compound Sodium Lactate Infusion is and what it is used for
2.
What you need to know before you are given Compound Sodium Lactate
Infusion
3.
How you will be given Compound Sodium Lactate Infusion
4.
Possible side effects
5.
How to store Compound Sodium Lactate Infusion
6.
Contents of the pack and other information
This medicine is called "Compound Sodium Lactate Solution for Infusion
BP”, but will be referred to
as "Compound Sodium Lactate Infusion” throughout the document.
1.
WHAT COMPOUND SODIUM LACTATE INFUSION IS AND WHAT IT IS USED FOR
Compound Sodium Lactate Infusion is a solution of the following
substances in water:
-
sodium chloride
-
potassium chloride
-
calcium chloride dihydrate
-
sodium lactate.
Sodium, potassium, calcium, chloride and lactate are chemical
substances (electrolytes) found in the
blood.
Compound Sodium Lactate Infusion is used:
-
to treat a loss of body water and chemicals (e.g. by heavy sweating,
kidney disorders)
-
to treat you, if the volume of blood in your blood vessels is low
(hypovolaemia) or if you
have low blood pressure (hypotension)
-
in metabolic acidosis (when the blood becomes too acidic).
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN COMPOUND SODIUM LACTATE
INFUSION
YOU MUST NOT RECEIVE COMPOUND SODIUM LACTATE INFUSION IF YOU ARE
SUFFERING FROM ANY OF THE
FOLLOWING CONDITIONS
-
if you’re a newborn (less than 28 days old) receiving ceftriaxone
(an antibiotic)
-
if you�

Summary of Product characteristics

HealthProductsRegulatoryAuthority
29March2019
CRN008KFH
Page1of9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CompoundSodiumLactateSolutionforInfusionBP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SodiumChloride: 6.00g/l
PotassiumChloride: 0.40g/l
CalciumChloridedihydrate: 0.27g/l
SodiumLactate: 3.20g/l
Na
+
K
+
Ca
++
Cl
-
C
3
H
5
O
3
-
(lactate)
mmol/l 131 5 2 111 29
mEq/l 131 5 4 111 29
Forafulllistofexcipientsseesection6.1.
3 PHARMACEUTICAL FORM
Solutionforinfusion.
Clearsolution,freefromvisibleparticles.
278mOsm/l(approx.) pH:5.0–7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CompoundSodiumLactatesolution(RingerLactatesolution)isusedinthefollowingindications:
o
Restorationofextracellularfluidandelectrolytesbalancesorreplacementofextracellularfluidlosswhereisotonic
concentrationsofelectrolytesaresufficient
o
Shorttermvolumereplacement(aloneorinassociationwithcolloid)incaseofhypovolaemiaorhypotension.
o
Regulationormaintenanceofmetabolicacidosisbalanceand/ortreatmentofmildtomoderatemetabolicacidosis(except
lacticacidosis)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, the Elderly and Children:
Dosage,rate,anddurationofadministrationaretobeindividualizedanddependupontheindicationforuse,thepatient’sage,
weight,clinicalcondition,andconcomitanttreatment,andonthepatient’sclinicalandlaboratoryresponsetotreatment.
_Recommended dosage:_
TheamountofCompoundSodiumLactatesolution(RingerLactatesolution)neededtorestorenormalbloodvolumeis3to�