Compound Sodium Lactate (Hartmanns)

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Calcium chloride dihydrate 0.27 g;  ;  ;  ;  ; Potassium chloride 0.4 g;  ;  ;  ; Sodium chloride 6 g;  ;  ;  ;  ;  ; Sodium lactate 3.17 g (as 6.34g sodium lactate solution 50%);  
Available from:
Fresenius Kabi New Zealand Limited
INN (International Name):
Calcium chloride dihydrate 0.27 g
Pharmaceutical form:
Solution for infusion
Composition:
Active: Calcium chloride dihydrate 0.27 g         Potassium chloride 0.4 g       Sodium chloride 6 g           Sodium lactate 3.17 g (as 6.34g sodium lactate solution 50%)   Excipient: Hydrochloric acid Sodium hydroxide Water for injection
Units in package:
Bag, 10 x 1000mL, 10 L
Class:
General sale
Prescription type:
General sale
Manufactured by:
Merck KGaA
Therapeutic indications:
Compound Sodium Lactate (Hartmann's) is used for intravenous fluid and electrolyte replacement.
Product summary:
Package - Contents - Shelf Life: Bag, 20 x 250mL - 5 L - 3 years from date of manufacture stored at or below 25°C - Bag, 30 x 250mL - 7.5 L - 3 years from date of manufacture stored at or below 25°C - Bag, 35 x 250mL - 8.75 L - 3 years from date of manufacture stored at or below 25°C - Bag, 40 x 250mL - 10 L - 3 years from date of manufacture stored at or below 25°C - Bag, 10 x 1000mL - 10 L - 3 years from date of manufacture stored at or below 25°C - Bag, 20 x 500mL - 10 L - 3 years from date of manufacture stored at or below 25°C
Authorization number:
TT50-8050
Authorization date:
2007-12-03

CMIforCompoundSodiumLactate(Hartmann’s) 6July2010

Hartmann’sCMI060710 1 Changes:Companynamechange

CompoundSodiumLactate

(Hartmann’s)SolutionforInjection

ConsumerMedicineInformation

Whatisinthisleaflet

Thisleafletanswerssomeofthe

common questions about

Compound Sodium Lactate

(Hartmann’s).Itdoesnotcontain

alltheinformation.Itdoesnottake

theplaceoftalkingtoyourdoctor.

Allmedicineshaverisksand

benefits.Yourdoctorhasweighed

therisksofyoubeinggiven

Compound Sodium Lactate

(Hartmann’s)againstthebenefits

theyexpectitwillhaveforyou.

Ifyouhaveanyconcernsabout

takingthismedicine,askyour

doctororpharmacist.

Keep this leaflet with the

medicine.

Youmayneedtoreaditagain.

WhatCompound

SodiumLactate

(Hartmann’s)isused

for

Compound Sodium Lactate

(Hartmann’s)isusedtoreplace

bodyfluidandmineralsaltsthat

maybelostforavarietyofmedical

reasons.Itisespeciallysuitable

whenthelossesresultintoomuch

acidbeingpresentintheblood.

Your doctor may have

prescribeditforanotherreason.

Askyourdoctorifyouhaveany

questions about why this

medicinehasbeenprescribed

foryou.

Beforeyouaregiven

CompoundSodium

WhenyoushouldNOTbegiven

it

Compound Sodium Lactate

(Hartmann’s)shouldnotbe

given;

Ifthesolutionisnotclear.

Throughthesametubingas

thosecontainingblood.

Aftertheexpirydateprintedon

thepack.

Ifthepackagingistornor

showssignoftempering.

Toothers.

Foruseinonepatientonone

occasiononly.

Itmayhavenoeffectatall,or

worse,anentirelyunexpected

effectifyouaregivenitafterthe

expirydatehaspassed.

Compound Sodium Lactate

(Hartmann’s)shouldnotbe

givenifyouhaveanallergyto:

Anyingredientlistedattheend

ofthisleaflet

Anysimilarmedicinesto

CompoundSodiumLactate

(Hartmann’s)

Somesymptomsofanallergic

reactionmayinclude:

Shortnessofbreath

Wheezing or difficulty

breathing

Swellingoftheface,lips,

tongueorotherpartsofthe

body

Skinrash,itchingorhives

You should not be given

Compound Sodium Lactate

(Hartmann’s)ifyouhave,or

havehad,anyofthefollowing

medicalconditions:

Congestive heart failure

(constantwheezing,shortness

Severereductioninkidney

function

Noproductionorpassingof

urine

Beforeyouaregivenit

Tellyourdoctororpharmacistif

youhaveallergiestoanyother

medicines,foods,preservatives

ordyes.

Tellyourdoctorifyouhaveor

have had any medical

conditions, especially the

following:

Heartproblems

Liverproblems

Anyotherillness

Pregnancy

Breastfeeding

Diabetes

Itmaynotbesafeforyoutobe

givenCompoundSodiumLactate

(Hartmann’s)ifyouhaveanyof

theseconditions.

TakingOtherMedicines

Tellyourdoctororpharmacistif

you are taking any other

medicines,includinganythat

youbuywithoutaprescription

from your pharmacy,

supermarketorhealthfood

shop.

Yourdoctororpharmacistwill

have more information on

medicinestobecarefulwithor

avoid while using Compound

SodiumLactate(Hartmann’s).

HowisCompound

SodiumLactate

(Hartmann’s)given

Compound Sodium Lactate

(Hartmann’s)willbegivento

CMIforCompoundSodiumLactate(Hartmann’s) 6July2010

Hartmann’sCMI060710 1 Changes:Companynamechange

youbyyourdoctororspecially

trainednursebyinfusionordrip

intothevein.

ThisallowstheCompoundSodium

Lactate(Hartmann’s)toreachthe

bodyquickly,whereitwilltreat

dehydrationandreplacemineral

salts.

Howmuchisgiven

Thedosageyouwillbegivenwill

dependonyourage,weight,

medicalconditionandresponse.

Yourdoctorwillhavehadalotof

experienceininjectingCompound

SodiumLactate(Hartmann’s)and

willchoosethebestdoseforyou.

Ifyouaregiventoomuch

(Overdose)

Thisrarelyhappensasitis

usuallyadministeredunderthe

careofatrainedprofessionalin

ahospitalorclinicsetting.

However,ifyouareparticularly

sensitivetoCompoundSodium

Lactate(Hartmann’s)youmay

become confused or

dehydrated.

ContactthePoisonsInformation

Centreinyourcountryforany

furtherinformation.

Australia:131126

Whileyouarebeing

given Compound

Sodium Lactate

(Hartmann’s)

Frequentclinicalevaluationand

laboratory tests may be

requiredasCompoundSodium

Lactate (Hartmann’s) is

normallygiveninahospital.

Yourdoctorornurse willmake

appropriaterecordsduringyour

treatmentandwillnoteany

unexpectedeffectsyoumay

experience.

SideEffects

Tellyourdoctororpharmacist

assoonaspossibleifyoudo

Compound Sodium Lactate

(Hartmann’s).

Allmedicinescanhavesomeside

effects. Sometimes they are

serious,mostofthetimetheyare

not.Youmayneedmedical

treatmentifyougetsomeofthe

sideeffects.

Askyourdoctororpharmacist

toansweranyquestionsyou

mayhave.

Thefollowingisalistof

possiblesideeffects.Tellyour

doctororpharmacistifyou

noticeanyofthefollowing:

Someswellingofthehands,

anklesandfeetmaybe

experiencedduetoretentionof

fluidinyourbody

Difficultybreathing

Chesttightness

Chestpain

Fastorslowheartbeatand

otherheartissues

Coughing

Sneezing

AbdominalCramps

Paralysis

Weakness

Tinglingornumbnessofhands

andfeet

Nausea(feelingsick)

Vomitinganddiarrhoea

Headache

Dizziness

Drowsiness

Confusion

Inflammationatthesiteof

injection

Swellingofyourveinsor

infectionnearthesiteof

injection

Donotbealarmedbythislist.

Youmaynotexperienceanyof

them.

Storage

Storage

Compound Sodium Lactate

(Hartmann’s)willbe storedby

yourdoctororpharmacistunder

therecommendedconditionsof

bags.

Disposal

AnyCompoundSodiumLactate

(Hartmann’s)whichisnotused

and which is left in the

container,willbedisposedofin

asafemannerbyyourdoctoror

pharmacist.

Productdescription

Whatitlookslike

Compound Sodium Lactate

(Hartmann’s)isaclearand

colourlesssolution.

Ingredients

Compound Sodium Lactate

(Hartmann’s) contains sodium

lactate(3.17g/L),sodiumchloride

(6.0g/L),potassiumchloride(400

mg/L) and calcium chloride

dihydrate(270mg/L)inwaterfor

injections.

Products

Compound Sodium Lactate

(Hartmann’s)comesinvarious

packsizes.Theycanbeidentified

bytheAUSTRnumbers.

FreeflexBags

250mLAUSTR148935

500mLAUSTR29771

1000mLAUSTR47410

Supplier

Fresenius Kabi Australia Pty

Limited

964PacificHighway

PymbleNSW2073

Australia

Telephone:(02)93915555

FreseniusKabiNewZealand

Limited

60PavilionDrive

AirportOaks,Auckland,2022

NewZealand

Freecall:0800144892

ThisleafletwasapprovedAugust

2005.

Dateofmostrecentamendment

July2010

Page 1 of 9

NEW ZEALAND DATA SHEET

1.

Compound Sodium Lactate (Hartmann’s)

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Molecular formulae. Potassium chloride: KCl; sodium chloride: NaCl; calcium

chloride dihydrate: CaCl

; sodium S- lactate (chemical name, sodium 2-

hydroxypropionate): C

Sterile solution intended for intravenous use containing Sodium Lactate (3.17

g/L), Sodium Chloride (6.0 g/L), Potassium Chloride (400 mg/L) and Calcium

Chloride Dihydrate (270 mg/L). Sodium Hydroxide and Hydrochloric acid is

added for pH adjustment.

3.

PHARMACEUTICAL FORM

The total amount of electrolytes per litre are: sodium 131 mmol, potassium 5

mmol, chloride 112 mmol, calcium 2 mmol, bicarbonate (as lactate) 28 mmol.

osmolality

approximately

mOsm/kg

water.The

solutions

isotonic, sterile, non-pyrogenic and do not contain antimicrobial agent or

added buffers. The pH range is 5.0 to 7.0. Compound Sodium Lactate

(Hartmann's) Solution for Injection is also known as Ringer-Lactate.

4.

CLINICAL PARTICULARS

4.1 Therapeutic Indications

Compound Sodium Lactate (Hartmann's) is used:

for intravenous fluid and electrolyte replacement

as a source of bicarbonate in the treatment of mild to moderate metabolic

acidosis

associated

with

dehydration

associated

with

potassium

deficiency

as a vehicle for intravenous drug delivery, if the drugs are compatible with

the solutions.

4.2 Dose and Method of Administration

To be used as directed by the physician. The dosage of Compound Sodium

Lactate (Hartmann’s) is dependent upon the age, weight and concomitant

conditions of the patient as well as laboratory determinations and response.

Parenteral drug products should be inspected visually for particulate matter

and discolouration prior to administration whenever solution and container

permit

only

sterile

non-pyrogenic

equipment

must

used

intravenous administration. Do not administer unless the solution is clear and

the seal is intact.

As with all parental solutions compatibility with additives with the solution must

be assessed before addition, by checking for a possible colour change and/or

the appearance of the precipitates, insoluble complexes or crystals.

Before adding a substance or medication, verify that it is soluble and/or stable

in water and that the pH range of Compound Sodium Lactate (Hartmanns)

infusion solution is appropriate. Complete information is not available. Those

Page 2 of 9

additives known to be incompatible should not be used. Consult with a

pharmacist, if available. If in the informed judgment of the physician, it is

deemed

advisable

introduce

additives,

aseptic

technique.

thoroughly when additives have been introduced.

Contains no antimicrobials. For use in one patient on one occasion only.

Discard

unused

portion.

Care

should

taken

with

intravenous

administration technique to avoid administration site reactions and infection.

4.3 Contraindications

Known hypersensitivity to sodium lactate

Congestive heart failure or severe impairment of renal function.

Clinical states in which the administration of sodium and chloride is

detrimental.

concomitant administration of ceftriaxone in neonates (≤28 days of

age) even if separate infusion lines are used

concomitant administration of ceftriaxone in infants (>28 days of age),

children and adults through same infusion line (e.g. via Y-connector)

4.4 Special Warnings and Precautions for Use

Compound Sodium Lactate (Hartmann’s) is not for use in the treatment of

lactic acidosis, severe metabolic acidosis or treatment of severe potassium

deficiency. Although the solutions have potassium concentrations similar to

that of plasma, it is insufficient to produce a useful effect in severe potassium

deficiency.

The introduction of additives to any solution, regardless of type of container,

requires special attention to ensure that no incompatibilities result. While

some incompatibilities are readily observed, one must be aware that subtle

physical, chemical and pharmacological incompatibilities can occur. The

medical

literature,

package

insert

other

available

sources

information

should

reviewed

thorough

understanding

possible

incompatibilities.

Concomitant administration with ceftriaxone in newborns (≤28 days of age) is

recommended

through

same

infusion

line

(see

section

4.3

Contraindications)

risk

fatal

ceftriaxone

calcium

salt

precipitation.

In patients older than 28 days (including adults), ceftriaxone must not be

administered simultaneously with intravenous calcium-containing solutions,

through the same infusion line. If the same infusion line is used for sequential

administration, the line must be thoroughly flushed between infusions with a

compatible fluid.

Do not administer Compound Sodium Lactate (Hartmanns) infusion solution

unless it is clear and the seal is intact.

In a dilute condition, osmolarity is approximately equivalent to osmolality.

Compound

Sodium

Lactate

(Hartmann’s)

isotonic.

addition

Page 3 of 9

potassium chloride (0.18%, 48mOsmol/L) to the Compound Sodium Lactate

(Hartmanns) solution does not result in a hypertonic solution (324mOsmol/L).

It is important to bear in mind that an administration of substantially hypertonic

solution may lead to a wide variety of complications, such as crenation

(shrinkage) of red blood cells and general cellular dehydration.

patients

with

diminished

renal

function,

administration

Compound

Sodium Lactate (Hartmann’s) may result in sodium, calcium and/or potassium

retention. If a patient receives prolonged therapy, or the rate of administration

warrants review, clinical evaluation and laboratory monitoring for changes in

fluid balance, electrolyte concentration and acid/base balance should be

conducted. Use with particular caution in patients with hyperkalaemia or risk

of such (e.g. potassium excretion impairment, adrenocortical insufficiency,

acute dehydration, severe renal impairement or extensive tissue injury or

burns) and patients with cardiac disease administration of IV potassium can

rapidly result in severe hyperkalaemia without symptoms, which may lead to

fatal adverse reactions. Consideration should be given to withholding

Compound Sodium Lactate (Hartmanns) infusion altogether in hypervolaemic

overhydrated

patients,

including

those

with

severe

renal

impairment,

primary or secondary hyperaldosteronism or preeclampsia, due to the risk of

potassium and/or sodium retention, fluid overload and oedema.

The intravenous administration of Compound Sodium Lactate (Hartmanns)

infusion solution can cause fluid and/or solute overloading resulting in dilution

of the serum electrolyte concentrations, over-hydration, congested states,

including pulmonary congestion and oedema, clinically relevant electrolyte

disturbance and acid-base imbalance. The risk of dilution states is inversely

proportional to the electrolyte concentrations of the injections. The risk of

solute overload causing congested states with peripheral and pulmonary

oedema

directly

proportional

electrolyte

concentrations

injections.

Compound

Sodium

Lactate

(Hartmann’s)

should

administered

simultaneously with blood preparations through the same administration set,

because of a possibility of coagulation.

The effect of the sodium lactate component in Compound Sodium Lactate

(Hartmann’s) on patients with metabolic or respiratory alkalosis should be

monitored closely. Compound Sodium Lactate (Hartmann’s) should be

administered with extreme caution, if at all, in patients with increase lactate

levels or impaired lactate utilisation such as cardiac disease, shock and

severe

hepatic

insufficiency

alkalinisation

achieved

hyperlactaemia can develop (see also Paediatric use below).

Lactate is a substrate for gluconeogenesis so consideration should be given

to the use of Compound Sodium Lactate (Hartmann’s) infusion in Type 2

diabetics.

Patients with calcium renal calculi or a history of such, and patients with

hypercalcaemia, or conditions predisposing to hypercalcaemia such as severe

Page 4 of 9

renal impairment and granulomatous diseases associated with increased

calcitriol

synthesis

including

sarcoidosis,

should

Compound

Sodium

Lactate (Hartmanns) infusion solution with caution.

Compound Sodium Lactate (Hartmann’s) should be used with caution in

patients

receiving

corticosteroids

corticotropin,

i.e.

potential

sodium

retention.

Similarly

with

patient

receiving

potassium

supplement

preparation, as it may result in hyperkalaemia.

The infusion must be stopped immediately if any signs or symptoms of a

suspected

hypersensitivity

reaction

develop.

Appropriate

therapeutic

countermeasures must be instituted as clinically indicated.

Use in the elderly:

Clinical studies of Compound Sodium Lactate (Hartmann’s) did not include

sufficient numbers of subjects aged 65 and over to determine whether they

respond differently from younger subjects. Other reported clinical experience

has not identified differences in responses between the elderly and younger

patients. In general, dose selection for an elderly patient should be cautious,

usually starting at the low end of the dosing range, reflecting the greater

frequency of decreased hepatic, renal or cardiac function, and of concomitant

disease or drug therapy.

Paediatric Population:

Safety

effectiveness

Compound

Sodium

Lactate

(Hartmann’s)

paediatric patients have not been established by adequate and well controlled

trials, however, the use of electrolyte solutions in the paediatric population is

referenced in the medical literature. Lactate-containing solutions should be

administered with particular caution to neonates and infants <6 months of

age. The warnings, precautions and adverse reactions identified in the label

copy should be observed in the paediatric population.

4.5 Interactions with other Medicines and other forms of Interaction

Compound

Sodium

Lactate

(Hartmann’s)

should

administered

simultaneously with blood preparations through the same administration set,

because of a possibility of coagulation.

Concomitant administration with ceftriaxone is not recommended through the

same infusion line (see sections 4.3 Contraindications and 4.4 Special

Warnings and Precautions for Use) due to the risk of fatal ceftriaxone-

calcium salt precipitation.

Administration of calcium may increase the effects of digitalis and lead to

serious

fatal

cardiac

arrhythmias.

Therefore

larger

volumes

faster

infusion rates should be used with caution in patients treated with digitalis

glycosides.

Page 5 of 9

Caution

advised

when

administering

Compound

Sodium

Lactate

(Hartmanns) infusion solution to patients treated with thiazide diuretics or

vitamin D as these can increase the risk of hypercalcaemia.

Caution

advised

when

administering

Compound

Sodium

Lactate

(Hartmanns) infusion solution to patients treated with medicines that may

increase the risk of sodium and fluid retention such as carbenoxolone and

corticosteroids (see section 4.4

Special

Warnings

and

Precautions

for

Use).

Compound Sodium Lactate (Hartmanns) infusion solution may interfere with

the elimination of medicines for which renal elimination is pH dependent.

Renal clearance of acidic medicines such as salicylates, barbiturates and

lithium may be increased. The renal clearance of alkaline medicines such as

sympathomimetics (e.g. pseudoephedrine), dexamphetamine sulphate and

fenfluramine hydrochloride may be decreased.

These products should not be administered concomitantly with potassium

sparing

diuretics

(amiloride,

spironolactone,

triamterene),

angiotensin

converting

enzyme

(ACE)

inhibitors,

angiotensin

receptor

antagonists

(ARAs)

immunosuppressants

tacrolimus

cyclosporin.

Simultaneous

administration

these

medicines

result

severe

hyperkalaemia, particularly in patients with severe renal insuficiency.

4.6 Fertility, Pregnancy and Lactation

Fertility:

Data not available.

Pregnancy:

There is no adequate data from the use of Compound Sodium Lactate

(Hartmann’s). The potential risks and benefits for each specific patient should

be carefully considered before using Compound Sodium Lactate (Hartmann’s)

solution in pregnant women.

Breast feeding:

There is no adequate data from the use of Compound Sodium Lactate

(Hartmann’s) in lactating women. The potential risks and benefits of each

specific

patient

should

carefully

considered

before

using

Compound

Sodium Lactate (Hartmann’s) solution in lactating women.

4.7 Effects on Ability to Drive and Use Machines

Data not available.

4.8 Undesirable Effects

Allergic reactions or anaphylactic/anaphylactoid symptoms such as localised

or generalised urticaria, skin rash and erythema and itching/pruritus; skin

swelling, periorbital, facial and/or laryngeal oedema (Quincke’s oedema);

chest tightness, chest pain, with tachycardia or bradycardia; nasal congestion,

coughing, sneezing, bronchospasm and/or difficulty breathing have been

reported during administration of Hartmann’s Solution.

Page 6 of 9

Adverse

reactions

occur

solution

technique

administration including fever response, or infection at the site of injection.

Prolonged intravenous infusion of this type of product may cause venous

thrombosis or phlebitis extending from the site of injection, extravasation, and

hypervolaemia.

If an adverse reaction does occur, discontinue the infusion and evaluate the

patient,

institute

appropriate

therapeutic

countermeasures,

save

remainder of the fluid for examination if deemed necessary.

Post-marketing Adverse Reactions

The following adverse reactions have been reported in the post-marketing

experience:

IMMUNE

SYSTEM

DISORDERS:

Hypersensitivity/infusion

reactions,

including

Anaphylactic/Anaphylactoid

reactions

following

manifestations:

Angioedema, chest pain, chest discomfort, decreased heart rate, tachycardia,

blood pressure decreased, respiratory distress, bronchospasm, dyspnoea,

cough,

urticaria,

rash,

pruritus,

erythema,

flushing,

throat

irritation,

paraesthesia’s,

hypoesthesia

oral,

dysgeusia,

nausea,

anxiety,

pyrexia,

headache.

METABOLISM AND NUTRITION DISORDERS: Hyperkalaemia

GENERAL

DISORDERS

ADMINISTRATION

SITE

CONDITIONS:

Infusion site reactions, including phlebitis, infusion site inflammation, infusion

site swelling, infusion site rash, infusion site pruritus, infusion site erythema,

infusion site pain, infusion site burning.

Class Reactions

Other adverse reactions reported with Lactated Ringer’s and 5% Dextrose

Injection are:

Infusion site anaesthesia (numbness).

During

administration

parenteral

nutrition

emulsions,

types

adverse reactions can occur.

Immediate reactions

At the beginning of the infusion, any of the following abnormal signs evoking a

hypersensitivity reaction should be cause for immediate discontinuation of the

infusion: sweating, shivering, cephalgia, dyspnoea.

Delayed reactions

During long-term parenteral nutrition of fat emulsions, the following adverse

reactions have been observed:

Hepato-biliary disorders:

increase of alkaline phosphatase, bilirubin and transaminases (ALT &

AST)

hepatomegaly

icterus

Page 7 of 9

Blood and lymphatic system disorders:

thrombocytopenia

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is

important. It allows continued monitoring of the benefit/risk balance of the

medicine.

Healthcare

professionals

asked

report

suspected

adverse reactions https://nzphvc.otago.ac.nz/reporting/

4.9 Overdose

There

overdose

experience

with

Compound

Sodium

Lactate

(Hartmanns) infusion solution. No specific antidotes to this preparation are

known. Should overdose occur, treat the symptoms and institute appropriate

supportive measures as required.

An excessive volume or too high a rate of administration may lead to fluid and

sodium

overload

with

risk

oedema

(peripheral

and/or

pulmonary),

particularly when renal sodium excretion is impaired. Excessive administration

of lactate may lead to metabolic alkalosis, which may be accompanied by

hypokalaemia.

Excessive

administration

potassium

lead

development

hyperkalaemia,

especially

patients

with

severe

renal

impairment.

Excessive

administration

calcium

salts

lead

hypercalcaemia.

When assessing an overdose, any additives in the solution must also be

considered.

For advice on the management of overdose please contact the National

Poisons Centre on 0800 POISON (0800 764766).

5 PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic Properties

multiple

electrolyte

intravenous

solution

intended

restoring

electrolyte

balance

water

hydration.

combination

multiple

electrolytes and sodium lactate, an alkalinising agent, will provide electrolyte

balance and normalise the pH of the acid-base balance of the physiological

system.

Sodium is the major cation of extracellular fluid and functions principally in the

control

water

distribution,

fluid

electrolyte

balance

osmotic

pressure of body fluids. Chloride, the major extracellular anion, closely

follows the physiologic disposition of the sodium cation in maintenance of the

acid-base balance, isotonicity and electrodynamic characteristic of the cells.

In contrast to the sodium ion, potassium is a major cation of the intracellular

fluid (160 mEq/L of intracellular water) and functions principally in the control

of body fluid composition and electrolyte balance. Potassium participates in

carbohydrate utilisation, protein synthesis and is critical in the regulation of

nerve conduction and muscle contraction, particularly in the heart.

Page 8 of 9

Calcium is essential for maintenance of the functional integrity of the nervous,

muscular, and skeletal systems and cell membrane and capillary permeability.

Calcium is the major component of the body skeleton. The calcium content in

bone is continuously undergoing a process of resorption and formation. The

normal concentration of calcium in plasma is between 2.2 and 2.6 mmol/L.

Sodium lactate is an alkalising agent. Lactate is slowly metabolised to

bicarbonate and water. This reaction depends on the cellular oxidative

activity. Under normal physiological conditions conversion of sodium lactate

to bicarbonate requires about one to two hours. The bicarbonate metabolite

then has similar actions to those of sodium bicarbonate preparations. That is,

bicarbonate metabolites react with acid to produce carbon dioxide and water.

5.2

Pharmacokinetic Properties

As Compound Sodium Lactate (Hartmann’s) is directly administered to the

systemic circulation, the bioavailability (absorption) of the active components

is complete (100%). Excess of calcium is predominantly excreted by the renal

system, as in the case of potassium and sodium excretion.

5.3

Preclinical Safety Data

Carcinogenesis, mutagenesis, impairment of fertility:

The active ingredients, potassium chloride, sodium chloride, calcium chloride

and sodium lactate, are neither carcinogenic nor mutagenic at physiological

concentrations.

6 PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Water for Injection. Sodium Hydroxide and Hydrochloric acid is added for pH

adjustment.

6.2

Incompatibilities

Additives may be incompatible. Complete information is not available. Those

additives

known

incompatible

should

used.

Consult

with

Pharmacist, if available. If, in the informed judgment of the doctor, it is

deemed

advisable

introduce

additives,

aseptic

technique.

thoroughly when additives have been introduced. Do not store solutions

containing additives.

6.3

Shelf life

3 years.

6.4

Special Precautions for Storage

Store at or below 25°C.

6.5

Nature and contents of container

Compound Sodium Lactate (Hartmann's) Solution for Injection in freeflex

®

bags;

Bag, 20 x 250mL

5 L

Bag, 30 x 250mL

7.5 L

Page 9 of 9

Bag, 35 x 250mL

8.75 L

Bag, 40 x 250mL

10 L

Bag, 10 x 1000mL

10 L

Bag, 20 x 500mL

10 L

6.6

Special Precautions for Disposal

Any unused medicine or waste material should be disposed of in accordance

with local requirements.

7 MEDICINE SCHEDULE

General Sales Medicine.

8. Sponsor

Fresenius Kabi New Zealand Limited

60 Pavilion Drive

Airport Oaks, Auckland, 2022

New Zealand

Freecall: 0800 144 892

9 DATE OF FIRST APPROVAL

10th May 2006

10 DATE OF REVISION OF THE TEXT

26 Sep 2018

SUMMARY TABLE OF CHANGES

Section Changed

Summary of new information

New format

Additional safety related information

regarding

addition

other

products to this medicine

Additional contraindications included

Additional safety relation information

inregards

warnings

precautions for the product

Additional safety related information

included

regarding

interactions

with

other medicine

Post

marketing

adverse

events

included

Additional safety related information

on potential over dosage included

Updated to reflect registration details

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