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KALILACTASOL SOLUTION FOR HAEMOFILTRATION AND HAEMODIALYSIS

Active substance(s): CALCIUM CHLORIDE DIHYDRATE / GLUCOSE MONOHYDRATE / MAGNESIUM CHLORIDE HEXAHYDRATE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM LACTATE 60% W/V

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Kalilactasol®
Solution for haemofiltration and
haemodialysis

Package Leaflet: Information for the user

Sodium chloride, calcium chloride
dihydrate, magnesium chloride
hexa-hydrate, potassium chloride,
sodium lactate solution 60% w/w,
glucose anhydrous.

Kalilactasol may also be used in
cases of drug poisoning with dialysable or filterable substances.

Read all of this leaflet carefully
before you start using this medicine.
••Keep this leaflet. You may need to
read it again.
••If you have any further questions,
ask your doctor or pharmacist.
••If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Kalilactasol is and
what it is used for
2. Before you are given
Kalilactasol
3. How to use Kalilactasol
4. Possible side effects
5. How to store
Kalilactasol
6. Further information
1. WHAT KALILACTASOL IS AND
WHAT IT IS USED FOR
Kalilactasol is used in hospitals in
intensive care treatments called
Continuous Renal Replacement
Therapy. It is administered to correct any fluid and chemical imbalance of the blood, which is a consequence of kidney (renal) failure.
The treatments, using continuous renal replacement therapy, are
designed to remove accumulated
waste products from the blood
when the kidneys are not functioning as they should.
The Kalilactasol solution is particularly used to treat critically ill patients with acute renal failure having
a high concentration of potassium
in the blood (hyperkalaemia).

Kalilactasol PL GB REG.indd 1

UK

2. BEFORE YOU ARE GIVEN
KALILACTASOL

Do not use Kalilactasol during
any of the following three
conditions:
••if you have a low concentration of
potassium in the blood (hypokalaemia)
••if you suffer from a very severe
metabolic problem with too low
pH in your blood (acidosis)
••if you have difficulties in metabolising lactate, an acidic component which should be converted
into bicarbonate and used to
increase the pH of your blood.
Take special care with
Kalilactasol
Before and during treatment, your
blood condition will be checked.
For example, your acid-base balance and concentrations of salts
(electrolytes) will be monitored.
Special attention should be given
to:
••the level of potassium in your
blood to ensure the most appropriate potassium concentration.
••the level of glucose in your blood,
especially if you suffer from diabetes
You must tell your doctor if you are
suffering from:
••liver disease
••heart disease
•• general infection of your blood
(sepsis)

Using other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines,
including medicines obtained without a prescription.
This is because the concentration
in your blood of some of these

medicines may be reduced during
treatment with Kalilactasol.
Your doctor will decide if other
medicines should be changed.
If you are treated with digitalis due
to heart problem the correction of
the electrolyte concentration in your
blood may lead to symptoms of
digitalis overload.
This is especially the case if your
blood level of digitalis is higher than
normally intended.

Pregnancy and breast-feeding
There are no adequate data from
the use of Kalilactasol in pregnant
or lactating women. Your doctor
will decide whether you should be
given Kalilactasol if you are pregnant or breast-feeding.
3. HOW TO USE KALILACTASOL
Kalilactasol is a sterile solution to
be used in hospitals and administered by medical professionals only.
The volume (which corresponds to
the dose) of Kalilactasol will depend
on your condition.
The dose volume will be determined by the physician, who is
responsible for your treatment.
Kalilactasol can be administered
into the venous blood line to replace fluid volume and electrolytes
lost during the process of continuous haemofiltration or haemodiafiltration (specific methods of
Continuous Renal Replacement
Therapies).
It can also be administered during
continuous haemodialysis, where
the sterile solution flows on one
side of a dialysis membrane while
the blood flows on the other side.

If you are given more Kalilactasol
than you should be given:
Your fluid balance and blood chemistry will be carefully monitored.
Therefore, it is unlikely that you

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will be given more Kalilactasol
than you should be given.
In the unlikely event that an overdose occurs, your doctor will take
the necessary corrective measures
and adjust your dose.
Overdose may result in electrolyte
or acid-based disturbances as well
as fluid overload if you suffer from
renal failure. Overdose could also
lead to problems with the heart.
If you have any further questions
on the use of this product, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Kalilactasol can
cause side effects, although not
everybody gets them.
The following side effects related
to the use of Kalilactasol are possible:
••changes in levels of salt in your
blood (electrolyte disturbances)
••high concentration of glucose in
your blood (hyperglycaemia)
There are also some side effects
which can be caused by the
process of haemodialysis and
haemofiltration, such as:
•• nausea (feeling sick)
••vomiting (being sick)
••muscle cramps
••convulsions (fits)
••low blood pressure (hypotension)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5. HOW TO STORE
KALILACTASOL
Keep out of the reach and sight of
children.
Do not use Kalilactasol after the
expiry date which is stated on the
label and the packaging. The expiry
date refers to the last day of that
month.

Kalilactasol PL GB REG.indd 2

Do not store below +4 °C.
Do not use Kalilactasol if the solution is cloudy or if the over wrap is
damaged. All seals must be intact.
Kalilactasol can be disposed of via
wastewater without harming the
environment.
6. FURTHER INFORMATION

What Kalilactasol contains
The active substances are:
1000 ml of solution contains:
Sodium chloride
5.961 g
Calcium chloride
(dihydrate)
0.257 g
Magnesium chloride
(hexahydrate)
0.152 g
Potassium chloride
0.149 g
Sodium lactate solution
60% w/w
7.471 g
(corresponding to sodium
lactate anhydrous
4.483 g)
Glucose anhydrous
1.100 g
(in glucose monohydrate 1.210 g)

Marketing Authorisation Holder:
Gambro Lundia AB,
Box 10 101,
SE-220 10 Lund, SWEDEN
Manufacturer:
Gambro Dasco S.p.A. Sondalo
Plant, Via Stelvio 94,
IT-23035 Sondalo (SO), ITALY
This medicinal product is authorised in the Member States of the
EEA under the following names:
Austria, Germany, Ireland, Portugal,
United Kingdom: Kalilactasol
Greece: Hemosol LG2
This leaflet was last approved in 03/2010

Kalilactasol solution contains
glucose anhydrous 1.1 g/l and in
mmol per litre:
Sodium, Na+
142
Chloride, Cl-
109
Potassium, K+
2.0
Calcium, Ca2+
1.75
Magnesium, Mg2+
0.75
Lactate
40
Theoretical osmolarity:
301.6 mOsml/l
The other ingredients in
Kalilactasol are:
••hydrochloric acid 3.646% w/v (for
pH adjustment)
••water for injections

What Kalilactasol looks like and
contents of the pack
Kalilactasol is presented in a one
compartment bag. The solution is
clear with a slightly yellow colour.
Each bag contains 5000 ml solution for haemofiltration and haemodialysis. The bag is over wrapped
with a transparent film.
Each box contains two bags and
one package leaflet.

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Kalilactasol®
Solution for haemofiltration
and haemodialysis

The following information is intended for
medical or healthcare professionals only

The solution is to be used only by
or under the direction of a physician
who should have sound experience
of intensive care nursing and/or applied Continuous Renal Replacement Therapies such as haemofiltration, haemodiafiltration and
haemodialysis.

tion) the hemofilter.
In continuous haemodialysis or
haemofiltration, the clearances obtained are directly proportional to
the dialysate flow.

The patient’s haemodynamic, fluid,
electrolyte and acid-base balance
shall be closely monitored throughout the procedure. Close monitoring of the potassium levels must be
carried out to enable selection of
the most appropriate potassium
concentration.
Severe metabolic acidosis shall be
corrected with a bicarbonate solution prior to using a lactate based
substitution fluid.

The range of flow rates used for the
substitution solution in haemofiltration and haemodiafiltration are:
••Adult:
500 - 1500 ml/hour
••Children: 15-20 ml/kg/hour
The range of flow rates for the dialysis solution in haemofiltration or
continuous haemodialysis are:
••Adult:
500 - 2000 ml/hour
••Children: 15-20 ml/kg/hour
Instructions for use /
handling

When used with a monitor, only
monitors for Continuous Renal Replacement Therapy must be used.

Aseptic technique shall be used
throughout the administration to
the patient.

The volume of Kalilactasol to be
administered will depend on the
patient’s clinical condition and the
target fluid balance. Continued application of haemofiltration, haemodiafiltration or haemodialysis will remove excess fluid and electrolytes.

Use only if the solution is clear and
the over wrap is undamaged. All
seals must be intact. If leakage is
discovered, discard the solution immediately since sterility can no
longer be assured.

Do not mix with bicarbonate containing solutions, as this may cause
precipitation of calcium and magnesium carbonate.

If heating of the solution to body
temperature (37 °C) is necessary
the procedure must be carefully
controlled verifying that the solution
is clear and without particles.

Kalilactasol, when used as a substitution solution, is administered into
the extracorporeal blood circuit before (pre-dilution) or after (post-dilu-

The bag is fitted with an injection
port for the possible addition of
other necessary drugs. Medication
shall only be added to the solution

Remove any fluid from the injection
port, hold the bag upside down, insert the drug through the injection
port and mix thoroughly. The solution must be administered immediately.
The dialysis or replacement fluid
line may be connected to either of
the two access ports.
a If the luer access is used, remove the cap and connect the
male luer lock on the dialysis or
replacement fluid line to the female luer connector on the bag;
tighten. Using both hands, break
the frangible pin at its base, and
move it back and forth. Do not
use a tool. Verify that the pin is
completely separated and that
the fluid is flowing freely. The pin
will remain in the luer port during
the treatment. (See figure a below)
b If the injection port is used, first
remove the snap-off cap. Then
introduce the spike through the
rubber septum. Verify that the
fluid is flowing freely. (See figure
b below)
The solution is for immediate and
single use only. Discard any unused
solution immediately after use.

b
D0xxxxxxx Rev. 2009-10/2

a

under the responsibility of a physician in the following way:

Kalilactasol PL GB REG.indd 3

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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