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LACTASOL SOLUTION FOR HAEMOFILTRATION AND HAEMODIALYSIS

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

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Package leaflet: Information for the user
LACTASOL®
Solution for haemofiltration and
haemodialysis
Sodium chloride, calcium chloride
dihydrate, magnesium chloride
hexahydrate, sodium lactate solution 60% w/w
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 become serious, or if you notice
any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. WHAT LACTASOL IS AND
WHAT IT IS USED FOR
2. BEFORE YOU ARE GIVEN
LACTASOL
3. HOW TO USE LACTASOL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE LACTASOL
6. FURTHER INFORMATION

1. WHAT LACTASOL IS AND
WHAT IT IS USED FOR

Lactasol 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 Lactasol solution is particularly
used to treat critically ill patients
with acute renal failure having a
high concentration of potassium in
the blood (hyperkalaemia).

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

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2. BEFORE YOU ARE GIVEN
LACTASOL
DO NOT USE LACTASOL 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
LACTASOL
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.
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 Lactasol.
Your doctor will decide if other
medicines should be changed.
If you are treated with digitalis due
to heart problems, 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.

UK

PREGNANCY AND BREASTFEEDING
There is no adequate data from
the use of Lactasol in pregnant
or lactating women. Your doctor
will decide whether you should be
given Lactasol if you are pregnant
or breast-feeding.

3. HOW TO USE LACTASOL

Lactasol is a sterile solution to be
used in hospitals and administered
by medical professionals only.
The volume (which corresponds to
the dose) of Lactasol will depend
on your condition. The dose volume
will be determined by the physician, who is responsible for your
treatment.
Lactasol 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
LACTASOL THAN YOU SHOULD
BE GIVEN:
Your fluid balance and blood chemistry will be carefully monitored.
Therefore, it is unlikely that you
will be given more Lactasol 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.

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Like all medicines, Lactasol can
cause side effects, although not
everybody gets them.

The following side effects related to the use of Lactasol are
possible:
• changes in levels of salt in your
blood (electrolyte disturbances)
• low concentration of potassium
in your blood (hypokalaemia),
as Lactasol is potassium-free.
There are also some side effects
which can be caused by the process of haemodialysis and haemofiltration, such as:






feeling sick (nausea)
being sick (vomiting)
muscle cramps
fits (convulsions)
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.

6. FURTHER INFORMATION
WHAT LACTASOL CONTAINS
The active substances are:
1000 ml of solution contains:
Sodium chloride
5.844 g
Calcium chloride
(dihydrate)
0.257 g
Magnesium chloride
(hexahydrate)
0.152 g
Sodium lactate solution
60% w/w
7.471 g
(corresponding to sodium lactate
anhydrous
4.483 g)
Lactasol solution contains in mmol
per litre:

Do not use Lactasol after the expiry
date which is stated on the label
and the packaging.

WHAT LACTASOL LOOKS LIKE
AND CONTENTS OF THE PACK
Lactasol is presented in a onecompartment bag. The solution is
clear and colourless.

Do not store below +4°C.
Do not use Lactasol if the solution
is cloudy or if the over-wrap is damaged. All seals must be intact.

This leaflet was last approved in
03/2010

Theoretical osmolarity:
287.5 mOsm/l

5. HOW TO STORE LACTASOL

The expiry date refers to the last
day of that month.

MANUFACTURER
Gambro Dasco S.p.A.
Sondalo Plant
Via Stelvio 94
23035 Sondalo (SO)
ITALY

Sodium, Na+ 140
Chloride, Cl- 105
Calcium, Ca2+ 1.75
Magnesium, Mg2+ 0.75
Lactate
40

The other ingredients in Lactasol
are:
• hydrochloric acid 3.646% w/v
(for pH adjustment)
• water for injections

Keep out of reach and sight of
children.

MARKETING AUTHORISATION
HOLDER
Gambro Lundia AB
Box 10101
SE-220 10 Lund
SWEDEN

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.

Lactasol can be disposed of via
wastewater without harming the
environment.

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4. POSSIBLE SIDE EFFECTS

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The following information is intended for medical or
healthcare professionals only
LACTASOL®
Solution for haemofiltration and
haemodialysis
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.

the extracorporeal blood circuit
before (pre-dilution) or after the hemofilter (post-dilution).

The patient’s haemodynamic, fluid,
electrolyte and acid-base balance should 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.

Adult:
Children:

Severe metabolic acidosis should
be corrected with a bicarbonate solution prior to using a lactate based
substitution fluid.
When used with a monitor, only
monitors for Continuous Renal Replacement Therapy must be used.
The volume of Lactasol 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.
Do not mix with bicarbonate containing solutions, as this may cause
precipitation of calcium and magnesium carbonate.
Lactasol, when used as a substitution solution, is administered into

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a

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In continuous haemodialysis or
haemofiltration, the clearances
obtained are directly proportional to
the dialysate flow.
The range of flow rates used for the
substitution solution in haemofiltration and haemodiafiltration are:
500 – 1500 ml/hour
15 – 20 ml/kg/hour

The range of flow rates for the dialysis solution in haemodiafiltration
or continuous haemodialysis are:
Adult:
Children:

500 – 2000 ml/hour
15 – 20 ml/kg/hour

INSTRUCTIONS FOR USE/
HANDLING
Aseptic technique shall be used
throughout the administration to the
patient.
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.
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.

UK

under the responsibility of a physician in the following way:
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.

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

b

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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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