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DUOSOL WITHOUT POTASSIUM SOLUTION FOR HAEMOFILTRATION

Active substance(s): CALCIUM CHLORIDE DIHYDRATE / GLUCOSE MONOHYDRATE / MAGNESIUM CHLORIDE HEXAHYDRATE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE

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688911D_Duosol-K0-GB 16.04.15 09:49 Seite 1

Package leaflet: Information for the patient

Duosol without Potassium solution for haemofiltration
Read all of this leaflet carefully before you are given 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 pharmacist.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.
What is in this leaflet
1. What Duosol without Potassium is and what it is used for
2. What you need to know before you are given Duosol
without Potassium
3. How to use Duosol without Potassium
4. Possible side effects
5. How to store Duosol without Potassium
6. Contents of the pack and other information
1. What Duosol without Potassium is and what it is
used for
Duosol without Potassium is a solution for
haemofiltration. It is intended for use in patients with
acute kidney failure, when the kidneys are no longer
able to remove waste products from the blood.
Continuous haemofiltration is a procedure which is
used to remove the waste products from the body
which would otherwise be excreted via the kidneys in
urine. The solution corrects the fluid balance and
ensures that salt (electrolyte) losses are replaced
following treatment.
2. What you need to know before you are given
Duosol without Potassium
Duosol without Potassium should not be given if
– you have an abnormally low blood potassium level
(hypokalaemia)
– your blood contains abnormally low acid levels
(metabolic alkalosis).
The haemofiltration procedure itself should not be
used if
– you have kidney failure in combination with a very
high metabolic turnover (hypercatabolic state), in
which situation the accumulation of waste products
in your body can no longer be corrected by
haemofiltration
– you have poor blood flow from the site of insertion
of the cannula in the vein
– you have a high risk of bleeding because you
receive drugs to prevent blood clotting (systemic
anticoagulation).
Warnings and precautions
Talk to your doctor or pharmacist before you are given
Duosol without Potassium.
Before and during haemofiltration your blood pressure,
fluid balance, salt (electrolyte) balance, acid-base

balance and kidney function will be monitored. Your
blood sugar and phosphate levels will regularly be
checked.
Furthermore serum potassium concentration will be
monitored before and during haemofiltration.
Other medicines and Duosol without
Potassium
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
The level of other medicines in your blood may be
reduced during haemofiltration and your doctor will
take this into account.
Interactions with other medicines can be avoided by
ensuring that the correct dose of the solution for
haemofiltration is used and by careful monitoring.
The following interactions will be considered:
– Infusions given in intensive care may change the
composition of your blood and your fluid status.
– Toxic effects of certain medicines used to treat heart
weakness (medicines containing digitalis) may not
become apparent if your potassium or magnesium
levels are too high or your calcium levels are too
low. If those levels are corrected by haemofiltration,
the toxic effects may then occur and cause for
instance an abnormal heart rhythm. If you have low
potassium levels or high calcium levels in your blood,
digitalis may have toxic effects at doses lower than
those usually used for therapy.
– Vitamin D and medicines containing calcium can
increase the risk that the calcium level in the blood
rises to abnormally high values (hypercalcaemia).
– Additional use of sodium hydrogen carbonate can
increase the risk of abnormally low acid levels in the
blood (metabolic alkalosis).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before you are given
this medicine.
There are at present no data known regarding the use
of solutions for haemofiltration during pregnancy.
However, because all the ingredients of this medicine
are naturally occurring substances only replacing
the same substances lost from the body during
haemofiltration, no risks for the child are to be
expected during pregnancy and breast-feeding,
and no effects on fertility are to be expected.

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Driving and using machines
This medicine is normally given to immobile patients in
a hospital/dialysis unit. This will exclude driving and
using machines.
3. How to use Duosol without Potassium
You will only be given this medicine under the
direction of a doctor with experience in
haemofiltration techniques.
Your doctor will decide on the proper dose for you,
taking into account your clinical status, your body
weight and your metabolic condition. Unless otherwise
prescribed, a filtration rate of 20–25 ml/kg body weight
per hour is recommended for patients of all ages for
the removal of those substances which are normally
excreted in the urine.
You are given the ready-to-use solution for
haemofiltration via the tubing of the haemofiltration
apparatus (the so-called extracorporeal circulation)
using an infusion pump.
The treatment of acute kidney failure is carried out for
a limited time period and ends when kidney function is
fully restored.
If you are given more Duosol without Potassium
than recommended
There have been no reports of life-threatening
situations following the administration of the
prescribed dose of this medicine. The administration
can be stopped immediately, if required.
Unbalanced administration can result in too much
or too little fluid being present in the body
(hyperhydration or dehydration). This situation can
become apparent through changes in blood pressure
or pulse.
Hydrogen carbonate overdose can occur if a too large
volume of solution for haemofiltration is given. This
can lead to abnormally low acid levels in the blood
(metabolic alkalosis), less calcium dissolved in the
blood (decrease of ionised calcium) or muscle cramps
(tetany).
An overdose can be the cause of a heart failure and/or
congested lung and can cause changes in the salt
(electrolyte) balance and acid-base balance.
Your doctor will decide on the appropriate treatment.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
At present, no side effects associated with this
medicine have been reported, however, the following
side effects are possible. The frequency of these side
effects is not known (cannot be estimated from the
available data):
Too much or too little fluid in the body (hyperhydration
or dehydration), abnormal salt (electrolyte) levels, low
blood phosphate levels (hypophosphataemia), high
blood sugar levels (hyperglycaemia), abnormally low

acid levels in the blood (metabolic alkalosis), high or
low blood pressure (hypertension or hypotension),
feeling sick (nausea), being sick (vomiting) and muscle
cramps.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of
this medicine.
5. How to store Duosol without Potassium
Keep this medicine out of the sight and reach of
children.
You should not be given this medicine after the expiry
date which is stated on the bag and on the carton
after “EXP”. The expiry date refers to the last day of
that month.
Storage conditions
Do not store above 30 °C.
Do not refrigerate or freeze.
Storage conditions after preparation of the
ready-to-use solution
The mixed product should be used immediately. The
mixed product is physically and chemically stable for
24 hours at 25 °C.

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6. Contents of the pack and other information
What Duosol without Potassium contains
Small Chamber Large Chamber
Electrolyte
Bicarbonate
Solution
Solution
555 ml
per 4445 ml per
contain 1000 ml contain 1000 ml

The active
substances are:
Sodium chloride

2.34 g

4.21 g

27.47 g

6.18 g

Calcium chloride
dihydrate

1.10 g

1.98 g

––

––

Magnesium chloride
0.51 g
hexahydrate

0.91 g

––

––

Glucose
monohydrate

5.49 g

9.90 g
––

––

equivalent to
glucose anhydrous

5.0 g

9.0 g

Sodium hydrogen
carbonate

––

––

15.96 g

3.59 g

Electrolytes:
Na+

[mmol/ [mmol/l] [mmol/ [mmol/l]
chamber]
chamber]
40.0

72

Ca

7.5

13.5

––

––

Mg2+
Cl–

2.5

4.5

––

––

75.0

135

470

106

HCO3–

––

––

190

42.8

2+

Theoretical
osmolarity
[mOsm/l]

275

660

149

297

Composition of the ready-to-use solution for
haemofiltration after mixing:
1000 ml ready-to-use solution for haemofiltration contain
[mmol/l]:
140
Na+
Ca2+
1.5
Mg2+
0.5
Cl–
109
HCO3–
35.0
Glucose anhydrous
5.6 (equiv. to 1.0 g)
Theoretical osmolarity [mOsm/l] 292
pH
7.0–8.0
The other ingredients are:
Electrolyte solution (small chamber)
Hydrochloric acid 25% (for pH adjustment),
water for injections
Bicarbonate solution (large chamber)
Carbon dioxide (for pH adjustment), water for injections
What Duosol without Potassium looks like and
contents of the pack
Solution for haemofiltration
Clear and colourless solution, free from visible particles

This medicine is delivered in a two-chamber bag. Mixing
of both solutions by opening the seam between the two
chambers results in the ready-to-use solution for
haemofiltration.
2 bags of 5000 ml (two-chamber bags, 4445 ml and
555 ml) per carton
Marketing Authorisation Holder and Manufacturer
B. Braun Avitum AG
Schwarzenberger Weg 73–79
34212 Melsungen
Germany
This medicinal product is authorised in the Member
States of the EEA under the following names:
Czech Republic:
Duosol bez kalia
Estonia:
Duosol ilma kaaliumita,
hemofiltratsioonilahus
Finland:
Duosol sine Kalium
hemofiltraationeste
Italy:
Duosol senza potassio soluzione
per emofiltrazione
Latvia:
Duosol bez kÇlija
‰˙¥dums hemofiltrÇcijai
Lithuania:
Duosol K 0 hemofiltracijos
tirpalas
Germany, Luxembourg: Duosol ohne Kalium
Hämofiltrationslösung
Poland:
Duosol nie zawierajàcy potasu
Slovenia:
Duosol brez kalija
raztopina za hemofiltracijo
Spain:
Priosol sin Potasio solución para
hemofiltración
The Netherlands:
Duosol zonder Kalium, oplossing
voor hemofiltratie
United Kingdom:
Duosol without Potassium
solution for haemofiltration
This leaflet was last revised in March 2015.

688911D_Duosol-K0-GB 16.04.15 09:49 Seite 4

The following information is intended for healthcare professionals only:

INSTRUCTIONS FOR PREPARATION OF THE READY-TO-USE SOLUTION FOR
HAEMOFILTRATION
The container and the solution must be visually inspected prior to use. The solution for haemofiltration must only be
used if the container (outer wrap and two-chamber bag), peel seam and connectors are undamaged and intact and
if the solution is clear and colourless and free from visible particles.
Remove outer wrap only immediately before use.

1.

Remove the outer wrap.

2.

Unfold the bag and place it on a clean, flat surface.

3.

Press with both hands on the smaller chamber of the
bag until the peel seam opens fully along its entire
length.

4.

Ensure the contents are thoroughly mixed by twisting
the bag 5 times back and forth.

The solution for haemofiltration should be warmed to approximately body temperature by an integrated or external
heater. The solution must not be infused under any circumstances if below room temperature.
During application of this medicinal product, white calcium carbonate precipitation has been observed in the tubing
lines in rare cases, particularly close to the pump unit and the heating unit. Therefore, the solution in the tubing lines
should be closely visually inspected every 30 min during haemofiltration in order to ensure that the solution in the
tubing system is clear and free from precipitate. Precipitations may occur also with substantial delay after start of
treatment. If precipitate is observed, the solution and the tubing lines must be replaced immediately and the patient
carefully monitored.
For single use only. Any unused portion of solution and any damaged containers must be discarded.

688 911/D

ADMINISTRATION OF THE READY-TO-USE SOLUTION FOR HAEMOFILTRATION

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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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