Duosol containing 4 mmol/l potassium

Package leaflet: Information for the patient

Duosol containing 4 mmol/l potassium, solution for hemofiltration
Please read all of this leaflet carefully before using this medicine, as it contains
important information for the patient

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Duosol containing 4 mmol/l potassium is and what it is used for
2. Important information before using Duosol containing 4 mmol/l potassium
3. How to use Duosol containing 4 mmol/l potassium
4. Possible side effects
5. How to store Duosol containing 4 mmol/l potassium
6. Contents of the pack and other information

1. What Duosol containing 4 mmol/l potassium is and what it is used for

Duosol containing 4 mmol/l potassium is a solution for hemofiltration. This medicine is intended for use in
patients with acute renal failure, whose kidneys are unable to remove metabolic waste products from the
blood. Continuous hemofiltration involves removing metabolic waste products from the body that under
normal conditions are excreted by the kidneys. The solution helps restore fluid balance and replenishes
lost salts (electrolytes).

2. Important information before using Duosol containing 4 mmol/l potassium

Do not use Duosol containing 4 mmol/l potassium if:

• the patient has abnormally high potassium levels in the blood (hyperkalaemia);
• the patient has abnormally low acid levels in the blood (metabolic alkalosis).

Haemofiltration should not be used in the following cases:

• renal failure combined with very intense metabolic processes (hypercatabolism); in such cases, accumulated metabolic waste products cannot be removed effectively over a prolonged period by haemofiltration;
• insufficient blood flow from the venous access;
• any conditions associated with an increased risk of bleeding, since the patient is receiving drugs preventing blood clotting (systemic anticoagulation).

Warnings and precautions
Before starting treatment with Duosol containing 4 mmol/l potassium, discuss this with your doctor or pharmacist.
Blood pressure, fluid balance, electrolyte balance, acid-base balance, and kidney function should be monitored before and during haemofiltration.
Blood glucose and phosphate levels should also be checked regularly.
Blood potassium levels should additionally be monitored before and during haemofiltration.

Duosol containing 4 mmol/l potassium and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The blood concentration of other medicines may decrease during haemofiltration, and the doctor will take this into account.
By using appropriate doses of the haemofiltration solution and careful monitoring, interactions with other medicines can be avoided.
The following interactions should be considered:

• Infusions used in intensive medical care may alter the patient's blood composition and fluid status.
• Toxic effects of certain drugs used in heart failure treatment (digitalis-containing drugs) may not be apparent when potassium or magnesium levels are too high or calcium levels are too low. If these levels are corrected by haemofiltration, toxic effects may then appear, potentially causing, for example, cardiac arrhythmias. If the patient has low potassium or high calcium levels in the blood, digitalis may exert toxic effects at doses lower than those usually used in treatment.
• Administration of vitamin D and calcium-containing drugs may increase the risk of high calcium levels in the blood (hypercalcaemia).
• Additional use of sodium bicarbonate may increase the risk of abnormally low acid levels in the blood (metabolic alkalosis).

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before receiving this medicine.
There are no data on the use of haemofiltration solutions in pregnant women. However, since all components of this medicine are naturally occurring substances that simply replace substances lost from the body during haemofiltration, no risk to the unborn child during pregnancy or to the breastfed infant is expected, and no effect on fertility is anticipated.

Driving and operating machinery
This medicine is usually administered to immobilized patients in hospital/dialysis units. Therefore, driving and operating machinery are not permitted.

3. How to use Duosol containing 4 mmol/l potassium

This medicine will be administered to the patient only under the supervision of a physician experienced in hemofiltration techniques.
The physician will determine the appropriate dose for the patient, taking into account the clinical condition, body weight, and metabolic status. Unless otherwise directed, in patients of all age groups, a filtration rate of 20–25 ml/kg body weight per hour is recommended to ensure the elimination of substances normally excreted in urine.
The ready-to-use hemofiltration solution is administered to the patient through tubing of the hemofiltration device (so-called extracorporeal circuit) using an infusion pump.
Treatment of acute renal failure is conducted for a limited period and is discontinued once kidney function has been restored.

Use of a higher than recommended dose of Duosol containing 4 mmol/l potassium
No life-threatening cases have been reported following administration of the recommended doses of this medicine. If necessary, administration can be stopped at any time.
Improper fluid balance may lead to excessive or insufficient body water (overhydration or dehydration). These conditions manifest as changes in blood pressure or heart rate.
Bicarbonate overdose may occur when too large a volume of hemofiltration solution is administered. This may lead to abnormally low blood acid concentration (metabolic alkalosis), reduced levels of ionized calcium in the blood (hypocalcemia), or muscle spasms (tetany).
Overdose may cause congestive heart failure and/or pulmonary congestion and may also disrupt electrolyte balance and acid-base equilibrium.
The physician will decide on appropriate treatment.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
No adverse reactions related to the use of this medicine have been reported to date; however, the following adverse reactions are possible. The frequency of occurrence of these adverse reactions is unknown (cannot be estimated from the available data):
Excess or deficiency of body water (overhydration or dehydration), electrolyte imbalance, low blood phosphate levels (hypophosphatemia), high blood sugar levels (hyperglycemia), abnormally low levels of acids in the blood (metabolic alkalosis), blood pressure that is too high or too low (hypertension, hypotension), nausea, vomiting, and muscle cramps.

Reporting of adverse reactions
After a medicinal product has been authorized, it is important to report suspected adverse reactions. This enables continuous monitoring of the benefit-risk ratio of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of using this medicine.

5. How to store Duosol containing 4 mmol/l potassium

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bag and carton after:
"Expiry date". The expiry date refers to the last day of the stated month.
Storage conditions
Do not store above 25°C. Do not store in the refrigerator or freeze.
Storage conditions after preparation of the ready-to-use solution
The mixed product should be used immediately. The product, after mixing, maintains physical and chemical stability for 24 hours at 25°C.

6. Contents of the packaging and other information

What the medicine Duosol containing 4 mmol/l potassium contains

Composition of the ready-to-use hemofiltration solution after mixing:
1000 ml of ready-to-use hemofiltration solution contains [mmol/l]:
Na 140
K 4.0
Ca 1.5
Mg 0.5
Cl 113
HCO 35.0
anhydrous glucose 5.6 (equivalent to 1.0 g)
Theoretical osmolarity [mOsm/l] 300
pH 7.0–8.0

Other ingredients:
Electrolyte solution (smaller chamber)
hydrochloric acid 25% (for pH adjustment), water for injections
Bicarbonate solution (larger chamber)
carbon dioxide (for pH adjustment), water for injections

What Duosol containing 4 mmol/l potassium looks like and contents of the pack
Hemofiltration solution
A clear, colourless solution free from visible particles.
This medicinal product is supplied in a dual-chamber bag. By mixing both solutions after opening the partition between the chambers, a ready-to-use hemofiltration solution is obtained.
2 bags of 5000 ml (dual-chamber bags, 4445 ml and 555 ml) in a cardboard box.

Marketing Authorisation Holder and Manufacturer
B. Braun Avitum AG
Schwarzenberger Weg 73–79
34212 Melsungen
Germany

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Czech Republic: Duosol s 4 mmol/l kalia
Greece: Duosol with 4 mmol/l Potassium Διάλυμα αιμοδιήθησης
Estonia: Duosol koos 4 mmol/l kaaliumiga, hemofiltratsioonilahus
Finland: Duosol cum 4 mmol/l Kalium hemofiltraationeste
Italy: Duosol con 4 mmol/l di potassio soluzione per emofiltrazione
Latvia: Duosol ar 4 mmol/l kālija šķīdums hemofiltrācijai
Lithuania: Duosol K 4 hemofiltracijos tirpalas
Germany, Luxembourg: Duosol mit 4 mmol/l Kalium Hämofiltrationslösung
Poland: Duosol containing 4 mmol/l potassium
Slovenia: Duosol s 4 mmol/l kalija raztopina za hemofiltracijo
Spain: Priosol con 4 mmol/l de Potasio solución para hemofiltración
Netherlands: Duosol met 4 mmol/l Kalium, oplossing voor hemofiltratie
United Kingdom: Duosol with 4 mmol/l Potassium solution for haemofiltration

Information intended exclusively for medical professionals:

Instructions for preparing the ready-to-use hemofiltration solution
Before use, visually inspect the container and solution. The hemofiltration solution may be used only if the container (protective outer packaging and the dual-chamber bag), the seal between chambers, and the connectors are intact and undamaged, and the solution is clear, colorless, and free from visible particles.
Remove the protective outer packaging immediately before use.

1. Remove the protective outer packaging.

2. Smooth out the bag and place it on a clean, flat surface.

3. Press the smaller chamber of the bag with both hands to fully open the seal between the chambers along its entire length.

4. Ensure thorough mixing by rotating the bag five times in each direction.

Administration of the ready-to-use hemofiltration solution
The hemofiltration solution should be warmed to approximately body temperature using an integrated or external warmer. Under no circumstances should the solution be administered if it is below room temperature.
White precipitates of calcium carbonate have been rarely observed in the tubing during administration of this medicinal product, particularly near the pump and heating device. Therefore, during hemofiltration, the solution in the infusion lines must be visually monitored every 30 minutes to ensure that it remains clear and free from precipitates.
Precipitation may also occur with significant delay after initiation of treatment. If precipitates are observed, the solution and infusion lines must be replaced immediately, and the patient must be closely monitored.
For single use only. Unused solution and any damaged containers must be discarded.