Duosol containing 2 mmol/l potassium

Package leaflet: Information for the patient

Duosol containing 2 mmol/l potassium, solution for haemofiltration
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient

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

Contents of the leaflet

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

1. What Duosol containing 2 mmol/l potassium is and what it is used for

Duosol containing 2 mmol/l potassium is a solution for haemofiltration. This medicinal product is intended for use in
patients with acute renal failure, whose kidneys are unable to remove metabolic waste products from the blood. Continuous haemofiltration is a process that removes metabolic waste products from the body which under normal conditions are excreted by the kidneys. The solution restores fluid balance and replenishes lost salts (electrolytes).

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

Do not use Duosol containing 2 mmol/l of potassium if:

• the patient has abnormally low blood potassium levels (hypokalaemia);
• the patient has abnormally low levels of acids 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 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, as the patient is receiving drugs preventing blood clotting (systemic anticoagulation).

Warnings and precautions
Before starting treatment with Duosol containing 2 mmol/l of potassium, discuss this with a doctor or pharmacist.
Blood pressure, fluid balance, electrolyte (salt) 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 2 mmol/l of potassium and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently used, 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 care may alter the patient's blood composition and fluid status.
• Toxic effects of certain drugs used to treat heart failure (cardiac glycosides, e.g. 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 emerge, 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 medicines may increase the risk of elevated blood calcium levels (hypercalcaemia).
• Concomitant use of sodium bicarbonate may increase the risk of abnormally low blood acid levels (metabolic alkalosis).

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before receiving this medicine.
There are no data available on the use of haemofiltration solutions in pregnant women. However, since all components of this medicine are naturally occurring substances that merely replace those lost from the body during haemofiltration, no risk to the unborn child during pregnancy or to the breastfed infant is expected, nor is any effect on fertility anticipated.

Driving and using machines
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 2 mmol/l potassium

This medicine will be administered to the patient only under the supervision of a physician experienced in haemofiltration 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, a filtration rate of 20–25 ml/kg body weight per hour is recommended for patients in all age groups to ensure elimination of substances normally excreted in urine.
The ready-to-use haemofiltration solution is administered to the patient via tubing of the haemofiltration device (so-called extracorporeal circuit) using an infusion pump.
Treatment of acute renal failure is conducted for a limited period of time and ends when kidney function is restored.

Use of a higher than recommended dose of Duosol containing 2 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 water in the body (overhydration or dehydration). These conditions manifest as changes in blood pressure or heart rate.
Overdose of bicarbonate may occur when too large a volume of haemofiltration solution is administered. This may lead to abnormally low blood acid levels (metabolic alkalosis), reduced levels of dissolved calcium in the blood (decreased ionized calcium concentration), or muscle spasms (tetany).
Overdose may cause congestive heart failure and/or pulmonary congestion and may disrupt electrolyte and acid-base balance.
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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
No side effects related to the use of this medicine have been reported so far; however, the following side effects are possible. The frequency of these side effects is unknown (cannot be estimated from the available data):
Excess or deficiency of body water (overhydration or dehydration), abnormal salt (electrolyte) levels, low blood phosphate levels (hypophosphataemia), high blood sugar levels (hyperglycaemia), 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 side effects
After the medicinal product has been authorised, it is important to report suspected side effects. This enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected side effects 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
Suspected side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store the medicine Duosol containing 2 mmol/l of 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 a refrigerator or freeze.
Storage conditions after preparation of the ready-to-use solution
The mixed product should be used immediately. The product remains physically and chemically stable for 24 hours at 25°C after mixing.

6. Contents of the pack and other information

What Duosol containing 2 mmol/l potassium contains

Composition of the ready-to-use haemofiltration solution after mixing:
1000 ml of ready-to-use haemofiltration solution contains [mmol/l]:
Na 140
K 2.0
Ca 1.5
Mg 0.5
Cl 111
HCO₃ 35.0
anhydrous glucose 5.6 (equivalent to 1.0 g)
Theoretical osmolarity [mOsm/l] 296
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 2 mmol/l potassium looks like and contents of the pack
Haemofiltration solution
A clear, colourless solution free from visible particles.
This medicinal product is supplied in a dual-chamber bag. The ready-to-use haemofiltration solution is obtained by mixing both solutions after opening the partition between the chambers.
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 2 mmol/l kalia
Estonia: Duosol koos 2 mmol/l kaaliumiga, hemofiltratsioonilahus
Finland: Duosol cum 2 mmol/l Kalium hemofiltraationeste
Italy: Duosol con 2 mmol/l di potassio soluzione per emofiltrazione
Latvia: Duosol ar 2 mmol/l kālija šķīdums hemofiltrācijai
Lithuania: Duosol K 2 hemofiltracijos tirpalas
Germany, Luxembourg: Duosol mit 2 mmol/l Kalium Hämofiltrationslösung
Poland: Duosol containing 2 mmol/l potassium
Slovenia: Duosol z 2 mmol/l kalija raztopina za hemofiltracijo
Spain: Priosol con 2 mmol/l de Potasio solución para hemofiltración
Netherlands: Duosol met 2 mmol/l Kalium, oplossing voor hemofiltratie
United Kingdom: Duosol with 2 mmol/l Potassium solution for haemofiltration

Information intended exclusively for healthcare 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 dual-chamber bag), the partition between the chambers, and the ports 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. Unfold the bag and place it on a

clean, flat surface.

3. Press the smaller chamber of the bag with both

hands so that the partition between the chambers opens fully along its entire length.

4. Ensure thorough mixing

by rotating the bag five times in both directions.

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 in the tubing, particularly near the pump and heating device, have been observed rarely during administration of this medicinal product. Therefore, during hemofiltration, the solution in the infusion lines must be visually monitored every 30 minutes to ensure that the solution remains clear and free from precipitates.
Precipitation may also occur with significant delay after the start of treatment. If precipitates are observed, the solution and infusion sets must be replaced immediately, and the patient must be closely monitored.
For single use only. Any unused solution and any damaged containers must be discarded.