Duosol nie zavieraiomci potasu

Leaflet accompanying the packaging: patient information

Duosol without potassium, solution for hemofiltration

Read the leaflet carefully before using the medicine, as it contains

important information for the patient

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

Table of contents of the leaflet

• 1. What is Duosol without potassium and what is it used for
• 2. Important information before using 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 packaging and other information

1. What is Duosol without potassium and what is it used for

Duosol without potassium is a solution for hemofiltration. This medicine is intended for use in patients with acute renal failure, where the kidneys are not able to remove waste products from the blood. The process of continuous hemofiltration involves removing waste products from the body that are normally excreted by the kidneys. The solution balances fluid and provides replacement of lost salts (electrolytes).

2. Important information before using Duosol without potassium

Duosol without potassium should not be used if:

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

Hemofiltration treatment should not be used in the following cases:

• renal failure combined with very intense metabolic processes (hyperkatabolism); in such cases, the accumulated waste products cannot be removed for a longer period through hemofiltration;
• insufficient blood flow from the venous access;
• any conditions where there is an increased risk of bleeding, as the patient is receiving medications that prevent blood clotting (systemic anticoagulation).

Warnings and precautions

Before starting treatment with Duosol without potassium, discuss it with your doctor or pharmacist.
Before and during hemofiltration, blood pressure, fluid balance, electrolyte balance, acid-base balance, and kidney function should be monitored. Blood sugar and phosphate levels should be regularly checked.
Before and during hemofiltration, potassium levels in the blood should also be monitored.

Duosol without potassium and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
The levels of other medicines in the blood may decrease during hemofiltration, and the doctor will take this into account.
By using appropriate doses of the hemofiltration solution and close monitoring, interactions with other medicines can be avoided.
The following interactions will be considered:

• Infusions given as part of intensive medical care may change the patient's blood composition and fluid status.
• Toxic effects of certain medications used to treat heart weakness (digitalis-containing medications) may not be visible when potassium or magnesium levels are too high or calcium levels are too low. If these levels are corrected by hemofiltration, toxic effects may then occur and cause, for example, heart rhythm disturbances. If the patient has low potassium or high calcium levels in the blood, digitalis may have toxic effects at lower doses than usually used in treatment.
• Administration of vitamin D and calcium-containing medications may increase the risk of high calcium levels in the blood (hypercalcemia).
• Additional use of sodium bicarbonate may increase the risk of abnormally low acid levels in the blood (metabolic alkalosis).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before receiving this medicine.
There are no data on the use of hemofiltration solutions in pregnant women. However, since all components of this medicine are naturally occurring substances that only replace the same substances lost from the body during hemofiltration, no risks to the child during pregnancy and breastfeeding are expected, and no effect on fertility is expected.

Driving and using machines

This medicine is usually given to patients who are bedridden in the hospital/dialysis ward. This excludes driving and operating machines.

3. How to use Duosol without potassium

This medicine will be given to you only under the supervision of a doctor with experience in hemofiltration techniques.
The doctor will decide on the appropriate dose for you, taking into account your clinical condition, body weight, and metabolic conditions. Unless otherwise recommended, for 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 that are normally excreted in the urine.
The patient is given a ready-to-use hemofiltration solution through the tubes of the hemofiltration device (so-called extracorporeal circuit) using an infusion pump.
Treatment of acute renal failure is carried out for a limited period and ends when kidney function is restored.

Using a higher dose of Duosol without potassium than recommended

No life-threatening cases have been reported after administration of the recommended doses of this medicine. If necessary, administration can be stopped at any time.
Incorrect fluid balance may lead to too much or too little water in the body (overhydration or dehydration). These conditions are characterized by changes in blood pressure or heart rate.
Overdose of bicarbonate may occur when too much hemofiltration solution is administered. This may lead to abnormally low acid levels in the blood (metabolic alkalosis), lower levels of calcium dissolved in the blood (decreased ionized calcium levels), or muscle cramps (tetany).
Overdose may cause congestive heart failure and (or) pulmonary congestion and may cause changes in electrolyte and acid-base balance.
The doctor will decide on the appropriate treatment.
If you have any further questions about 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 .
No side effects have been reported so far in connection with the use of this medicine, but 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 water in the body (overhydration or dehydration), abnormal electrolyte levels, low phosphate levels in the blood (hypophosphatemia), high blood sugar levels (hyperglycemia), abnormally low acid levels in the blood (metabolic alkalosis), too high or too low blood pressure (hypertension, hypotension), nausea, vomiting, and muscle cramps.

Reporting side effects

After the product has been placed on the market, it is important to report any suspected side effects. This allows for continuous monitoring of the benefit-risk balance of the product. Healthcare professionals should report any suspected side effects via the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Duosol without potassium

Store the medicine out of 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 given 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 remains physically and chemically stable for 24 hours at 25°C.

6. Contents of the packaging and other information

What Duosol without potassium contains

Composition of the ready-to-use hemofiltration solution after mixing:

1000 ml of the ready-to-use hemofiltration solution contains [mmol/l]:
Na
140
Ca
1.5
Mg
0.5
Cl
109
HCO
35.0
anhydrous glucose
5.6 (equivalent to 1.0 g)
Theoretical osmolality [mOsm/l]
292
pH
7.0–8.0

Other ingredients are:

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 without potassium looks like and what the packaging contains

Hemofiltration solution
Clear and colorless solution, free from visible particles
This medicine is supplied in a dual-chamber bag. By mixing the two 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 authorization holder and manufacturer

• B. Braun Avitum AG Schwarzenberger Weg 73-79 34212 Melsungen Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Duosol without potassium
Estonia:
Duosol ilma kaaliumita, hemofiltratsioonilahus
Finland:
Duosol sine Kalium hemofiltraationeste
Italy:
Duosol senza potassio soluzione per emofiltrazione
Latvia:
Duosol bez kālija šķīdums hemofiltrācijai
Lithuania:
Duosol K 0 hemofiltracijos tirpalas
Germany, Luxembourg:
Duosol ohne Kalium Hämofiltrationslösung
Poland:
Duosol without potassium
Slovenia:
Duosol brez kalija raztopina za hemofiltracijo
Spain:
Priosol sin Potasio solución para hemofiltración
Netherlands:
Duosol zonder Kalium, oplossing voor hemofiltratie
United Kingdom:
Duosol without Potassium solution for haemofiltration

Date of last revision of the leaflet: 05.05.2023

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Information intended for healthcare professionals only:

Instructions for preparing the ready-to-use hemofiltration solution
Before use, the container and solution should be visually inspected. The hemofiltration solution should only be used if the container (outer protective packaging and dual-chamber bag), the partition between the chambers, and the connections are undamaged and intact, and the solution is clear, colorless, and free from visible particles.
The outer protective packaging should be removed immediately before use.
1
Remove the outer protective 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 of the contents 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.
Rarely, during the use of this medicinal product, the formation of a white calcium carbonate precipitate has been observed in the tubes, especially near the pump and heating device. Therefore, during hemofiltration, the solution in the infusion tubes should be visually monitored every 30 minutes to ensure that the solution in the tubes is clear and free from precipitates.
Precipitates may also occur with significant delay after the start of treatment. If precipitates are observed, the solution and infusion tubes should be replaced immediately, and the patient should be closely monitored.
For single use only. Unused solution and any damaged containers should be discarded.