Priosol with 4 mmol/L potassium solution for hemofiltration

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Priosol with 4 mmol/l of Potassium solution for hemofiltration

Read the entire leaflet carefully before you are administered this medicine, because it contains important information for you.

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

Leaflet contents

1. What Priosol with 4 mmol/l of Potassium is and what it is used for
2. What you need to know before you are administered Priosol with 4 mmol/l of Potassium
3. How to use Priosol with 4 mmol/l of Potassium
4. Possible side effects
5. How to store Priosol with 4 mmol/l of Potassium
6. Contents of the pack and other information

1. What Priosol with 4 mmol/l of Potassium is and what it is used for

Priosol with 4 mmol/l of Potassium is a solution for haemofiltration. It is used in patients with acute renal failure, when the kidneys are unable to remove waste products from the blood. Continuous haemofiltration is a procedure used to remove waste products from the body that would otherwise be excreted through the kidneys in urine. The solution corrects fluid balance and ensures replacement of salts (electrolytes) lost during treatment.

2. What you need to know before Priosol with 4 mmol/l of Potassium is administered to you

Do not use Priosol with 4 mmol/l of Potassium if:

• you have abnormally high levels of potassium in your blood (hyperkalemia)
• your blood contains abnormally low levels of acidic substances (metabolic alkalosis)

Hemofiltration should not be used if you have:

• renal failure together with very high metabolic turnover (hypercatabolic state); in this situation, the accumulation of waste products in your body can no longer be corrected by hemofiltration
• inadequate blood flow at the site where the cannula is inserted into the vein
• a high risk of bleeding due to receiving medications to prevent blood clotting (systemic anticoagulation).

Warnings and precautions

Talk to your doctor or pharmacist before you are administered Priosol with 4 mmol/l of Potassium.

Before and during hemofiltration, your blood pressure and fluid balance, salts (electrolytes), acid-base balance, and kidney function will be monitored. Your blood sugar and phosphate levels will also be checked regularly.

In addition, serum potassium concentrations will be monitored before and during hemofiltration.

Use of Priosol with 4 mmol/l of Potassium with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The levels of other medicines in your blood may decrease during hemofiltration, which your doctor will take into account.

Interactions with other medicines can be avoided by using the correct dose of the hemofiltration solution and careful monitoring.

The following interactions will be considered:

• Infusions administered in intensive care may alter blood composition and your fluid status.
• The toxic effects of certain medicines used to treat heart failure (medicines containing digitalis) may not become apparent if your potassium or magnesium levels are too high, or your calcium levels are too low. When these levels are corrected by hemofiltration, such toxic effects may then appear and may cause, for example, irregular heart rhythms. If you have low potassium levels or high calcium levels in your blood, digitalis may produce toxic effects at doses lower than those normally used for treatment.
• Vitamin D and medicines containing calcium may increase the risk of elevated blood calcium levels to abnormally high values (hypercalcemia).
• The use of additional sodium hydrogen carbonate may increase the risk of low acid levels in the blood (metabolic alkalosis).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before this medicine is administered to you.

Currently, there are insufficient data available on the use of hemofiltration solutions during pregnancy. However, since all components of this medicine are natural substances that simply replace the same substances lost from the body during hemofiltration, no risk to the child during pregnancy and breastfeeding is expected, nor are any effects on fertility expected.

Driving and using machines

This medicine is normally administered to immobilized patients in a hospital or dialysis unit, which excludes driving and operating machinery.

3. How to use Priosol with 4 mmol/l of Potassium

This medicine will only be administered to you under the supervision of a physician experienced in hemofiltration techniques.

Your doctor will determine the appropriate dose for you, taking into account your clinical condition, body weight, and metabolic status. Unless otherwise indicated, in patients of any age, a filtration rate of 20–25 ml/kg body weight per hour is recommended for the removal of substances normally excreted in urine under normal circumstances.

The ready-to-use hemofiltration solution will be administered to you via the tubing system of the hemofiltration equipment (extracorporeal circuit) using an infusion pump.

Treatment of acute renal failure is carried out for a limited period of time and ends when kidney function is fully restored.

If you are given more Priosol with 4 mmol/l of Potassium than recommended

No life-threatening situations have been described following administration of the prescribed dose of this medicine. Administration can be stopped immediately if necessary.

Unbalanced administration may lead to excess or deficit of fluid in the body (overhydration or dehydration). This situation becomes evident by changes in blood pressure or pulse.

If too large a volume of the hemofiltration solution is administered, an overdose of bicarbonate may occur. This could result in abnormally low levels of acid in the blood (metabolic alkalosis), reduced levels of ionized calcium in the blood (decreased ionized calcium), or muscle cramps (tetany).

An overdose may cause cardiac failure and/or pulmonary congestion and may disturb acid-base and electrolyte balance.

Your 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

To date, no cases of adverse effects associated with this medicine have been reported. However, the following adverse effects could occur. The frequency of these adverse effects is unknown (cannot be estimated from the available data):

Excess or deficiency of fluid in the body (hyperhydration or dehydration), abnormal levels of salts (electrolytes) –for example, too much potassium in the blood (hyperkalemia)–, low levels of phosphate in the blood (hypophosphatemia), high blood sugar levels (hyperglycemia), abnormally low levels of acid in the blood (metabolic alkalosis), high or low blood pressure (hypertension or hypotension), feeling sick (nausea), vomiting, and muscle cramps.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Annex V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Priosol with 4 mmol/l of Potassium

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bag and the carton after “EXP”. The expiry date refers to the last day of the month indicated.

Storage conditions

Do not store above 25 °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.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Priosol with 4 mmol/l of Potassium

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

1,000 ml of ready-to-use haemofiltration solution contains [mmol/l]:

Na+ 140

K+ 4.0

Ca2+ 1.5

Mg2+ 0.5

Cl- 113

HCO3- 35.0

Anhydrous glucose 5.6 (equiv. to 1.0 g)

Theoretical osmolarity [mOsm/l] 300

pH 7.0–8.0

Other components 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

Appearance of the product and contents of the pack

Haemofiltration solution.

Clear, colourless solution, free from visible particles.

This medicine is supplied in a dual-chamber bag. When the two solutions are mixed by opening the seal between the two chambers, the ready-to-use haemofiltration solution is obtained.

Two bags of 5,000 ml (dual-chamber bags, 4,445 ml and 555 ml) per carton.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

• Braun Avitum AG

Schwarzenberger Weg 73–79

34212 Melsungen

Germany

Manufacturer

• Braun Avitum AG

Kattenvenner Str. 32

49219 Glandorf

Germany

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

Austria, Germany, Luxembourg: Duosol mit 4 mmol/l Kalium Hämofiltrationslösung

Bulgaria: ?????? 4 mmol/l ?????, ??????? ?? ?????????????

Croatia: Duosol s 4 mmol/l kalija otopina za hemofiltraciju

Czech Republic: Duosol s 4 mmol/l kalia

Denmark, Norway, Sweden: Duosol Kalium 4 mmol/l

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

France: Subsol avec 4 mmol/l potassium, solution pour hémofiltration hémodialyse et hémodiafiltration

Hungary: Nefrosol 4 mmol/l kálium hemofiltrációs oldat

Ireland: Nefrosol with 4 mmol/l Potassium solution for haemofiltration

Italy: Duosol con 4 mmol/l di potassio soluzione per emofiltrazione

Latvia: Duosol ar 4 mmol/l kalija šķīdums hemofiltrācijai

Lithuania: Duosol K 4 hemofiltracijos tirpalas

Poland: Duosol zawierajacy 4 mmol/l potasu

Portugal: Duosol com potássio 4 mmol/l, solução para hemofiltração

Romania: Nefrosol cu 4 mmol/l potasiu, solutie pentru hemofiltrare

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

Date of most recent review of this summary: September 2018

This information is intended for healthcare professionals only:

Instructions for the preparation of the ready-to-use haemofiltration solution

The packaging and solution must be visually inspected before use. Only use haemofiltration solutions if the packaging (outer wrapper and dual-chamber bag), the peel seal, and the connectors are undamaged and intact, and if the solution is clear, colourless, and free from visible particles.

Remove the outer wrapper only immediately before use.

Administration of ready-to-use hemofiltration solution

The hemofiltration solution must be warmed to approximately body temperature using an integrated or external warmer. Under no circumstances should the solution be infused if it is below room temperature.

During administration of this medicinal product, rare cases of precipitation of calcium carbonate in the tubing have been observed, particularly near the pump unit and the heating unit. Therefore, during hemofiltration, the tubing must be visually inspected carefully every 30 minutes to ensure that the solution in the tubing system is clear and free from precipitates. Precipitation may also occur with a considerable delay after initiation of treatment. If precipitates are observed, the tubing must be replaced immediately and the patient must be carefully monitored.

For single use only. Any remaining portion of the solution and any damaged container must be discarded.