PRIOSOL SIN POTASIO SOLUTION FOR HEMOFILTRATION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Priosol without Potassium solution for haemofiltration

Read the entire leaflet carefully before you are given 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, ask your doctor or pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What Priosol without Potassium is and what it is used for
2. What you need to know before being administered Priosol without Potassium
3. How to use Priosol without Potassium
4. Possible adverse effects
5. How to store Priosol without Potassium
6. Contents of the pack and other information

1. What Priosol without Potassium is and what it is used for

Priosol without Potassium is a solution for hemofiltration. It is used in patients with acute renal failure, when the kidneys are unable to remove waste products from the blood. Continuous hemofiltration is a procedure used to eliminate waste products from the body that would otherwise be excreted through the kidneys in urine. The solution corrects fluid balance and ensures that, after treatment, the loss of salts (electrolytes) is restored.

2. What you need to know before Priosol without Potassium is administered to you

Do not administer Priosol without Potassium if:

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

The hemofiltration procedure should not be used if you have:

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

Warnings and precautions

Consult your doctor or pharmacist before Priosol without Potassium is administered to you.

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 be checked regularly.

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

Use of Priosol without Potassium with other medicines

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

The blood levels of other medicines may be reduced 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 cause, for example, heart rhythm abnormalities. 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 calcium levels in the blood 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 effects on fertility expected.

Driving and use of machines

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

3. How to use Priosol without 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 via the tubing system of the hemofiltration equipment (extracorporeal circulation) 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 without Potassium than recommended

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

Unbalanced administration may lead to excess or deficit of fluid in the body (hyperhydration or dehydration). This situation becomes evident through 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 the 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 may 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), low phosphate levels 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), 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 may 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 without Potassium

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

Do not use this medicine after the expiry date stated on the bag and the carton following "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 medicines and their containers at the SIGRE point located at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Priosol without Potassium

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

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

Na+ 140

Ca2+ 1.5

Mg2+ 0.5

Cl- 109

HCO3- 35.0

Anhydrous glucose 5.6 (equiv. to 1.0 g)

Theoretical osmolarity [mOsm/l] 292

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 container

Hemofiltration solution.

Clear, colourless solution, free from visible particles.

This medicine is supplied in a dual-chamber bag. By mixing the two solutions through opening the seal between the two chambers, the ready-to-use hemofiltration solution is obtained.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Braun Avitum AG
Schwarzenberger Weg 73–79
34212 Melsungen
Germany

Manufacturer

Braun Avitum AG
Kattenvenner Str. 32
49219 Glandorf
Germany

This medicine is authorized in the European Economic Area member states under the following names:

Austria, Germany, Luxembourg: Duosol ohne Kalium Hämofiltrationslösung

Bulgaria: ?????? ??? ?????????? ?? ?????, ??????? ?? ?????????????

Croatia: Duosol bez kalija otopina za hemofiltraciju
Czech Republic: Duosol bez kalia

Denmark, Norway, Sweden: Duosol Kaliumfri

Estonia: Duosol ilma kaaliumita hemofiltratsioonilahus

Finland: Duosol sine Kalium hemofiltraationeste

France: Subsol sans potassium, solution pour hémofiltration hémodialyse et hémodiafiltration

Greece: Duosol without Potassium διάλυμα αιμοδιαδιάθησης

Ireland: Nefrosol solution for haemofiltration
Italy: Duosol senza potassio soluzione per emofiltrazione

Latvia: Duosol bez kalija šķīdums hemofiltrācijai

Lithuania: Duosol K 0 hemofiltracijos tirpalas

Poland: Duosol nie zawierajacy potasu

Portugal: Duosol sem potássio, solução para hemofiltração

Romania: Nefrosol fara potasiu, solutie pentru hemofiltrare
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 latest review of this leaflet: September 2018

This information is intended for healthcare professionals only:

Instructions for preparing the ready-to-use hemofiltration solution

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

Remove the outer wrapper immediately before use.

Administration of 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 infused if it is below room temperature.

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

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