Prospect: information for the patient

Priosol without Potassium solution for hemofiltration

Read this prospect carefully before this medication is administered to you, because it contains important information for you.

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

1. What is Priosol without Potassium and how is it used

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

3. How to use Priosol without Potassium

4. Possible adverse effects

5. Storage of Priosol without Potassium

6. Contents of the package and additional information

Priosol without Potassium is a solution for hemofiltration. It is used in patients who present acute renal insufficiency, when the kidneys are not able to eliminate the waste products from the blood. Continuous hemofiltration is a procedure that is used to eliminate the waste products from the body, which otherwise are excreted through the kidneys in the urine. The solution corrects the balance of the liquids and ensures that, after the treatment, the loss of salts (electrolytes) is restored.

Do not administer Priosol without Potassium if:

• you have an abnormally low level 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 insufficiency combined with a very high metabolic exchange rate (hypercatabolic state), in this situation, the accumulation of waste products in your body can no longer be corrected by hemofiltration
• insufficient blood flow at the site of the catheter insertion in the vein
• a high risk of hemorrhage due to the fact that you are receiving medications to prevent blood coagulation (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, electrolyte balance, acid-base balance, and renal function will be monitored. Your blood sugar and phosphate levels will be regularly checked.

Additionally, your serum potassium levels will be monitored before and during hemofiltration.

Use of Priosol without Potassium with other medications

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

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

Interactions with other medications can be avoided with the use of the correct dose of the hemofiltration solution and careful monitoring.

The following interactions will be considered:

• Infusions administered in intensive care may change the composition of your blood and your fluid status.
• The toxic effects of certain medications used to treat heart failure (medications 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 through hemofiltration, these toxic effects may then appear and cause, for example, heart rhythm abnormalities. If you have low potassium or high calcium levels in your blood, digitalis may produce toxic effects at doses lower than those normally used for treatment.
• Vitamin D and medications containing calcium may increase the risk of high calcium levels in your blood to abnormally high levels (hypercalcemia).
• The use of additional sodium bicarbonate may increase the risk of low acid levels in your blood (metabolic alkalosis).

Pregnancy, breastfeeding, and fertility

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

There is currently not enough data available on the use of hemofiltration solutions during pregnancy. However, as all components of this medication are natural substances that only replace the same substances that disappear from the body during hemofiltration, no risks to the fetus are expected during pregnancy and breastfeeding, nor are there expected to be any effects on fertility.

Driving and operating machinery

This medication is usually administered to patients who are bedridden in a hospital or dialysis unit, which excludes driving and operating machinery.

This medication will only be administered under the direction of a doctor with experience in hemofiltration techniques.

Your doctor will decide on the appropriate dose for you, taking into account your clinical condition, body weight, and metabolic disorder. Unless otherwise indicated, in patients of any age, a filtration rate of 20-25 ml/kg of body weight per hour is recommended for the elimination of substances that are normally excreted in the urine.

The hemofiltration solution ready for use will be administered through the tubing system of the hemofiltration equipment (extracorporeal circulation) using a perfusion pump.

Acute renal insufficiency treatment is carried out for a limited period of time and ends when kidney function is completely restored.

If you are administered more Priosol without Potassium than recommended

No fatal situations have been described following the administration of the prescribed dose of this medication. Administration can be interrupted immediately if necessary.

Unbalanced administration may lead to an excess or deficiency of fluid in the body (hyperhydration or dehydration). This situation becomes apparent through changes in blood pressure or pulse.

Administering too large a volume of the hemofiltration solution may cause a hydrogen carbonate overdose. This can result in abnormally low levels of acids in the blood (metabolic alkalosis), a lower amount of dissolved calcium in the blood (decreased ionized calcium) or muscle cramps (tetany).

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

Your doctor will decide on the appropriate treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

No adverse effects associated with this medication have been described to date. Nevertheless, the following adverse effects could occur. The frequency of these adverse effects is unknown (cannot be estimated from available data):

Excess or deficiency of fluid in the body (hyperhydration or dehydration), abnormal levels of salts (electrolytes), low levels of phosphate in the blood (hypophosphatemia), high levels of sugar in the blood (hyperglycemia), abnormally low levels of acids in the blood (metabolic alkalosis), high or low blood pressure (hypertension or hypotension), desire to vomit (nausea), vomiting, and muscle cramps.

Reporting 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 prospectus. You can also report them directly through the national notification system included in theAnnex V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not administer this medication after the expiration date that appears on the bag and on the box after “CAD”. The expiration date is 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 must be used immediately. The mixed product is physically and chemically stable for 24 hours at 25 °C.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Priosol without Potassium

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

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

Na+140

Ca2+1.5

Mg2+0.5

Cl-109

HCO3-35.0

Anhydrous glucose5.6 (equiv. to 1.0 g)

Theoretical osmolality [mOsm/l]292

pH7.0-8.0

The other components are:

Electrolyte solution (small chamber)

25% hydrochloric acid (for pH adjustment), injectable water

Bicarbonate solution (large chamber)

Carbon dioxide (for pH adjustment), injectable water

Appearance of the product and contents of the package

Hemofiltration solution.

Transparent and colorless solution, free of visible particles.

This medicinal product is supplied in a two-chamber bag. By mixing the two solutions by opening the closure between the two chambers, the ready-to-use solution for hemofiltration is obtained.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

B. Braun Avitum AG

Schwarzenberger Weg 73-79

34212 Melsungen

Germany

Responsible for manufacturing

B. Braun Avitum AG

Kattenvenner Str. 32

49219 Glandorf

Germany

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

Austria, Germany, Luxembourg:Duosol ohne Kalium Hämofiltrationslösung

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

Croatia:Duosol bez kalija otopina za hemofiltracijuRepublic of Czechia: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 Potassiumδι?λυμααιμοδιαδι?θησης

Ireland:Nefrosol solution for haemofiltrationItaly:Duosol senza potassio soluzione per emofiltrazione

Lithuania:Duosol K 0 hemofiltracijos tirpalas

Poland:Duosol nie zawierajacy potasu

Portugal:Duosol sem potássio, solução para hemofiltração

Romania:Nefrosol fara potasiu, solutie pentru hemofiltrareSlovenia:Duosol brez kalija raztopina za hemofiltracijo

Spain:Priosol sinPotasio solución para hemofiltración

Netherlands:Duosol zonder Kalium, oplossing voor hemofiltratie

United Kingdom:Duosol without Potassium solution for haemofiltration

Last review date of this leaflet:September 2018

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This information is intended solely for healthcare professionals:

Instructions for preparing the ready-to-use solution for hemofiltration

The packaging and solution must be visually inspected before use. Only ready-to-use solutions for hemofiltration should be used if the packaging (outer packaging and two-chamber bag), the closurepeeland the connectors are not damaged and intact, and if the solution is transparent and colorless and free of visible particles.

Remove the outer packaging only immediately before use.

Administration of the ready-to-use solution for hemofiltration

The ready-to-use solution for hemofiltration must be heated to approximately body temperature using an integrated or external heater. The solution must not be infused under any circumstances if it is below ambient temperature.

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

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