Prismasol

Leaflet accompanying the packaging: information for the user

Prismasol 2 mmol/l potassium

Solution for hemodialysis/hemofiltration

Calcium chloride dihydrate/magnesium chloride hexahydrate/glucose monohydrate/lactic acid solution 90% w/w/sodium chloride/potassium chloride/sodium bicarbonate

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.
• In case of any doubts, consult a doctor, pharmacist or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, inform the doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Prismasol and what is it used for
• 2. Important information before using Prismasol
• 3. How to use Prismasol
• 4. Possible side effects
• 5. How to store Prismasol
• 6. Package contents and other information

1. What is Prismasol and what is it used for

Prismasol contains the active substances: calcium chloride dihydrate, magnesium chloride hexahydrate, glucose monohydrate, lactic acid solution 90% w/w, sodium chloride, potassium chloride, sodium bicarbonate.

Prismasol is used to treat kidney failure as a solution for continuous hemofiltration or hemodiafiltration (as a substitution solution in case of fluid loss from blood passing through the filter) and continuous hemodialysis or hemodiafiltration (blood flows on one side of the dialysis membrane, while the dialysis solution flows on the other side of the membrane).

Prismasol can also be used in case of poisoning with drugs that are subject to dialysis or filtration.

Prismasol 2 mmol/l potassium is indicated especially for patients who have a tendency to hyperkalemia (high potassium levels in the blood).

2. Important information before using Prismasol

Do not use Prismasol 2 mmol/l potassium solution in the following cases:

• hypersensitivity to one of the active substances or any of the other ingredients of this medicine (listed in section 6),
• low potassium levels in the blood (hypokalemia),
• high bicarbonate levels in the blood (metabolic alkalosis).

The presence of corn antigen in the Prismasol solution cannot be ruled out.

Do not use hemofiltration/dialysis in the following cases:

• kidney failure with significant hypercatabolism (abnormal increase in catabolism), if uremia symptoms (symptoms caused by high urea levels in the blood) cannot be alleviated by hemofiltration;

Prismasol 2 mmol/l Potassium / PL / PL Polyolefin luer connector with valve

• insufficient arterial pressure in vascular access;
• systemic anticoagulation (reduced blood clotting) with a risk of bleeding.

Warnings and precautions

Before starting to use the Prismasol solution, consult a doctor, pharmacist or nurse.

The solution should only be used by or under the supervision of a doctor qualified in the treatment of kidney failure using hemofiltration, hemodiafiltration and continuous hemodialysis.

Before and during treatment, the patient's blood will be examined, e.g. acid-base balance and electrolyte levels (salts in the blood) will be monitored, including any administered fluids (intravenous infusions) and those produced by the body (urine production), even if not directly related to therapy.

Potassium levels in the blood must be monitored before and during hemofiltration and/or hemodialysis.

Prismasol and other medicines

Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

The blood levels of other medicines taken may be reduced during treatment. The doctor will decide whether a change in the medicines taken is necessary.

In particular, inform the doctor about the use of the following medicines:

• glycosides (used to treat certain heart diseases), as they may increase the risk of cardiac arrhythmias (irregular or rapid heartbeat) during hypokalemia (low potassium levels in the blood);
• vitamin D and calcium-containing medicines, as they may increase the risk of hypercalcemia (high calcium levels in the blood);
• any sodium bicarbonate supplements (or other buffers), as they may increase the risk of metabolic alkalosis (excess bicarbonate in the blood);
• citrate, used as an anticoagulant (as a protective additive in dialysis equipment), as it may reduce calcium levels in the blood.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks she may be pregnant or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

The doctor will decide whether to administer the Prismasol solution to pregnant or breastfeeding women.

Driving and using machines

It is not known whether Prismasol affects the ability to drive and use machines.

3. How to use Prismasol

This medicine should always be used in accordance with the doctor's or pharmacist's recommendations. In case of doubts, consult a doctor or pharmacist.

The volume of the Prismasol solution used depends on the patient's clinical condition and target fluid balance. Therefore, the decision on the volume of the dose is made by the doctor responsible for the treatment.

Route of administration: for intravenous administration and hemodialysis.

Prismasol 2 mmol/l Potassium / PL / PL Polyolefin luer connector with valve

Using a higher dose of Prismasol than recommended

The patient will have their fluid balance, electrolyte balance, and acid-base balance closely monitored.

In the unlikely event of an overdose, the doctor will take the necessary measures and adjust the patient's dose.

Overdose may lead to:

• fluid overload in the patient's blood,
• increased bicarbonate levels in the blood (metabolic alkalosis)
• and/or decreased electrolyte levels in the blood (hypophosphatemia, hypokalemia). Overdose may lead to serious consequences, such as congestive heart failure, electrolyte imbalance, or acid-base imbalance.

Instructions for use are found in the section "Information intended exclusively for healthcare professionals".

In case of any further doubts related to the use of this medicine, consult a doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported:

Frequency not known: frequency cannot be estimated from the available data

• changes in electrolyte levels in the blood (electrolyte imbalance, such as hypophosphatemia or hypokalemia)
• increased bicarbonate levels in the blood (metabolic alkalosis) or decreased bicarbonate levels in the blood (metabolic acidosis)
• abnormally high or low water volume in the body (hyper- or hypovolemia)
• abnormally high glucose levels in the blood (hyperglycemia)
• nausea
• vomiting
• muscle cramps
• low blood pressure (hypotension).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, inform the doctor, pharmacist or nurse.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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

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.

Prismasol 2 mmol/l Potassium / PL / PL Polyolefin luer connector with valve

5. How to store Prismasol

Store the medicine in a place out of sight and reach of children.

Do not store below +4°C.

Do not use this medicine after the expiry date stated on the label and packaging. The expiry date refers to the last day of the month stated.

The chemical and physical stability of the ready-to-use solution has been demonstrated for 24 hours at +22°C. If not used immediately, the user is responsible for the storage time and conditions before use, and this time should not exceed 24 hours, including the treatment time.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Prismasol contains

Active substances:

Before reconstitution/mixing:

1000 ml of electrolyte solution (small chamber A) contains:

Calcium chloride dihydrate

5.145 g

Magnesium chloride hexahydrate

2.033 g

Glucose

22.000 g

Lactic acid

5.400 g

1000 ml of buffer solution (large chamber B) contains:

Sodium chloride

6.450 g

Sodium bicarbonate

3.090 g

Potassium chloride

0.157 g

After reconstitution/mixing:

The solutions in chambers A (250 ml) and B (4750 ml) are mixed to obtain one ready-to-use solution (5000 ml) consisting of:

mmol/l

mEq/l

Calcium

Ca

1.75

3.50

Magnesium

Mg

0.50

1.00

Sodium

Na

140.00

140.00

Chloride

Cl

111.50

111.50

Lactate

3.00

3.00

Bicarbonate

HCO

32.00

32.00

Potassium

K

2.00

2.00

Glucose

6.10

Theoretical osmolality:

297 mOsm/l

Other ingredients of the medicine are:carbon dioxide (E 290), water for injections.

The pH of the ready-to-use solution is: 7.0 to 8.5

Prismasol 2 mmol/l Potassium / PL / PL Polyolefin luer connector with valve

What Prismasol looks like and what the package contains

Prismasol is packaged in dual-chamber bags containing an electrolyte solution in the smaller chamber A and a buffer solution in the larger chamber B. The final ready-to-use solution is obtained after breaking the frangible seal and mixing the two solutions. The ready-to-use solution is clear and slightly yellow. Each bag (A+B) contains 5000 ml of solution for hemofiltration and hemodialysis. The bag is placed in a transparent outer packaging.

Each package contains two bags and an information leaflet.

Marketing authorization holder and manufacturer:

Vantive Belgium SRL

Boulevard d’Angleterre 2

1420 Braine-l’Alleud

Belgium

Manufacturer:

Bieffe Medital S.p.A.,

Via Stelvio 94,

23035 Sondalo (SO),

Italy

or

Vantive Manufacturing Limited,

Moneen Road,

Castlebar

County Mayo

F23 XR63

Ireland

This medicine is authorized for sale in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland): Prismasol 2.

Date of last revision of the leaflet: September 2024

--------------------------------------------------------------------------------------------------------------------------

Information intended exclusively for healthcare professionals:

Prismasol 2 mmol/l potassium solution for hemodialysis/hemofiltration

Precautions:

Strictly follow the instructions for use/handling of the medicinal product Prismasol.

The solutions from both chambers must be mixed before use.

Using a contaminated solution for hemofiltration and hemodialysis may cause sepsis, shock, or life-threatening conditions.

To increase patient comfort, the Prismasol medicinal product can be warmed to a temperature of 37°C.

Warming the solution before use should be done before reconstitution and only using a dry heat source. The solutions should not be heated in water or a microwave oven. Before administration, visually inspect the solution for the presence of solid particles and changes in color, if the solution and packaging allow. Do not administer the solution if it is not clear or the seal is broken.

This solution contains potassium. Potassium levels in the blood must be monitored before and during hemofiltration and/or hemodialysis. Depending on the potassium levels in the blood before treatment, hypokalemia or hyperkalemia may develop.

If hypokalemia occurs, it may be necessary to add potassium and/or administer a dialysate with a higher potassium concentration.

If hyperkalemia occurs after starting treatment, evaluate additional sources that may affect potassium levels in the blood. If the solution is used as a substitution solution, reduce the infusion rate and confirm that the desired potassium concentration has been achieved. If hyperkalemia does not resolve, discontinue the infusion immediately.

If hyperkalemia develops when using the solution as a dialysate, it may be necessary to administer a potassium-free dialysate to increase the rate of potassium removal.

Regularly measure the levels of inorganic phosphates. In case of low phosphate levels in the blood, inorganic phosphates must be supplemented. Phosphates can be added to the solution in a quantity of up to 1.2 mmol/l. When adding potassium phosphate, the total potassium concentration should not exceed 4 mEq/l (4 mmol/l).

Although no cases of severe corn allergy have been reported in connection with the use of Prismasol, solutions containing glucose derived from hydrolyzed corn starch should not be used in patients with a known allergy to corn or corn products.

Immediately discontinue administration if any objective or subjective symptoms of suspected hypersensitivity reactions occur. Implement appropriate therapeutic measures according to clinical indications.

Since the solution contains glucose and lactate, hyperglycemia may develop, especially in patients with diabetes. Regularly monitor blood glucose levels. If hyperglycemia develops, it may be necessary to administer a glucose-free substitution solution/dialysate. Other measures may be necessary to maintain the desired blood glucose level.

The Prismasol medicinal product contains bicarbonate (bicarbonate) and lactate (a precursor to bicarbonate), which may affect the patient's acid-base balance. If metabolic alkalosis occurs or worsens during treatment with the solution, it may be necessary to reduce the administration rate or discontinue the medicinal product.

Before and during treatment, closely monitor electrolyte levels and acid-base balance.

In case of fluid imbalance, closely monitor the patient's clinical condition and correct fluid balance if necessary.

Method of administration:

For intravenous administration and hemodialysis. Prismasol used as a substitution solution is administered to the circuit before the hemofilter (pre-dilution) or after the hemofilter (post-dilution).

Dosage:

The volume and rate of administration of the Prismasol solution depend on the patient's electrolyte levels, acid-base balance, and overall clinical condition. The parameters of administration (dose, infusion rate, total volume) of the Prismasol product should be determined by the doctor.

Prismasol 2 mmol/l Potassium / PL / PL Polyolefin luer connector with valve

Flow rates for the substitution solution in hemofiltration and hemodiafiltration are:

Adults:

500 to 3000 ml/hour.

Flow rates for the dialysate solution in continuous hemodialysis and continuous hemodiafiltration are:

Adults:

500 to 2500 ml/hour.

The most commonly used flow rates in adults are approximately 2000 to 2500 ml/hour, which corresponds to a daily fluid volume of approximately 48 to 60 liters.

Children and adolescents

The range of flow rates for the substitution solution in hemofiltration and hemodiafiltration and for the dialysate solution in continuous hemodialysis is:

children (from newborns to adolescents up to 18 years): 1000 to 2000 ml/hour/1.73 m².

The required flow rates may be up to 4000 ml/hour/1.73 m², especially in younger children (≤10 kg). The absolute flow rate (in ml/hour) in children and adolescents should not normally exceed the maximum flow rate used in adults.

Instructions for use:

To obtain the ready-to-use solution, the electrolyte solution (small chamber A) is added to the buffer solution (large chamber B) by opening the frangible seal directly before use.

Only use with the appropriate equipment for extracorporeal renal replacement therapy.

During the procedure and administration of the product to the patient, use aseptic technique.

Use only if the protective packaging is not damaged, all seals are intact, the frangible seal is not damaged, and the solution is clear. Squeeze the bag firmly to check its integrity. If a leak is detected, the solution should be discarded immediately, as its sterility can no longer be guaranteed.

The large chamber B has a injection port that allows the addition of other necessary medicinal products after reconstitution of the solution. The doctor is responsible for determining the compatibility of additional medicinal products with the Prismasol solution by checking for any change in color and/or precipitation of insoluble complexes or crystals.

Before adding a medicinal product, check if it is soluble and stable in water with a pH similar to that of the Prismasol solution (the pH of the ready-to-use solution is between 7.0 and 8.5). Additional ingredients may be incompatible. Consult the instructions for use of the added medicinal product.

Remove the fluid from the injection port, hold the bag upside down, inject the medicinal product through the port, and mix carefully. The solution should be administered immediately. Additional ingredients must always be added and mixed before connecting the bag with the solution to the extracorporeal circuit.

I

Remove the outer packaging directly before use and mix the solutions from the two chambers. Hold the small chamber with both hands and squeeze until a hole is made in the frangible seal separating the two chambers. (See figure I below)

II

Squeeze the large chamber with both hands until the frangible seal between the two chambers is completely open. (See figure II below)

III

Ensure thorough mixing by gently shaking the bag. The solution is now ready for use, and the bag can be hung on a stand. (See figure III below)

IV

Either of the two access ports can be connected to a dialysis or exchange line.

IV.aIf using a luer-type access, remove the cap by twisting and pulling, then connect the male luer lock of the dialysis or exchange line to the female luer receptor on the bag, pushing and twisting. Ensure the connection is fully seated and secure. The connector is now open. Check that the fluid flows freely. (See figure IV.a below)

When the dialysis or exchange lines are disconnected from the luer connector, the connection will be closed, and fluid flow will be stopped. The luer port is needle-free and can be wiped with disinfectants.

IV.bIf using an injection port, first remove the cap by breaking it off. The injection port can be wiped with disinfectants. Then, puncture the rubber septum with a needle. Check that the fluid flows freely. (See figure IV.b below)

The solution should be used immediately after removal from the outer packaging. If not used immediately, the reconstituted solution should be used within 24 hours, including the time of the procedure, after adding the electrolyte solution and buffer solution.

The ready-to-use solution is for single use only. Discard any unused solution immediately after use.

Dispose of any unused product or waste material in accordance with local regulations.

1. What is Prismasol and what is it used for

Prismasol contains the active substances: calcium chloride dihydrate, magnesium chloride hexahydrate, glucose monohydrate, lactic acid solution 90% w/w, sodium chloride, potassium chloride, and sodium bicarbonate. Prismasol is used to treat renal failure as a solution for continuous hemofiltration or hemodiafiltration (as a substitution solution for fluid loss from blood passing through the filter) and continuous hemodialysis or hemodiafiltration (blood flows on one side of the dialysis membrane, while the dialysis solution flows on the other side of the membrane). Prismasol can also be used in cases of poisoning with dialyzable or filterable substances. Prismasol 2 mmol/l potassium is particularly indicated for patients with a tendency to hyperkalemia (high potassium levels in the blood).

2. Important information before using Prismasol

Do not use Prismasol 2 mmol/l potassium solution in the following cases:

• hypersensitivity to one of the active substances or any of the other ingredients of this medicine (listed in section 6),
• low potassium levels in the blood (hypokalemia),
• high bicarbonate levels in the blood (metabolic alkalosis).

The presence of corn antigen in the Prismasol solution cannot be ruled out.

Do not use hemofiltration/dialysis in the following cases:

• renal failure with significant hypercatabolism (abnormal increase in catabolism), if uremic symptoms (symptoms caused by high urea levels in the blood) cannot be alleviated by hemofiltration;

Prismasol 2 mmol/l Potassium / PL / PL PVC luer connector with valve 1/8 insufficient arterial blood pressure in vascular access;

• systemic anticoagulation (reduced blood clotting) with a risk of bleeding (bleeding).

Warnings and precautions

Before starting treatment with the Prismasol solution, consult a doctor, pharmacist, or nurse. The solution should only be used by or under the supervision of a doctor qualified in the treatment of renal failure using hemofiltration, hemodiafiltration, and continuous hemodialysis. Before and during treatment, the patient's blood will be tested, e.g., acid-base balance and electrolyte concentration (salt levels in the blood), including any administered fluids (intravenous infusions) and those produced by the body (urine production), even if not directly related to therapy. Glucose levels in the blood should be closely monitored, especially if the patient has diabetes.

Prismasol and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. The blood concentration of other medicines taken may be reduced during treatment. The doctor will decide if a change in the taken medicines is required. In particular, tell your doctor about the use of the following medicines:

• glycosides (used to treat certain heart diseases), as they increase the risk of cardiac arrhythmias (irregular or rapid heartbeat) during hypokalemia (low potassium levels in the blood);
• vitamin D and calcium-containing medicines, as they may increase the risk of hypercalcemia (high calcium levels in the blood);
• any sodium bicarbonate supplements (or other buffers), as they may increase the risk of metabolic alkalosis (excess bicarbonate in the blood);
• citrate, used as an anticoagulant (as a protective additive in dialysis equipment), as it may reduce calcium levels in the blood.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine. The doctor will decide on the administration of the Prismasol solution to pregnant or breastfeeding women.

Driving and using machines

It is not known whether Prismasol affects the ability to drive and use machines.

3. How to use Prismasol

This medicine should always be used as directed by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist. The volume of the Prismasol solution used depends on the patient's clinical condition and target fluid balance. Therefore, the decision on the volume of the dose is made by the doctor responsible for the treatment. Route of administration: for intravenous administration and hemodialysis. Prismasol 2 mmol/l Potassium / PL / PL PVC luer connector with valve 2/8

Overdose of Prismasol

The patient will have their fluid balance, electrolyte balance, and acid-base balance closely monitored. In the unlikely event of an overdose, the doctor will take the necessary measures and adjust the patient's dose. Overdose may lead to:

• fluid overload in the patient's blood,
• an increase in bicarbonate levels in the blood (metabolic alkalosis)
• and/or a decrease in salt levels in the blood (hypophosphatemia, hypokalemia). Overdose may lead to serious consequences, such as congestive heart failure, electrolyte imbalance, or acid-base imbalance.

Instructions for use are found in the section "Information intended for healthcare professionals only". If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported: Frequency not known: frequency cannot be estimated from the available data

• changes in salt levels in the blood (electrolyte imbalance, such as hypophosphatemia or hypokalemia)
• an increase in bicarbonate levels in the blood (metabolic alkalosis) or a decrease in bicarbonate levels in the blood (metabolic acidosis)
• abnormally high or low fluid volume in the body (hyper- or hypovolemia)
• abnormally high glucose levels in the blood (hyperglycemia)
• nausea
• vomiting
• muscle cramps
• low blood pressure (hypotension).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prismasol

Keep the medicine out of the sight and reach of children. Do not store below +4°C. Do not use this medicine after the expiry date stated on the label and packaging. The expiry date refers to the last day of the month. The chemical and physical stability of the ready-to-use solution has been demonstrated for 24 hours at +22°C. If not used immediately, the user is responsible for the storage conditions and time before use, and this time should not exceed 24 hours, including the time of the procedure. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Prismasol contains

Active substances:

Before reconstitution/mixing:

1000 ml of the electrolyte solution (small chamber A) contains:

Calcium chloride dihydrate 5.145 g Magnesium chloride hexahydrate 2.033 g Glucose 22.000 g Lactic acid 5.400 g

1000 ml of the buffer solution (large chamber B) contains:

Sodium chloride 6.450 g Sodium bicarbonate 3.090 g Potassium chloride 0.157 g

After reconstitution/mixing:

The solutions in chambers A (250 ml) and B (4750 ml) are mixed to obtain a single ready-to-use solution (5000 ml) consisting of: mmol/l mEq/l Calcium Ca 1.75 3.50 Magnesium Mg 0.50 1.00 Sodium Na 140.00 140.00 Chloride Cl 111.50 111.50 Lactate 3.00 3.00 Bicarbonate HCO 32.00 32.00 Potassium K 2.00 2.00 Glucose 6.10 Theoretical osmolality: 297 mOsm/l Other ingredients of the medicine are: carbon dioxide (E 290), water for injections. The pH of the ready-to-use solution is: 7.0 to 8.5 Prismasol 2 mmol/l Potassium / PL / PL PVC luer connector with valve 4/8

What Prismasol looks like and contents of the packaging

Prismasol is packaged in dual-chamber bags containing the electrolyte solution in the smaller chamber A and the buffer solution in the larger chamber B. The final ready-to-use solution is obtained after breaking the fragile stopper and mixing the two solutions. The ready-to-use solution is clear and slightly yellow. Each bag (A+B) contains 5000 ml of the hemofiltration and hemodialysis solution. The bag is placed in a transparent outer packaging. Each packaging contains two bags and an information leaflet.

Marketing authorization holder and manufacturer:

Vantive Belgium SRL Boulevard d’Angleterre 2 1420 Braine-l’Alleud Belgium

Manufacturer:

Bieffe Medital S.p.A., Via Stelvio 94, 23035 Sondalo (SO), Italy or Vantive Manufacturing Limited, Moneen Road, Castlebar County Mayo F23 XR63 Ireland

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland): Prismasol 2.

Date of last revision of the leaflet: September 2024

-------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Prismasol 2 mmol/l potassium solution for hemodialysis/hemofiltration

Precautions:

Strictly follow the instructions for use/handling of the Prismasol medicinal product. The solutions from both chambers must be mixed before use. The use of a contaminated hemofiltration and hemodialysis solution may cause sepsis, shock, or a life-threatening condition. To increase patient comfort, the Prismasol product can be warmed to a temperature of 37°C. Warming of the solution before use should be done before reconstitution and only using a dry heat source. The solution should not be warmed in water or a microwave oven. Before administration, the solution should be visually inspected for the presence of particulate matter and color change, if the solution and packaging allow. Do not administer the solution if it is not clear or if the weld has been compromised. The solution contains potassium. The potassium concentration in the serum must be monitored before the hemofiltration and/or hemodialysis procedure and during its course. Depending on the potassium concentration in the serum before treatment, hypokalemia or hyperkalemia may develop. If hypokalemia occurs, it may be necessary to add potassium and/or administer a dialysate with a higher potassium concentration. If hyperkalemia occurs after starting treatment, additional sources affecting potassium levels in the blood should be assessed. If the solution is used as a substitution solution, the infusion rate should be reduced and it should be confirmed that the desired potassium concentration has been achieved. If hyperkalemia does not resolve, the infusion should be stopped immediately. If hyperkalemia develops when using the solution as a dialysate, it may be necessary to administer a potassium-free dialysate to increase the rate of potassium removal. Inorganic phosphate levels should be regularly measured. In the case of low phosphate levels in the blood, inorganic phosphates must be supplemented. Phosphates can be added to the solution up to 1.2 mmol/l. When adding potassium phosphate, the total potassium concentration should not exceed 4 mEq/l (4 mmol/l). Although no serious hypersensitivity reactions to corn have been reported with the use of the Prismasol product, solutions containing glucose derived from hydrolyzed corn starch should not be used in patients with a known allergy to corn or corn products. Administration should be stopped immediately if any objective or subjective symptoms of suspected hypersensitivity reaction occur. Appropriate therapeutic measures should be taken, according to clinical judgment. As the solution contains glucose and lactate, hyperglycemia may develop, especially in diabetic patients. Glucose levels in the blood should be regularly monitored. If hyperglycemia develops, it may be necessary to administer a glucose-free substitution solution/dialysate. Other measures may be necessary to maintain the desired blood glucose level. The Prismasol product contains bicarbonate (carbonate) and lactate (a precursor to bicarbonate), which may affect the patient's acid-base balance. If metabolic alkalosis occurs or worsens during treatment with the solution, it may be necessary to reduce the administration rate or discontinue the product. Before and during treatment, the electrolyte concentration and acid-base balance should be closely monitored. In case of fluid imbalance, the patient's clinical condition should be closely monitored and the fluid balance corrected if necessary.

Method of administration:

For intravenous administration and hemodialysis. Prismasol used as a substitution solution is administered to the extracorporeal circuit before the hemofilter (predilution) or after the hemofilter (postdilution).

Dosage:

The volume and rate of administration of the Prismasol solution depend on the patient's blood electrolyte concentration, acid-base balance, and overall clinical condition. The administration parameters (dose, infusion rate, total volume) of the Prismasol product should be determined by the doctor. Prismasol 2 mmol/l Potassium / PL / PL PVC luer connector with valve 6/8 The flow rates for the substitution solution in hemofiltration and hemodiafiltration are: Adults: 500 to 3000 ml/hour. The flow rates for the dialysis solution (dialysate) in continuous hemodialysis and continuous hemodiafiltration are: Adults: 500 to 2500 ml/hour. The most commonly used flow rates in adults are approximately 2000 to 2500 ml/hour, which corresponds to a daily fluid volume of approximately 48 to 60 liters.

Children and Adolescents

The range of flow rates for the substitution solution in hemofiltration and hemodiafiltration and the dialysis solution (dialysate) in continuous hemodialysis is: children (from newborns to adolescents up to 18 years): 1000 to 2000 ml/hour/1.73 m². The required flow rates may be up to 4000 ml/hour/1.73 m², especially in younger children (≤10 kg). The absolute flow rate (in ml/hour) in children and adolescents should not usually exceed the maximum flow rate used in adults.

Instructions for Use:

To obtain a ready-to-use solution, the electrolyte solution (small chamber A) is added to the buffer solution (large chamber B) by breaking the fragile stopper just before use. The solution should only be used with the appropriate equipment for extracorporeal renal replacement therapy. During the procedure and administration of the product to the patient, aseptic technique should be used. Use only if the protective packaging is not damaged, all welds are intact, the fragile stopper is not broken, and the solution is clear. Squeeze the bag firmly to check its integrity. If a leak is detected, the solution should be discarded immediately, as its sterility can no longer be guaranteed. The large chamber B is equipped with an injection port, which, after reconstitution of the solution, allows the addition of other necessary medicinal products. The doctor is responsible for determining the compatibility of additional medicinal products with the Prismasol solution by checking for any change in color and/or precipitation of sediment, insoluble complexes, or crystals. Before adding a medicinal product, check if it is soluble and stable in water with a pH similar to that of the Prismasol solution (the pH of the ready-to-use solution is between 7.0 and 8.5). Additional ingredients may be incompatible. Consult the instructions for the added medicinal product. Remove the fluid from the injection port, hold the bag upside down, inject the medicinal product through the port, and mix carefully. The solution should be administered immediately. Additional ingredients must always be added and mixed before connecting the bag with the solution to the extracorporeal circuit.

I

Remove the outer packaging immediately before use and discard all remaining packaging materials. Open the closure by breaking the fragile stopper located between the two chambers of the bag. The fragile stopper will remain in the bag. (See Figure I below)

II

Make sure that all fluid from the small chamber A has been transferred to the large chamber B. (See Figure II below)

III

Flush the small chamber A twice, expressing the mixed solution back into the small chamber A and then again into the large chamber B. (See Figure III below)

IV

When the small chamber A is empty: shake the large chamber B to mix its contents completely. The solution is now ready for use and the bag can be hung on a stand. (See Figure IV below)

V

A dialysis or exchange line can be connected to each of the two access ports. Prismasol 2 mmol/l Potassium / PL / PL PVC luer connector with valve 7/8

V.a

If a luer-type access is used, remove the cap by twisting and pulling, and then connect the male luer lock of the dialysis or exchange line to the female luer receptor on the bag, tightening and twisting. Ensure the connection is fully seated and secure. The connection is now open. Check if the fluid flows freely. (See Figure V.a below) When the dialysis or exchange lines are disconnected from the luer connection, the connection will be closed and the fluid flow stopped. The luer port is needle-free and can be wiped with disinfectants. V.bIf an injection port is used, first remove the cap by breaking it off. The injection port can be wiped with disinfectants. Then, puncture the rubber septum with a needle. Check if the fluid flows freely. (See Figure V.b below) The solution should be used immediately after removal from the outer packaging. If it is not used immediately, the reconstituted solution should be used within 24 hours, including the time of the procedure after adding the electrolyte solution and buffer solution. The ready-to-use solution is intended for single use only. Discard any unused solution immediately after use. Any unused medicinal product or waste should be disposed of in accordance with local regulations.

Prismasol 2 mmol/l Potassium / PL / PL PVC luer connector with valve 8/8