Prismasol

Package leaflet: Information for the user

Prismasol 4 mmol/l potassium
Solution for haemodialysis/haemofiltration
Calcium chloride dihydrate / magnesium chloride hexahydrate / glucose monohydrate / lactic acid 90% w/w / sodium chloride / potassium chloride / sodium bicarbonate
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Prismasol is and what it is used for
2. Important information before using Prismasol
3. How to use Prismasol
4. Possible side effects
5. How to store Prismasol
6. Contents of the pack and other information

1. What Prismasol is and what it is used for

Prismasol contains the active substances: calcium chloride dihydrate, magnesium chloride hexahydrate, glucose monohydrate, lactic acid 90% w/w, sodium chloride, potassium chloride, sodium bicarbonate.
Prismasol is used in the treatment of renal failure as a solution for continuous haemofiltration or haemodiafiltration (as a replacement fluid for blood fluid lost during passage through the filter), and for continuous haemodialysis or haemodiafiltration (blood flows on one side of the dialysis membrane, while the haemodialysis solution flows on the other side of the membrane).
Prismasol may also be used in cases of poisoning with drugs that are dialysable or filterable.
Prismasol 4 mmol/l potassium is indicated for patients with normal blood potassium levels.

2. Important information before using Prismasol

Do not use Prismasol 4 mmol/l potassium solution if:

• you are allergic to any of the active substances or to any of the other ingredients of this medicine (listed in section 6),
• you have high blood potassium levels (hyperkalaemia),
• you have high blood bicarbonate levels (metabolic alkalosis).

The presence of corn antigen in Prismasol solution cannot be ruled out.
Hemofiltration/dialysis must not be used in the following cases:

• renal failure with marked hypercatabolism (abnormal increase in catabolism) when symptoms of uraemia (symptoms caused by high blood urea levels) cannot be alleviated by hemofiltration;

Prismasol 4 mmol/l Potassium / PL / PL Polyolefin luer connector with valve 1/8

• inadequate arterial pressure in the vascular access,
• systemic anticoagulation (reduced blood clotting) with risk of bleeding.

Warnings and precautions
Before starting treatment with Prismasol solution, consult a doctor, pharmacist, or nurse.
This solution should be used only under the supervision of a physician experienced in the treatment of renal failure using hemofiltration, hemodiafiltration, and continuous hemodialysis.
Before and during treatment, your blood will be tested, for example, to monitor acid-base balance and electrolyte levels (blood salts), including fluids administered (intravenous infusions) and those produced by the body (urine production), even if not directly related to therapy.
Blood glucose levels must be closely monitored, especially if the patient has diabetes.

Prismasol and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Blood levels of other medicines may be reduced during treatment. Your doctor will decide whether any changes to your medication are necessary.
In particular, inform your doctor if you are taking the following medicines:

• cardiac glycosides (used in the treatment of certain heart conditions), as they increase the risk of cardiac arrhythmias (irregular or rapid heartbeat) during hypokalaemia (low blood potassium levels),
• vitamin D and calcium-containing medicines, as they may increase the risk of hypercalcaemia (high blood calcium levels),
• any additional sodium bicarbonate (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 plasma calcium levels.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, you should consult your doctor or pharmacist before using this medicine.
Your doctor will decide whether to administer Prismasol solution to pregnant or breastfeeding women.

Driving and operating machinery
It is unknown whether Prismasol affects the ability to drive or operate machinery.

3. How to use Prismasol

This medicine should always be used according to the instructions given by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
The volume of Prismasol solution used depends on the patient's clinical condition and the desired fluid balance.
Therefore, the decision on the volume of the dose is made by the physician responsible for treatment.
Route of administration: for intravenous and hemodialysis use.
Prismasol 4 mmol/l Potassium / PL / PL Polyolefin luer connector with valve 2/8
Use of a higher than recommended dose of Prismasol
The patient will be closely monitored for fluid balance, electrolyte and acid-base balance.
In the unlikely event of overdose, the doctor will take necessary corrective measures and adjust the patient's dose.
Overdose may lead to:

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

Instructions for use are provided in the section "Information intended exclusively for medical professionals".
If there are any further doubts regarding the use of this medicine, consult the doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported:
Frequency unknown: frequency cannot be determined from the available data

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.
Prismasol 4 mmol/l Potassium / PL / PL Polyolefin luer connector with valve 3/8

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 stated month.
Chemical and physical in-use stability has been demonstrated for the ready-to-use solution for 24 hours at +22°C. If not used immediately, the responsibility for storage conditions and duration prior to use lies with the user, and the total storage time should not exceed 24 hours, including administration time.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the package 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
(S)-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 0.314 g
After reconstitution/mixing:
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 113.50 113.50
Lactate 3.00 3.00
Bicarbonate HCO₃ 32.00 32.00
Potassium K 4.00 4.00
Glucose 6.10
Theoretical osmolarity: 301 mOsm/l
Other components of the medicinal product are: carbon dioxide (E 290), water for injections.
The pH of the ready-to-use solution is: 7.0 to 8.5
Prismasol 4 mmol/l Potassium / PL / PL Polyolefin luer connector with valve 4/8
What Prismasol looks like and contents of the pack
Prismasol is packed in dual-chamber bags containing in the smaller chamber A an electrolyte solution, and in the larger chamber B a buffer solution. The final ready-to-use solution is obtained by breaking the peelable seal and mixing both 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 pack contains two bags and a package leaflet.
Marketing Authorisation 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 medicinal product is authorised in 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 4.

Information intended exclusively for healthcare professionals:

Prismasol 4 mmol/l potassium solution for hemodialysis/hemofiltration
Precautions:
Strictly follow the instructions for use/handling of the medicinal product Prismasol.
Solutions from both chambers must be mixed before use.
Administration of a contaminated solution for hemofiltration and hemodialysis may lead to
sepsis, shock, or life-threatening conditions.
To increase patient comfort, the medicinal product Prismasol may be warmed to 37°C.
Warming the solution prior to use should be performed before reconstitution and only using a
dry heat source. Do not warm solutions in water or microwave oven. Prior to
administration, visually inspect the solution for presence of particulate matter and discoloration, if the solution and packaging permit. Do not administer if the solution is not
clear or if the seal is compromised.
This solution contains potassium. The solution must not be used in patients with hyperkalemia. Serum potassium concentration must be monitored before and during hemofiltration and/or hemodialysis.
If hyperkalemia develops after initiation of treatment, additional sources affecting blood potassium concentration should be evaluated. If the solution is used as a replacement fluid, reduce the infusion rate and confirm that the desired potassium concentration has been achieved. If hyperkalemia persists, infusion must be discontinued immediately.
If hyperkalemia occurs during use of the solution as dialysate, administration of potassium-free dialysate may be necessary to increase the rate of potassium removal.
Serum inorganic phosphate concentration should be monitored regularly. In cases of low serum phosphate concentration, inorganic phosphates must be supplemented. Phosphates may be added to the solution up to 1.2 mmol/l. In case of adding phosphate to the bag, sodium phosphate should be used.
Although no severe hypersensitivity reactions related to corn have been reported with use of the medicinal product Prismasol, solutions containing glucose derived from hydrolyzed corn starch should not be administered to patients with confirmed allergy to corn or corn products.
Administration must be discontinued immediately if any objective or subjective symptoms of suspected hypersensitivity reaction occur. Appropriate therapeutic countermeasures should be applied according to clinical indication.
Since the solution contains glucose and lactate, hyperglycemia may develop, especially in patients with diabetes. Blood glucose concentration should be monitored regularly. If hyperglycemia develops, administration of glucose-free replacement/dialysis solution may be necessary. Additional measures may be required to maintain desired glycemic levels.
The medicinal product Prismasol contains bicarbonate (carbonate) and lactate (a bicarbonate precursor), which may affect the patient's acid-base balance. If metabolic alkalosis develops or worsens during treatment with this solution, it may be necessary to reduce or interrupt administration of the medicinal product.
Serum electrolyte concentrations and acid-base balance must be closely monitored before and during treatment.
In case of fluid imbalance, the patient's clinical condition should be carefully monitored and fluid balance corrected as needed.
Route of administration:
For intravenous and hemodialysis use. Prismasol used as a replacement solution is administered pre-hemofilter (predilution) or post-hemofilter (postdilution).
Dosage:
The volume and rate of administration of Prismasol solution depend on serum electrolyte concentrations, acid-base balance, and the patient's overall clinical condition. The parameters of administration (dose, infusion rate, total volume) of Prismasol should be determined by a physician.
Flow rates for replacement solution in hemofiltration and hemodiafiltration are:
Adults: 500 to 3000 ml/hour.
Flow rates for dialysis solution (dialysate) in continuous hemodialysis and continuous hemodiafiltration are:
Adults: 500 to 2500 ml/hour.
Most commonly used flow rates in adults are approximately 2000 to 2500 ml/hour, corresponding to a daily fluid volume of approximately 48 to 60 liters.
Children and adolescents
Flow rate range for replacement solution in hemofiltration and hemodiafiltration and for dialysis solution (dialysate) in continuous hemodialysis is:
Children (from newborns to adolescents up to 18 years): 1000 to 2000 ml/hour/1.73 m².
Required flow rates may reach up to 4000 ml/hour/1.73 m², especially in younger children (≤10 kg). Absolute flow rate (in ml/hour) in children and adolescents generally should not exceed the maximum flow rate used in adults.
Handling instructions:
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 breakable seal immediately before use.
Use only with appropriate extracorporeal renal replacement equipment.
Aseptic technique must be used during handling and administration of the product to the patient.
Use only if the protective packaging is intact, all seals are undamaged, the breakable seal is not damaged, and the solution is clear. Squeeze the bag firmly to check for leakage. If leakage is detected, the solution must be discarded immediately, as sterility can no longer be assured.
Large chamber B is equipped with an injection port, which after reconstitution allows addition of other necessary medicinal products. The physician is responsible for determining compatibility of additional medicinal products with Prismasol solution by checking for color change and/or precipitation of insoluble complexes or crystals.
Before adding a medicinal product, verify that it is soluble and stable in water at a pH similar to that of Prismasol solution (pH of ready-to-use solution ranges from 7.0 to 8.5). Additional components may be incompatible. Refer to the instructions for use of the added medicinal product.
Remove fluid from the injection port, hold the bag upside down, inject the medicinal product through the port, and mix thoroughly. The solution should be administered promptly. Additional components must always be added and mixed before connecting the solution bag to the extracorporeal circuit.
I Remove the outer packaging immediately before use and mix the solutions from the two chambers. Hold the small chamber with both hands and squeeze until an opening forms in the breakable seal separating the two chambers. (See Figure I below)
II Press the large chamber with both hands until the breakable seal between the two chambers is fully opened. (See Figure II below)
III Ensure thorough mixing by gently agitating the bag. The solution is now ready for use and the bag can be hung on an IV pole. (See Figure III below)
IV Dialysis or replacement lines can be connected to each of the two access ports.
IV.a If using a luer-type access, remove the cap by twisting and pulling, then connect the male luer lock end of the dialysis or replacement line to the female luer receptor on the bag by pushing and twisting. Ensure the connection is fully seated and secure. The port is now open. Check that fluid flows freely. (See Figure IV.a below)
When dialysis or replacement lines are disconnected from the luer connector, the connection will close and fluid flow will stop. The luer-type port is needle-free and can be wiped with disinfectants.
IV.b If using the 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 spike. Check that fluid flows freely. (See Figure IV.b below)
The solution should be used promptly after removal of the outer packaging. If not used immediately, the reconstituted solution should be used within 24 hours, including the duration of the procedure after adding the electrolyte and buffer solutions.
The ready-to-use solution is for single use only. Discard any unused solution immediately after use.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

Prismasol 4 mmol/l Potassium / PL / PL Polyolefin luer connector with valve 8/8

Package leaflet: information for the user

Prismasol 4 mmol/l potassium
Solution for hemodialysis/hemofiltration
Calcium chloride dihydrate / magnesium chloride hexahydrate / monohydrate glucose / 90% w/w lactic acid solution / sodium chloride / potassium chloride / sodium bicarbonate
Please read this leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Prismasol is and what it is used for
2. Important information before using Prismasol
3. How to use Prismasol
4. Possible side effects
5. How to store Prismasol
6. Contents of the pack and other information

1. What Prismasol is and what it is used for

Prismasol contains the following active substances: calcium chloride dihydrate, magnesium chloride hexahydrate, glucose monohydrate, 90% w/w lactic acid solution, sodium chloride, potassium chloride, sodium hydrogen carbonate.
Prismasol is used in the treatment of kidney failure as a solution for continuous hemofiltration or hemodiafiltration (as a replacement fluid for loss of blood fluid passing through the filter), and for continuous hemodialysis or hemodiafiltration (blood flows on one side of the dialysis membrane, while the hemodialysis solution flows on the other side of the membrane).
Prismasol may also be used in cases of poisoning with drugs containing substances that are dialyzable or filterable.
Prismasol 4 mmol/l potassium is indicated for patients with normal blood potassium levels.

2. Important information before using Prismasol

Do not use Prismasol 4 mmol/l potassium solution if:

• you are allergic to one of the active substances or any of the other ingredients of this medicine (listed in section 6),
• you have high levels of potassium in your blood (hyperkalaemia),
• you have high levels of bicarbonate in your blood (metabolic alkalosis).

The presence of corn antigen in Prismasol solution cannot be excluded.
Do not perform haemofiltration/dialysis in the following cases:

• renal failure with marked hypercatabolism (abnormal increase in catabolism), when symptoms of uraemia (symptoms caused by high levels of urea in the blood) cannot be relieved by haemofiltration;

Prismasol 4 mmol/l Potassium / PL / PL PVC luer connector with pin 1/8

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

Warnings and precautions
Before starting treatment with Prismasol solution, consult a doctor, pharmacist or nurse.
The solution should be used exclusively by or under the supervision of a physician experienced in the treatment of renal failure using haemofiltration, haemodiafiltration and continuous haemodialysis.
Before and during treatment, your blood will be tested, for example, to monitor acid-base balance and electrolyte levels (salts in the blood), including fluids administered (intravenous infusions) and those produced by the body (urine production), even if not directly related to therapy.
Blood glucose levels should be closely monitored, especially if the patient has diabetes.
Prismasol and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken or plan to take.
Blood levels of other medicines may be reduced during treatment. Your doctor will decide whether adjustment of your medication is necessary.
In particular, inform your doctor if you are taking the following medicines:

• cardiac glycosides (used in the treatment of certain heart conditions), as they increase the risk of cardiac arrhythmias (irregular or rapid heartbeat) during hypokalaemia (low potassium levels in the blood);
• vitamin D and calcium-containing medicines, as they may increase the risk of hypercalcaemia (high calcium levels in the blood);
• any additional sodium bicarbonate (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 serum calcium levels.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant or are planning to become pregnant, you should consult your doctor or pharmacist before using this medicine.
Your doctor will decide whether to administer Prismasol solution to pregnant or breastfeeding women.
Driving and operating machinery
It is unknown whether Prismasol affects the ability to drive or operate machinery.

3. How to use Prismasol

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
The volume of Prismasol solution used depends on the patient's clinical condition and the desired
fluid balance. Therefore, the decision on the volume of dose is made by the treating physician.
Route of administration: for intravenous and hemodialysis use.
Prismasol 4 mmol/l Potassium / PL / PL PVC luer connector with pin 2/8
Use of a higher than recommended dose of Prismasol

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

• fluid overload in the patient's blood,
• increased bicarbonate concentration in blood (metabolic alkalosis),
• and (or) decreased salt concentration in blood (hypophosphatemia, hypokalemia). Overdose may result in serious consequences such as congestive heart failure, disturbances in electrolyte or acid-base balance.

Instructions for use are provided in the section "Information intended exclusively for healthcare professionals".
If you have any further doubts regarding the use of this medicine, consult a physician, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been reported:
Frequency unknown: frequency cannot be estimated from the available data

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Prismasol 4 mmol/l Potassium / PL / PL PVC luer connector with pin 3/8

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 stated month.
Chemical and physical in-use stability has been demonstrated for the ready-to-use solution for 24 hours at +22°C. If not used immediately, the responsibility for storage conditions and duration prior to use lies with the user, and this time should not exceed 24 hours, including administration time.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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
(S)-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 0.314 g
After reconstitution/mixing:
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 113.50 113.50
Lactate 3.00 3.00
Bicarbonate HCO₃ 32.00 32.00
Potassium K 4.00 4.00
Glucose 6.10
Theoretical osmolarity: 301 mOsm/l
Other components of the medicinal product are: carbon dioxide (E 290), water for injections.
pH of the ready-to-use solution: 7.0 to 8.5
Prismasol 4 mmol/l Potassium / PL / PL PVC luer connector with pin 4/8
What Prismasol looks like and contents of the pack
Prismasol is packed in dual-chamber bags containing in the smaller chamber A an electrolyte solution, and in the larger chamber B a buffer solution. The final ready-to-use solution is obtained after breaking the frangible seal and mixing both 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 pack contains two bags and a patient information leaflet.
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area and in Great Britain (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 4.

Information intended exclusively for medical professionals:

Prismasol 4 mmol/l potassium solution for hemodialysis/hemofiltration
Precautions:
Strictly follow the instructions for use/handling of the medicinal product Prismasol.
Solutions from both chambers must be mixed before use.
Administration of a contaminated solution for hemofiltration and hemodialysis may lead to
sepsis, shock, or life-threatening conditions.
To increase patient comfort, the medicinal product Prismasol may be warmed to 37°C.
Heating the solution prior to use must be performed before reconstitution and only using a
dry heat source. Solutions must not be heated in water or in a microwave oven. Prior to
Prismasol 4 mmol/l Potassium / PL / PL PVC luer connector with pin 5/8
administration, visually inspect the solution for the presence of particulate matter and discoloration, if the solution and packaging permit. Do not administer the solution if it is not clear or if the seal is compromised.
This solution contains potassium. It must not be used in patients with hyperkalemia. Serum potassium concentration must be monitored before and during hemofiltration and/or hemodialysis.
If hyperkalemia occurs after initiation of treatment, additional sources affecting blood potassium levels should be evaluated. If the solution is used as a substitution fluid, the infusion rate should be reduced and it must be confirmed that the desired potassium concentration has been achieved. If hyperkalemia persists, infusion must be discontinued immediately.
If hyperkalemia develops when the solution is used as a dialysate, administration of a potassium-free dialysate may be necessary to increase the rate of potassium removal.
Serum inorganic phosphate levels should be measured regularly. In cases of low serum phosphate levels, inorganic phosphates must be supplemented. Phosphates may be added to the solution up to 1.2 mmol/l. When adding phosphate to the bag, sodium phosphate should be used.
Although no severe hypersensitivity reactions to corn have been reported with the use of Prismasol, solutions containing glucose derived from hydrolyzed corn starch should not be administered to patients with confirmed allergy to corn or corn products.
Administration must be discontinued immediately if any objective or subjective symptoms suggestive of a hypersensitivity reaction occur. Appropriate therapeutic countermeasures should be taken according to clinical indication.
Since the solution contains glucose and lactate, hyperglycemia may develop, especially in diabetic patients. Blood glucose levels should be monitored regularly. If hyperglycemia develops, administration of a glucose-free substitution/dialysis solution may be necessary. Other countermeasures may be required to maintain desired glycemic levels.
The medicinal product Prismasol contains bicarbonate (carbonate) and lactate (a precursor of bicarbonate), which may affect the patient's acid-base balance. If metabolic alkalosis occurs or worsens during treatment with this solution, it may be necessary to reduce or suspend administration of the medicinal product.
Serum electrolyte levels and acid-base balance must be closely monitored before and during treatment.
In case of fluid imbalance, the patient's clinical status should be carefully monitored and fluid balance corrected as needed.
Route of administration:
For intravenous and hemodialysis use. Prismasol used as a substitution solution is administered into the circuit before the hemofilter (predilution) or after the hemofilter (postdilution).
Dosage:
The volume and rate of administration of Prismasol solution depend on serum electrolyte concentrations, acid-base balance, and the patient's overall clinical condition. The parameters of administration (dose, infusion rate, total volume) should be determined by a physician.
Prismasol 4 mmol/l Potassium / PL / PL PVC luer connector with pin 6/8
Flow rates for substitution solution in hemofiltration and hemodiafiltration are:
Adults: 500 to 3000 ml/hour.
Flow rates for 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, corresponding to a daily fluid volume of approximately 48 to 60 liters.
Children and adolescents
The flow rate range for substitution solution in hemofiltration and hemodiafiltration and for dialysis solution (dialysate) in continuous hemodialysis is:
children (from newborns to adolescents up to 18 years): 1000 to 2000 ml/hour/1.73 m².
Required flow rates may reach up to 4000 ml/hour/1.73 m², especially in younger children (≤10 kg). Absolute flow rate (in ml/hour) in children and adolescents generally should not 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 breakable seal immediately before use.
Only use with appropriate equipment for extracorporeal renal replacement therapy.
Aseptic technique must be used during handling and administration of the product to the patient.
Use only if the protective packaging is undamaged, all seals are intact, the breakable seal is not broken, and the solution is clear. Squeeze the bag firmly to check for leaks. If leakage is detected, discard the solution immediately, as sterility can no longer be assured.
The large chamber B is equipped with an injection port, which allows addition of other necessary medicinal products after reconstitution of the solution. The physician is responsible for verifying compatibility of additional medicinal products with Prismasol solution by checking for color change and/or precipitation of insoluble complexes or crystals.
Before adding a medicinal product, verify that it is soluble and stable in water at a pH similar to that of Prismasol solution (the pH of the ready-to-use solution ranges from 7.0 to 8.5). Additional components may be incompatible. Refer to the instructions for use of the added medicinal product.
Remove fluid from the injection port, hold the bag upside down, inject the medicinal product through the port, and mix thoroughly. The solution should be administered immediately. Additional components must always be added and mixed before connecting the solution bag to the extracorporeal circuit.
I Remove the outer packaging immediately before use and discard all other packaging materials. Open the closure by breaking the breakable seal located between the two chambers of the bag. The breakable seal will remain in the bag. (See Figure I below)
II Ensure that all fluid from small chamber A has been transferred to large chamber B. (See Figure II below)
III Rinse small chamber A twice by squeezing the mixed solution back into small chamber A and then back into large chamber B. (See Figure III below)
IV When small chamber A is empty: shake large chamber B thoroughly to ensure complete mixing of its contents. The solution is now ready for use and the bag may be hung on an IV pole. (See Figure IV below)
Prismasol 4 mmol/l Potassium / PL / PL PVC luer connector with pin 7/8
V Each of the two access ports may be connected to a dialysis or replacement line.
V.a If using a luer-type access, remove the plug and connect the male luer lock end of the dialysis or replacement line to the female luer receptor on the bag: tighten securely. Using thumb and fingers, break the blue breakable seal at the base and move it back and forth. Do not use tools. Ensure the seal has completely detached and fluid flows freely. The seal will remain in the luer port during therapy. (See Figure V.a below)
V.b If using the injection port, first remove the plug by breaking it off. The injection port may be wiped with disinfectants. Then puncture the rubber septum with a needle. Check that fluid flows freely. (See Figure V.b below)
The solution should be used immediately after removal of the outer packaging. If not used immediately, the reconstituted solution must be used within 24 hours, including the duration of the procedure after adding the electrolyte and buffer solutions.
The ready-to-use solution is for single use only. Discard any unused solution immediately after use.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.

Prismasol 4 mmol/l Potassium / PL / PL PVC luer connector with pin 8/8

Package leaflet: information for the user

Prismasol 4 mmol/l potassium
Solution for hemodialysis/hemofiltration
Calcium chloride dihydrate / magnesium chloride hexahydrate / glucose monohydrate / lactic acid 90% w/w / sodium chloride / potassium chloride / sodium bicarbonate
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Prismasol is and what it is used for
2. Important information before using Prismasol
3. How to use Prismasol
4. Possible side effects
5. How to store Prismasol
6. Contents of the pack and other information

1. What Prismasol is and what it is used for

Prismasol contains the following active substances: calcium chloride dihydrate, magnesium chloride hexahydrate, glucose monohydrate, lactic acid 90% w/w solution, sodium chloride, potassium chloride, sodium hydrogen carbonate.
Prismasol is used in the treatment of kidney failure as a solution for continuous hemofiltration or hemodiafiltration (as a replacement solution for fluid loss from blood passing through the filter), and for continuous hemodialysis or hemodiafiltration (blood flows on one side of the dialysis membrane, while the hemodialysis solution flows on the other side of the membrane).
Prismasol may also be used in cases of poisoning with drugs containing substances that are dialyzable or filterable.
Prismasol 4 mmol/l potassium is indicated for patients with normal blood potassium concentration.

2. Important information before using Prismasol medicine

Do not use Prismasol 4 mmol/l potassium solution if:

• you are allergic to any of the active substances or to any of the other ingredients of this medicine (listed in section 6),
• you have high blood potassium levels (hyperkalaemia),
• you have high blood bicarbonate levels (metabolic alkalosis).

The presence of corn antigen in Prismasol solution cannot be ruled out.
Hemofiltration/dialysis must not be used in the following cases:

• renal failure with marked hypercatabolism (abnormal increase in catabolism) when symptoms of uraemia (symptoms caused by high blood urea levels) cannot be relieved by hemofiltration;

Prismasol 4 mmol/l Potassium / PL / PL PVC luer connector with valve 1/8

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

Warnings and precautions
Before starting treatment with Prismasol solution, consult your doctor, pharmacist, or nurse.
The solution should be used exclusively by or under the supervision of a physician qualified in the treatment of renal failure using hemofiltration, hemodiafiltration, and continuous hemodialysis.
Before starting treatment and during its course, your blood will be tested, for example, to monitor acid-base balance and electrolyte levels (salts in the blood), including fluids administered (intravenous infusions) and those produced by the body (urine production), even if not directly related to therapy.
Blood glucose levels should be closely monitored, especially if the patient has diabetes.

Prismasol and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The blood levels of other medicines you are taking may be reduced during treatment. Your doctor will decide whether adjustment of your medication is necessary.
In particular, inform your doctor if you are taking the following medicines:

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

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Your doctor will decide whether to administer Prismasol solution to women who are pregnant or breastfeeding.

Driving and operating machinery
It is unknown whether Prismasol affects the ability to drive or operate machinery.

3. How to use Prismasol

This medicine should always be used as directed by the physician or pharmacist. If in doubt,
consult the physician or pharmacist.
The volume of Prismasol solution used depends on the patient's clinical condition and the desired
fluid balance. Therefore, the decision on the volume of dose is made by the physician responsible for treatment.
Route of administration: for intravenous and hemodialysis use.
Prismasol 4 mmol/l Potassium / PL / PL PVC luer connector with valve 2/8
Use of a higher than recommended dose of Prismasol
The patient will be closely monitored for fluid balance, electrolyte and acid-base balance.
In the unlikely event of overdose, the physician will take necessary corrective measures and adjust the patient's dose.
Overdose may lead to:

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

Instructions for use are provided in the section "Information intended exclusively for medical professionals".
If there are any further doubts regarding the use of this medicine, consult the physician, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported:
Frequency unknown: frequency cannot be estimated from the available data

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in the package leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Prismasol 4 mmol/l Potassium / PL / PL PVC luer connector with valve 3/8

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 stated month.
Chemical and physical in-use stability has been demonstrated for the ready-to-use solution for 24 hours at +22°C. If not used immediately, the responsibility for storage conditions and duration prior to use lies with the user, and this period should not exceed 24 hours, including administration time.
Medicines must 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 pack 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
(S)-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 0.314 g
After reconstitution/mixing:
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 113.50 113.50
Lactate 3.00 3.00
Bicarbonate HCO₃ 32.00 32.00
Potassium K 4.00 4.00
Glucose 6.10
Theoretical osmolarity: 301 mOsm/l
Other components of the medicinal product are: carbon dioxide (E 290), water for injections.
The pH of the ready-to-use solution is: 7.0 to 8.5
Prismasol 4 mmol/l Potassium / PL / PL PVC luer connector with valve 4/8
What Prismasol looks like and contents of the pack
Prismasol is packed in dual-chamber bags containing in the smaller chamber A an electrolyte solution, and in the larger chamber B – a buffer solution. The final ready-to-use solution is obtained after breaking the frangible seal and mixing both 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 pack contains two bags and a patient information leaflet.
Marketing Authorisation 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 medicinal product is authorised in 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 4.

Information intended exclusively for medical professionals:

Prismasol 4 mmol/l potassium solution for hemodialysis/hemofiltration
Precautions:
Strictly follow the instructions for use/handling of the medicinal product Prismasol.
Solutions from both chambers must be mixed before use.
Administration of a contaminated solution for hemofiltration and hemodialysis may lead to
sepsis, shock, or life-threatening conditions.
To increase patient comfort, the medicinal product Prismasol may be warmed to 37°C.
Warming the solution prior to use must be performed before reconstitution and only using
a dry heat source. Do not warm solutions in water or a microwave oven. Prior to
administration, visually inspect the solution for the presence of particulate matter and discoloration, if the solution and packaging allow. Do not administer the solution if it is not
clear or if the seal has been compromised.
This solution contains potassium. The solution must not be used in patients with hyperkalemia. Serum potassium concentration must be monitored before and during hemofiltration and/or hemodialysis.
If hyperkalemia occurs after initiation of treatment, additional sources affecting blood potassium levels should be evaluated. If the solution is used as a substitution fluid, reduce the infusion rate and confirm that the desired potassium concentration has been achieved. If hyperkalemia persists, discontinue infusion immediately.
If hyperkalemia develops when using the solution as dialysate, it may be necessary to administer potassium-free dialysate to increase the rate of potassium removal.
Serum inorganic phosphate levels should be regularly monitored. In cases of low serum phosphate levels, inorganic phosphates must be supplemented. Phosphates may be added to the solution up to 1.2 mmol/l. When adding phosphate to the bag, use sodium phosphate.
Although no severe hypersensitivity reactions related to corn have been reported with the use of Prismasol, glucose-containing solutions derived from hydrolyzed corn starch should not be administered to patients with confirmed allergy to corn or corn products.
Immediately discontinue administration if any objective or subjective symptoms suggestive of hypersensitivity occur. Appropriate therapeutic measures should be taken according to clinical indication.
Since the solution contains glucose and lactate, hyperglycemia may develop, especially in diabetic patients. Blood glucose levels should be monitored regularly. If hyperglycemia occurs, administration of glucose-free substitution/dialysis solution may be necessary. Additional measures may be required to maintain desired glycemic levels.
The medicinal product Prismasol contains bicarbonate (carbonate) and lactate (a precursor of bicarbonate), which may affect the patient's acid-base balance. If metabolic alkalosis occurs or worsens during treatment with this solution, it may be necessary to reduce or temporarily stop administration of the medicinal product.
Serum electrolyte concentrations and acid-base balance must be closely monitored before and during treatment.
In case of fluid imbalance, the patient's clinical condition should be carefully monitored and fluid balance corrected as needed.

Route of administration:
For intravenous use and hemodialysis. Prismasol used as substitution fluid is administered pre-hemofilter (predilution) or post-hemofilter (postdilution).

Dosage:
The volume and rate of administration of Prismasol solution depend on blood electrolyte concentrations, acid-base balance, and the patient's overall clinical condition. The parameters of administration (dose, infusion rate, total volume) should be determined by a physician.

Flow rates for substitution fluid in hemofiltration and hemodiafiltration:
Adults: 500 to 3000 ml/hour.

Flow rates for dialysis solution (dialysate) in continuous hemodialysis and continuous hemodiafiltration:
Adults: 500 to 2500 ml/hour.

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

Children and adolescents
Flow rate range for substitution fluid in hemofiltration and hemodiafiltration and for dialysis solution (dialysate) in continuous hemodialysis:
Children (from neonates up to adolescents under 18 years): 1000 to 2000 ml/hour/1.73 m².
Required flow rates may reach up to 4000 ml/hour/1.73 m², especially in younger children (≤10 kg). Absolute flow rate (in ml/hour) in children and adolescents generally should not exceed the maximum flow rate used in adults.

Handling instructions:
To obtain the ready-to-use solution, the electrolyte solution (small chamber A) is added to the buffer solution (large chamber B) by breaking the frangible seal immediately before use.
Use only with appropriate equipment for extracorporeal renal replacement therapy.
Maintain aseptic technique during handling and administration to the patient.
Use only if the protective packaging is intact, all seals are undamaged, the frangible seal is not broken, and the solution is clear. Squeeze the bag firmly to check for leaks. If leakage is detected, discard the solution immediately, as sterility can no longer be assured.

Large chamber B is equipped with an injection port, allowing addition of other necessary medicinal products after reconstitution. The physician is responsible for verifying compatibility of additional medicinal products with Prismasol solution by checking for color change and/or precipitation of insoluble complexes or crystals. Before adding a medicinal product, verify that it is soluble and stable in water at the pH of Prismasol solution (the pH of the ready-to-use solution ranges from 7.0 to 8.5). Additional components may be incompatible. Refer to the instructions for use of the added medicinal product.

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

I Remove the outer packaging immediately before use and discard all other packaging materials. Open the closure by breaking the frangible seal located between the two chambers of the bag. The frangible seal will remain inside the bag. (See Figure I below)
II Ensure that all fluid from small chamber A has been transferred into large chamber B. (See Figure II below)
III Rinse small chamber A twice by squeezing the mixed solution back into small chamber A, then back into large chamber B. (See Figure III below)
IV When small chamber A is empty: shake large chamber B thoroughly to ensure complete mixing of its contents. The solution is now ready for use and the bag may be hung on an IV pole. (See Figure IV below)
V Each of the two access ports may be connected to a dialysis or replacement line.
V.a If using a luer-type connector, remove the cap by twisting and pulling, then connect the male luer-lock end of the dialysis or replacement line to the female luer receptor on the bag by pushing and twisting. Ensure the connection is fully seated and secure. The connector is now open. Check that fluid flows freely. (See Figure V.a below)
When the dialysis or replacement lines are disconnected from the luer connector, the connection will close automatically and fluid flow will stop. The luer port is needle-free and may be wiped with disinfectants.
V.b If using the injection port, first remove the cap by snapping it off. The injection port may be wiped with disinfectants. Then puncture the rubber septum with a needle. Check that fluid flows freely. (See Figure V.b below)

The solution should be used immediately after removal of the outer packaging. If not used immediately, the reconstituted solution should be used within 24 hours, including the duration of the procedure after adding the electrolyte and buffer solutions.
The ready-to-use solution is intended for single use only. Discard any unused solution immediately after use.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.