Prismasol

,
or
Vantive Manufacturing Limited
Moneen Road,
Castlebar
County Mayo
F23 XR63
Ireland
This medicinal product is authorised in the European Economic Area Member States 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.

Patient Information Leaflet: Information for the user

Prismasol 2 mmol/l Potassium solution for haemodialysis/haemofiltration

Calcium chloride dihydrate/magnesium chloride hexahydrate/90% p/p lactic acid solution/
glucose monohydrate/sodium chloride/sodium bicarbonate/potassium chloride
Please read this leaflet carefully before starting to use this medicine as it
contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Prismasol is and what it is used for
2. What you need to know 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% p/p lactic acid solution, sodium chloride, potassium chloride, and
sodium bicarbonate.
Prismasol is used in the treatment of renal failure as a solution for continuous hemofiltration
or hemodiafiltration (to replace fluids lost from filtered blood) and for
continuous hemodialysis or hemodiafiltration (blood flows on one side of a dialysis
membrane while a dialysis solution flows on the other side of the membrane).
The Prismasol solution may also be used in cases of poisoning with dialyzable or filterable drugs.
Prismasol 2 mmol/l potassium is particularly indicated for patients who are prone to
hyperkalemia (high concentration of potassium in the blood).

2. What you need to know before using Prismasol

Do not use Prismasol 2 mmol/l potassium if you have:

• hypersensitivity to any of the active substances or to any of the other ingredients (listed in section 6)
• low potassium levels in the blood (hypokalemia)
• high bicarbonate concentration in plasma (metabolic alkalosis)

The presence of maize antigen in Prismasol cannot be excluded.
Do not use hemofiltration/dialysis in the following cases:

• renal failure with marked hypercatabolism (abnormally increased catabolism), when uremic symptoms (symptoms due to high blood urea levels) cannot be corrected by hemofiltration,
• insufficient arterial pressure in the vascular access,
• systemic anticoagulation (reduced blood coagulation), if there is a risk of hemorrhage (bleeding).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Prismasol.
This solution must be used only by, or under the direct supervision of, a physician experienced in treatments for renal failure using hemofiltration, hemodiafiltration, and continuous hemodialysis.
Before and during treatment, your blood parameters will be monitored, for example acid-base balance, and concentrations of electrolytes (blood salts), including all fluids administered (intravenous infusion) and excreted (urine output), even those not directly related to therapy.
Blood glucose levels must be closely monitored, especially if you are diabetic.
Other medicines and Prismasol
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The blood concentration of certain medicines may be reduced during treatment. Your doctor will decide whether your therapy needs adjustment.
In particular, inform your doctor in the following cases:

• Digitalis preparations (used to treat certain heart conditions), since the risk of cardiac arrhythmia (irregular or rapid heartbeat) caused by digitalis increases during hypokalemia (low potassium levels in the blood).
• Vitamin D and medicinal products containing calcium, as they may increase the risk of hypercalcemia (elevated calcium levels in the blood).
• Addition of sodium bicarbonate (or other buffer sources), as they may increase the risk of metabolic alkalosis (excess bicarbonate in the blood).
• When citrate is used as an anticoagulant (as a protective additive in dialysis machines), it may reduce plasma calcium levels.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will decide whether you may use Prismasol during pregnancy or breastfeeding.
Driving and using machines
It is not known whether Prismasol affects the ability to drive or use machinery.

3. How to use Prismasol

Use this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The volume of Prismasol will depend on your clinical condition and the desired fluid balance. Therefore, the dosage volume is at the discretion of the responsible physician.
Route of administration: for intravenous use and for hemodialysis.
If you think you are receiving more Prismasol than you should
Fluid, electrolyte, and acid-base balance will be closely monitored.
In the unlikely event of an overdose, your doctor will take the necessary corrective measures and adjust the dose accordingly.
An overdose may cause:

• fluid overload in the blood,
• increased blood bicarbonate levels (metabolic alkalosis),
• and/or reduced levels of salts in the blood (hypophosphatemia, hypokalemia).
  An overdose may lead to serious consequences such as congestive heart failure, electrolyte or acid-base imbalance.

For instructions on use, see section "The following information is intended only for healthcare professionals."
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

• Changes in blood electrolyte levels (electrolyte imbalances such as hypophosphatemia, hypokalemia)
• Increased plasma bicarbonate concentration (metabolic alkalosis) or reduced plasma bicarbonate concentration (metabolic acidosis)
• Abnormal increase or decrease in body water volume (hyper- or hypovolemia)
• Abnormally increased blood glucose concentration (hyperglycemia)
• Nausea
• Vomiting
• Muscle cramps
• Hypotension (low blood pressure)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse.
You may also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prismasol

Keep this 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.
It has been demonstrated that the reconstituted solution remains physically and chemically stable for 24 hours at +22°C. If not used immediately, the duration and conditions of storage of the reconstituted solution prior to use are the responsibility of the user and should normally not exceed 24 hours, including the treatment period.
Do not dispose of any medicine 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
The active substances are:
Before reconstitution:
1000 ml of electrolyte solution (in small compartment 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 (in large compartment B) contains
sodium chloride 6.450 g
sodium bicarbonate 3.090 g
potassium chloride 0.157 g
After reconstitution:
The solutions in compartments A (250 ml) and B (4750 ml) are mixed to obtain a reconstituted solution (5000 ml) with the following composition:

Excipients: Carbon dioxide (E 290), water for injections
pH of the reconstituted solution: 7.0 – 8.5
Description of the appearance of Prismasol and contents of the pack
Prismasol is supplied in a two-compartment bag, with the small compartment A containing the electrolyte solution and the large compartment B containing the buffer solution. The final reconstituted solution is obtained after breaking the breakable cone and mixing the two solutions.
The reconstituted solution is clear and slightly yellowish. Each bag (A+B) contains 5000 ml of dialysis/hemofiltration solution. The bag is wrapped in a transparent film.
Each pack contains two bags and a package leaflet.
Marketing Authorization Holder:
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 authorized 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 2.

The following information is intended exclusively for healthcare professionals:

Prismasol 2 mmol/l Potassium solution for hemodialysis/hemofiltration
Precautions for use
The instructions for use/handling of Prismasol must be strictly followed.
The two-compartment solution must be mixed before use.
The use of contaminated solutions in hemofiltration and hemodialysis may cause sepsis, shock, and fatal conditions.
Prismasol may be warmed to 37°C to improve patient comfort. Heating of the solution prior to use must be performed before reconstitution and only with dry heat. Solutions must not be heated in water or in a microwave oven. The solution should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Do not administer unless the solution is clear and the seal is intact.
The solution contains potassium. Plasma potassium concentration must be monitored before and during hemofiltration and/or hemodialysis. Depending on the plasma potassium concentration before treatment, hypo- or hyperkalemia may develop.
In case of hypokalemia, potassium supplementation and/or administration of a dialysis solution (dialysate) with a higher potassium concentration may be required.
In case of hyperkalemia after initiation of treatment, additional sources of potassium that may influence plasma potassium concentration should be evaluated. When the solution is used as replacement fluid, reduce the infusion rate and ensure that the desired potassium concentration has been reached. If hyperkalemia does not resolve, discontinue the infusion immediately.
If hyperkalemia develops when the solution is used as dialysate, administration of a potassium-free dialysate may be necessary to increase the rate of potassium removal.
Measure inorganic phosphate concentration regularly. Replace inorganic phosphate in case of low blood phosphate levels. Phosphate may be added to the solution up to 1.2 mmol/l. If potassium phosphate is added, the total potassium concentration must not exceed 4 mEq/l (4 mmol/l).
Although no cases of severe hypersensitivity reactions to maize have been reported with Prismasol, solutions containing glucose derived from hydrolyzed maize starch should not be used in patients with known allergy to maize and its derivatives.
Administration must be discontinued immediately if signs or symptoms of a suspected hypersensitivity reaction occur. Appropriate therapeutic countermeasures should be adopted as clinically indicated.
Since the solution contains glucose and lactate, hyperglycemia may occur, especially in diabetic patients. Blood glucose levels should be monitored regularly. In case of hyperglycemia, administration of glucose-free replacement/dialysis solution may be necessary. Additional corrective measures may be required to maintain desired glycemic control.
Prismasol contains bicarbonate and lactate (a precursor of bicarbonate), which may affect the patient's acid-base balance. If metabolic alkalosis develops or worsens during therapy with this solution, reduction or discontinuation of the infusion rate may be necessary.
Electrolyte and acid-base balance must be closely monitored before and during treatment throughout the entire procedure.
In case of fluid imbalance, monitor the clinical condition carefully and restore fluid balance if necessary.
Route of administration:
For intravenous use and for hemodialysis. When used as replacement solution, Prismasol is administered into the circuit before (pre-dilution) or after (post-dilution) the hemofilter.
Instructions for use:
The electrolyte solution (small compartment A) is added to the buffer solution (large compartment B) after breaking the frangible cone and immediately before use to obtain the reconstituted solution.
Use only with equipment dedicated to extracorporeal renal replacement therapy.
Maintain aseptic techniques throughout the duration of treatment and administration to the patient.
Use only if the outer wrapper is intact, all seals are undamaged, the frangible cone is not broken, and the solution is transparent. Press the bag firmly to check for leaks. If leaks are detected, discard the solution immediately, as sterility can no longer be guaranteed.
Compartment B is equipped with an injection port for the possible addition of other necessary medications after reconstitution of the solution. It is the physician's responsibility to assess the compatibility of any additional drug with Prismasol solution by checking for changes in color and/or precipitation, insoluble complexes, or crystals.
Before adding a drug, verify that it is soluble and stable in water at the pH of Prismasol (the pH of the reconstituted solution ranges from 7.0 to 8.5). Additives may not be compatible. Consult the instructions for use of the drug to be added.
Remove any liquid from the injection port, invert the bag, inject the drug through the injection port, and mix thoroughly. Administer the solution immediately. The addition and mixing of additives must always be performed before connecting the solution bag to the extracorporeal circuit.
I Remove the outer wrapper from the bag immediately before use and discard any other packaging material. Open the seal by breaking the frangible cone between the two compartments of the bag. The frangible cone will remain inside the bag (see figure I below).
II Ensure that all liquid from small compartment A is transferred into large compartment B (see figure II below).
III Rinse small compartment A twice by pressing the mixed solution back into compartment A and then into compartment B (see figure III below).
IV Once small compartment A is emptied: shake large compartment B to ensure complete mixing of the contents. The solution is now ready for use and the bag can be hung on the equipment (see figure IV below).
V The dialysis or replacement line may be connected to either of the two access ports.
V.a If using a luer access, using aseptic technique, remove the cap and connect the male luer lock of the dialysis or replacement line to the female luer connector on the bag, then tighten. Using both hands, break the blue frangible cone at the base and move it back and forth. Do not use any tools. Ensure that the cone has completely separated and that fluid flows freely. During treatment, the cone will remain in the luer port (see figure V.a below).
V.b If using the injection port, first remove the snap-off cap. The injection site is disinfectable. Then insert the spike through the rubber septum. Ensure that fluid flows freely (see figure V.b below).
The solution must be used immediately after removal of the outer wrapper. If not used immediately, the reconstituted solution must be used within 24 hours, including the duration of treatment after addition of the electrolyte solution to the buffer solution.
The reconstituted solution is for single use only. Discard unused solution immediately after use.
Unused medicines or waste material must be disposed of in accordance with local requirements.

Package leaflet: information for the user

Prismasol 2 mmol/l Potassium solution for haemodialysis/haemofiltration

Calcium chloride dihydrate / magnesium chloride hexahydrate / 90% p/p lactic acid solution /
glucose monohydrate / sodium chloride / sodium bicarbonate / potassium chloride
Please read this leaflet carefully before starting to use this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Prismasol is and what it is used for
2. What you need to know 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% p/p lactic acid solution, sodium chloride, potassium chloride and
sodium bicarbonate.
Prismasol is used in the treatment of renal failure as a solution for continuous hemofiltration
or hemodiafiltration (as a replacement for fluids lost from the filtered blood) and for
continuous hemodialysis or hemodiafiltration (blood flows on one side of a dialysis
membrane while a hemodialysis solution flows on the other side of the membrane).
The Prismasol solution may also be used in cases of poisoning with dialyzable or filterable drugs.
Prismasol 2 mmol/l potassium is particularly indicated for patients who are prone to
hyperkalemia (high concentration of potassium in the blood).

2. What you need to know before using Prismasol

Do not use Prismasol 2 mmol/l potassium if:

• you are allergic to one of the active substances or to any of the other components (listed in section 6)
• low potassium levels in the blood (hypokalemia)
• high bicarbonate concentration in plasma (metabolic alkalosis)

The presence of maize antigen in Prismasol cannot be excluded.
Do not use hemofiltration/dialysis in the following cases:

• renal failure with marked hypercatabolism (abnormally increased catabolism), if uremic symptoms (symptoms due to high blood urea concentrations) cannot be corrected by hemofiltration,
• insufficient arterial pressure in the vascular access,
• systemic anticoagulation (reduced blood coagulation), if there is a risk of hemorrhage (bleeding).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Prismasol.
This solution must be used only by, or under the direct supervision of, a physician experienced in treatments for renal failure using hemofiltration, hemodiafiltration, and continuous dialysis.
Before and during treatment, your blood parameters will be monitored, for example, acid-base balance, and your electrolyte concentrations (blood salts) will be checked, including all administered fluids (intravenous infusions) and excreted fluids (urine output), even those not directly related to the therapy.
Blood glucose levels must be closely monitored, especially if you are diabetic.

Other medicines and Prismasol
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
The blood concentration of certain medicines may be reduced during treatment. Your doctor will determine whether your therapy needs to be adjusted.
In particular, inform your doctor in the following cases:

• Digitalis medications (used to treat certain heart conditions), since the risk of digitalis-induced cardiac arrhythmia (irregular or rapid heartbeat) increases during hypokalemia (low potassium levels in the blood).
• Vitamin D and medicinal products containing calcium, as they may increase the risk of hypercalcemia (high calcium levels in the blood).
• Addition of sodium bicarbonate (or other buffer sources), as they may increase the risk of metabolic alkalosis (excess bicarbonate in the blood).
• When citrate is used as an anticoagulant (as a protective additive in dialysis machines), it may reduce plasma calcium levels.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will decide whether you can use Prismasol during pregnancy or breastfeeding.

Driving and using machines
It is not known that Prismasol affects the ability to drive or use machinery.

3. How to use Prismasol

Use this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The volume of Prismasol will depend on your clinical condition and the desired fluid balance. Therefore, the dosage volume is at the discretion of the responsible physician.
Route of administration: for intravenous use and for hemodialysis.
If you think you are receiving more Prismasol than you should
Fluid, electrolyte, and acid-base balance will be closely monitored.
In the unlikely event of an overdose, the doctor will take the necessary corrective measures and adjust the dose accordingly.
Overdose may cause:

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

For instructions on use, see section "The following information is intended only for healthcare professionals".
If you have any questions about the use of this medicine, consult 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:
Not known: frequency cannot be estimated from the available data

• Changes in blood electrolyte levels (electrolyte imbalances such as hypophosphatemia, hypokalemia)
• Increased plasma bicarbonate concentration (metabolic alkalosis) or reduced plasma bicarbonate concentration (metabolic acidosis)
• Abnormal increase or decrease in body water volume (hyper- or hypovolemia)
• Abnormally increased blood glucose concentration (hyperglycemia)
• Nausea
• Vomiting
• Muscle cramps
• Hypotension (low blood pressure)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse.
You may also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prismasol

Keep this 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 on the
packaging. The expiry date refers to the last day of the month.
It has been demonstrated that, at +22°C, the reconstituted solution maintains its physico-chemical stability
for 24 hours. If not used immediately, the storage conditions and duration of the reconstituted solution prior to use are the responsibility of the user and should normally not exceed 24 hours, including the treatment period.
Do not dispose of any medicine via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Package contents and other information

What Prismasol contains
The active substances are:
Before reconstitution:
1000 ml of electrolyte solution (in small compartment 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 (in large compartment B) contains
Sodium chloride 6.450 g
Sodium bicarbonate 3.090 g
Potassium chloride 0.157 g
After reconstitution:
The solutions in compartments A (250 ml) and B (4750 ml) are mixed to obtain a reconstituted solution (5000 ml) with the following composition:

The excipients are: Carbon dioxide (E 290), water for injections
pH of the reconstituted solution: 7.0 – 8.5
Description of the appearance of Prismasol and contents of the pack
Prismasol is supplied in a two-compartment bag, containing in compartment A (small) the electrolyte solution, and in compartment B (large) the buffer solution. The final reconstituted solution is obtained after breaking the breakable cone and mixing the two solutions.
The reconstituted solution is clear, slightly yellowish. Each bag (A+B) contains 5000 ml of dialysis/hemofiltration solution. The bag is wrapped in a transparent film.
Each pack contains two bags and a package leaflet.
Marketing Authorization Holder:
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 authorized in the European Economic Area Member States 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.

The following information is intended exclusively for healthcare professionals:

Prismasol 2 mmol/l Potassium solution for hemodialysis/hemofiltration
Precautions for use
Instructions for use/handling of Prismasol must be followed meticulously.
The dual-compartment solution must be mixed before use.
The use of contaminated solutions in hemofiltration and hemodialysis may cause sepsis, shock, and fatal conditions.
Prismasol may be warmed to 37 °C to improve patient comfort. Heating of the solution prior to use must only be performed with dry heat and before reconstitution. Solutions must not be heated in water or in a microwave oven. The solution should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Do not administer unless the solution is clear and the seal is intact.
The solution contains potassium. Plasma potassium concentration must be monitored before and during hemofiltration and/or hemodialysis. Depending on the plasma potassium concentration prior to treatment, hypo- or hyperkalemia may develop.
In case of hypokalemia, potassium supplementation and/or administration of a dialysis solution (dialysate) with a higher potassium concentration may be necessary.
In case of hyperkalemia after initiation of treatment, additional sources of potassium that may influence plasma concentration should be evaluated. When the solution is used as replacement fluid, reduce the infusion rate and ensure that the desired potassium concentration has been achieved. If hyperkalemia does not resolve, discontinue infusion immediately.
If hyperkalemia develops when the solution is used as dialysate, administration of a potassium-free dialysate may be required to increase the rate of potassium removal.
Measure inorganic phosphate concentration regularly. Replace inorganic phosphate in case of low blood phosphate levels. Phosphate may be added to the solution up to 1.2 mmol/l. If potassium phosphate is added, the total potassium concentration must not exceed 4 mEq/l (4 mmol/l).
Although no cases of severe hypersensitivity reactions to maize have been reported with Prismasol, solutions containing glucose derived from hydrolyzed maize starch must not be used in patients with known allergy to maize and its derivatives.
Administration must be discontinued immediately if signs or symptoms of a suspected hypersensitivity reaction occur. Appropriate therapeutic countermeasures should be adopted as clinically indicated.
Since the solution contains glucose and lactate, hyperglycemia may occur, especially in diabetic patients. Blood glucose levels should be monitored regularly. In case of hyperglycemia, administration of glucose-free replacement/dialysis solution may be necessary. Other corrective measures may be required to maintain desired glycemic control.
Prismasol contains bicarbonate and lactate (a precursor of bicarbonate), which may affect the patient's acid-base balance. If metabolic alkalosis develops or worsens during therapy with this solution, it may be necessary to reduce the administration rate or discontinue administration.
Electrolyte and acid-base balance must be closely monitored before and during treatment throughout the entire procedure.
In case of fluid imbalance, monitor the clinical condition carefully and restore fluid balance as necessary.

Route of administration:
For intravenous use and for hemodialysis. When used as replacement solution, Prismasol is administered into the circuit either before (pre-dilution) or after (post-dilution) the hemofilter.

Instructions for use:
The electrolyte solution (small compartment A) is added to the buffer solution (large compartment B) by breaking the frangible cone immediately before use to obtain the reconstituted solution.
Use only with equipment dedicated to extracorporeal renal support therapy.
Maintain aseptic techniques throughout the duration of treatment and administration to the patient.
Use only if the outer wrapper is intact, all seals are undamaged, the frangible cone is unbroken, and the solution is transparent. Press the bag firmly to check for leaks. If leaks are detected, discard the solution immediately, as sterility cannot be guaranteed.
Compartment B is equipped with an injection port for the addition of other necessary medications after reconstitution of the solution. It is the physician’s responsibility to assess compatibility of any additive with Prismasol solution by checking for changes in color and/or precipitation, insoluble complexes, or crystals.
Before adding a medication, verify that it is soluble and stable in water at the pH of Prismasol (the pH of the reconstituted solution ranges from 7.0 to 8.5). Additives may not be compatible. Consult the instructions for use of the medication to be added.
Remove any liquid from the injection port, invert the bag, insert the drug through the injection port, and mix thoroughly. Administer the solution immediately. Introduction and mixing of additives must always be performed before connecting the solution bag to the extracorporeal circuit.

I Remove the outer wrapper from the bag immediately before use and discard any other packaging materials. Open the seal by breaking the frangible cone between the two compartments of the bag. The frangible cone will remain inside the bag (see figure I below).

II Ensure that all liquid from small compartment A is transferred into large compartment B (see figure II below).

III Rinse small compartment A twice by pressing the mixed solution back into compartment A and then into compartment B (see figure III below).

IV Once small compartment A is emptied: shake large compartment B thoroughly to ensure complete mixing. The solution is now ready for use and the bag can be hung on the equipment (see figure IV below).

V The dialysis or replacement line can be connected to either of the two access ports.

V.a If using a luer access, remove the cap with a twisting and pulling motion and connect the male luer lock of the dialysis or replacement line to the female luer connector on the bag with a twisting and pulling motion. Ensure the connection is correct and secure. The connector is now open. Verify that fluid flows freely (see figure V.a below).
When the dialysis or replacement line is disconnected from the luer connector, the connector closes and solution flow stops. The luer port is a needle-free, cleanable port.

V.b If using the injection port, first remove the snap-off cap. The injection port is disinfectable. Then insert the spike through the rubber septum. Verify that fluid flows freely (see figure V.b below).

The solution must be used immediately after removal of the outer wrapper. If not used immediately, the reconstituted solution must be used within 24 hours, including the duration of treatment after adding the electrolyte solution to the buffer solution.
The reconstituted solution is for single use only. Discard unused solution immediately after use.
Unused medicines or waste material must be disposed of in accordance with local requirements.

o
Vantive Manufacturing Limited
Moneen Road,
Castlebar
County Mayo
F23 XR63
Ireland
This medicinal product is authorised in the European Economic Area and 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.

o
Vantive Manufacturing Limited
Moneen Road,
Castlebar
County Mayo
F23 XR63
Ireland
This medicinal product is authorised in the European Economic Area Member States 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.

o
Vantive Manufacturing Limited
Moneen Road,
Castlebar
County Mayo
F23 XR63
Ireland
This medicinal product is authorised in the European Economic Area Member States 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.