Prismasol 2 mmol/l potassium, solution for hemodialysis and hemofiltration
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Prismasol 2 mmol/l Potassium solution for hemodialysis and hemofiltration
Calcium chloride dihydrate / Magnesium chloride hexahydrate / Glucose monohydrate / Lactic acid 90% solution / Sodium chloride / Potassium chloride / Sodium hydrogen carbonate
Read the entire leaflet carefully before you start using this medicine, because 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, including any side effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Prismasol is and what it is used for
- What you need to know before using Prismasol
- How to use Prismasol
- Possible side effects
- How to store Prismasol
- Contents of the pack and other information
1. What Prismasol is and what it is used for
Primasol contains the following active substances: calcium chloride dihydrate; magnesium chloride hexahydrate; glucose monohydrate; 90% lactic acid solution; sodium chloride; potassium chloride; and sodium hydrogen carbonate.
Primasol is used in the treatment of renal failure as a solution for continuous hemofiltration or hemodiafiltration (as replacement for fluid lost due to blood passing through the filter) and for continuous hemodialysis or hemodiafiltration (where blood passes on one side of the dialysis membrane while the hemodialysis solution passes on the other side).
Primasol may also be used in cases of intoxication with dialyzable or filterable substances.
Primasol 2 mmol/l potassium is specifically indicated for patients with a tendency towards hyperkalemia (high levels of potassium in the blood).
2. What you need to know before starting to administer Prismasol
Do not use Prismasol 2 mmol/l potassium if:
- you are allergic to any of the active substances or to any of the other components (listed in section 6),
- low level of potassium in the blood (hypokalaemia),
- high concentration of bicarbonate in the blood (metabolic alkalosis).
The presence of corn-derived antigen in Prismasol cannot be ruled out.
Do not use hemofiltration or dialysis treatment if:
- Renal failure with pronounced hypercatabolism (abnormally increased catabolism), when uraemic symptoms (symptoms caused by high concentration of urea in the blood) cannot be corrected by hemofiltration.
- Inadequate blood pressure in the vascular access.
- Systemic anticoagulation (reduced blood clotting) if there is a high risk of haemorrhage (bleeding).
Warnings and precautions
Consult your doctor, pharmacist or nurse before starting to use Prismasol.
The solution may only be used by or under the supervision of a physician experienced in the treatment of renal failure using techniques of hemofiltration, hemodiafiltration, and continuous hemodialysis.
Before and during treatment, your blood status will be monitored; for example, acid-base balance and electrolyte concentrations (salts in the blood) will be followed, as well as all fluids administered (intravenous infusion) and produced (urine output), including those not directly related to the treatment.
Blood glucose concentration 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 have taken any other medicines.
The blood concentration of some other medicines may be reduced during treatment. Your doctor will decide whether your medication needs to be adjusted.
In particular, inform your doctor in the following cases:
-
Digitalis medicines (for the treatment of certain heart failures), as the risk of cardiac arrhythmias (irregular or rapid heartbeats) induced by these medicines increases during hypokalaemia (low potassium levels in the blood).
-
Vitamin D and medicines containing calcium, as they may increase the risk of hypercalcaemia (high calcium levels in the blood).
-
Any sodium hydrogen carbonate supplement (or other buffer source), as this may increase the risk of metabolic alkalosis (excess bicarbonate in the blood).
-
When citrate is used as an anticoagulant (as a protective agent in dialysis equipment), 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, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, your doctor will decide whether Prismasol should be administered to you.
Driving and using machines
There are no data indicating that Prismasol affects the ability to drive or operate machinery.
3. How to use Prismasol
Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The volume of Prismasol to be administered will depend on your clinical condition and the desired fluid balance. Therefore, the dose volume will be determined at the discretion of your doctor.
Route of administration: intravenous and hemodialysis.
If you think you have used more Prismasol than you should:
Your fluid, acid-base, and electrolyte balance must be carefully monitored.
In the unlikely event of an overdose, your doctor will take the necessary corrective measures to adjust the dose.
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 could lead to serious consequences such as congestive heart failure, electrolyte imbalance, or acid-base imbalance.
For instructions on use, refer to the section “This information is 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 adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects have been reported:
Not known: frequency cannot be estimated from available data
-
Changes in blood electrolyte levels (electrolyte imbalances such as hypophosphatemia or hypokalemia)
-
Increased plasma bicarbonate concentration (metabolic alkalosis) or decreased plasma bicarbonate concentration (metabolic acidosis)
-
Abnormally high or low water volume in the body (hyper- or hypovolemia)
-
Abnormally high blood glucose concentration (hyperglycemia)
-
Nausea
-
Vomiting
-
Muscle cramps
-
Hypotension (low blood pressure)
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect not listed in this leaflet.
You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Prismasol
Keep this medicine out of the sight and reach of children.
Do not store at temperatures below +4°C.
Do not use this medicine after the expiry date stated on the label and packaging after EXP. The expiry date refers to the last day of the month indicated.
Chemical and physical stability of the reconstituted solution has been demonstrated for 24 hours at a temperature of +22°C. If the solution is not used immediately, the in-use storage duration and conditions prior to use are the responsibility of the user and must not exceed 24 hours, including the duration of administration.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the package and other information
(PVC FORMAT WITH VALVE)
What PRISMASOL contains
Active substances:
Before reconstitution:
1000 ml of Electrolyte Solution (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 (Large Compartment B) contains:
Sodium chloride 6.450 g
Sodium hydrogen carbonate 3.090 g
Potassium chloride 0.157 g
After reconstitution:
The solution from compartment A (250 ml) and compartment B (4750 ml) is mixed to form a reconstituted solution (5000 ml) with the following composition:
mmol/l | mEq/l | |
Calcium Ca2+ | 1.75 | 3.50 |
Magnesium Mg2+ | 0.50 | 1.00 |
Sodium Na+ | 140.00 | 140.00 |
Chloride Cl- | 111.50 | 111.50 |
Lactate | 3.00 | 3.00 |
Bicarbonate HCO3- | 32.00 | 32.00 |
Potassium K+ | 2.00 | 2.00 |
Glucose | 6.10 | |
Theoretical osmolarity: | 297 mOsm/l |
The other components are: carbon dioxide (E-290), water for injections.
pH of the reconstituted solution: 7.0 – 8.5
Appearance of the product and contents of the container
Prismasol is supplied in a dual-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 seal and mixing both solutions. The reconstituted solution is clear and slightly yellow. Each bag (A+B) contains 5000 ml of solution for hemodialysis and hemofiltration. The bag is enclosed in a transparent overpouch.
Each carton 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 Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Germany, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Slovakia, Slovenia, Estonia, Spain, Finland, France, Greece, Netherlands, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Sweden, United Kingdom (Northern Ireland): Prismasol 2
More information about this medicinal product can be requested from the local representative of the Marketing Authorization Holder:
Vantive Health, S.L.
Polígono industrial sector 14
C/ Pouet de Camilo nº2
46394 Ribarroja del Turia
Valencia
Spain
Date of the most recent revision of this leaflet: 03/2018
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.es
This information is intended for healthcare professionals only
Prismasol 2 mmol/l Potassium solution for hemodialysis and hemofiltration
Precautions
The instructions for use and handling of Prismasol must be strictly followed.
The solutions in the two compartments must be mixed before use.
The use of contaminated hemofiltration and hemodialysis solutions may cause sepsis, shock, and conditions that may lead to death.
Prismasol may be warmed to 37°C to improve patient comfort. Warming of the solution prior to use should only be performed before reconstitution and using dry heat only. Solutions must not be warmed in water or in a microwave. The solution should be visually inspected before administration for the presence of particles and any change in color, whenever the solution and container permit. Do not administer if the solution is not clear or if the seal is not intact.
Prismasol is a potassium-containing solution. Blood potassium concentration must be monitored before and during hemofiltration and/or hemodialysis. Depending on the blood potassium concentration before treatment, hypokalemia or hyperkalemia may develop.
If hypokalemia occurs, potassium supplementation and/or administration of a dialysate with a higher potassium concentration may be necessary.
If hyperkalemia develops during treatment, the addition of potassium sources affecting concentrations should be reassessed. When the solution is used as a replacement solution, the infusion rate should be reduced and confirmation obtained that the desired potassium concentration has been achieved. If hyperkalemia is not resolved, stop the infusion immediately.
If hyperkalemia develops when the solution is used as dialysate, administration of a potassium-free dialysate may be necessary to enhance potassium removal.
Inorganic phosphate concentration should be measured regularly. If blood inorganic phosphate levels are low, they should be corrected. Phosphate may be added to the solution at a concentration of up to 1.2 mmol/l. If potassium phosphate is added, the total potassium concentration should not exceed 4 mEq/l (4 mmol/l).
Although no cases of severe hypersensitivity reactions to corn with Prismasol have been reported, solutions containing glucose derived from hydrolyzed corn starch should not be used in patients with known allergy to corn or corn-derived products.
If signs or symptoms suggestive of a hypersensitivity reaction occur, administration must be stopped immediately. Appropriate corrective therapeutic measures clinically indicated should be initiated.
Due to the glucose and lactate content of the solution, hyperglycemia may occur, especially in diabetic patients. Blood glucose levels should be monitored regularly. If hyperglycemia develops, administration of a dextrose-free replacement or dialysate solution may be necessary. Additional corrective measures may be required to maintain desired glycemic control.
Prismasol contains sodium hydrogen carbonate (bicarbonate) and lactate (a bicarbonate precursor), which may influence acid-base balance. If metabolic alkalosis develops or worsens during treatment with this solution, it may be necessary to reduce or stop the rate of administration.
Close monitoring of electrolyte and acid-base balance should be performed before and throughout the treatment.
In case of fluid imbalance, the clinical condition should be carefully monitored and fluid balance corrected as needed.
Method of administration
Intravenous route and for hemodialysis. Prismasol, when used as a replacement solution, is administered into the circuit before the hemofilter (pre-dilution) or after the hemofilter (post-dilution).
Dosage
The volume and rate of use of Prismasol depend on blood electrolyte concentrations, acid-base balance, and the patient's overall clinical condition. The administration regimen (dose, infusion rate, and cumulative volume) of Prismasol should be determined by a physician.
Flow rates used for replacement solution in hemofiltration and hemodiafiltration are:
Adults: 500 – 3000 ml/hour
Flow rates used for dialysis solution (dialysate) in continuous hemodialysis and continuous hemodiafiltration are:
Adults: 500 – 2500 ml/hour
Typically, flow rates used in adults are approximately 2000 to 2500 ml/h, corresponding to a daily fluid volume of approximately 48 to 60 liters.
Paediatric population
Flow rate ranges for replacement solution in hemofiltration and hemodiafiltration and for dialysis solution (dialysate) in continuous hemodialysis are:
Children (from neonates to adolescents up to 18 years of age): 1000 to 2000 ml/h/1.73 m².
Flow rates of up to 4000 ml/h/1.73 m² may be required, especially in small children (≤10 kg). The absolute flow rate (in ml/h) in the paediatric population should generally not exceed the maximum adult flow rate.
Handling instructions
The electrolyte solution (small compartment A) is added to the buffer solution (large compartment B) after breaking the breakable seal just before use to obtain the reconstituted solution.
Use only with appropriate extracorporeal renal replacement equipment.
Aseptic technique must be maintained throughout the handling and administration process.
Use only if the overpouch is intact, all seals are intact, the breakable seal is not broken, and the solution is clear. Squeeze the bag firmly to ensure there are no leaks. If leaks are observed, discard the solution immediately as sterility cannot be guaranteed.
The large compartment (B) is equipped with an injection port for adding any necessary drugs after reconstitution. It is the physician's responsibility to assess the compatibility of any added drug by checking for potential color change 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 between 7.0 and 8.5). Additives may be incompatible. Refer to the instructions for use of the added medication.
Remove any liquid from the injection port, invert the bag, add the medication through the injection port, and mix thoroughly. The solution must be administered immediately. Introduction and mixing of additives must always be performed before connecting the solution bag to the extracorporeal circuit.
I Remove the overpouch from the bag immediately before use and discard any other packaging materials. Open the seal by breaking the breakable seal located between the two compartments of the bag. The broken seal will remain inside the bag. (See figure I below).
II Ensure that all liquid from the small compartment A passes into the large compartment B. (See figure II below).
III Flush the small compartment A twice by forcing the mixed solution back into this compartment and then back again into the large compartment B. (See figure III below).
IV Once the small compartment A is emptied, shake the large compartment B thoroughly to ensure complete mixing of its contents. The solution is now ready for use and may 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 the luer connector, remove the cap by twisting and pulling, then connect the male luer connector of the dialysis or replacement line to the female luer receptor on the bag by pressing and twisting. Ensure the connection is secure and tight. The connection will open. Check that fluid flows freely. (See figure Va below).
If the dialysis or replacement line is disconnected from the luer connector, the connector will close and solution flow will stop. The luer port is a needle-free port that can be cleaned.
V.b If using the injection access, remove the cap first. The injection port is a disinfectable port. Insert the spike through the rubber wall. Verify that the solution flows freely. (See figure Vb below).
The solution should be used immediately after removal of the overpouch. If not, the reconstituted solution should 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. Immediately discard any unused solution.
Disposal of unused medicinal product and all materials that have been in contact with it must be carried out in accordance with local regulations.
(PVC FORMAT WITH BREAKABLE SEAL)
What PRISMASOL contains
The active substances are:
Before reconstitution:
1000 ml of Electrolyte Solution (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 (large compartment B) contains:
Sodium chloride 6.450 g
Sodium hydrogen carbonate 3.090 g
Potassium chloride 0.157 g
After reconstitution:
The solution from compartment A (250 ml) and compartment B (4750 ml) is mixed to form a reconstituted solution (5000 ml) with the following composition:
mmol/l | mEq/l | |
Calcium Ca2+ | 1.75 | 3.50 |
Magnesium Mg2+ | 0.50 | 1.00 |
Sodium Na+ | 140.00 | 140.00 |
Chloride Cl- | 111.50 | 111.50 |
Lactate | 3.00 | 3.00 |
Bicarbonate HCO3- | 32.00 | 32.00 |
Potassium K+ | 2.00 | 2.00 |
Glucose | 6.10 | |
Theoretical osmolarity: | 297 mOsm/l |
The other components are: carbon dioxide (E-290), water for injections.
pH of the reconstituted solution: 7.0 – 8.5
Appearance of the product and contents of the container
Prismasol is supplied in a dual-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 rod and mixing both solutions. The reconstituted solution is clear and slightly yellowish. Each bag (A+B) contains 5000 ml of solution for hemodialysis and hemofiltration. The bag is enclosed in a transparent overpouch.
Each carton 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:
Germany, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Slovakia, Slovenia, Estonia, Spain, Finland, France, Greece, Netherlands, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Sweden, United Kingdom (Northern Ireland): Prismasol 2
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Vantive Health, S.L.
Polígono industrial sector 14
C/ Pouet de Camilo nº2
46394 Ribarroja del Turia
Valencia
Spain
Date of the most recent revision of this leaflet: 03/2018
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es
This information is intended for healthcare professionals only
Prismasol 2 mmol/l Potassium solution for hemodialysis and hemofiltration
Precautions
The instructions for use and handling of Prismasol must be strictly followed.
The solutions from both compartments must be mixed before use.
The use of contaminated hemofiltration and hemodialysis solutions may cause sepsis, shock, and conditions that may lead to death.
Prismasol may be warmed to 37°C to improve patient comfort. Warming of the solution prior to use should only be performed before reconstitution and using dry heat only. Solutions must not be warmed in water or in a microwave. The solution should be visually inspected prior to administration for the presence of particles and any discoloration, whenever the solution and container permit. Do not administer if the solution is not clear or if the seal is not intact.
Prismasol is a solution containing potassium. Blood potassium concentration must be monitored before and during hemofiltration and hemodialysis. Depending on the blood potassium concentration before treatment, hypokalemia or hyperkalemia may develop.
If hypokalemia occurs, potassium supplementation and/or administration of a dialysate with a higher potassium concentration may be required.
If hyperkalemia develops after treatment initiation, the addition of potassium sources affecting potassium concentrations should be evaluated. When the solution is used as a substitution solution, the infusion rate should be reduced and the desired potassium concentration confirmed. If hyperkalemia is not resolved, stop the infusion immediately.
If hyperkalemia develops when the solution is used as dialysate, administration of a potassium-free dialysate may be necessary to enhance potassium removal.
Inorganic phosphate concentration should be measured regularly. If blood inorganic phosphate levels are low, phosphate should be replenished. A phosphate concentration of up to 1.2 mmol/l may be added to the solution. If potassium phosphate is added, the total potassium concentration should not exceed 4 mEq/l (4 mmol/l).
Although no cases of severe hypersensitivity reactions to corn with Prismasol have been reported, solutions containing glucose derived from hydrolyzed corn starch should not be used in patients with known allergy to corn or corn-derived products.
If signs or symptoms suggestive of a hypersensitivity reaction occur, administration must be stopped immediately. Appropriate corrective therapeutic measures indicated by clinical condition should be initiated.
Due to the glucose and lactate content of the solution, hyperglycemia may occur, especially in diabetic patients. Blood glucose levels should be monitored regularly. If hyperglycemia develops, administration of a dextrose-free substitution or dialysate solution may be necessary. Additional corrective measures may be required to maintain desired glycemic control.
Prismasol contains sodium hydrogen carbonate (bicarbonate) and lactate (a bicarbonate precursor), which may influence acid-base balance. If metabolic alkalosis develops or worsens during treatment with this solution, the infusion rate may need to be reduced or administration stopped.
Close monitoring of electrolyte and acid-base balance must be performed before and during treatment throughout the procedure.
In case of fluid imbalance, the clinical status should be carefully monitored and fluid balance corrected as necessary.
Method of administration
Intravenous route and for hemodialysis. Prismasol, when used as a substitution solution, is administered into the circuit before the hemofilter (pre-dilution) or after the hemofilter (post-dilution).
Dosage
The volume and rate of use of Prismasol depend on blood electrolyte concentrations, acid-base balance, and the patient's overall clinical condition. The administration regimen (dose, infusion rate, and cumulative volume) of Prismasol should be determined by a physician.
Flow rates used for substitution solution in hemofiltration and hemodiafiltration are:
Adults: 500 – 3000 ml/h
Flow rates used for dialysis solution (dialysate) in continuous hemodialysis and continuous hemodiafiltration are:
Adults: 500 – 2500 ml/h
Typically, flow rates used in adults are approximately 2000 to 2500 ml/h, corresponding to a daily fluid volume of approximately 48 to 60 liters.
Paediatric population
Flow rate ranges for substitution solution in hemofiltration and hemodiafiltration and for dialysis solution (dialysate) in continuous hemodialysis are:
Children (from neonates to adolescents up to 18 years of age): 1000 to 2000 ml/h/1.73 m².
Flow rates of up to 4000 ml/h/1.73 m² may be required, especially in small children (≤10 kg). The absolute flow rate (in ml/h) in the paediatric population should generally not exceed the maximum adult flow rate.
Handling instructions
The electrolyte solution (small compartment A) is added to the buffer solution (large compartment B) after breaking the breakable rod immediately before use, to obtain the reconstituted solution.
Use only with appropriate extracorporeal renal replacement equipment.
Aseptic technique must be maintained throughout the handling and administration process.
Use only if the overpouch is intact, all seals are intact, the breakable rod is not broken, and the solution is clear. Squeeze the bag firmly to ensure there are no leaks. If leaks are observed, discard the solution immediately, as sterility cannot be guaranteed.
The large compartment (B) is equipped with an injection port for adding any necessary drugs after reconstitution. It is the physician's responsibility to assess the compatibility of any added drug, checking for potential color change 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 is between 7.0 and 8.5). Additives may be incompatible. Refer to the Instructions for Use of the added medication.
Remove any liquid from the injection port, invert the bag, add the medication through the injection port, and mix thoroughly. The solution should be administered immediately. Introduction and mixing of additives must always be performed before connecting the solution bag to the extracorporeal circuit.
I Remove the overpouch from the bag immediately before use and discard any other packaging materials. Open the seal by breaking the breakable rod located between the two compartments of the bag. The rod will remain inside the bag. (See figure I below).
II Ensure that all liquid from the small compartment A passes into the large compartment B. (See figure II below).
III Flush the small compartment A twice by forcing the mixed solution back into this compartment and then back into the large compartment B. (See figure III below).
IV Once the small compartment A is emptied, shake the large compartment B thoroughly to ensure complete mixing of its contents. The solution is now ready for use and may be hung on the equipment. (See figure IV below).
V The dialysis or substitution line may be connected to either of the two access ports.
V.a If using the luer access, remove the cap and connect the male luer lock connector on the dialysis or substitution line to the female luer receptor on the bag: tighten securely. Using thumb and fingers, break the blue breakable rod at its base and move it back and forth. Do not use tools. Confirm that the rod is completely separated and that the solution flows freely. The rod will remain in the luer access during treatment. (See figure Va below).
V.b If using the injection access, first remove the cap. The injection port is a disinfectable port. Insert the spike through the rubber wall. Confirm that the solution flows freely. (See figure Vb below).
The solution should be used immediately after removal of the overpouch. If not, the reconstituted solution should 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. Immediately discard any unused portion of the solution.
Disposal of unused medicine and all materials that have come into contact with it must be carried out in accordance with local regulations.
(POLYOLEFIN FORMAT WITH VALVE)
What PRISMASOL contains
The active substances are:
Before reconstitution:
1000 ml of Electrolyte Solution (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 (large compartment B) contains:
Sodium chloride 6.450 g
Sodium hydrogen carbonate 3.090 g
Potassium chloride 0.157 g
After reconstitution:
The solution from compartment A (250 ml) and compartment B (4750 ml) are mixed to form a reconstituted solution (5000 ml) with the following composition:
mmol/l | mEq/l | |
Calcium Ca2+ | 1.75 | 3.50 |
Magnesium Mg2+ | 0.50 | 1.00 |
Sodium Na+ | 140.00 | 140.00 |
Chloride Cl- | 111.50 | 111.50 |
Lactate | 3.00 | 3.00 |
Bicarbonate HCO3- | 32.00 | 32.00 |
Potassium K+ | 2.00 | 2.00 |
Glucose | 6.10 | |
Theoretical osmolarity: | 297 mOsm/l |
The other components are: carbon dioxide (E-290), water for injections.
pH of the reconstituted solution: 7.0 – 8.5
Appearance of the product and contents of the pack
Prismasol is supplied in a dual-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 sealed partition and mixing both solutions. The reconstituted solution is clear and slightly yellow. Each bag (A+B) contains 5000 ml of solution for hemodialysis and hemofiltration. The bag is enclosed in a transparent overpouch.
Each carton 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:
Germany, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Slovakia, Slovenia, Estonia, Spain, Finland, France, Greece, Netherlands, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Sweden, United Kingdom (Northern Ireland): Prismasol 2
Further information about this medicinal product may be requested from the local representative of the Marketing Authorization Holder:
Vantive Health, S.L.
Polígono industrial sector 14
C/ Pouet de Camilo nº2
46394 Ribarroja del Turia
Valencia
Spain
Date of latest review of this leaflet: 03/2018
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es
This information is intended for healthcare professionals only
Prismasol 2 mmol/l Potassium solution for hemodialysis and hemofiltration
Precautions
The instructions for use and handling of Prismasol must be strictly followed.
The solutions in the two compartments must be mixed before use.
The use of contaminated hemofiltration and hemodialysis solutions may cause sepsis, shock, and conditions that may lead to death.
Prismasol may be warmed to 37°C to improve patient comfort. Warming of the solution prior to use should be performed before reconstitution and only using dry heat. Solutions must not be heated in water or in a microwave. The solution should be visually inspected before administration for the presence of particles and any possible color change, whenever the solution and container permit. Do not administer if the solution is not clear or if the seal is not intact.
Prismasol is a potassium-containing solution. Blood potassium concentration should be monitored before and during hemofiltration and/or hemodialysis. Depending on the pre-treatment blood potassium concentration, hypokalemia or hyperkalemia may develop.
If hypokalemia occurs, potassium supplementation and/or administration of a dialysate with a higher potassium concentration may be necessary.
If hyperkalemia develops after starting treatment, the addition of potassium sources affecting potassium concentrations should be evaluated. When the solution is used as a replacement solution, the infusion rate should be reduced and confirmation obtained that the desired potassium concentration has been achieved. If hyperkalemia is not resolved, stop the infusion immediately.
If hyperkalemia develops when the solution is used as dialysate, administration of a potassium-free dialysate may be necessary to increase potassium removal.
The concentration of inorganic phosphates should be measured regularly. If blood inorganic phosphate levels are low, phosphate should be replenished. A phosphate concentration of up to 1.2 mmol/l may be added to the solution. If potassium phosphate is added, the total potassium concentration should not exceed 4 mEq/l (4 mmol/l).
Although no cases of severe hypersensitivity reactions to corn with Prismasol have been reported, solutions containing glucose derived from hydrolyzed corn starch should not be used in patients with known allergy to corn or corn-derived products.
If signs or symptoms suggestive of a hypersensitivity reaction develop, administration must be stopped immediately. Appropriate corrective therapeutic measures indicated by the clinical situation should be initiated.
Due to the glucose and lactate content of the solution, hyperglycemia may occur, especially in diabetic patients. Blood glucose levels should be monitored regularly. If hyperglycemia develops, administration of a dextrose-free replacement or dialysate solution may be necessary. Additional corrective measures may be required to maintain desired glycemic control.
Prismasol contains sodium hydrogen carbonate (bicarbonate) and lactate (a bicarbonate precursor), which may influence acid-base balance. If metabolic alkalosis develops or worsens during treatment with the solution, it may be necessary to reduce or stop the administration rate.
Close monitoring of electrolyte and acid-base balance should be maintained before and throughout the treatment.
In case of fluid imbalance, the clinical condition should be carefully monitored and fluid balance corrected as necessary.
Method of administration
Intravenous route and for hemodialysis. Prismasol, when used as a replacement solution, is administered into the circuit before the hemofilter (pre-dilution) or after the hemofilter (post-dilution).
Dosage
The volume and rate of Prismasol use will depend on blood electrolyte concentrations, acid-base balance, and the patient's overall clinical condition. The administration regimen (dose, infusion rate, and cumulative volume) of Prismasol should be determined by a physician.
Flow rates used for replacement solution in hemofiltration and hemodiafiltration are:
Adults: 500 – 3000 ml/h
Flow rates used for dialysis solution (dialysate) in continuous hemodialysis and continuous hemodiafiltration are:
Adults: 500 – 2500 ml/h
Typically, flow rates used in adults are approximately 2000 ml/h to 2500 ml/h, corresponding to a daily fluid volume of approximately 48 to 60 liters.
Paediatric population
Flow rate ranges for replacement solution in hemofiltration and hemodiafiltration and for dialysis solution (dialysate) in continuous hemodialysis are:
Children (from neonates to adolescents up to 18 years of age): 1000 to 2000 ml/h/1.73 m².
Flow rates of up to 4000 ml/h/1.73 m² may be required, especially in small children (≤10 kg). The absolute flow rate (in ml/h) in the paediatric population should generally not exceed the maximum adult flow rate.
Handling instructions
The electrolyte solution (small compartment A) is added to the buffer solution (large compartment B) after breaking the sealed partition immediately before use to obtain the reconstituted solution.
Use only with appropriate extracorporeal renal replacement equipment.
Aseptic technique must be maintained throughout the handling and administration process.
Use only if the overpouch is intact, all seals are undamaged, the sealed partition is not broken, and the solution is clear. Squeeze the bag firmly to ensure there are no leaks. If leaks are observed, discard the solution immediately, as sterility cannot be guaranteed.
The large compartment (B) is equipped with an injection port for adding any necessary medications after reconstitution of the solution. It is the physician's responsibility to assess the compatibility of any added drug by checking for potential color change 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 between 7.0 and 8.5). Additives may be incompatible. Refer to the Instructions for Use of the added medication.
Remove any liquid from the injection port, invert the bag, add the medication through the injection port, and mix thoroughly. The solution should be administered immediately. Introduction and mixing of additives must always be performed before connecting the solution bag to the extracorporeal circuit.
I Remove the overpouch from the bag immediately before use and mixing the solutions from the two compartments. Hold the small compartment with both hands and squeeze until the peelable sealed wall between the two compartments opens. (See figure I below).
II Press the large compartment with both hands until the sealed wall between the two compartments is fully open. (See figure II below).
III Ensure that the solutions are completely mixed by gently agitating the bag. The solution is now ready for use and the bag may be hung on the equipment. (See figure III below).
IV The dialysis or replacement line may be connected to either of the two access ports.
IV.a If using the luer connector, remove the cap by twisting and pulling, then connect the male luer connector of the dialysis or replacement line to the female luer receptor on the bag by pushing and twisting. Ensure the connection is secure and tight. The connection will open. Check that fluid flows freely. (See figure IVa below).
If the dialysis or replacement line is disconnected from the luer connector, the connector will close and solution flow will stop. The luer port is a needle-free port that can be cleaned.
IV.b If using the injection access, first remove the cap. The injection port is a disinfectable port. Insert the spike through the rubber membrane. Verify that the solution flows freely. (See figure IVb below).
The solution should be used immediately after removing the overpouch. If not, the reconstituted solution should 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. Immediately discard any unused solution.
Disposal of unused medicine and all materials that have come into contact with it must be carried out in accordance with local regulations.
