What it is and what it is used for

FOR

Prismasol is not known to affect the ability to drive or use machines.

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

What you need to know before you take it

E PRISMASOL

Overdose may result in:

• allergy to one of the active substances or any of the other ingredients (listed in section 6),
• a high concentration of potassium in your blood (hyperkalaemia),
• a high concentration of bicarbonate in the blood (metabolic alkalosis). Presence of corn antigen in Prismasol cannot be excluded.

• fluid overload in your blood,
• elevation of the bicarbonate blood level (metabolic alkalosis),
• and/or reduction of levels of salts in the blood (hypophosphataemia, hypokalaemia). Overdose could lead to severe consequences, such as congestive heart failure, electrolyte or acidbase disturbances.

Do not use haemofiltration/ dialysis in the following cases:

For instructions for use, please see section "The following information is intended for healthcare professionals only".

Do not use Prismasol 4 mmol/l Potassium in case of:

• Renal failure with pronounced hypercatabolism (abnormally increased catabolism), if the uraemic symptoms (symptoms caused by high concentration of urea in your blood) cannot be corrected with haemofiltration,
• Insufficient arterial pressure in the vascular access,
• Systemic anticoagulation (reduced clotting of your blood), if there is a high risk of haemorrhage (bleeding).

If you have any further questions on the use of this medicine, please ask your doctor, pharmacist or nurse.

How to take it

PRISMASOL

Prismasol is used in the treatment of renal failure as a solution for continuous haemofiltration or haemodiafiltration (as a replacement for fluid lost from the blood passing through a filter) and continuous haemodialysis or haemodiafiltration (the blood flows on one side of a dialysis membrane while a haemodialysis solution flows on the other side of the membrane).

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Prismasol solution may also be used in case of drug poisoning with dialysable or filterable substances.

Administration route: Intravenous use and for haemodialysis.

The volume of Prismasol used will depend on your clinical condition and the target fluid balance. The dose volume is therefore at the discretion of the responsible doctor. If you think you use more Prismasol than you should

Prismasol 4 mmol/l Potassium is indicated particularly in patients who are normokalaemic (a normal concentration of potassium in the blood).

Your fluid balance, electrolyte and acid-base balance will be carefully monitored. In the unlikely event that an overdose occurs, your doctor will take necessary corrective measures and adjust your dose.

Possible side effects

Warnings and precautions

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

Talk to your doctor, pharmacist or nurse before using Prismasol.

The following side effects have been reported:

The solution should be used only by, or under the direction of a doctor competent in renal failure treatments using haemofiltration, haemodiafiltration and continuous haemodialysis.

Not known: frequency cannot be estimated from the available data

• Changes of levels of salts in the blood (electrolyte imbalances such as hypophosphataemia)
• Elevation of the plasma bicarbonate concentration (metabolic alkalosis) or reduction of the plasma bicarbonate concentration (metabolic acidosis)
• Abnormally high or low volume of water in the body (hyper or hypovolaemia)
• Abnormally high concentration of glucose in the blood (hyperglycaemia)
• Nausea
• Vomiting
• Muscle cramps
• Hypotension (low blood pressure)
• Hypercalcaemia (a high concentration of calcium in your blood).

Before and during treatment, your blood condition will be checked, e.g. your acid-base balance and concentrations of electrolytes (salts in the blood) will be monitored, including all fluid you are given (intravenous infusion) and that you produce (urine production), even those not directly related to the therapy. Your blood glucose concentration should be closely monitored, especially if you are diabetic. Other medicines and Prismasol Tell your doctor or pharmacist if you are given, have recently been given or might be given any other medicines.

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Reporting of side effects

What Prismasol looks like and contents of the pack

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Prismasol is presented in a twocompartment bag containing in the smaller compartment A, the electrolyte solution, and in the larger compartment B, the buffer solution. The final reconstituted solution is obtained after breaking the peel seal and mixing both solutions. The reconstituted solution is clear and slightly yellow. Each bag (A+B) contains 5000 ml solution for haemofiltration and haemodialysis. The bag is overwrapped with a transparent film.

You can also report side effects directly via: Yellow Card Scheme www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

Each box contains two bags and a package leaflet. Marketing Authorisation Holder: Vantive Limited, Wavertree Technology Park, 2 Wavertree Boulevard, Liverpool, L7 9PE, United Kingdom

How to store it

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 which is stated on the label and the packaging. The expiry date refers to the last day of that month.

Manufacturer:

Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 22° C. If not used immediately in-use storage times and conditions prior to use are the responsibility of the user and shall not be longer than 24 hours including the duration of the treatment.

Vantive Manufacturing Limited Moneen Road, Castlebar, County Mayo F23 XR63 Ireland This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungaria, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland): Prismasol 4.

What Prismasol contains The active substances are: Before reconstitution: 1000 ml of electrolyte solution (from the small compartment (A)) contains Calcium chloride dihydrate Magnesium chloride hexahydrate Glucose (S)-Lactic acid

This leaflet was last revised in 01/2026

5.145 g 2.033 g 22.000 g 5.400 g

1000 ml of buffer solution (from the large compartment (B)) contains Sodium chloride Sodium hydrogen carbonate Potassium chloride

6.450 g 3.090 g 0.314 g

After reconstitution: The solutions in the compartments A (250 ml) and B (4750 ml) are mixed to give one reconstituted solution (5000 ml) of which the composition is: mmol/l

mEq/l

Calcium Magnesium Sodium

Ca2+ Mg2+ Na+

1.75 0.50 140.00

3.50 1.00 140.00

Chloride Lactate

Cl-

113.50 3.00

113.50 3.00

Hydrogen carbonate Potassium Glucose

HCO3K+

32.00 4.00 6.10

32.00 4.00

Theoretical Osmolarity: 301 mOsm/l The other ingredients are: carbon dioxide (E 290), water for injections pH of the reconstituted solution: 7.0-8.5 03172

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UK The following information is intended for healthcare professionals only Prismasol 4 mmol/l Potassium Solution for haemodialysis/ haemofiltration Precautions:

Commonly used flow rates in adults are approximately 2000 to 2500 ml/h which correspond to a daily fluid volume of approximately 48 to 60 L. Paediatric population The range of flow rates for the substitution solution in haemofiltration and haemodiafiltration and for the dialysis solution (dialysate) in continuous haemodialysis are: Children (from neonates to adolescents to 18 years): 1000 to 2000 ml/h/1.73m2. Flow rates up to 4000 mL/h/1.73 m2 may be needed, especially in younger children (≤10 kg). The absolute flow rate (in mL/h) in the paediatric population should generally not exceed the maximum adult flow rate.

The instructions for use/handling for Prismasol must be strictly followed. The solutions in the two compartments must be mixed before use. Use of contaminated haemofiltration and haemodialysis solution may cause sepsis, shock and fatal conditions. Prismasol may be warmed to 37°C to enhance patient comfort. Warming of the solution prior to use should be done before reconstitution with dry heat only. Solutions should 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 is a potassium-containing solution. The solution should not be used in patients with hyperkalaemia. The serum potassium concentration must be monitored before and during haemofiltration and/or haemodialysis. If hyperkalaemia occurs after treatment is initiated, additional sources of potassium influencing blood concentrations should be assessed. When the solution is used as a replacement solution, decrease the infusion rate and confirm that the desired potassium concentration is achieved. If hyperkalaemia does not resolve, stop the infusion promptly. If hyperkalaemia develops when the solution is used as a dialysate, administration of a potassiumfree dialysate may be necessary to increase the rate of potassium removal. The inorganic phosphate concentration should be measured regularly. Inorganic phosphate must be substituted in cases of low level of phosphate in the blood. Phosphate up to 1.2 mmol/L may be added to the solution. Use sodium phosphate if adding phosphate to the bag. Despite no cases of severe corn hypersensitivity reactions being reported with Prismasol, solutions containing glucose derived from hydrolysed maize starch should not be used in patients with a known allergy to maize or maize products. The administration must be stopped immediately if any signs or symptoms of a suspected hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Because the solution contains glucose and lactate, hyperglycaemia may develop, especially in diabetic patients. Blood glucose levels should be monitored regularly. If hyperglycaemia develops, administration of dextrose-free replacement solution/dialysate may be necessary. Other corrective measures may be needed to maintain desired glycaemic control. Prismasol contains hydrogen carbonate (bicarbonate), and lactate (a hydrogen carbonate precursor) which can influence the patient's acid-base balance. If metabolic alkalosis develops or worsens during therapy with the solution, the administration rate may need to be decreased, or the administration stopped. Before and during treatment, electrolyte and acid-base balance should be closely monitored throughout the procedure. In case of fluid imbalance, the clinical situation must be carefully monitored and fluid balance should be corrected as needed.

Instructions for handling: The electrolyte solution (small compartment A) is added to the buffer solution (large compartment B) after opening the peel seal immediately before use to obtain the reconstituted solution. Use only with appropriate extracorporeal renal replacement equipment. Aseptic technique should be used throughout the handling and administration to the patient. Use only if the overwrap is undamaged, all seals are intact, peel seal is not broken and the solution is clear. Press bag firmly to test for any leakage. If leakage is discovered, discard the solution immediately since sterility can no longer be assured. The large compartment B is fitted with an injection port for the possible addition of other necessary drugs after reconstitution of the solution. It is the responsibility of the physician to judge the compatibility of an additive medication with the Prismasol solution by checking for eventual colour change and/ or eventual precipitation, insoluble complexes or crystals. Before adding a medication, verify if it is soluble and stable in water at the pH of Prismasol (pH of reconstituted solutions is 7.0 to 8.5). Additives may be incompatible. The Instructions for Use of the medication to be added must be consulted. Remove any fluid from the injection port, hold the bag upside down, insert the drug through the injection port and mix thoroughly. The solution must be administered immediately. The introduction and mixing of additives must always be performed prior to connecting the solution bag to the extracorporeal circuit. I. Immediately before use remove the overwrap from the bag and mix the solutions in the two different compartments. Hold the small compartment with both hands and squeeze it until an opening is created in the peel seal between the two compartments. (See figure I below) II. Push with both hands on the large compartment until the peel seal between the two compartments is entirely open. (See figure II below) III. Secure complete mixing of the solution by shaking the bag gently. The solution is now ready for use, and can 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 the luer access is used, remove the cap with a twist and pull motion, and connect the male luer lock on the dialysis or replacement line to the female luer receptor on the bag using a push and twist motion. Ensure that the connection is fully seated and tighten. The connector is now open. Verify that the fluid is flowing freely. (See figure IV.a below). When the dialysis or replacement line is disconnected from the luer connector, the connector will close and the flow of the solution will stop. The luer port is a needle-less and swabbable port. IV.b If the injection port is used, first remove the snap-off cap. The injection port is a swabbable port. Then introduce the spike through the rubber septum. Verify that the fluid is flowing freely. (See figure IV.b below) The solution should be used immediately after removal of the overwrap. If not used immediately, the reconstituted solution should be used within 24 hours, including the duration of the treatment after addition of the electrolyte solution to the buffer solution. The reconstituted 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 requirements.

Method of administration: Intravenous use and for haemodialysis. Prismasol, when used as a substitution solution is administered into the circuit before (pre-dilution) or after the haemofilter (postdilution). Posology: The volume and rate at which Prismasol is used will depend on the blood concentration of electrolytes, acid-base balance, and overall clinical condition of the patient. Administration (dose, infusion rate and cumulative volume) of Prismasol should be established by a physician. Flow rates for the substitution solution in haemofiltration and haemodiafiltration are: Adults 500 – 3000 mL/h Flow rates for the dialysis solution (dialysate) in continuous haemodialysis and continuous haemodiafiltration are: Adults 500 – 2500 mL/h

I

II

III

IV.a

IV.b

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Vantive and Prismasol are trademarks of Vantive Health LLC or its affiliates

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