Prismasol B0

Electrolyte solution: Calcium chloride dihydrate, Magnesium chloride hexahydrate, lactic acid. Buffer solution: Sodium bicarbonate, sodium chloride.

Prismasol B0 consists of a two-compartment polyolefin bag containing the electrolyte solution in the small compartment (compartment A) and the buffer solution in the large compartment (compartment B).
Before reconstitution: 1000 ml of electrolyte solution (small compartment A) contains: active substances: Calcium chloride, 2H₂O 5.145 g; Magnesium chloride, 6H₂O 2.033 g; Lactic acid 5.4 g.
1000 ml of buffer solution (large compartment B) contains: active substances: Sodium bicarbonate 3.09 g, Sodium chloride 6.45 g.
After reconstitution: The small and the large compartments are mixed to give one reconstituted solution whose ionic composition is: see Table 1.

Click on icon to see table/diagram/image

Theoretical Osmolarity: 287 mOsm/l.
Excipients/Inactive Ingredients: In the small compartment A: Water for injections.
In the large compartment B: Water for injections, Carbon dioxide.

Pharmacotherapeutic Group: Hemofiltrates. ATC Code: B05ZB.
Pharmacology: Pharmacodynamics: Mechanism of Action: The solution is used to replace water and electrolytes removed during haemofiltration or to serve as a suitable exchange medium for use during haemodiafiltration or continuous haemodialysis. Hydrogen carbonate is used as an alkalising buffer.
Pharmacodynamic Effects: Prismasol B0 is pharmacologically inactive. The sodium, calcium, magnesium and chloride ions are present at concentrations similar to physiological levels in plasma.
Pharmacokinetics: Not relevant. The active ingredients are pharmacologically inactive and are present at concentrations similar to physiological plasma levels.
Toxicology: Preclinical Safety Data: Not relevant. The active ingredients are pharmacologically inactive and are present at concentrations similar to physiological plasma levels.

As substitution solution in continuous haemofiltration and continuous haemodiafiltration and as a dialysis solution in continuous haemodialysis and continuous haemodiafiltration.

Posology: The rate at which Prismasol B0 is administered depends on the blood concentration of electrolytes, acid-base balance, fluid balance and overall clinical condition of the patient. The volume of replacement solution and/or dialysate to be administered will also depend on the desired intensity (dose) of the treatment. The solution should be prescribed and administration (dose, infusion rate, and cumulative volume) should be established only by a physician experienced in critical care medicine and CRRT (Continuous Renal Replacement Therapy).
Commonly used flow rates for the substitution solution in haemofiltration and haemodiafiltration are: Adult: 500 - 3000 mL/hour.
Commonly used flow rates for the dialysis solution (dialysate) in continuous haemodialysis are: Adult: 500 - 2500 mL/hour.
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.
Special population: Elderly population: Evidence from clinical studies and experience suggests that use in the elderly population is not associated with differences in safety or effectiveness.
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/1.73 m².
Flow rates up to 4,000 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.
Method of administration: Intravenous use and for haemodialysis.
Prismasol B0, when used as a substitution solution is administered into the extracorporeal circuit before (pre-dilution) or after the haemofilter or haemodiafilter (post-dilution).
For instructions on reconstitution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.

Overdose with Prismasol B0 substitution fluid should not occur if the procedure is carried out correctly and the fluid balance, electrolyte and acid-base balance of the patient are carefully monitored.
However, overdose could lead to severe consequences, such as congestive heart failure, electrolyte or acid-base disturbances.
If hypervolaemia or hypovolaemia occur, this should be corrected immediately. If electrolyte imbalance and acid-base balance abnormalities (e.g., metabolic alkalosis, hypophosphataemia, hypokalaemia, etc.) occur, stop administration promptly. There is no specific antidote for overdose. The risk can be minimized by close monitoring and adequate supplementation during treatment (see Precautions).

Hypersensitivity to the active substances or to any of the excipients listed in Description.

The substitution solution Prismasol B0 is potassium-free. The serum potassium concentration must be monitored before and during hemofiltration and/or hemodialysis.
The electrolyte solution must be mixed with the buffer solution before use to obtain the final solution suitable for haemofiltration/haemodiafiltration/continuous haemodialysis.
Use only with appropriate extracorporeal renal replacement equipment.
Because the solution contains no glucose, administration may lead to hypoglycemia. Blood glucose levels should be monitored regularly.
Prismasol B0 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.
The use of contaminated haemofiltration solution may cause sepsis, shock and fatal conditions.

Prismasol B0 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.
Before and during treatment, electrolyte and acid-base balance should be closely monitored throughout the procedure.
Phosphate 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). Potassium supplement might be necessary.
The patient's hemodynamic status and fluid balance should be monitored throughout the procedure and corrected as needed.
Effects on ability to drive and use machines: Not relevant.
Fertility: There are no clinical data on fertility. However no effects on fertility are anticipated.
Use in Children: There are no specific warnings and precautions when using this medicine for children.

No effects during pregnancy or on the breast-fed newborn/infant are anticipated. There is no report on Prismasol B0 during pregnancy or lactation but literature on renal replacement therapy during acute kidney injury does not suggest risks associated with solutions. The prescriber should consider the benefit/risk relationship before administering Prismasol B0 to pregnant or breast feeding women.

The following undesirable effects are reported from post-marketing experience. The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies: Not known (cannot be estimated from the available data). (See Table 2.)

Click on icon to see table/diagram/image

Special attention must be taken for patients with hypokalaemia as this solution is potassium-free (see Precautions).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the relevant national reporting system.

The blood concentration of filterable/dialysable drugs may be reduced during treatment. Corresponding corrective therapy should be instituted if necessary to establish the desired blood concentrations for drugs removed during treatment.
Interactions with other medications due to electrolyte and/or acid-base imbalances can be avoided by correct dosage of the solution for haemodialysis/haemofiltration and precise monitoring.
However, the following interactions are conceivable: The risk of digitalis-induced cardiac arrhythmia is increased during hypokalaemia.
Vitamin D and vitamin D analogues, as well as medicinal products containing calcium (e.g. calcium chloride or calcium gluconate used for maintenance of calcium homeostasis, in CRRT patients receiving citrate anticoagulation and calcium carbonate as phosphate binder) can increase the risk of hypercalcaemia.
Additional sodium hydrogen carbonate (or other buffer source) contained in the CRRT fluids or in other fluids administered during therapy may increase the risk of metabolic alkalosis.
When citrate is used as an anticoagulant, it contributes to the overall buffer load and can reduce plasma calcium levels.

Special precautions for disposal and other 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.
A patient information leaflet with instruction for use is enclosed in the box.
Aseptic technique should be used throughout the handling and administration to the patient.
Use only if the overwrap is not damaged, 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 is fitted with an injection port for the possible addition of other necessary drugs after reconstitution of the solution.
Before adding a substance or medication, verify that it is soluble and stable in Prismasol B0, and that the pH range is appropriate (pH of reconstituted solution is 7.0 to 8.5).
Additives may be incompatible. The instructions for use of the medication to be added and other relevant literature must be consulted. After addition, if there is a colour change and/or the appearance of precipitates, insoluble complexes, or crystals, do not use.
Mix the solution thoroughly when additives have been introduced.
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.
II. Push with both hands on the large compartment until the peel seal between the two compartments is entirely open.
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.
IV. The dialysis or replacement line may be connected to either of the two access ports.
IVa. 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.
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.
IVb. If the injection port is used, first remove the snap-off cap. Then introduce the spike through the rubber septum. Verify that the fluid is flowing freely.
The solution should be used immediately after removal of the over wrap. 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. Do not use if container is damaged or if solution is not clear. Discard any unused portion immediately after use.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
It is the responsibility of the physician to judge the incompatibility of an additive medication with the Prismasol B0 solution by checking for eventual colour change and/or eventual precipitation, insoluble complexes or crystals. The Instructions for Use of the medication to be added must be consulted. Before adding a drug, verify it is soluble and stable in water at the pH of Prismasol B0 (pH of reconstituted solution is 7.0 to 8.5).
The compatible medication must be added to the reconstituted solution and the solution must be administered immediately.

Store below 30°C. Do not refrigerate or freeze.
Shelf-life: 18 months as packaged for sale.
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 22° C. From a microbiological point of view, once opened (i.e. connected to the line), and as hydrogen carbonate is present, the reconstituted solution should be used immediately. Other in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours, including the duration of the treatment.

Intravenous & Other Sterile Solutions

B05ZB - Hemofiltrates ; Used in hemofiltration.

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