Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Baxter Holding B.V., Kobaltweg 49, 3542CE Utrecht, Netherlands
As substitution solution in continuous haemofiltration and haemodiafiltration and as dialysis solution in continuous haemodialysis for acute renal failure in adult and children of all ages.
The rate at which Hemosol 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.
Evidence from clinical studies and experience suggests that use in the elderly population is not associated with differences in safety or effectiveness.
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.
Intravenous use and for haemodialysis.
Hemosol 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 section 6.6.
Overdose with Hemosol 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 section 4.4).
1 year 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.
Do not store below +4°C.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
The container made in Polyvinyl chloride (PVC) is a two-compartment bag. The 5000 ml bag is comprised of a small compartment (250 ml) and a large compartment (4750 ml). The two compartments are separated by a frangible pin.
The large compartment B is fitted with an injection connector (or spike connector) made of polycarbonate (PC), which is closed with a rubber disc covered by a cap as well as a luer connector (PC) with a frangible pin (PC) or a valve made of silicone rubber for the connection of the bag with a suitable replacement solution line or dialysis line.
The bag is over wrapped with a transparent overwrap made of multilayer polymer film.
Each two-compartment bag contains 5000 ml.
Package size: 2 × 5000 ml in a box.
The electrolyte solution (small compartment A) is added to the buffer solution (large compartment B) after breaking the frangible pin immediately before use to obtain the reconstituted solution.
A patient information leaflet with detailed 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, frangible pin or 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 Hemosol 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. The introduction and mixing of additives must always be performed prior to connecting the solution bag to the extracorporeal circuit.
If a frangible pin separates the two compartments of the bag and a frangible pin is located in the luer connector the following instructions for use should be followed:
I Remove the over-wrap from the bag immediately before use and discard any other packaging materials. Open the seal by breaking the frangible-pin between the two compartments of the bag. The frangible-pin will remain in the bag.
II Make sure all the fluid from the small compartment A is transferred into the large compartment B.
III Rinse the small compartment A twice by pressing the mixed solution back into the small compartment and then back into the large compartment B.
IV When the small compartment is empty: shake the large compartment B so that the contents mix completely. The solution is now ready for use and the bag can be hung on the equipment.
V The dialysis or replacement line may be connected to either of the two access ports.
V.a If the luer connector is used, remove the cap and connect the male luer lock on the dialysis or replacement line to the female luer receptor on the bag; tighten. Using thumb and fingers, break the coloured frangible pin at its base, and move it back and forth. Do not use a tool. Verify that the pin is completely separated and that the fluid is flowing freely. The pin will remain in the luer port during the treatment.
V.b 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.
If a frangible pin separates the two compartments of the bag and a valve is located in the luer connector, the following instructions for use shall be followed:
I Remove the over wrap from the bag immediately before use and discard any other packaging materials. Open the seal by breaking the frangible pin between the two compartments of the bag. The frangible pin will remain in the bag.
II Make sure all the fluid from the small compartment A is transferred into the large compartment B.
III Rinse the small compartment A twice by pressing the mixed solution back into the small compartment A and then back into the large compartment B.
IV When the small compartment A is empty: shake the large compartment B so that the contents mix completely. The solution is now ready for use and the bag can be hung on the equipment.
V The dialysis or replacement line may be connected to either of the two access ports.
Va 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.
Vb 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.
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