Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
Phoxilium is used for CRRT (continuous renal replacement therapy) in critically ill patients with ARF (acute renal failure) when pH and kalaemia have been restored to normal and when the patients need phosphate supplementation for loss of phosphate in the ultrafiltrate or to the dialysate during CRRT.
Phoxilium may also be used in cases of drug poisoning or intoxications when the poisons are dialysable or pass through the membrane.
Phoxilium is indicated for use in patients with normal kalaemia and normal or hypophosphataemia.
The volume and rate at which Phoxilium is administered depends on the blood concentration of phosphate and other 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. Administration (dose, infusion rate and cumulative volume) of Phoxilium should only be established by a physician experienced in critical care medicine and CRRT (Continuous Renal Replacement Therapy).
The dose volume is therefore at the discretion and prescription of the responsible physician.
The range of flow rates for the replacement solution in haemofiltration and haemodiafiltration are:
Adult: 500-3000 ml/hour.
The range of flow rates for the dialysate in continuous haemodialysis and continuous haemodiafiltration are:
Adult: 500-2500 ml/hour.
Commonly used combined total flow rates for CRRT (dialysate and replacement solutions) in adults are approximately 2000 to 2500 ml/h which correspond to a daily fluid volume of approximately 48 to 60 l.
In children from neonates to adolescents to 18 years, the range of flow rates used as substitution solution in haemofiltration and haemodiafiltration and as dialysis solution (dialysate) in continuous haemodialysis and continuous haemodiafiltration are 1000 to 4000 ml/h/1.73 m².
For adolescents (12-18 years), the adult dose recommendation should be used when the paediatric dose is calculated to exceed the maximum adult dose.
Intravenous use and for haemodialysis.
Phoxilium, when used as a replacement solution is administered into the extracorporeal circuit before (pre-dilution) or after the haemofilter or haemodiafilter (post-dilution).
Phoxilium, when used as a dialysate, it is administered in the dialysate compartment of the extracorporeal filter separated from the blood flow by a semipermeable membrane.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Overdose with Phoxilium should not occur if the procedure is carried out correctly and the fluid balance, electrolyte and acid-base balance of the patient is carefully monitored by trained medical personnel.
However, Phoxilium overdose can lead to severe clinical conditions, such as congestive heart failure, electrolyte or acid-base disturbances.
If hypervolaemia or hypovolaemia occur, instruction for handling of hypervolaemia or hypovolaemia in section 4.4 must be strictly followed.
If metabolic acidosis and/or hyperphosphatemia occur, stop administration promptly. There is no specific antidote for overdose. The risk can be minimized by close monitoring during treatment (see section 4.3 and 4.4).
18 months.
After reconstitution:
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 would not normally be longer than 24 hours including the duration of the treatment.
Store between +4°C - +30°C. Do not refrigerate or freeze.
For the storage condition of the reconstituted solution, see section 6.3.
The container made in polyvinyl chloride (PVC) or polyolefin 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 or a peel seal.
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 a multilayer polymer film.
Each two-compartment bag contains 5000 ml.
Package size: 2 × 5000 ml in a box.
The solution in the small compartment A is added to the solution in the large compartment B after breaking the frangible pin or the peel seal immediately before use. The reconstituted solution shall be clear and colourless.
A package leaflet with detailed instruction for use is enclosed in the box.
Aseptic technique shall be used throughout the handling and administration to the patient.
Use only if the overwrap is undamaged, 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 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 user to judge the compatibility of an additive medication with Phoxilium 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 this medicine and that the pH range of Phoxilium is appropriate (pH of reconstituted solution is 7.0–8.5). 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 introduction and mixing of additives must always be performed prior to connecting the solution bag to the extracorporeal circuit. The solution must be administered immediately.
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 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, using aseptic technique, 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 both hands, break the blue 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.
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.
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 dialysate 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.
If a peel seal 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 holding the small compartment with both hands and squeezing 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 reconstituted solution shall be used immediately. If not used immediately, the reconstituted solution should be used within 24 hours including the duration of the treatment after addition of the solution A to solution B.
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.
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