Phoxilium 1.2 mmol/L phosphate solution for hemodialysis/hemofiltration
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
PHOXILIUM® 1.2 mmol/l phosphate
Solution for haemodialysis and haemofiltration
Calcium chloride dihydrate, magnesium chloride hexahydrate, sodium chloride, sodium bicarbonate, potassium chloride, disodium phosphate dihydrate
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 adverse reactions, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Phoxilium is and what it is used for
- What you need to know before receiving Phoxilium
- How to use Phoxilium
- Possible side effects
- How to store Phoxilium
- Contents of the pack and other information
1. What Phoxilium is and what it is used for
Phoxilium, which belongs to the group of haemofiltration solutions, contains calcium chloride dihydrate, magnesium chloride hexahydrate, sodium chloride, sodium bicarbonate, potassium chloride, and disodium phosphate dihydrate.
Phoxilium is used in hospitals for intensive care treatments to correct chemical imbalances in the blood caused by kidney injury.
The aim of these treatments, which include renal replacement therapy, is to remove waste products from the blood that accumulate when the kidneys are not functioning properly.
Phoxilium solution is particularly used in the treatment of critically ill patients with acute kidney injury who also have:
- normal blood potassium levels (normal kaliemia), or
- normal or low blood phosphate levels (normal phosphatemia or hypophosphatemia).
This medicine may also be used in cases of poisoning by drugs or other dialysable or filterable substances.
2. What you need to know before using Phoxilium
Do not use Phoxilium in the following three cases:
- High potassium levels in the blood (hyperkalemia)
- High bicarbonate levels in the blood (metabolic alkalosis)
- High phosphate levels in the blood (hyperphosphatemia)
Do not subject the patient to hemodialysis or hemofiltration in the following three
situations:
- If hemofiltration cannot correct symptoms caused by elevated blood urea levels (uremic symptoms) resulting from kidney injury with pronounced hypercatabolism (an abnormal increase in the breakdown process of substances).
- If the blood pressure in the vascular access is insufficient.
- If blood coagulation capacity is reduced (systemic anticoagulation) and there is a high risk of bleeding.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Phoxilium.
Your blood condition will be monitored before and during treatment. For example, acid-base balance and blood electrolyte concentrations (including all fluid inputs (intravenous infusions) and outputs (urine output)) will be checked, even those not directly related to the treatment.
Use of Phoxilium with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. You must do so because the concentration of certain medicines may affect treatment with Phoxilium. Your doctor will decide whether it is necessary to adjust the dose of your medicines.
Specifically, talk to your doctor if you are taking any of the following medicines:
- Phosphate supplements (e.g., nutritional liquids), as they may increase the risk of high phosphate levels in the blood (hyperphosphatemia).
- Vitamin D and medicines containing calcium chloride or calcium gluconate, as they may increase the risk of high calcium levels in the blood (hypercalcemia).
- Sodium bicarbonate, as it may increase the risk of excess base in the blood (metabolic alkalosis).
- Citrate used as an anticoagulant, as it may reduce calcium levels in plasma.
Pregnancy, breastfeeding, and fertility
Pregnancy and breastfeeding:
There are no documented clinical data on the use of this medicine during pregnancy and breastfeeding. This medicine should be administered to pregnant and breastfeeding women only if clearly necessary.
Fertility:
No effect on fertility is expected, since calcium, sodium, potassium, magnesium, chloride, hydrogenphosphate, and bicarbonate are normal components of the body.
Driving and using machines
Phoxilium does not affect the ability to drive or operate machinery.
3. How to use Phoxilium
Phoxilium is a hospital-use product that must only be administered by medical professionals.
The volume of Phoxilium used, and therefore the dose, will depend on your individual condition. The dose volume will be determined by the physician responsible for treatment.
Phoxilium may be administered directly into the bloodstream (intravenous route) via a CRRT device or through hemodialysis, a technique in which the solution circulates on one side of the dialysis membrane while blood circulates on the other.
Follow exactly the administration instructions for the medicine provided in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
For instructions on use, refer to the section “This information is intended exclusively for healthcare professionals”.
If you use more Phoxilium than you should
Phoxilium is a hospital-use product administered exclusively by medical professionals; in addition, careful monitoring of fluid balance and blood tests is performed.
Therefore, it is unlikely that you will receive more Phoxilium than required.
In the unlikely event of an overdose, the physician will take necessary corrective measures and adjust the dose accordingly.
An overdose may lead to fluid overload, decreased plasma bicarbonate concentration (metabolic acidosis), and/or elevated phosphate concentration (hyperphosphatemia) in patients with renal impairment. This could result in serious consequences such as congestive heart failure or abnormalities in blood test results.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone gets them.
The patient may experience the three side effects related to the use of Phoxilium described below:
- Abnormally high or low body water volume (hyper- or hypovolemia)
- Changes in blood salt levels (electrolyte imbalances, such as hyperphosphatemia)
- Increased bicarbonate concentration in plasma (metabolic alkalosis) or reduced bicarbonate concentration in plasma (metabolic acidosis).
There are also some side effects that may be due to dialysis treatments, for example:
- Nausea, vomiting, muscle cramps, and low blood pressure (hypotension).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet.
You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Conservation of Phoxilium
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the
package. The expiry date refers to the last day of the month indicated.
Store at a temperature between 4°C and 30°C. Do not refrigerate or freeze.
The physical and chemical stability of the reconstituted solution has been demonstrated for 24 hours at 22°C. If the solution is not used immediately, the conditions and duration of storage shall be the responsibility of the user; in any case, this period must not exceed 24 hours, including the duration of administration.
Do not use this medicine if the solution is cloudy or if the packaging is damaged.
All seals must be intact.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines and packaging that you no longer need. In this way,
you will help protect the environment.
6. Package Contents and Additional Information
PHOXILIUM ES PL POLYOLEFIN WITH LUER CONNECTOR AND VALVE; 2016-07
Composition of Phoxilium
The following lists the active ingredients before and after mixing (reconstitution) of the solution.
The active ingredients before mixing are:
1,000 ml of solution from the small compartment (A) contains:
Calcium chloride, 2 H₂O 3.68 g
Magnesium chloride, 6 H₂O 2.44 g
1,000 ml of solution from the large compartment (B) contains:
Sodium chloride 6.44 g
Sodium bicarbonate 2.92 g
Potassium chloride 0.314 g
Disodium phosphate, 2 H₂O 0.225 g
The active ingredients after mixing are:
Solutions from compartments A (250 ml) and B (4,750 ml) are mixed to produce a reconstituted solution (5,000 ml) with the following composition:
mmol/l
Calcium, Ca²⁺ 1.25
Magnesium, Mg²⁺ 0.6
Sodium, Na⁺ 140
Chloride, Cl⁻ 115.9
Hydrogen phosphate, HPO₄²⁻ 1.2
Bicarbonate, HCO₃⁻ 30
Potassium, K⁺ 4
Theoretical osmolarity: 293 mOsm/l
Other components are:
- Carbon dioxide (for pH adjustment) E290
- Hydrochloric acid (for pH adjustment) E507
- Water for injections
Appearance of the product and contents of the pack
Phoxilium is a solution for hemodialysis and hemofiltration supplied in a bag consisting of two compartments. The final reconstituted solution is obtained by breaking the hermetic seal and mixing both solutions. The reconstituted solution is clear and colourless. Each bag (A+B) contains 5,000 ml of solution for hemodialysis and hemofiltration. The bag is wrapped in transparent film.
Each carton contains two bags and a leaflet.
Marketing Authorisation Holder and Manufacturer:
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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Vantive Health, S.L.
Polígono Industrial Sector 14.
C/ Pouet de Camilo, 2
46394 Ribarroja del Turia (Valencia)
Spain
This medicinal product is authorised 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, Denmark, Slovakia, Slovenia, Spain, Estonia, Finland, France, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, the Netherlands, Poland, Portugal, United Kingdom (Northern Ireland), Romania and Sweden: Phoxilium
Hungary: Phoxil
Date of the most recent review of this leaflet:
10/2018
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
Phoxilium 1.2 mmol/l phosphate
Solution for hemodialysis and hemofiltration
Precautions
You must strictly follow the instructions for use and handling of Phoxilium.
The solutions from the two compartments must be mixed before use.
The use of a contaminated solution may cause sepsis and shock.
To increase patient comfort, Phoxilium may be warmed up to 37°C. Pre-warming of the solution must be performed before reconstitution and only using dry heat. Solutions must not be warmed in water or in a microwave oven. Before administration, visually check that Phoxilium contains no particles and has not changed colour. Do not administer the solution unless it is clear and the seal is intact.
The concentration of inorganic phosphate should be determined periodically. Inorganic phosphate should be replaced in cases where blood phosphate levels are low.
The addition of replacement sodium bicarbonate may increase the risk of metabolic alkalosis.
In case of fluid imbalance, the clinical condition should be closely monitored and fluid balance restored:
- In case of hypervolemia, the prescribed net ultrafiltration rate for the CRRT device may be increased and/or the administration rate of solutions other than rehydration fluids and/or dialysis fluid may be reduced.
- In case of hypovolemia, the prescribed net ultrafiltration rate for the CRRT device may be reduced and/or the administration rate of solutions other than rehydration fluids and/or dialysis fluid may be increased.
Warnings:
Phoxilium must not be used in patients with hyperkalemia. Serum potassium concentration should be monitored before and during hemofiltration and/or hemodialysis.
Phoxilium is a potassium-containing solution and may cause transient hyperkalemia once treatment is initiated. In such cases, reduce the infusion rate and ensure that the required potassium concentration is achieved. If hyperkalemia does not resolve, discontinue treatment immediately.
If hyperkalemia occurs when Phoxilium is used as dialysis fluid, it may be necessary to administer a potassium-free dialysis fluid to increase the rate of potassium removal.
Since Phoxilium is a phosphate-containing solution, it may cause temporary hyperphosphatemia once treatment is initiated. In such cases, the infusion rate should be reduced until the desired phosphate concentration is achieved. If hyperphosphatemia does not resolve, administration must be stopped immediately.
Electrolytes and acid-base parameters in blood should be monitored periodically in patients treated with Phoxilium. Phoxilium contains hydrogen phosphate, a weak acid, which may affect the patient's acid-base balance. If metabolic acidosis develops or worsens during treatment with Phoxilium, it may be necessary to reduce the infusion rate or discontinue administration.
Phoxilium does not contain glucose and its administration may therefore cause hypoglycemia. Blood glucose levels should be monitored regularly in diabetic patients (including careful consideration in patients taking insulin or other hypoglycemic agents), but also in non-diabetic patients, due to, for example, the risk of asymptomatic hypoglycemia during the procedure. If hypoglycemia occurs, the use of a glucose-containing solution should be considered. Other corrective measures may be necessary to maintain desired glycemic control.
Dosage:
The volume and rate at which Phoxilium is administered depend on the concentration of phosphate and other electrolytes in the blood, acid-base balance, fluid balance, and the patient's overall clinical condition. The volume of replacement solution and/or dialysis fluid to be administered also depends on the desired intensity (dose) of treatment. The administration regimen (dose, infusion rate, and cumulative volume) of Phoxilium should only be determined by a physician experienced in intensive care and CRRT (continuous renal replacement therapy).
Therefore, the dose volume will be determined and prescribed by the responsible physician.
The flow rate of replacement solution in hemofiltration and hemodiafiltration therapies is:
Adults: 500–3,000 ml/h
The flow rate of dialysis fluid in hemodialysis and continuous hemodiafiltration therapies is:
Adults: 500–2,500 ml/h
The combined total flow rate commonly used for CRRT (dialysis fluid and replacement solutions) in adults is approximately 2,000 to 2,500 ml/h, corresponding to an approximate daily fluid volume of 48 to 60 litres.
Paediatric population:
For children, from neonates up to adolescents up to 18 years of age, the flow rate range when used as replacement solution in hemofiltration and hemodiafiltration and as dialysis solution (dialysis fluid) in continuous hemodialysis and continuous hemodiafiltration is 1,000 to 4,000 ml/h/1.73 m².
In adolescents (12 to 18 years), when the calculated paediatric dose exceeds the maximum adult dose, the recommended adult dose should be used.
Instructions for use and handling
The solution from the small compartment A is added to the solution from the large compartment B after breaking the hermetic seal and immediately before use. The reconstituted solution must be clear and colourless.
Aseptic technique must be used during handling and administration to the patient.
Use only if the packaging is intact, seals are undamaged, the peelable seal is not broken, and the solution is clear. Squeeze the bag to ensure there are no leaks. If any leak is detected, discard the solution immediately as sterility cannot be guaranteed.
The large compartment B has an injection port for adding other necessary medications after reconstitution of the solution. It is the physician's responsibility to assess the compatibility of any medication added to Phoxilium solution by checking for any change in colour and/or precipitation, insoluble complexes, or crystals. Before adding a medication, verify that it is soluble and stable in this product and that the pH range of Phoxilium is suitable (the pH range of the reconstituted solution is 7.0–8.5). Additives may not be compatible. The instructions for use of the medication to be added must be consulted.
Remove any liquid from the injection port, hold the bag vertically downwards, add the medication through the injection port, and mix thoroughly. The addition and mixing of additives must always be performed before connecting the solution bag to the extracorporeal circuit. The solution must be administered immediately.
I Remove the bag from its packaging immediately before use and discard all other packaging materials. Break the hermetic seal by holding the small compartment between both hands and pressing until the wall separating the two compartments opens (see figure I below).
II Press the large compartment with both hands until the wall between the two compartments is fully open (see figure II below).
III Ensure complete mixing of the solutions by gently agitating the bag. The solution is now ready for use and the bag can be hung on the equipment (see figure III below).
IV The dialysis or replacement fluid line can be connected to either of the two access connectors.
IV.a If using the luer connector, remove the cap with a twisting and pulling motion and connect the male luer connector of the dialysis or replacement line to the female luer receptor of the bag using a push-and-turn motion. Ensure the connection is secure and tight. The connection will open. Check that fluid flows freely (see figure IV.a below).
If the dialysis or replacement line is disconnected from the luer connector, the connector will close and the flow of solution 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 by lifting it. The injection port is a port that can be disinfected with a swab. Then insert the spike through the rubber wall. Check that fluid flows freely (see figure IV.b below).
The reconstituted solution must be used immediately. If not used immediately, note that the reconstituted solution must be used within 24 hours after adding solution A to solution B, including the duration of treatment.
The reconstituted solution is for single use only. Discard any remaining solution immediately after use.
Disposal of unused medicine and all materials that have been in contact with it must be carried out in accordance with local regulations.
PHOXILIUM ES PVC LUER CONNECTOR WITH SPIKE; 2016-07
Composition of Phoxilium
The following lists the active ingredients before and after mixing (reconstitution) of the solution.
The active ingredients before mixing are:
1,000 ml of solution from the small compartment (A) contains:
Calcium chloride, 2 H₂O 3.68 g
Magnesium chloride, 6 H₂O 2.44 g
1,000 ml of solution from the large compartment (B) contains:
Sodium chloride 6.44 g
Sodium bicarbonate 2.92 g
Potassium chloride 0.314 g
Disodium phosphate, 2 H₂O 0.225 g
The active ingredients after mixing are:
Solutions from compartments A (250 ml) and B (4,750 ml) are mixed to produce a reconstituted solution (5,000 ml) with the following composition:
mmol/l
Calcium, Ca²⁺ 1.25
Magnesium, Mg²⁺ 0.6
Sodium, Na⁺ 140
Chloride, Cl⁻ 115.9
Hydrogen phosphate, HPO₄²⁻ 1.2
Bicarbonate, HCO₃⁻ 30
Potassium, K⁺ 4
Theoretical osmolarity: 293 mOsm/l
Other components are:
Carbon dioxide (for pH adjustment) E290
Hydrochloric acid (for pH adjustment) E507
Water for injections
Appearance of the product and contents of the pack
Phoxilium is a solution for hemodialysis and hemofiltration supplied in a bag consisting of two compartments. The final reconstituted solution is obtained by breaking the breakable spike and mixing both solutions. The reconstituted solution is clear and colourless. Each bag (A+B) contains 5,000 ml of solution for hemodialysis and hemofiltration. The bag is wrapped in transparent film.
Each carton contains two bags and a leaflet.
Marketing Authorisation Holder and Manufacturer:
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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Vantive Health, S.L.
Polígono Industrial Sector 14.
C/ Pouet de Camilo, 2
46394 Ribarroja del Turia (Valencia)
Spain
This medicinal product is authorised 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, Denmark, Slovakia, Slovenia, Spain, Estonia, Finland, France, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, the Netherlands, Poland, Portugal, United Kingdom (Northern Ireland), Romania and Sweden: Phoxilium
Hungary: Phoxil
Date of the most recent review of this leaflet:
10/2018
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
Phoxilium 1.2 mmol/l phosphate
Solution for hemodialysis and hemofiltration
Precautions
You must strictly follow the instructions for use and handling of Phoxilium.
The solutions from the two compartments must be mixed before use.
The use of a contaminated solution may cause sepsis and shock.
To increase patient comfort, Phoxilium may be warmed up to 37°C. Pre-warming of the solution must be performed before reconstitution and only using dry heat. Solutions must not be warmed in water or in a microwave oven. Before administration, visually check that Phoxilium contains no particles and has not changed colour. Do not administer the solution unless it is clear and the seal is intact.
The concentration of inorganic phosphate should be determined periodically. Inorganic phosphate should be replaced in cases where blood phosphate levels are low.
The addition of replacement sodium bicarbonate may increase the risk of metabolic alkalosis.
In case of fluid imbalance, the clinical condition should be closely monitored and fluid balance restored:
- In case of hypervolemia, the prescribed net ultrafiltration rate for the CRRT device may be increased and/or the administration rate of solutions other than rehydration fluids and/or dialysis fluid may be reduced.
- In case of hypovolemia, the prescribed net ultrafiltration rate for the CRRT device may be reduced and/or the administration rate of solutions other than rehydration fluids and/or dialysis fluid may be increased.
Warnings:
Phoxilium must not be used in patients with hyperkalemia. Serum potassium concentration should be monitored before and during hemofiltration and/or hemodialysis.
Phoxilium is a potassium-containing solution and may cause transient hyperkalemia once treatment is initiated. In such cases, reduce the infusion rate and ensure that the required potassium concentration is achieved. If hyperkalemia does not resolve, discontinue treatment immediately.
If hyperkalemia occurs when Phoxilium is used as dialysis fluid, it may be necessary to administer a potassium-free dialysis fluid to increase the rate of potassium removal.
Since Phoxilium is a phosphate-containing solution, it may cause temporary hyperphosphatemia once treatment is initiated. In such cases, the infusion rate should be reduced until the desired phosphate concentration is achieved. If hyperphosphatemia does not resolve, administration must be stopped immediately.
Electrolytes and acid-base parameters in blood should be monitored periodically in patients treated with Phoxilium. Phoxilium contains hydrogen phosphate, a weak acid, which may affect the patient's acid-base balance. If metabolic acidosis develops or worsens during treatment with Phoxilium, it may be necessary to reduce the infusion rate or discontinue administration.
Phoxilium does not contain glucose and its administration may therefore cause hypoglycemia. Blood glucose levels should be monitored regularly in diabetic patients (including careful consideration in patients taking insulin or other hypoglycemic agents), but also in non-diabetic patients, due to, for example, the risk of asymptomatic hypoglycemia during the procedure. If hypoglycemia occurs, the use of a glucose-containing solution should be considered. Other corrective measures may be necessary to maintain desired glycemic control.
Dosage:
The volume and rate at which Phoxilium is administered depend on the concentration of phosphate and other electrolytes in the blood, acid-base balance, fluid balance, and the patient's overall clinical condition. The volume of replacement solution and/or dialysis fluid to be administered also depends on the desired intensity (dose) of treatment. The administration regimen (dose, infusion rate, and cumulative volume) of Phoxilium should only be determined by a physician experienced in intensive care and CRRT (continuous renal replacement therapy).
Therefore, the dose volume will be determined and prescribed by the responsible physician.
The flow rate of replacement solution in hemofiltration and hemodiafiltration therapies is:
Adults: 500–3,000 ml/h
The flow rate of dialysis fluid in hemodialysis and continuous hemodiafiltration therapies is:
Adults: 500–2,500 ml/h
The combined total flow rate commonly used for CRRT (dialysis fluid and replacement solutions) in adults is approximately 2,000 to 2,500 ml/h, corresponding to an approximate daily fluid volume of 48 to 60 litres.
Paediatric population:
For children, from neonates up to adolescents up to 18 years of age, the flow rate range when used as replacement solution in hemofiltration and hemodiafiltration and as dialysis solution (dialysis fluid) in continuous hemodialysis and continuous hemodiafiltration is 1,000 to 4,000 ml/h/1.73 m².
In adolescents (12 to 18 years), when the calculated paediatric dose exceeds the maximum adult dose, the recommended adult dose should be used.
Instructions for use and handling
The solution from the small compartment A is added to the solution from the large compartment B after breaking the breakable spike and immediately before use. The reconstituted solution must be clear and colourless.
Aseptic technique must be used during handling and administration to the patient.
Use only if the packaging is intact, seals are undamaged, the breakable spike is not broken, and the solution is clear. Firmly squeeze the bag to ensure there are no leaks. If any leak is detected, discard the solution immediately as sterility cannot be guaranteed.
The large compartment B has an injection port for adding other necessary medications after reconstitution of the solution. It is the physician's responsibility to assess the compatibility of any medication added to Phoxilium solution by checking for any change in colour and/or precipitation, insoluble complexes, or crystals. Before adding a medication, verify that it is soluble and stable in this product and that the pH range of Phoxilium is suitable (the pH range of the reconstituted solution is 7.0–8.5). Additives may not be compatible. The instructions for use of the medication to be added must be consulted.
Remove any liquid from the injection port, hold the bag vertically downwards, add the medication through the injection port and mix thoroughly. The mixing of additives must always be performed before connecting the solution bag to the extracorporeal circuit. The solution must be administered immediately.
I Remove the bag from its packaging immediately before use and discard all other packaging materials. Open the closure by breaking the spike located between the two compartments of the bag. The spike remains in 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 Rinse the small compartment A twice by forcing the mixed solution back into this small compartment A and then back into the large compartment B (see figure III below).
IV Once the small compartment A is emptied, agitate the large compartment B to ensure complete mixing of its contents. The solution is now ready for use and the bag can be hung on the equipment (see figure IV below).
V The dialysis or replacement fluid line can be connected to either of the two access connectors.
V.a If using the luer access, remove the cap using an aseptic technique and connect the male luer connector of the dialysis or replacement fluid line to the female luer receptor of the bag; do so firmly. With both hands, break the blue breakable spike at the base and move it back and forth. Do not use tools. Check that the breakable spike is completely separated and that fluid flows freely. The breakable spike will remain in the luer port during treatment (see figure V.a below).
V.b If using the injection access, first remove the cap by lifting it. The injection port is a port that can be disinfected with a swab. Then insert the spike through the rubber wall. Check that fluid flows freely (see figure V.b below).
The reconstituted solution must be used immediately. If not used immediately, note that the reconstituted solution must be used within 24 hours after adding solution A to solution B, including the duration of treatment.
The reconstituted solution is for single use only. Discard any remaining solution immediately after use.
Disposal of unused medicine and all materials that have been in contact with it must be carried out in accordance with local regulations.
PHOXILIUM ES PVC LUER CONNECTOR WITH VALVE; 2016-07
Composition of Phoxilium
The following lists the active ingredients before and after mixing (reconstitution) of the solution.
The active ingredients before mixing are:
1,000 ml of solution from the small compartment (A) contains:
Calcium chloride, 2 H₂O 3.68 g
Magnesium chloride, 6 H₂O 2.44 g
1,000 ml of solution from the large compartment (B) contains:
Sodium chloride 6.44 g
Sodium bicarbonate 2.92 g
Potassium chloride 0.314 g
Disodium phosphate, 2 H₂O 0.225 g
The active ingredients after mixing are:
Solutions from compartments A (250 ml) and B (4,750 ml) are mixed to produce a reconstituted solution (5,000 ml) with the following composition:
mmol/l
Calcium, Ca²⁺ 1.25
Magnesium, Mg²⁺ 0.6
Sodium, Na⁺ 140
Chloride, Cl⁻ 115.9
Hydrogen phosphate, HPO₄²⁻ 1.2
Bicarbonate, HCO₃⁻ 30
Potassium, K⁺ 4
Theoretical osmolarity: 293 mOsm/l
Other components are:
Carbon dioxide (for pH adjustment) E290
Hydrochloric acid (for pH adjustment) E507
Water for injections
Appearance of the product and contents of the pack
Phoxilium is a solution for hemodialysis and hemofiltration supplied in a bag consisting of two compartments. The final reconstituted solution is obtained by breaking the breakable spike and mixing both solutions. The reconstituted solution is clear and colourless. Each bag (A+B) contains 5,000 ml of solution for hemodialysis and hemofiltration. The bag is wrapped in transparent film.
Each carton contains two bags and a leaflet.
Marketing Authorisation Holder and Manufacturer:
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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Vantive Health, S.L.
Polígono Industrial Sector 14.
C/ Pouet de Camilo, 2
46394 Ribarroja del Turia (Valencia)
Spain
This medicinal product is authorised 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, Denmark, Slovakia, Slovenia, Spain, Estonia, Finland, France, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, the Netherlands, Poland, Portugal, United Kingdom (Northern Ireland), Romania and Sweden: Phoxilium
Hungary: Phoxil
Date of the most recent review of this leaflet:
10/2018
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
Phoxilium® 1.2 mmol/l phosphate
Solution for hemodialysis and hemofiltration
Precautions
You must strictly follow the instructions for use and handling of Phoxilium.
The solutions from the compartments must be mixed before use.
The use of a contaminated solution may cause sepsis and shock.
To increase patient comfort, Phoxilium may be warmed up to 37°C. Pre-warming of the solution must be performed before reconstitution and only using dry heat. Solutions must not be warmed in water or in a microwave oven. Before administration, visually check that Phoxilium contains no particles and has not changed colour. Do not administer the solution unless it is clear and the seal is intact.
The concentration of inorganic phosphate should be determined periodically. Inorganic phosphate should be replaced in cases where blood phosphate levels are low.
The addition of replacement sodium bicarbonate may increase the risk of metabolic alkalosis.
In case of fluid imbalance, the clinical condition should be closely monitored and fluid balance restored:
- In case of hypervolemia, the prescribed net ultrafiltration rate for the CRRT device may be increased and/or the administration rate of solutions other than rehydration fluids and/or dialysis fluid may be reduced.
- In case of hypovolemia, the prescribed net ultrafiltration rate for the CRRT device may be reduced and/or the administration rate of solutions other than rehydration fluids and/or dialysis fluid may be increased.
Warnings:
Phoxilium must not be used in patients with hyperkalemia. Serum potassium concentration should be monitored before and during hemofiltration and/or hemodialysis.
Phoxilium is a potassium-containing solution and may cause transient hyperkalemia once treatment is initiated. In such cases, reduce the infusion rate and ensure that the required potassium concentration is achieved. If hyperkalemia does not resolve, discontinue treatment immediately.
If hyperkalemia occurs when Phoxilium is used as dialysis fluid, it may be necessary to administer a potassium-free dialysis fluid to increase the rate of potassium removal.
Since Phoxilium is a phosphate-containing solution, it may cause temporary hyperphosphatemia once treatment is initiated. In such cases, the infusion rate should be reduced until the desired phosphate concentration is achieved. If hyperphosphatemia does not resolve, administration must be stopped immediately.
Electrolytes and acid-base parameters in blood should be monitored periodically in patients treated with Phoxilium. Phoxilium contains hydrogen phosphate, a weak acid, which may affect the patient's acid-base balance. If metabolic acidosis develops or worsens during treatment with Phoxilium, it may be necessary to reduce the infusion rate or discontinue administration.
Phoxilium does not contain glucose and its administration may therefore cause hypoglycemia. Blood glucose levels should be monitored regularly in diabetic patients (including careful consideration in patients taking insulin or other hypoglycemic agents), but also in non-diabetic patients, due to, for example, the risk of asymptomatic hypoglycemia during the procedure. If hypoglycemia occurs, the use of a glucose-containing solution should be considered. Other corrective measures may be necessary to maintain desired glycemic control.
Dosage:
The volume and rate at which Phoxilium is administered depend on the concentration of phosphate and other electrolytes in the blood, acid-base balance, fluid balance, and the patient's overall clinical condition. The volume of replacement solution and/or dialysis fluid to be administered also depends on the desired intensity (dose) of treatment. The administration regimen (dose, infusion rate, and cumulative volume) of Phoxilium should only be determined by a physician experienced in intensive care and CRRT (continuous renal replacement therapy).
Therefore, the dose volume will be determined and prescribed by the responsible physician.
The flow rate of replacement solution in hemofiltration and hemodiafiltration therapies is:
Adults: 500–3,000 ml/h
The flow rate of dialysis solution (dialysis fluid) in hemodialysis and continuous hemodiafiltration therapies is:
Adults: 500–2,500 ml/h
The combined total flow rate commonly used for CRRT (dialysis fluid and replacement solutions) in adults is approximately 2,000 to 2,500 ml/h, corresponding to an approximate daily fluid volume of 48 to 60 litres.
Paediatric population:
For children, from neonates up to adolescents up to 18 years of age, the flow rate range when used as replacement solution in hemofiltration and hemodiafiltration and as dialysis solution (dialysis fluid) in continuous hemodialysis and continuous hemodiafiltration is 1,000 to 4,000 ml/h/1.73 m².
In adolescents (12 to 18 years), when the calculated paediatric dose exceeds the maximum adult dose, the recommended adult dose should be used.
Instructions for use and handling
The solution from the small compartment A is added to the solution from the large compartment B after breaking the breakable spike and immediately before use. The reconstituted solution must be clear and colourless.
Aseptic technique must be used throughout the administration process to the patient.
Use only if the packaging is intact, seals are undamaged, the breakable spike is not broken, and the solution is clear. Firmly squeeze the bag to ensure there are no leaks. If any leak is detected, discard the solution immediately as sterility cannot be guaranteed.
The large compartment B has an injection port for adding other necessary medications after reconstitution of the solution. It is the physician's responsibility to assess the compatibility of any medication added to Phoxilium solution by checking for any change in colour and/or precipitation, insoluble complexes, or crystals. Before adding a medication, verify that it is soluble and stable in this product and that the pH range of Phoxilium is suitable (the pH range of the reconstituted solution is 7.0–8.5). Additives may not be compatible. The instructions for use of the medication to be added must be consulted.
Remove any liquid from the injection port, hold the bag vertically downwards, add the medication through the injection port and mix thoroughly. The mixing of additives must always be performed before connecting the solution bag to the extracorporeal circuit. The solution must be administered immediately.
I Remove the bag from its packaging immediately before use and discard all other packaging materials. Open the closure by breaking the spike located between the two compartments of the bag. The spike remains in 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 Rinse the small compartment A twice by forcing the mixed solution back into this small compartment A and then back into the large compartment B (see figure III below).
IV Once the small compartment A is emptied, agitate the large compartment B to ensure complete mixing of its contents. The solution is now ready for use and the bag can be hung on the equipment (see figure IV below).
V The dialysis or replacement line can be connected to either of the two access connectors.
V.a If using the luer access, remove the cap with a twisting and pulling motion and connect the male luer connector of the dialysis or replacement line to the female luer receptor of the bag using a push-and-turn motion. Ensure the connection is secure and tight. The connection will open. Check that fluid flows freely (see figure V.a below).
If the dialysis or replacement line is disconnected from the luer connector, the connector will close and the flow of solution will stop. The luer port is a needle-free port that can be cleaned.
V.b If using the injection access, first remove the cap by lifting it. The injection port is a port that can be disinfected with a swab. Then insert the spike through the rubber wall. Check that fluid flows freely (see figure V.b below).
The reconstituted solution must be used immediately. If not used immediately, note that the reconstituted solution must be used within 24 hours after adding solution A to solution B, including the duration of treatment.
The reconstituted solution is for single use only. Discard any remaining solution immediately after use.
Disposal of unused medicine and all materials that have been in contact with it must be carried out in accordance with local regulations.
