Patient Leaflet Updated 27-May-2025 | Vantive Limited
PHOXILIUM 1.2 mmol/l phosphate Solution for haemodialysis/haemofiltration
PHOXILIUM 1.2 mmol/l phosphate
Solution for haemodialysis and haemofiltration
Calcium chloride dihydrate, magnesium chloride hexahydrate, sodium chloride, sodium hydrogen carbonate, potassium chloride, disodium phosphate dihydrate
1. What Phoxilium is and what it is used for
2. What you need to know before you are given Phoxilium
3. How to use Phoxilium
4. Possible side effects
5. How to store Phoxilium
6. Contents of the pack and other information
Phoxilium, belonging to the group of hemofiltrates solution, contains calcium chloride dihydrate, magnesium chloride hexahydrate, sodium chloride, sodium hydrogen carbonate, potassium chloride, disodium phosphate dihydrate.
Phoxilium is used in hospitals in intensive care treatments to correct chemical imbalances in the blood which are caused by kidney injury.
The treatments, using continuous renal replacement therapy, are designed to remove accumulated waste products from the blood when the kidneys are not functioning.
The Phoxilium solution is particularly used to treat critically ill patients with acute kidney injury having:
Do not use haemodialysis or haemofiltration in any of the following three cases:
Talk to your doctor or pharmacist or nurse before you are using Phoxilium.
Before and during treatment, your blood condition will be checked, e.g. your acid-base balance and concentrations of salts in the blood (electrolytes) will be monitored, including all fluid inputs (intravenous infusion) and outputs (urine output), even those not directly related to the therapy.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This is because the concentration of other medicines may influence the treatment with Phoxilium. Your doctor will decide if any changes in the dosage of your medicines should be made.
In particular, tell your doctor if you are using either of the following:
Pregnancy and breast-feeding:
There is no documented clinical data on the use of this medicine during pregnancy and lactation. This medicine should only be administered to pregnant and lactating women if clearly needed.
Fertility:
No effects on fertility are anticipated, since calcium, sodium, potassium, magnesium, chloride, hydrogen phosphate and hydrogen carbonate are normal constituents of the body.
Phoxilium will not have any effect on the ability to drive or use machines.
Phoxilium is a product to be used in hospitals and administered by medical professionals only. The volume of Phoxilium, and therefore the dose, used will depend on your condition. The dose volume will be determined by the physician responsible for your treatment.
Phoxilium can be administered directly into the bloodstream (intravenously) through a CRRT machine or via haemodialysis, where the solution flows on one side of a dialysis membrane while the blood flows on the other side.
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
For instructions for use, please see section “The following information is intended for healthcare professionals only”.
If you use more Phoxilium than you should
Phoxilium is a product to be used in hospitals and administered by medical professionals only and your fluid balance and blood chemistry will be carefully monitored.
Therefore it is unlikely that you will use more Phoxilium than you should
In the unlikely event that an overdose occurs, your doctor will take the necessary corrective measures and adjust your dose.
Overdose may result in fluid overload, reduction of the plasma bicarbonate concentration (metabolic acidosis) and/or high phosphate concentration (hyperphosphataemia) if you are suffering from renal injury.
It could lead to severe consequences, such as congestive heart failure or disturbances in your blood chemistry.
If you have any further questions on the use of this product, please ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
There are also some side effects which can be caused by dialysis treatments, such as:
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via:
or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
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.
Store between +4° - +30°C. Do not refrigerate or freeze.
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 should not be longer than 24 hours including the duration of the treatment.
Do not use this medicine if the solution is cloudy or the overwrap is damaged. All seals must be intact.
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.
The active substances before and after mixing (reconstitution) are shown below.
Active substances before mixing:
1000 ml of solution from the small compartment (A) contains:
Calcium chloride, 2 H2O 3.68 g
Magnesium chloride, 6 H2O 2.44 g
1000 ml of solution from the large compartment (B) contains:
Sodium chloride 6.44 g
Sodium hydrogen carbonate 2.92 g
Potassium chloride 0.314 g
Disodium phosphate, 2 H2O 0.225 g
Active substances after mixing:
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
Calcium, Ca2+ 1.25
Magnesium, Mg2+ 0.6
Sodium, Na+ 140
Chloride, Cl− 115.9
Hydrogen phosphate, HPO42− 1.2
Hydrogen carbonate, HCO3− 30
Potassium, K+ 4
Theoretical Osmolarity:
293 mOsm/l
The other ingredients are:
Phoxilium is a solution for haemodialysis and haemofiltration presented in a two compartment bag. The final reconstituted solution is obtained after breaking the peel seal and mixing both solutions. The reconstituted solution is clear and colourless. Each bag (A+B) contains 5000 ml solution for haemodialysis and haemofiltration. The bag is overwrapped with a transparent film.
Each box contains two bags and one package leaflet.
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland): Phoxilium
Hungary: Phoxil
This leaflet was last revised
in 09/2024
CB-30-03-002
Wavertree Technology Park, 2 Wavertree Boulevard, Liverpool, L7 9PE
0151 250 1560
www.vantive.com
0151 250 1560
0800 023 4002
