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PHOXILIUM 1.2 mmol/l phosphate Solution for haemodialysis/ haemofiltration

Active Ingredient:
potassium chloride , sodium chloride , sodium hydrogen carbonate , calcium chloride , magnesium chloride , disodium phosphate
Company:  
Vantive Limited See contact details
ATC code: 
B05ZB
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL)
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 27 May 2025
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 58711/0008.

{printer} Print patient leaflet as text only

PHOXILIUM 1.2 mmol/l phosphate Solution for haemodialysis/haemofiltration

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 hydrogen carbonate, potassium chloride, disodium phosphate dihydrate

Read all of this 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 further questions, ask your doctor or pharmacist or nurse.
  • 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. See section 4.

WHAT IS IN THIS LEAFLET:

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

1. WHAT PHOXILIUM IS AND WHAT IT IS USED FOR

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:

  • a normal concentration of potassium in the blood (normal kalaemia) or
  • a normal or low concentration of phosphate in the blood (normal or hypophosphataemia). This medicine may also be used in case of drug poisoning or intoxications with dialysable or filterable substances.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE PHOXILIUM
DO NOT USE PHOXILIUM IN THE FOLLOWING THREE CASES:
  • a high concentration of potassium in the blood (hyperkalaemia)
  • a high concentration of bicarbonate in the blood (metabolic alkalosis)
  • a high concentration of phosphate in the blood (hyperphosphataemia)

Do not use haemodialysis or haemofiltration in any of the following three cases:

  • when haemofiltration cannot correct the symptoms caused by a high blood concentration of urea (uraemic symptoms) which are the result of renal injury with pronounced hypercatabolism (an abnormally increased process of breaking down substances),
  • insufficient arterial pressure in the access to the blood vessel,
  • reduced clotting of the blood (systemic anticoagulation), if there is a high risk of bleeding.

WARNINGS AND PRECAUTIONS

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.

OTHER MEDICINES AND PHOXILIUM

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:

  • Additional sources of phosphate (e.g. nutritional fluids); as this may increase the risk of a high concentration of phosphate in the blood (hyperphosphataemia).
  • Vitamin D and medicinal products containing calcium chloride or calcium gluconate; as they can increase the risk of a high concentration of calcium in the blood (hypercalcaemia).
  • Sodium bicarbonate; as this may increase the risk of excess of bicarbonate in your blood (metabolic alkalosis).
  • When citrate is used as an anticoagulant, as it can reduce plasma calcium levels.

PREGNANCY, BREAST-FEEDING AND FERTILITY

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.

DRIVING AND USING MACHINES

Phoxilium will not have any effect on the ability to drive or use machines.

3. HOW TO USE PHOXILIUM

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.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

THE FOLLOWING THREE SIDE EFFECTS RELATED TO THE USE OF PHOXILIUM ARE POSSIBLE:
  • abnormally high or low volume of water in the body (hyper or hypovolaemia),
  • changes in levels of salt in the blood (electrolyte imbalance such as hyperphosphataemia)
  • Elevation of the plasma bicarbonate concentration (metabolic alkalosis) or reduction of the plasma bicarbonate concentration (metabolic acidosis).

There are also some side effects which can be caused by dialysis treatments, such as:

  • nausea, vomiting, muscle cramps and low blood pressure (hypotension).

REPORTING OF SIDE EFFECTS

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:

The Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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.

5. HOW TO STORE PHOXILIUM

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT PHOXILIUM CONTAINS.

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:

  • carbon dioxide
    (for pH adjustment) E290,
  • hydrochloric acid (for pH adjustment) E507 and
  • water for injections.

WHAT PHOXILIUM LOOKS LIKE AND CONTENTS OF THE PACK

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.

MARKETING AUTHORISATION HOLDER:
Vantive Limited
Wavertree Technology Park
2 Wavertree Boulevard
Liverpool
L7 9PE
United Kingdom

MANUFACTURER:
Vantive Manufacturing Limited
Moneen Road
Castlebar
County Mayo
F23 XR63
Ireland

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

Vantive Limited
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Address
Wavertree Technology Park, 2 Wavertree Boulevard, Liverpool, L7 9PE
WWW
www.vantive.com
Telephone
0151 250 1560
Medical Information Direct Line
0151 250 1560
Medical Information e-mail
[email protected]
Customer Care direct line
0800 023 4002