1.2 mmol / l phosphate hemodialysis fluid / haemofiltration fluid
calcium chloride dihydrate, magnesium chloride hexahydrate, sodium chloride, sodium bicarbonate, potassium chloride, disodium phosphate dihydrate
What Phoxilium is and what it is used for
Phoxilium belongs to the group of haemofiltration fluids and contains calcium chloride dihydrate, magnesium chloride hexahydrate, sodium chloride, sodium bicarbonate, potassium chloride and disodium phosphate dihydrate.
Phoxilium is used in hospitals in intensive care to correct chemical imbalances in the blood caused by kidney damage.
Continuous kidney replacement therapy is used to remove waste products from the blood that have accumulated when the kidneys are not functioning.
Phoxilium solution is mainly used to treat critically ill patients with acute kidney injury and:
- normal potassium level in the blood or
- normal or low phosphate levels ( hypophosphatemia ) in the blood.
This drug can also be used for drug poisoning or intoxication of dialyzable or filterable substances.
What you need to know before using Phoxilium
Do not use Phoxilium in the following three cases:
- high potassium levels in the blood ( hyperkalaemia )
- high bicarbonate content in the blood ( metabolic alkalosis )
- high phosphate levels in the blood ( hyperphosphatemia ).
Do not use hemodialysis or haemofiltration in any of the following three cases:
- if symptoms caused by high levels of urea in the blood ( uremic symptoms ) due to kidney damage with pronounced hypercatabolism ( abnormally high degradation of tissues ) can not be corrected with hemofiltration
- if the arterial pressure in the vessel access is insufficient
- if the coagulation capacity is reduced ( systemic anticoagulation ) and there is a high risk of bleeding.
Warnings and cautions
Talk to your doctor, pharmacist or nurse before using Phoxilium.
Before and during treatment, your blood condition will be checked and, for example, the acid / base balance and salt concentration in the blood ( electrolytes ) will be monitored, including all fluid supply ( intravenous infusion ) and all fluid withdrawals (urine production), even those not directly related to the treatment. .
Other drugs and Phoxilium
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is important because the concentration of other medicines may affect the treatment with Phoxilium. Your doctor will decide if the dosage of any of the medicines you are taking may need to be adjusted.
It is especially important that you tell your doctor if you are taking any of the following:
- Additional phosphate sources (eg nutritional fluids) as they may increase the risk of high phosphate levels in the blood ( hyperphosphatemia ).
- Vitamin D and medicines that contain calcium chloride or calcium gluconate as they may increase the risk of high calcium levels in the blood ( hypercalcaemia ).
- Sodium bicarbonate as it may increase the risk of excess bicarbonate in the blood ( metabolic alkalosis ).
- When citrate is used to counteract blood coagulation, as it can lower the calcium concentration in the blood.
Pregnancy, breastfeeding and fertility
Pregnancy and breast-feeding:
There are no documented clinical data on the use of this medicine during pregnancy or lactation. This medicine should only be given to pregnant or lactating women if there is a clear need.
Fertility:
No effects on fertility are expected as calcium , sodium , potassium , magnesium , chloride, hydrogen phosphate and bicarbonate are normal constituents of the body.
Driving and using machines
Phoxilium does not affect the ability to drive or use machines.
How to use Phoxilium
Phoxilium should be used in hospitals and only administered by healthcare professionals. The volume of Phoxilium, and thus the dose used, will depend on your condition. Dosage one will be determined by the doctor responsible for your treatment.
Phoxilium can be administered directly into the bloodstream ( intravenously ) through a CRRT machine or via hemodialysis 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. If you are not sure, talk to your doctor, pharmacist, or nurse.
Instructions for use can be found in the section “The following information is only intended for healthcare professionals”.
If you use more Phoxilium than you should
Phoxilium should be used in a hospital and only administered by healthcare professionals, and your fluid balance and blood status will be closely monitored.
Therefore, it is unlikely that you will use too much Phoxilium.
If this is unlikely to happen and you get an overdose, your doctor will take the necessary steps and adjust your dose.
Overdose may result in dehydration, reduction of blood bicarbonate concentration (metabolic acidosis ), and/or high phosphate levels ( hyperphosphatemia ) if you have kidney damage.
It can lead to serious consequences, such as heart failure or blood disorder.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following three side effects may be associated with the use of Phoxilium :
- the abnormally high or low fluid level in the body ( hyper- or hypovolemia )
- altered salt balance in the blood (disturbed electrolyte balance such as hyperphosphatemia )
- increased bicarbonate content in the blood ( metabolic alkalosis ) or reduction of the bicarbonate content in the blood (metabolic acidosis ).
Some side effects can be caused by dialysis treatments, such as:
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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 carton. The expiration date is the last day of the specified month.
Store between + 4 ° C and + 30 ° C. Store in a cold place. Do not freeze.
For the reconstituted solution, chemical and physical in-use stability have been demonstrated for up to 24 hours at 22 ° C. If not used immediately, in-use storage times and conditions before administration are the responsibility of the user and should not exceed 24 hours, including treatment time.
Do not use this medicine if the solution is cloudy or if the cover is damaged. All seals must be unbroken.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
The active substances before and after reconstitution ( mixture ) are shown below.
Active substances before reconstitution:
1,000 ml solution from the small chamber (A) contains:
| Calcium chloride, 2 H 2 O | 3.68 g |
| Magnesium chloride, 6 H 2 O | 2.44 g |
1,000 ml solution from the large chamber (B) contains:
| Sodium chloride | 6.44 g |
| Sodium bicarbonate | 2.92 g |
| Potassium chloride | 0.314 g |
| Disodium phosphate, 2 H 2 O | 0.225 g |
Active substances after reconstitution:
The solutions in chambers A (250 ml) and B (4 750 ml) are reconstituted with the reconstituted solution (5,000 ml), the composition of which is:
| mmol / l | |
| Calcium Ca 2+ | 1.25 |
| Magnesium Mg 2+ | 0.6 |
| Sodium, Na + | 140 |
| Chloride, Cl – | 115.9 |
| Hydrogen phosphate, HPO 4 2- | 1.2 |
| Hydrogen carbonate, HCO 3 – | 30 |
| Potassium, K + | 4 |
Theoretical osmolarity: 293 mOsm / l
Other ingredients are:
- carbon dioxide (for pH adjustment) E 290
- hydrochloric acid (for pH adjustment) E 507
- water for injections.
What the medicine looks like and the contents of the pack
Phoxilium is a solution for hemodialysis and hemofiltration and is packaged in a two-chamber bag. The ready-mixed solution is obtained by breaking the seal and mixing the two solutions. The reconstituted solution is clear and colorless. Each bag (A + B) contains 5,000 ml of solution for hemodialysis and haemofiltration. The bag is covered with a transparent film.
Each carton contains two bags and a package leaflet.
Marketing Authorisation Holder
Baxter Holding BV
Kobaltweg 49
3542CE Utrecht
Netherlands
Manufacturer:
Bieffe Medital SpA, Via Stelvio 94, 23035 Sondalo (SO), ITALY
Local representative
Baxter Medical AB
Box 63
164 94 Kista