PHOXILIUM 1.2 mmol/l phosphate Solution for haemodialysis/ haemofiltration

Section 4.2 - changes in RED
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 and adolescents:           500 - 3000 ml/hour

Children:                                 15 - 35 ml/kg/hour

 

The range of flow rates for the dialysate in continuous haemodialysis and continuous haemodiafiltration are:

Adult and adolescents:           500 - 2500 ml/hour

Children:                                 15 - 30 ml/kg/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 replacement fluid volume of approximately 48 to 60 l.

 

Paediatric population:

 

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.

Section 4.4 changes in red

 

The solution shall be used only by, or under the direction of, a physician competent in CRRT treatments using haemofiltration, haemodiafiltration and haemodialysis.

 

Warnings:

 

Phoxilium should not be used in patients with hyperkalemia (see section 4.3). The serum potassium concentration must be monitored before and during haemofiltration and/or haemodialysis.

 

Because Phoxilium is a potassium-containing solution, hyperkalemiahyperkalaemia may occur transiently after treatment is initiated. Decrease the infusion rate and confirm that the desired potassium concentration is achieved. If hyperkalemiahyperkalaemia does not resolve, stop administration promptly.

 

If hyperkalaemia develops when Phoxilium is used as a dialysate, administration of a potassium-free dialysate may be necessary to increase the rate of potassium removal.

 

Because Phoxilium is a phosphate-containing solution, hyperphosphatemia may occur transiently after treatment is initiated.  Decrease the infusion rate and confirm that the desired phosphate concentration is achieved.  If hyperphosphatemia does not resolve, stop administration promptly (See Section 4.3 Contraindication).

 

Electrolyte and blood acid/base parameters should be monitored regularly in patients treated with Phoxilium.  Phoxilium contains hydrogen phosphate, a weak acid that can influence the patient’s acid/base balance.  If metabolic acidosis develops or worsens during therapy with Phoxilium, the infusion rate may need to be decreased or its administration stopped. 

 

Because Phoxilium contains no glucose, administration may lead to hypoglycaemia. Blood glucose levels should be monitored regularly in diabetic patients (including careful consideration of patients receiving insulin or other glucose lowering medications), but also considered in non-diabetic patients, e.g. risk for silent hypoglycemia during the procedure. If hypoglycaemia develops, use of a glucose-containing solution should be considered. Other corrective measures may be necessary to maintain desired glycaemic control.

 

The instructions for use (see section 6.6) must be strictly followed.

The solutions in the two compartments must be mixed before use.

 Use of a contaminated solution may cause sepsis and shock

 

Do not administer the solution unless it is clear. Aseptic technique must be used during connection / disconnection of the line sets to the Phoxilium container.

 

Use only with an appropriate extracorporal renal replacement equipment.

 

Special precautions for use:

Phoxilium may be warmed to 37 °C to enhance patient comfort. However, only dry heat should be used.Warming of the solution prior to use should be done before reconstitution with dry heat only. Solutions should not be heated in water or in a microwave oven. Phoxilium should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless the solution is clear and the seal is intact.

 

Haemodynamic status, fluid balance, electrolyte and acid-base balance shall be closely monitored throughout the procedure including all fluid inputs and outputs, even those not directly related to CRRT.

 

In case of hypervolemiahypervolaemia, the net ultrafiltration rate prescribed for the CRRT device can be increased and/or the rate of administration of solutions other than replacement fluid and/or dialysate can be reduced.

 

In case of hypovolemiahypovolaemia, the net ultrafiltration rate prescribed for the CRRT device can be reduced and/or the rate of administration of solutions other than replacement fluid and/or dialysate can be increased.

Section 4.5 Changes in red - added to final paragraph

When citrate is used as an anticoagulant, it contributes to the overall buffer load and can reduce plasma calcium levels 

Section 7 - small address change
Section 10 - revision 10

Section 4.2 - changes in RED
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 and adolescents:           500 - 3000 ml/hour

Children:                                 15 - 35 ml/kg/hour

 

The range of flow rates for the dialysate in continuous haemodialysis and continuous haemodiafiltration are:

Adult and adolescents:           500 - 2500 ml/hour

Children:                                 15 - 30 ml/kg/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 replacement fluid volume of approximately 48 to 60 l.

 

Paediatric population:

 

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.

Section 4.4 changes in red

 

The solution shall be used only by, or under the direction of, a physician competent in CRRT treatments using haemofiltration, haemodiafiltration and haemodialysis.

 

Warnings:

 

Phoxilium should not be used in patients with hyperkalemia (see section 4.3). The serum potassium concentration must be monitored before and during haemofiltration and/or haemodialysis.

 

Because Phoxilium is a potassium-containing solution, hyperkalemiahyperkalaemia may occur transiently after treatment is initiated. Decrease the infusion rate and confirm that the desired potassium concentration is achieved. If hyperkalemiahyperkalaemia does not resolve, stop administration promptly.

 

If hyperkalaemia develops when Phoxilium is used as a dialysate, administration of a potassium-free dialysate may be necessary to increase the rate of potassium removal.

 

Because Phoxilium is a phosphate-containing solution, hyperphosphatemia may occur transiently after treatment is initiated.  Decrease the infusion rate and confirm that the desired phosphate concentration is achieved.  If hyperphosphatemia does not resolve, stop administration promptly (See Section 4.3 Contraindication).

 

Electrolyte and blood acid/base parameters should be monitored regularly in patients treated with Phoxilium.  Phoxilium contains hydrogen phosphate, a weak acid that can influence the patient’s acid/base balance.  If metabolic acidosis develops or worsens during therapy with Phoxilium, the infusion rate may need to be decreased or its administration stopped. 

 

Because Phoxilium contains no glucose, administration may lead to hypoglycaemia. Blood glucose levels should be monitored regularly in diabetic patients (including careful consideration of patients receiving insulin or other glucose lowering medications), but also considered in non-diabetic patients, e.g. risk for silent hypoglycemia during the procedure. If hypoglycaemia develops, use of a glucose-containing solution should be considered. Other corrective measures may be necessary to maintain desired glycaemic control.

 

The instructions for use (see section 6.6) must be strictly followed.

The solutions in the two compartments must be mixed before use.

 Use of a contaminated solution may cause sepsis and shock

 

Do not administer the solution unless it is clear. Aseptic technique must be used during connection / disconnection of the line sets to the Phoxilium container.

 

Use only with an appropriate extracorporal renal replacement equipment.

 

Special precautions for use:

Phoxilium may be warmed to 37 °C to enhance patient comfort. However, only dry heat should be used.Warming of the solution prior to use should be done before reconstitution with dry heat only. Solutions should not be heated in water or in a microwave oven. Phoxilium should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless the solution is clear and the seal is intact.

 

Haemodynamic status, fluid balance, electrolyte and acid-base balance shall be closely monitored throughout the procedure including all fluid inputs and outputs, even those not directly related to CRRT.

 

In case of hypervolemiahypervolaemia, the net ultrafiltration rate prescribed for the CRRT device can be increased and/or the rate of administration of solutions other than replacement fluid and/or dialysate can be reduced.

 

In case of hypovolemiahypovolaemia, the net ultrafiltration rate prescribed for the CRRT device can be reduced and/or the rate of administration of solutions other than replacement fluid and/or dialysate can be increased.

Section 4.5 Changes in red - added to final paragraph

When citrate is used as an anticoagulant, it contributes to the overall buffer load and can reduce plasma calcium levels 

Section 7 - small address change
Section 10 - revision 10

major updates in line with updated CCDS to most section quoted - changes in red
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Phoxilium is presented in a two-compartment bag. The final reconstituted solution is obtained after breaking the frangible pin or the peel seal and mixing both solutions
AFTER RECONSTITUTION
1000 ml of the reconstituted solution contains
Each 1000 ml of the final reconstituted solution corresponds to 50 ml of solution A and 950 ml of solution B.
 3. PHARMACEUTICAL FORM
Solution for haemodialysis/ haemofiltration.
'Deletion of Before Constitution' Clear and colourless solutions

4.2 Posology and method of administration
Posology:
The volume and rate at which Phoxilium is administered depends on the blood concentration of phosphate and other electrolytes, acid–base balance, and overall clinical condition of the patient. Administration (dose, infusion rate and cumulative volume) of Phoxilium should be established by a physician.

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.

4.4 Special warnings and precautions for use
The solution shall be used only by, or under the direction of, a physician competent in CRRT treatments using haemofiltration, haemodiafiltration and haemodialysis.

Warnings:
Because Phoxilium is a potassium-containing solution, hyperkalemia may occur transiently after treatment is initiated. Decrease the infusion rate and confirm that the desired potassium concentration is achieved. If hyperkalemia does not resolve, stop administration promptly.

Because Phoxilium is a phosphate-containing solution, hyperphosphatemia may occur transiently after treatment is initiated. Decrease the infusion rate and confirm that the desired phosphate concentration is achieved. If hyperphosphatemia does not resolve, stop administration promptly (See Section 4.3 Contraindication).

Electrolyte and blood acid/base parameters should be monitored regularly in patients treated with Phoxilium. Phoxilium contains hydrogen phosphate, a weak acid that can influence the patient’s acid/base balance. If metabolic acidosis develops or worsens during therapy with Phoxilium, the infusion rate may need to be decreased or its administration stopped.

The instructions for use (see section 6.6) must be strictly followed.
The solutions in the two compartments must be mixed before use.
Use of a contaminated solution may cause sepsis and shock

Do not administer the solution unless it is clear. Aseptic technique must be used during connection / disconnection of the line sets to the Phoxilium container.

Use only with an appropriate extracorporal renal replacement equipment.

Special precautions for use:
Phoxilium may be warmed to 37 °C to enhance patient comfort. However, only dry heat should be used. Solutions should not be heated in water or in a microwave oven. Phoxilium should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless the solution is clear and the seal is intact.

Haemodynamic status, fluid balance, electrolyte and acid-base balance shall be closely monitored throughout the procedure including all fluid inputs and outputs, even those not directly related to CRRT.

In case of hypervolemia, the net ultrafiltration rate prescribed for the CRRT device can be increased and/or the rate of administration of solutions other than replacement fluid and/or dialysate can be reduced.

In case of hypovolemia, the net ultrafiltration rate prescribed for the CRRT device can be reduced and/or the rate of administration of solutions other than replacement fluid and/or dialysate can be increased.

4.5 & 4.6 Major changes to text
4.8 Major changes to text and table
4.9 Major changes to text

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Hemofiltrates.
ATC code: B05ZB
Phoxilium, solution for haemofiltration and haemodialysis, is pharmacologically inactive. The sodium, calcium, magnesium, potassium, phosphate and chloride ions are present at concentrations similar to physiological concentrations in normal plasma.
Phoxilium is used to replace water and electrolytes removed during haemofiltration and haemodiafiltration or to serve as a suitable dialysate for use during continuous haemodiafiltration or continuous haemodialysis

6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.6 Major changes to text

10 Date change

major updates in line with updated CCDS to most section quoted - changes in red
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Phoxilium is presented in a two-compartment bag. The final reconstituted solution is obtained after breaking the frangible pin or the peel seal and mixing both solutions
AFTER RECONSTITUTION
1000 ml of the reconstituted solution contains
Each 1000 ml of the final reconstituted solution corresponds to 50 ml of solution A and 950 ml of solution B.
 3. PHARMACEUTICAL FORM
Solution for haemodialysis/ haemofiltration.
'Deletion of Before Constitution' Clear and colourless solutions

4.2 Posology and method of administration
Posology:
The volume and rate at which Phoxilium is administered depends on the blood concentration of phosphate and other electrolytes, acid–base balance, and overall clinical condition of the patient. Administration (dose, infusion rate and cumulative volume) of Phoxilium should be established by a physician.

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.

4.4 Special warnings and precautions for use
The solution shall be used only by, or under the direction of, a physician competent in CRRT treatments using haemofiltration, haemodiafiltration and haemodialysis.

Warnings:
Because Phoxilium is a potassium-containing solution, hyperkalemia may occur transiently after treatment is initiated. Decrease the infusion rate and confirm that the desired potassium concentration is achieved. If hyperkalemia does not resolve, stop administration promptly.

Because Phoxilium is a phosphate-containing solution, hyperphosphatemia may occur transiently after treatment is initiated. Decrease the infusion rate and confirm that the desired phosphate concentration is achieved. If hyperphosphatemia does not resolve, stop administration promptly (See Section 4.3 Contraindication).

Electrolyte and blood acid/base parameters should be monitored regularly in patients treated with Phoxilium. Phoxilium contains hydrogen phosphate, a weak acid that can influence the patient’s acid/base balance. If metabolic acidosis develops or worsens during therapy with Phoxilium, the infusion rate may need to be decreased or its administration stopped.

The instructions for use (see section 6.6) must be strictly followed.
The solutions in the two compartments must be mixed before use.
Use of a contaminated solution may cause sepsis and shock

Do not administer the solution unless it is clear. Aseptic technique must be used during connection / disconnection of the line sets to the Phoxilium container.

Use only with an appropriate extracorporal renal replacement equipment.

Special precautions for use:
Phoxilium may be warmed to 37 °C to enhance patient comfort. However, only dry heat should be used. Solutions should not be heated in water or in a microwave oven. Phoxilium should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless the solution is clear and the seal is intact.

Haemodynamic status, fluid balance, electrolyte and acid-base balance shall be closely monitored throughout the procedure including all fluid inputs and outputs, even those not directly related to CRRT.

In case of hypervolemia, the net ultrafiltration rate prescribed for the CRRT device can be increased and/or the rate of administration of solutions other than replacement fluid and/or dialysate can be reduced.

In case of hypovolemia, the net ultrafiltration rate prescribed for the CRRT device can be reduced and/or the rate of administration of solutions other than replacement fluid and/or dialysate can be increased.

4.5 & 4.6 Major changes to text
4.8 Major changes to text and table
4.9 Major changes to text

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Hemofiltrates.
ATC code: B05ZB
Phoxilium, solution for haemofiltration and haemodialysis, is pharmacologically inactive. The sodium, calcium, magnesium, potassium, phosphate and chloride ions are present at concentrations similar to physiological concentrations in normal plasma.
Phoxilium is used to replace water and electrolytes removed during haemofiltration and haemodiafiltration or to serve as a suitable dialysate for use during continuous haemodiafiltration or continuous haemodialysis

6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.6 Major changes to text

10 Date change

None provided

None provided