BIPHOZYL Solution for haemodialysis Ref.[28147] Active ingredients: Magnesium chloride Potassium chloride Sodium bicarbonate Sodium chloride Sodium phosphate

Posology

The volume and rate at which Biphozyl 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 Biphozyl should only be established by a physician experienced in critical care medicine and CRRT (Continuous Renal Replacement Therapy).

The range of flow rates when used as replacement solution in haemofiltration and haemodiafiltration are: Adult: 500-3000 ml/h

The range of flow rates when used as dialysate in continuous haemodialysis and continuous haemodiafiltration are: Adult: 500-2500 ml/h

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 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

Elderly patients

Adults >65 years of age: Evidence from clinical studies and experience suggests that use in the elderly population is not associated with differences in safety or effectiveness.

Method of administration

Intravenous use and use in haemodialysis.

Biphozyl, when used as a replacement solution, is administered into the extracorporeal circuit before (predilution) or after (post-dilution) the haemofilter or haemodiafilter.

Biphozyl, 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.

For instructions on reconstitution of the medicinal product before administration, see section 6.6 (Special precautions for disposal and other handling).

Overdose of Biphozyl can lead to severe clinical condition, such as congestive heart failure, electrolyte or acid-base disturbances.

• If hypervolaemia or hypovolaemia occur, instruction for handling of hypervolaemia or hypovolaemia in section 4.4 must be strictly followed.
• If metabolic acidosis and/or hyperphosphatemia occur in the event of an overdose, stop administration promptly. There is no specific antidote for overdose. The risk can be minimized by close monitoring during treatment (see section 4.3 and 4.4).

18 months.

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.

This medicinal product does not require any special storage conditions.

Do not freeze.

For the storage condition of the reconstituted solution, see section 6.3.

The container is a two-compartment bag made of a multilayer film containing polyolefins and elastomers. The 5000 ml bag is comprised of a small compartment (250 ml) and a large compartment (4750 ml). The two compartments are separated by a peel seal. The bag is fitted with an injection connector (or spike connector) made of polycarbonate (PC) and a luer connector (PC) with a valve made of silicone rubber for the connection with a suitable solution line. The bag is overwrapped with a transparent overwrap made of polymer film.

Pack size: 2 × 5000 ml in a box.

The solution in the small compartment is added to the solution in the large compartment after breaking the peel seal immediately before use. The reconstituted solution shall be clear and colourless.

Aseptic technique should be used throughout administration to the patient. Use only if the overwrap is undamaged, all seals are intact, peel seal is not broken, and the solution is clear. Press bag firmly to test for any leakage. If leakage is discovered, discard the solution immediately since sterility can no longer be assured.

The large compartment is fitted with an injection port for the possible addition of other necessary drugs after reconstitution of the solution. It is the responsibility of the user to determine the compatibility of an additive medication with Biphozyl by checking for possible colour change and/or possible precipitation, insoluble complexes or crystals. Before adding a medication, verify if it is soluble and stable in this medicine and that the pH range of Biphozyl is appropriate (pH of reconstituted solution is 7.0-8.0). Additives may be incompatible. The instructions for use of the medication to be added must be consulted.

Mix the solution thoroughly when additives have been introduced. The introduction and mixing of additives must always be performed prior to connecting the solution bag to the extracorporeal circuit.

Remove the overwrap from the bag immediately before use.

Open the seal by holding the small compartment with both hands and squeezing it until an opening is created in the peel seal between the two compartments. Push with both hands on the large compartment until the peel seal is entirely open.

Secure complete mixing of the solution by shaking the bag gently. The solution is now ready for use, and should be used immediately.

The dialysis or replacement line may be connected to either of the two access ports. After connection verify that the fluid is flowing freely.

The reconstituted solution is for single use only. Any unused solution must be discarded. The solution can be disposed of via wastewater without harming the environment.