DUOSOL WITH

The use of solutions for haemofiltration in patients with acute renal failure should be under the direction of a physician with experience in using such treatment. Posology The filtration rate prescribed is dependent on the clinical status and the body weight of the patient.

Unless otherwise prescribed, a filtration rate of 20-25 ml/kg body weight per hour is recommended for the removal of metabolic waste products normally excreted in the urine, depending on the metabolic condition of the patient. The dose-volume is at the discretion of the physician because the volume of substitution solution depends on the intensity of treatment performed and on the amount of fluid to be replaced in order to achieve fluid balance.

Paediatric population The dosage recommendations mentioned above are also applicable for the paediatric population. Method of administration Intravenous use. The ready-to-use solution for haemofiltration has to be prepared by opening the peel seam.

The mixing is performed by twisting the bag five times. 6. The ready-to-use solution for haemofiltration is infused into the extracorporeal circulation by means of an infusion pump. During haemofiltration the solution for haemofiltration replaces the ultrafiltrate removed from the blood taking into account overall fluid balance.

In acute renal failure, treatment is carried out for a limited time period and is discontinued when renal function is fully restored.

There have been no reports of adverse reactions that might possibly be associated with the bicarbonate- buffered solution for haemofiltration. However, the following adverse reactions could result from the treatment or the solution used.

g. hyperkalaemia), hypophosphataemia, hyperglycaemia, metabolic alkalosis Vascular disorders Hypertension, hypotension Gastrointestinal disorders Nausea, vomiting Musculoskeletal and connective tissue disorders Muscle cramps Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

The haemodynamic status, fluid balance, electrolyte and acid-base balance, blood glucose, and levels of urea and plasma creatinine should be closely monitored before and during haemofiltration. The serum potassium concentration must be regularly monitored before and during haemofiltration.

If the serum potassium falls and hypokalaemia develops, supplementation of potassium may become necessary. In cases of increased serum potassium, hyperkalaemia, an increase in the filtration rate and/or changing to a 3 substitution solution with a lower potassium concentration may be indicated together with the usual measures of intensive care medicine.

The inorganic phosphate concentration should be measured regularly during haemofiltration. Inorganic phosphate must be substituted in cases of hypophosphataemia. Plastic containers are occasionally damaged during transport from the manufacturer to the hospital/dialysis unit or within the hospital/dialysis unit.

This can lead to contamination with microbial or fungal growth in the solution for haemofiltration. Therefore, careful visual inspection of the container and the solution for haemofiltration is necessary before attaching the container and before administration of the solution.

Particular attention should be paid to the slightest damage to the closure, to the preparation seal, to the peel seam and to the corners of the container as sources of possible contamination. The solution for haemofiltration must only be used if the container (outer wrap and two-chamber bag), peel seam and connectors are undamaged and intact and if the solution is clear and colourless and free from visible particles.

The solution must only be used after opening the peel seam and mixing of the two solutions. 6. If in doubt the decision concerning the use of the solution should be made by the physician in charge of the treatment. The solution for haemofiltration should be warmed to approximately body temperature by an integrated or external heater.

The solution must not be infused under any circumstances if below room temperature. During application of this medicinal product, white calcium carbonate precipitation has been observed in the tubing lines in rare cases, particularly close to the pump unit and the heating unit.

Therefore, the solution in the tubing lines should be closely visually inspected every 30 min during haemofiltration in order to ensure that the solution in the tubing system is clear and free from precipitate. Precipitations may occur also with substantial delay after start of treatment.

If precipitate is observed, the solution and the tubing lines must be replaced immediately and the patient carefully monitored.

Specific to the ready-to-use solution for haemofiltration: ● Hyperkalaemia ● Metabolic alkalosis For haemofiltration in general: ● Acute renal failure with a marked hypercatabolic state when uraemic symptoms can no longer be corrected by haemofiltration ● Inadequate blood flow from the vascular access ● All states of increased risk of haemorrhage due to systemic anticoagulation