Duosol 00 555 mL Solution for haemofiltration

The ready-to-use solution is indicated for the treatment by continuous haemofiltration, of intensive care unit patients with acute renal failure of any origin.

Posology
If not otherwise prescribed, for adults a filtration rate of ca.600 u2013 1200 mL/h is adequate for the removal of those substances, that are obligatorily excreted in the urine, depending on the metabolic condition of the patient. Nevertheless a maximum filtration rate of 75 L per day should not be exceeded. The dose-volume is at the discretion of the medical practitioner 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. The treatment of acute renal failure is carried out for a limited period and is ended when renal function is stored.
Paediatric population
Regarding substitution rate for children an initial creatinine GFR (glomerula filtration rate) of 10 mL/min/1,73 m2 should be reached. The substitution rate can range from 150 to 1500 mL/hr.
Method of administration
Intravenous use. 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 of the patient.

Specific to the ready-to-use solution for haemofiltration:
u2022 Hypokalaemia
u2022 Metabolic alkalosis
For haemofiltration in general:
u2022 Acute renal failure with a marked hypercatabolic state when uraemic symptoms can no longer be corrected by haemofiltration
u2022 Inadequate blood flow from the vascular access
u2022 All states of increased risk of haemorrhage due to systemic anticoagulation

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 and/or changing to a substitution solution with higher potassium concentration may become necessary. In cases of increased serum potassium, hyperkalaemia, an increase in the filtration rate 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 must only be used after opening the peel seam and mixing of the two solutions. For further instructions, see 6.6. If in doubt the decision concerning the use of the solution should be made by the medical practitioner 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.

The blood concentration of filterable medicinal products, e.g. medicinal products with low protein binding capacity, may be reduced during treatment and corresponding corrective therapy should be instituted if necessary. Interactions with other medicinal products can be avoided by correct dosing of the solution for haemofiltration and strict monitoring of clinical chemistry parameters and vital signs.
However, the following interactions are conceivable:
u2022 Electrolyte substitutions, parenteral nutrition and other infusions usually given in intensive care medicine interact with the serum composition and the fluid status of the patient. This must be considered when prescribing haemofiltration treatment.
u2022 Toxic effects of digitalis may be masked by hyperkalaemia, hypermagnesaemia and hypocalcaemia. The correction of these electrolytes by haemofiltration may precipitate signs and symptoms of digitalis toxicity, e.g. cardiac arrhythmia. If potassium levels are low or calcium levels high, digitalis toxicity may occur at sub-optimal doses of digitalis therapy.
u2022 Vitamin D and medicinal products containing calcium, e.g. calcium carbonate as phosphate binder, can increase the risk of hypercalcaemia.
u2022 Additional sodium bicarbonate substitution can increase the risk of metabolic alkalosis.

Pregnancy
There are no data from the use of Duosol in pregnant women or from animal studies. However, because all the ingredients of the solution for haemofiltration are physiological substances that serve to replace essential plasma components removed by haemofiltration, no risks for the unborn child are to be expected. The use of Duosol may be considered during pregnancy, if necessary.
Lactation
Because all the ingredients of the solution for haemofiltration are physiological substances that serve to replace essential plasma components removed by haemofiltration, no risks for the child are to be expected. The use of Duosol may be considered during lactation, if necessary.
Fertility
Because all the ingredients of the solution for haemofiltration are physiological substances that serve to replace essential components removed by haemofiltration, no effects on fertility are to be expected.

Not relevant.

There have been no reports of adverse reaction that might possibly be associated with the bicarbonate-buffered solution for haemifiltration. However, the following adverse reactions could result from the treatment or the solution used. The frequency of these adverse reactions is not known (cannot be estimated from the available data):
Metabolism and nutrition disorders
Hyper- or dehydration, electrolyte disturbances, hypophosphataemia, hyperglycaemia, metabolic alkalosis
Vascular disorders
Hypertension, hypotension
Gastrointestinal disorders
Nausea, vomiting
Musculoskeletal and connective tissue disorders
Muscle cramps

Following the use of recommended doses no reports of emergency situations have arisen; moreover, the administration of the solution can be discontinued at any time. If fluid is not accurately calculated and monitored, hyperhydration or dehydration may occur, manifest through changes in blood pressure, central venous pressure, heart rate and pulmonary arterial pressure. In cases of hyperhydration, ultrafiltration should be increased and the rate and volume of solution for haemofiltration infused should be reduced. In cases of severe dehydration, ultrafiltration should be decreased or discontinued and the volume of solution for haemofiltration infused should be increased as appropriate. Bicarbonate overdose can occur if an inappropriately large volume of solution for haemofiltration is administered and this might lead to metabolic alkalosis, decrease of ionised calcium or tetany. Overtreatment can cause congestive cardiac failure and/or pulmonary congestion and may result in disturbances in electrolyte concentrations and acid-base balance.