REGIOCIT

Posology The rate at which Regiocit is administered depends on the targeted citrate dose and the prescribed blood flow rate (BFR). The prescription of Regiocit must consider the flow rates of the effluent and other therapeutic fluids, the patient’s fluid removal requirements, additional fluid inputs and outputs, and the desired acid-base and electrolyte balance.

Regiocit should be prescribed and administration (dose, infusion rate, and cumulative volume) should be established only by a physician experienced in critical care medicine and CRRT. The pre-filter infusion rate of Regiocit must be prescribed and adapted relative to the blood flow rate to achieve a target blood citrate concentration of 3 to 4 mmol/l of blood.

35 mmol/l. The patient’s systemic ionized calcium concentration should be maintained in the normal physiologic range by adjustment of calcium supplementation. , dialysate and/or replacement fluid). Regiocit must be used together with a dialysis solution/replacement solution with appropriate bicarbonate concentration.

A separate infusion of calcium is always required. Adjust or stop calcium infusion according to physician’s prescription when anticoagulation is stopped. 4). Plasma levels of sodium, magnesium, potassium, and phosphate should be monitored regularly and should be supplemented as needed.

5 l/h with a blood flow rate between 100 and 200 ml/min. • In continuous veno-venous haemodiafiltration o 1-2 l/h with a blood flow rate between 100 and 200 ml/min.

Paediatric population:

For neonates to toddlers (0 to 23 months) Regiocit should target a dose of 3 mmol citrate per litre of blood flow in continuous veno-venous haemofiltration or haemodiafiltration. For children (2 to 11 years) dosage should be adapted to both the weight of the patient and the blood flow rate.

Special populations:

In the elderly population there is no specific modification of the dosage compared to adults. , Child-Pugh ≤12). g. 4). Frequent monitoring of citrate accumulation is advised. 3). Method of administration For intravenous use. Regiocit must be used with appropriate extracorporeal renal replacement equipment intended for CRRT in pre-dilution mode only, using a dedicated pump for citrate anticoagulation where the solution flow rate is automatically adapted based on an operator set target dose (mmol citrate/l blood).

Undesirable effects can result from the Regiocit solution or the dialysis treatment. 4. g. g. 4) Vascular disorder Not known Hypotension* Gastrointestinal disorder Not known Nausea* Vomiting* Musculoskeletal and connective tissue disorders Not known Muscle spasms* * undesirable effects related to the dialysis treatment 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.

Regiocit is not for direct intravenous infusion. It should be used in predilution only, with appropriate extracorporeal renal replacement equipment intended for CRRT. The dialysis machine must be suitable for citrate anticoagulation.

Regiocit may be warmed to 37°C to enhance patient comfort. Warming of the solution prior to use should be done with dry heat only. Solutions should not be heated in water or in a microwave oven due to the potential for patient injury or discomfort.

Regiocit 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. Use only if the overwrap and solution bag are undamaged.

Use of a contaminated solution may cause sepsis and shock. Considering the composition of Regiocit, other solutions used in the treatment must have appropriate hydrogen carbonate concentration. Regiocit contains citrate, which can influence the patient’s electrolyte and acid–base balance.

The patient’s haemodynamic status, fluid balance, glucose level, electrolyte and acid/base balance should be closely monitored before and during treatment. Closely monitor sodium, magnesium, potassium, phosphate, and calcium. Blood concentration and patients’ needs should be assessed several times daily including assessment of infusate inputs and all outputs.

9). Regiocit contains no calcium, and may lead to systemic ionized hypocalcaemia due to loss of calcium bound to citrate in the effluent and/or in the case of systemic citrate accumulation. Regiocit contains no magnesium. Use of Regiocit may result in hypomagnesaemia due to CRRT effluent losses.

Patient should be monitored as infusion of magnesium may be necessary. Regiocit contains no glucose. Administration of Regiocit may lead to hypoglycaemia. Blood glucose levels should be monitored regularly. Regiocit contains no potassium.

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