REGIOCIT SOLUTION FOR HAEMOFILTRATION [SIN15513P]

Product Info

REGIOCIT SOLUTION FOR HAEMOFILTRATION

[SIN15513P]

4.1 THERAPEUTIC INDICATIONS
Regiocit solution is indicated as replacement fluid before dialyzer for continuous renal replacement therapy (CRRT) using regional citrate anticoagulation. Citrate is particularly relevant when systemic anticoagulation with heparin is contraindicated, for example in patients with increased bleeding risks.

In paediatric patients, Regiocit solution is indicated in all age groups provided that the equipment used is adapted to the weight of the child.

4.2 POSOLOGY AND METHOD OF ADMINISTRATION

Posology
The rate at which Regiocit solution is administered depends on the targeted citrate dose and the prescribed blood flow rate (BFR). The prescription of Regiocit solution 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 solution 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 solution 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.

Flow rate for anticoagulation of the extracorporeal circuit should be titrated to achieve a post-filter concentration of ionized calcium in the range 0.25 to 0.35 mmol/l. The patient’s systemic ionized calcium concentration should be maintained in the normal physiologic range by adjustment of calcium supplementation.

Citrate also acts as a buffer source (due to conversion to bicarbonate); the infusion rate of Regiocit solution must be considered in relation to the rate at which buffer administration occurs from other sources (e.g., dialysate and/or replacement fluid). Regiocit solution 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.

Monitoring of the post-filter blood ionized calcium (iCa), systemic blood iCa, and total blood calcium levels in conjunction with other laboratory and clinical parameters are essential to guide appropriate Regiocit solution dosage based on the desired level of anticoagulation (see Section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Plasma levels of sodium, magnesium, potassium, and phosphate should be monitored regularly and should be supplemented as needed.

Flow rates for Regiocit solution in adult and adolescents:

• In continuous veno-venous haemofiltration

  • 1–2.5 l/h with a blood flow rate between 100 and 200 ml/min.

• In continuous veno-venous haemodiafiltration

  • 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 solution 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.

Hepatic impairment or shock:
Dose reduction may be needed in patients with mild to moderate hepatic impairment (e.g., Child-Pugh ≤12). In case of liver impairment (including e.g. liver cirrhosis), initial starting dose of citrate should be reduced as metabolism may be inadequate (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Frequent monitoring of citrate accumulation is advised. Regiocit solution must not be administered to patients with severely reduced liver function or shock with muscle hypoperfusion (e.g., conditions such as septic shock and lactic acidosis) due to limited citrate metabolism (see section 4.3).

Method of administration
For intravenous use. Regiocit solution 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).

Regiocit solution should be used only by, or under the direction of, a physician competent in the application of regional citrate anticoagulation in CRRT.

4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Severely impaired liver function

Shock with muscle hypoperfusion