CALRECIA

Application of Calrecia should take place only based on the prescription of a physician familiar with citrate anticoagulation in the specific mode of CRRT, SLEDD and TPE. Posology Adults Calrecia is applied in an amount adequate to keep the systemic ionised calcium concentration in the desired range.

If not otherwise prescribed, the normal range for systemic ionised calcium should be targeted. 9 mmol/l systemic ionised calcium. The amount of Calrecia needed to keep the systemic ionised calcium concentration within the desired range depends on: - Calcium removed during CRRT, SLEDD and TPE.

- The amount of calcium required to compensate effects of citrate reaching the systemic circulation, which can originate from the citrate solution used for regional anticoagulation or from plasma preparations used as substitution solution in TPE.

- Calcium shifts between the plasma and other compartments of the patient’s body. - Any intended change of the baseline systemic calcium concentration. - Any impact on patient’s ionised calcium concentration by other medicinal interventions.

e. the fluid discarded from the extracorporeal circuit with which calcium is eliminated. 8 mmol/l effluent. Dosing of Calrecia needs to be controlled by regularly measuring the systemic ionised calcium. Based on these controls, adjustments of the flow of Calrecia need to be made in order to reach the targeted range of systemic ionised calcium.

A maximum dose of 3 l/d is recommended and no chronic use is intended. Paediatric population The posology of Calrecia in children is the same as in adults. Due to the generally lower prescribed effluent flows in children, correspondingly lower absolute flows of Calrecia will result.

Method of administration - Infusion only by a pump of the extracorporeal blood purification device, which is intended by its manufacturer for infusion of a 100 mmol/l calcium chloride solution and comprises an appropriate balancing of fluid volumes.

- Infusion only into the extracorporeal blood circuit or, if advised by the instruction for use of the extracorporeal blood purification device, via a separate central venous access. Calrecia is not intended for intramuscular or subcutaneous use.

- Handling instructions of the manufacturer of the used extracorporeal blood purification device and of the tubing line must be adhered to. 6.

The following adverse reactions can be anticipated for the treatment mode:

General disorders and administration site conditions - Hypothermia Metabolism and nutrition disorders - Hyper- or hypohydration - Hypercalcaemia at a dose of Calrecia considered appropriate. 4) - Hypocalcaemia due to underdosing of Calrecia.

g. hypokalaemia, hypophosphataemia) Vascular disorders - Hypotension. e. infusion into the extracorporeal circuit or central venous infusion). In this context irritation at the site of infusion can occur. 9). The exact frequency of such events is not known (cannot be estimated from the available data).

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 or search for MHRA Yellow Card in the Google Play or Apple App Store

Calcium chloride infusion should be used with caution in patients treated with Digitalis-Glycosides. 5). Comorbidities affecting calcium metabolism and calcium excretion such as but not limited to nephrocalcinosis, hypercalciuria and overdose of vitamin D should carefully be considered when prescribing Calrecia.

Dose adaptations might be required and blood calcium levels should be closely monitored. Pre- existing hypercalcaemia should be considered by reducing initial calcium infusion rate and close monitoring of blood calcium levels. Pre-existing hypocalcaemia should be corrected prior to starting citrate anticoagulation.

Pre-existing hyperchloremia might be corrected by adequate dialysis conditions; alternatively adjusted application of chloride-poor infusion solutions can be considered. The precautions during use of the applied extracorporeal blood purification therapy must be adhered to.

The electrolyte and acid-base balance must be regularly controlled during citrate-anticoagulated extracorporeal blood purification treatments. When infused into the extracorporeal circuit, the site of Calrecia infusion should regularly be inspected for signs of locally developing clotting and if observed a change of the extracorporeal circuit should be considered.

During the application of Calrecia, the serum ionised calcium concentration must be regularly checked. The calcium status of the patient and its trend during blood purification therapy must be considered. If hypocalcaemia is present or tends to develop, starting or increasing the supplementation of calcium may be required.

g. caused by accumulation of calcium due to inefficient blood purification resulting from a clogged membrane or due to overdose) decreasing the supplementation of calcium may be required. Hypocalcaemia and an unexpectedly high need of Calrecia infusion to stabilise the systemic ionised calcium in the desired range might be caused by citrate accumulation: Citrate anticoagulation mostly will result in a moderate increase of the systemic citrate concentration and of systemically present calcium-citrate chelate complexes.

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