CALRECIA Solution for infusion Ref.[27904] Active ingredients: Calcium chloride

Revision Year: 2018  Publisher: Fresenius Medical Care Deutschland GmbH, Else-Krรถner-StraรŸe 1, 61352 Bad Homburg v.d.H., Germany

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Electrolyte solutions, calcium chloride
ATC code: B05XA07

Solution for calcium substitution in CRRT, SLEDD and TPE using regional citrate-anticoagulation.

Basic principles of extracorporeal blood purification and regional citrate anticoagulation e.g. CRRT, SLEDD and TPE

Extracorporeal blood purification therapies are applied for various indications, for instance CRRT, SLEDD and TPE. These therapies have in common that blood is taken from the patient’s blood circulation and is guided through an extracorporeal circuit. There the blood is purified from toxins, the type of which varies between the different extracorporeal blood purification therapies. After the blood has been purified, it is re-transfused into the patient’s blood circulation.

Extracorporeal blood purification techniques usually require anticoagulation to prevent clotting in the extracorporeal circuit. Depending on the patientยดs status and the intended extracorporeal blood purification therapy, the prescribing physician might have decided to apply regional citrate anticoagulation. In this case, citrate is infused into the blood taken from the patient where it forms soluble chelate complexes with ionized calcium and thereby reduces the ionized calcium concentration in the blood flowing through the extracorporeal circuit.

Depending on the individual citrate-anticoagulated extracorporeal blood purification therapy, calcium is extracted from the patient’s blood in variable quantity which makes calcium substitution necessary. Further, a part of the citrate infused for regional citrate anticoagulation unavoidably enters the patient’s systemic circulation with the re-transfused blood. This induces an increase of the systemic citrate concentration, which generally stabilises at a new level depending on the actual citrate infusion rate and the citrate metabolism in the liver and other tissues. In the extracorporeal circuit citrate binds ionised calcium and reduces the systemic ionised calcium concentration, which can be counteracted by calcium substitution.

Calcium-citrate chelate complexes present in the patient’s blood dissociate when more citrate is metabolised than systemically infused. As a net effect, free ionised calcium remains in the patient’s blood and thereafter redistributes in the patient’s body where it is essential both for bone remodelling and as an electrolyte with crucial cellular functions throughout the body (e.g. in muscle cells and neurons).

5.2. Pharmacokinetic properties

Calrecia has to be administered by a pump of the extracorporeal blood purification device, which is intended to be used for calcium infusion.

Distribution / Biotransformation / Elimination

As the therapeutic purpose of Calrecia of calcium substitution in CRRT, SLEDD and TPE employing regional citrate anticoagulation is limited to stabilise the calcium in the patient’s blood at physiological levels, the pharmacokinetic properties of calcium provided via infusion of Calrecia are considered to be identical to those of calcium found endogenously in the systemic circulation and resulting from the physiological regulation of blood calcium.

5.3. Preclinical safety data

There are no preclinical data of relevance to the prescriber.

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