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

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. The target range must not be below 0.9 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.

When estimating the calcium removal during CRRT, SLEDD and TPE, the prescriber has to take into account:

• Permeability of the filter membrane for calcium and calcium-citrate complexes
• The calcium concentration in any applied fluid during CRRT, SLEDD and TPE such as dialysis fluids, haemofiltration solutions or substitution solutions used in TPE
• Prescribed blood flow and all other prescribed fluid flows during the therapy; this includes specifically the effluent flow, i.e. the fluid discarded from the extracorporeal circuit with which calcium is eliminated. In CRRT a typical calcium dose is 1.7-1.8 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.

For instructions on handling of the medicinal product before administration, see section 6.6.

Rapid or excessive administration of calcium salts may lead to hypercalcaemia (total plasma concentration >3 mmol/l, ionised calcium >1.2 mmol/l, respectively). Too rapid injection of calcium salts may also lead to the signs and symptoms of hypercalcaemia as well as chalky taste, tingling, hot flushes, nausea, vomiting and peripheral vasodilation with hypotension, bradycardia, syncope and arrhythmia with a possibility of cardiac arrest.

Signs and symptoms of hypercalcaemia

• Nervous system disorders, e.g. lethargy, disorientation, hyporeflexia
• Cardiac disorders, e.g. tachycardia and tendency to develop cardiac arrhythmia, hypertension, changes in the electrocardiogram (shortening of QT-interval)
• Gastrointestinal disorders, e.g. nausea, vomiting, constipation, tendency to develop ulcers
• Renal and urinary disorders, e.g. increased diuresis, thirst, aquaresis, renal deposition of calcium salts
• General disorders, e.g. fatigue.

Hypercalcaemic crisis (plasma total calcium concentration >4 mmol/l) results in vomiting, colic, intestinal atony, intestinal obstruction, generalised asthenia, disturbance of consciousness, initially increased diuresis, subsequently often diminished or completely absent.

Therapy

Immediate stop or dose reduction of Calrecia.

Particularly in cases of excessively increased calcium levels an acute reduction of calcium levels is mandatory, therefore in case of still sufficient renal function forced diuresis with concomitant infusion of normal saline solution (0.9% NaCl) should be considered under stringent supervision of fluid balance and plasma electrolyte concentrations. In patients with impaired renal function, dialysis against calcium-free dialysate can be indicated.

2 years.

Shelf life after opening: The content must be used immediately.

Do not refrigerate or freeze.

Solution bag with 1500 ml ready-to-use solution.

The medicinal product is provided pairwise, as two identical solution bags which can be separated by a tear seam. The solution bag is made of a polyolefine based foil. Each bag is equipped with connective tubing made of polyolefines and a connector made of polycarbonate and is covered by a protective multilayer foil.

Pack sizes: 8 bags of 1500 ml.

Disposal

The solution is for single use only. Any unused solution and damaged container should be discarded.

Handling

The following points prior to the use of the solution bag have to be considered:

1. Separate the two bags at the tear seam.
2. Remove the overwrap only immediately before using the solution. Check the solution bag (label, expiry date, clearness of the solution, bag and overwrap not damaged). Plastic containers may occasionally be damaged during transport from the manufacturer to the dialysis clinic or hospital clinic or within the clinic itself. This can lead to contamination and the growth of bacteria or a fungus in the solution. Therefore careful inspection of the bag and the solution before use is essential. Particular attention should be paid to even the slightest damage to the closure of the bag, the welding seams and the corners of the bag. The solution should only be used if colorless and clear and if the bag and connector are undamaged and intact.
3. Put the bag on the dedicated attachment by its hanger hole.
4. For connection remove the protection cap from the connector. The connector only fits to its counterpart to prevent misconnection. Do not touch the unprotected part especially do not touch on top of the connector. The inner part of the connector is sterile and is not intended to be further treated with chemical disinfectants. Put together the connector with the appropriate counterpart and press together until you can turn it clockwise against the resistance to the stop point. You may hear a “click” sound when the connection is fixed.
5. Proceed with the further steps as indicated in the treatment description.

The solution is not intended to be used for the addition of any drugs and not intended to be used for peripheral intravenous infusion. See also section 4.2.