Calrecia

Package Leaflet: Information for the Patient

Calrecia,100 mmol/l, solution for infusion
Calcium chloride dihydrate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Calrecia and what is it used for
• 2. Important information before using Calrecia
• 3. How to use Calrecia
• 4. Possible side effects
• 5. How to store Calrecia
• 6. Contents of the pack and other information

1. What is Calrecia and what is it used for

Calrecia is a solution for infusion that contains calcium chloride dihydrate as the active substance. This medicine is indicated for use in adults and children during continuous renal replacement therapies (CRRT), slow low-efficiency (daily) hemodialysis (SLEDD), and therapeutic plasma exchange (TPE) to maintain the desired blood calcium levels.

2. Important information before using Calrecia

When not to use Calrecia

• if the blood calcium level is too high;
• if the blood chloride level is too high.

Warnings and precautions

Before starting treatment with Calrecia, discuss it with your doctor.
Tell your doctor before using Calrecia:

• if you are taking heart medicines (e.g., digitalis glycosides);
• if you have other diseases that affect calcium metabolism and excretion, such as kidney stone formation, increased calcium excretion in urine, and vitamin D overdose. Your doctor will:
• check the bag and solution before use;
• regularly check for blood clots at the Calrecia infusion site;
• ensure that the calcium level is maintained and closely monitored during the procedure;
• monitor parathyroid hormone levels and other bone metabolism parameters;
• regularly check electrolyte levels and acid-base balance.

Calrecia and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Interactions are possible with the following medicines:

• certain diuretics (thiazide diuretics);
• certain heart medicines (digitalis glycosides);
• infusions containing medicines that are incompatible with calcium, such as antibiotics (e.g., tetracyclines, ceftriaxone) and certain salts (e.g., inorganic phosphate, carbonates).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before using this medicine.
There is limited data on the use of Calrecia in pregnant women. Calrecia should only be used during pregnancy if your doctor considers it absolutely necessary.
Calrecia can be used during breastfeeding.

3. How to use Calrecia

Calrecia will be administered in a hospital. Your doctor will determine the dosage.

Using more than the recommended dose of Calrecia

Since this medicine will be administered by a doctor, it is unlikely that too little or too much of the medicine will be given. However, if you think you have received too much Calrecia, tell your doctor or nurse.
Signs of overdose may include symptoms of high blood calcium levels, such as fatigue, tingling, lack of energy, disorientation, increased reflexes, nausea, vomiting, constipation, tendency to form stomach ulcers, rapid, slow, or irregular heartbeat with possible cardiac arrest, high blood pressure, changes in the electrocardiogram, fainting, excessive urine production, thirst, water loss without electrolyte loss, calcium deposits in the kidneys, taste disturbances, hot flashes, and vasodilation with low blood pressure.
In the case of very high calcium levels, i.e., hypercalcemic crisis, the following symptoms are present: vomiting, colic, lack of intestinal muscle tone, intestinal obstruction, generalized weakness, changes in consciousness, initially excessive urine production, then often decreased urine production or urinary retention.
If you notice any of these symptoms, tell your doctor or nurse immediately.
In case of doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, Calrecia can cause side effects, although not everybody gets them.

The following side effects may occur as a result of the procedure:

• low body temperature
• too much or too little fluid in the body
• high or low blood calcium levels
• high or low blood acidity
• electrolyte disturbances (e.g., low potassium or phosphate levels in the blood)
• low blood pressure.

The following side effects may occur during the use of Calrecia:

• improper administration of the medicine may cause irritation at the infusion site, bleeding or fluid leakage into tissues, which can cause burning, necrosis, tissue breakdown, inflammation of connective tissue, and scarring of soft tissues.
• high blood calcium levels caused by the administration of too much of this medicine.

The exact frequency of these side effects is not known (cannot be estimated from the available data).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. Side effects can be reported directly to the "national reporting system" listed in Annex V.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Calrecia

Store the medicine out of sight and reach of children.
Do not store in the refrigerator or freeze.
Do not use this medicine after the expiry date stated on the bag and carton after "EXP". The expiry date refers to the last day of the month.
The contents must be used immediately after opening.
The solution is for single use only. Any unused solution and damaged container should be discarded.

6. Contents of the pack and other information

What Calrecia contains

• The active substance is calcium chloride dihydrate. 1000 ml of the solution contains 14.7 g of calcium chloride dihydrate, which corresponds to 100 mmol of calcium and 200 mmol of chloride.
• The other ingredient is water for injections.

What Calrecia looks like and contents of the pack

Calrecia is supplied in a bag containing 1500 ml of the ready-to-use solution.
The solution is clear and colorless, practically free from particles.
Each bag is equipped with a connecting tube and connector and is covered with a protective foil.
Pack sizes:
8 bags of 1500 ml
Responsible entity:
Fresenius Medical Care Deutschland GmbH
Else-Kröner-Straße 1
61352 Bad Homburg v.d.H.
Germany

Manufacturer:

Fresenius Medical Care Deutschland GmbH
Frankfurter Straße 6-8
66606 St. Wendel
Germany

Distributor:

Fresenius Medical Care Polska SA,
tel.: +48 61 83 92 600
Date of last revision of the leaflet:25.08.2023
Information intended for healthcare professionals only:
1000 ml of the solution contains:
Calcium chloride dihydrate
14.7 g
Ca
100 mmol
Cl
200 mmol
Theoretical osmolality:
300 mOsm/l
pH:
5.0 – 7.0
Can only be used if the solution is clear and colorless and the bag and connector are undamaged. The solution is for single use only. Any unused solution should be discarded.
Dosage
The dosage of Calrecia requires control through regular measurements of systemic ionized calcium. Based on these controls, the flow of Calrecia should be adjusted to achieve the target range of systemic ionized calcium.
A maximum dose of 3 liters per day is recommended, assuming that the use is not prolonged.
Detailed information is contained in the Summary of Product Characteristics.
Method of administration

• Infusion only using a pump of an extracorporeal blood treatment device that is designed by its manufacturer for the infusion of a 100 mmol/l calcium chloride solution and has the possibility of adequate fluid volume balancing.
• Infusion only into the extracorporeal blood circuit or, if indicated in the device's instructions, through a separate central venous access. Calrecia is not intended for intramuscular or subcutaneous use.
• Also, follow the manufacturer's instructions for the extracorporeal blood treatment device and tubing. The solution is not intended for dilution of any medicines or for infusion into peripheral veins.

Handling the product
Before using the bag with the solution, follow these steps:

• 1. Separate the bags along the seam.
• 2. Remove the outer packaging only immediately before using the solution. Check the bag with the solution (label, expiry date, clarity of the solution, no damage to the bag and outer packaging). Plastic containers may sometimes be damaged during transport from the manufacturer to the dialysis center or hospital or in the hospital itself. This can lead to contamination and growth of bacteria or fungi in the solution. Therefore, the bag and solution should be carefully checked before use. Particular attention should be paid to any damage, even minor, to the bag's closures, seams, and corners. This solution can only be used if it is clear and colorless and the bag and connector are not damaged or compromised.
• 3. Hang the bag on the designated hanger, using the hanging hole.
• 4. To connect, remove the protective cap from the connector. The connector only fits its corresponding part to prevent incorrect connection. Do not touch the unprotected part, especially the top of the connector. The inner part of the connector is sterile and not intended for later contact with chemical disinfectants. Connect the connector to its corresponding part, press together until it can be turned clockwise, against the resistance, to the end point. You may hear a click when the connection is closed.
• 5. Proceed with the further steps according to the instructions in the procedure description.