CALRECIA 100 mmol/L SOLUTION FOR INFUSION

Introduction

Leaflet:Information for the user

Calrecia100 mmol/l solution for infusion

Calcium chloride dihydrate

Read this leaflet carefully before starting to use this medicine,as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience side effects, ask your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Calrecia and what is it used for
2. What you need to know before starting to use Calrecia
3. How to use Calrecia
4. Possible side effects

5 Conservation of Calrecia

1. Contents of the package and additional information

1. What is Calrecia and what is it used for

Calrecia is a solution for infusion that contains the active substance calcium chloride dihydrate. This medicine is intended to be used in adults and children in continuous renal replacement therapies (CRRT), sustained low-efficiency daily dialysis (SLEDD), and therapeutic plasma exchange (TPE) to maintain blood calcium levels within the desired range.

2. What you need to know before starting to use Calrecia

Do not useCalrecia:

• if you have high levels of calcium in your blood
• if you have high levels of chloride in your blood.

Warnings and precautions

Consult your doctor before starting to use Calrecia

Consult your doctor before Calrecia is administered to you if:

• you are receiving treatment with medicines for heart problems (e.g., digitalis glycosides)
• you have other diseases that affect calcium metabolism and excretion, such as kidney stone deposits, increased calcium excretion through urine, and vitamin D overdose.

Your doctor will ensure that:

• the bag and solution are checked before use
• the Calrecia infusion point of the blood tube is regularly checked for blood clots
• the calcium level is correct and closely monitored during your treatment
• parathyroid hormone levels and other bone metabolism parameters are monitored
• electrolyte and acid-base balance are regularly monitored.

Using Calreciawithother medicines

Tell your doctor if you are using, have recently used, or may need to use any other medicine.

Interactions may occur with:

• certain medicines used to increase urine production (thiazide diuretics)
• certain medicines used to treat heart problems (digitalis glycosides).
• infusions containing medicines incompatible with calcium, such as certain antibiotics (e.g., tetracyclines, ceftriaxone) and specific salts (e.g., inorganic phosphate, carbonates).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

There are insufficient data on the use of Calrecia in pregnant women. Calrecia should only be used during pregnancy if your doctor considers the treatment absolutely necessary.

Breastfeeding with Calrecia is possible if you need treatment at that time.

3. How to use Calrecia

Calrecia will be administered in a hospital or clinic. The dosage will be determined by your doctor.

If you use more Calrecia than you should

Since Calrecia will only be administered by a doctor, it is unlikely that you will receive more or less than the necessary amount. However, if you think you have been given too much of this medicine, tell your doctor or nurse.

Signs of an overdose may be symptoms of high calcium levels in the blood, e.g., fatigue, tingling, lack of energy, disorientation, excessive reflex response, nausea, vomiting, constipation, tendency to develop gastrointestinal ulcers, increased heart rate, slow heart rate, and irregular heartbeat with possible cardiac arrest, high blood pressure, changes in the electrocardiogram, fainting, excessive urination, thirst, loss of fluids without loss of electrolytes, calcium deposits in the kidneys, chalky taste, hot flashes, and vasodilation with decreased blood pressure.

In case of very high calcium levels, also known as hypercalcemic crisis, the following signs occur: vomiting, colic, lack of intestinal muscle tone, intestinal obstruction, generalized weakness, altered consciousness, excessive urination at first, and then decreased or no urination.

If you experience any of the above symptoms, inform your doctor or nurse immediately.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

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

The following side effects may occur as a result of treatment in general:

• low body temperature
• excess or deficit of fluid in your body
• high or low calcium levels in the blood
• high acidity or high alkalinity of the blood
• electrolyte disturbances (e.g., low potassium or phosphate levels in the blood)
• low blood pressure.

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

• incorrect application can cause irritation at the infusion site, blood or fluid accumulation in the tissue, which can cause burning, gangrene, tissue detachment, cellulitis, and hardening of the soft tissues
• high calcium levels in the blood due to the administration of too much of this medicine.

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

Reporting side effects

If you experience any side effects, ask your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Calrecia

Keep this medicine out of the sight and reach of children.

Do not refrigerate or freeze.

Do not use this medicine after the expiration date stated on the bag and carton after EXP. The expiration date is the last day of the month indicated.

The contents must be used immediately after opening.

The solution is for single use. Any unused solution or damaged packaging must be discarded.

6. Contents of the package and additional information

Composition of Calrecia

• The active substance is calcium chloride dihydrate.

1,000 ml of solution contain 14.7 g of calcium chloride dihydrate corresponding to 100 mmol of calcium and 200 mmol of chloride.

• The other component is water for injectable preparations.

Appearance of the product and package contents

Calrecia is presented in a bag with 1,500 ml of ready-to-use solution.

The solution is transparent, colorless, and practically free of particles.

Each bag is equipped with a connector tube and a connection piece and is covered by a protective film.

Package size:

8 bags of 1,500 ml

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Local representative

Fresenius Medical Care España, S.A.

C/ Ronda de Poniente, 8, ground floor, Parque Empresarial Euronova,

28760 Tres Cantos (Madrid).

Spain

Date of the last revision of thisleaflet: 07/2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

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This information is intended only for healthcare professionals:

1,000 ml of solution contain:

Calcium chloride dihydrate 14.7 g

Ca2+ 100 mmol

Cl- 200 mmol

Theoretical osmolality: 300 mOsm/l

pH: 5.0 – 7.0

Use only if the solution is transparent, colorless, and free of visible particles.

The solution is for single use. Any unused solution or damaged packaging must be discarded.

Dosage

The dosage of Calrecia should be controlled by regularly measuring systemic ionized calcium. Based on these controls, adjustments should be made to the Calrecia flow rate to achieve the desired range of systemic ionized calcium. A maximum dose of 3 l/day is recommended, and it is not intended for chronic use. For more details, consult the Summary of Product Characteristics or Package Leaflet.

Method of administration

• Infuse only through the pump of an extracorporeal blood purification device that is intended by its manufacturer for infusing a 100 mmol/l calcium chloride solution and contains an appropriate fluid volume balance.
• Infuse only within the extracorporeal blood circuit or, if recommended by the instructions for use of the extracorporeal blood purification device, through a separate central venous access. Calrecia is not designed for intramuscular or subcutaneous use.
• Follow the handling instructions of the manufacturer of the extracorporeal blood purification device and the tubes used.

The solution is not intended for the addition of any medicine or for peripheral intravenous infusion.

Handling

The following points should be considered before using the solution bag:

1. Separate the two bags through the weld.
2. Remove the wrapper only just before using the solution. Check the solution bag (label, expiration date, clarity of the solution, bag, and wrapper are not damaged).

Plastic containers may occasionally be damaged during transport from the manufacturer to the dialysis clinic or hospital or within the clinic itself. This can cause contamination and bacterial or fungal growth in the solution. Therefore, careful inspection of the bag and solution is essential before use. Particular attention should be paid to even minor damage to the closure, welds, and corners of the bag. The solution should only be used if it is colorless and transparent, and if the bag and connector are intact and undamaged.

1. Hang the bag by its hole on the accessory intended for this purpose.
2. For connection, remove the protective cap from the connector. The connector only fits with its counterpart to prevent incorrect connection. Do not touch the unprotected part, especially not the top of the connector. The inner part of the connector is sterile and cannot be used for additional treatment with chemical disinfectants. Connect the connector to the appropriate counterpart and press simultaneously until it can be turned clockwise against the resistance to the stop. You may hear a "click" when the connection is fixed.

Continue with the additional steps as indicated in the treatment description.