Leaflet:Information for the user

Calrecia100mmol/l solution for infusion

Calcium chloride dihydrate

Read this leaflet carefully before you start using this medicine,because it contains important information for you.

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

1.What Calrecia is and what it is used for

2.What you need to knowbeforestarting touse Calrecia

3.How to use Calrecia

4.Possible side effects

5Storage of Calrecia

6.Contents of the pack and additional information

Calrecia is a perfusion solution containing the active ingredient calcium chloride dihydrate. This medication is intended for use in adults and children in continuous renal replacement therapies (CRRT),low-efficiency sustained dialysis (daily) (SLED)and therapeutic plasma exchange (TPE) to maintain blood calcium levels within the desired range.

Do not use Calrecia :

• 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 medications for heart problems (e.g., digitalis glycosides)
• you have other diseases that affect calcium metabolism and excretion, such as calcium salt deposits in the kidneys, increased calcium excretion through urine, and vitamin D overdose.

Your doctor will ensure:

• to check the bag and solution before use
• to regularly check the Calrecia infusion site on the blood tube for blood clots
• that the calcium level is correct and closely monitor it during your treatment
• to control parathyroid hormone levels and other bone metabolism parameters
• to regularly control electrolyte and acid-base balance.

Use of Calrecia with other medications

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

Interactions may occur with:

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

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

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

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

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

If you take 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 believe you have been given an excessive amount of this medication, inform your doctor or nurse.

The signs of an overdose may include symptoms of elevated blood calcium levels, such as fatigue, numbness, lack of energy, disorientation, excessive reflex response, nausea, vomiting, constipation, tendency to develop gastrointestinal ulcers, rapid heart rate, slow heart rate, irregular heart rhythm with the possibility of cardiac arrest, high blood pressure, electrocardiogram alterations, fainting, excessive urination, thirst, loss of fluids without loss of electrolytes, calcium deposits in the kidneys, chalky taste, hot flashes, dilation of blood vessels with a decrease in blood pressure.

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

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

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

• Low body temperature
• Excess or deficiency of fluid in your body
• High or low levels of calcium in the blood
• High acidity or high alkalinity of the blood
• Electrolyte imbalances (for example, low levels of potassium or phosphate in the blood)
• Low blood pressure.

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

• Incorrect application may cause irritation at the infusion site, accumulation of blood or fluid in the tissue, which may cause burns, gangrene, tissue detachment, cellulitis, and hardening of soft tissues
• High levels of calcium in the blood due to the administration of too much of this medication.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly to the Spanish System for Pharmacovigilance of Medicines for Human Use : www.notificaRAM.es . By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not refrigerate or freeze.

Do not usethis medicationafter the expiration date that appears onthe bag and on the boxafter CAD. 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 a damaged container must be discarded.

Composition of Calrecia

• The active principle is dihydrate calcium chloride.

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

• The other componentis water for injection preparations.

Aspect of the product and content of the packaging

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

The solution is transparent and colorless andpractically free ofparticles.

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

Package size:

8 bags of 1,500 ml

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Fresenius Medical Care Deutschland GmbH,

Else-Kröner-Straße 1,

61352 Bad Homburg v.d.H.,

Germany

Responsible for manufacturing

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 review of thisleaflet: 07/2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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This information is intended solely for healthcare professionals:

1,000 ml of solution contain:

Calcium chloride dihydrate14.7 g

Ca2+100 mmol

Cl-200 mmol

Theoretical osmolarity:300 mOsm/l

pH:5.0 – 7.0

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

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

Dosage

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

Administration form

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

The solution is not intended to be used for the addition of any medication and is not intended for peripheral intravenous infusion.

Handling

The following points should be taken into account before using the solution bag:

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

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

1. Hang the bag on the accessory designed for this purpose.
2. To connect, 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 do not touch the top of the connector. The internal part of the connector is sterile and cannot be used in additional treatments with chemical disinfectants. Join the connector with the appropriate counterpart and press at the same time 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.