Calrecia 100 mmol/l solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Calrecia 100 mmol/l solution for infusion

calcium chloride dihydrate

Read the entire 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 your doctor or nurse.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What Calrecia is and what it is used for
2. What you need to know 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 Calrecia is and what it is used for

Calrecia is an infusion solution containing the active substance calcium chloride dihydrate. This medicinal product is intended for use in adults and children undergoing continuous renal replacement therapy (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 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

Talk to your doctor before starting to use Calrecia.

Consult your doctor before being administered Calrecia if:

• you are receiving treatment with medicines for heart problems (e.g., digitalis glycosides)
• you have other diseases affecting calcium metabolism and excretion, such as calcium salt deposits in the kidneys, increased calcium excretion in urine, or vitamin D overdose.

Your doctor will ensure:

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

Use of Calrecia with other medicines

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

Interactions may occur with:

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

Pregnancy and breastfeeding

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

There is 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 is possible with Calrecia if you require 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 are given more Calrecia than you should

Since Calrecia is administered only by a doctor, it is unlikely that you will receive too much or too little. However, if you think an excessive amount of this medicine has been administered, inform your doctor or nurse.

Signs of an overdose may include symptoms of increased calcium levels in the blood, e.g. tiredness, tingling, lack of energy, disorientation, exaggerated reflex response, nausea, vomiting, constipation, tendency to develop gastrointestinal ulcers, accelerated heartbeat, slow heartbeat, and irregular heartbeat with possible cardiac arrest, high blood pressure, changes in the electrocardiogram, fainting, urinating more than normal, thirst, fluid loss without electrolyte loss, calcium deposits in the kidneys, chalky taste, hot flushes, blood vessel dilation with drop in blood pressure.

In cases of very high calcium levels, also known as hypercalcemic crisis, the following signs may occur: vomiting, colic, loss of intestinal muscle tone, intestinal obstruction, generalized weakness, altered consciousness, increased urination at first, followed by decreased urination or no urination.

If you experience any of the symptoms listed above, 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

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

• incorrect administration may cause irritation at the infusion site, accumulation of blood or fluid in the tissue which may lead to burning, gangrene, tissue necrosis, cellulitis, and hardening of soft tissues
• high blood calcium levels due to administration of excessive amounts of this medicine.

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

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Calrecia

Keep this medicine out of sight and reach of children.

Do not refrigerate or freeze.

Do not use this medicine after the expiry date stated on the bag and the box after EXP. The expiry date refers to the last day of the month indicated.

The contents must be used immediately after opening.

The solution is for single use only. Any unused solution or solution from a damaged container must be discarded.

6. Contents of the pack and other information

Composition of Calrecia

• The active substance is calcium chloride dihydrate.

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

• The other component is water for injections.

Appearance of the product and contents of the pack

Calrecia is supplied as a bag containing 1,500 ml of ready-to-use solution.

The solution is clear, colourless, and practically free from visible particles.

Each bag is equipped with a connecting tube and a connector piece, and is covered by a protective foil.

Pack 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, planta baja, Parque Empresarial Euronova,
28760 Tres Cantos (Madrid).
Spain

Date of latest revision of this package leaflet: 07/2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended for healthcare professionals only:

1,000 ml of solution contain:

Calcium chloride dihydrate 14.7 g
Ca²⁺ 100 mmol
Cl^– 200 mmol

Theoretical osmolarity: 300 mOsm/l
pH: 5.0 – 7.0

Use only if the solution is clear, colourless, and free from visible particles.

The solution is for single use only. Any unused solution must be discarded, as well as if the container is damaged.

Dosage

Calrecia dosage should be adjusted based on regular measurements of systemic ionized calcium. According to these measurements, adjustments to the Calrecia infusion rate are necessary to achieve the desired range of systemic ionized calcium. A maximum dose of 3 L/day is recommended, and the product is not intended for chronic use. For further details, refer to the Summary of Product Characteristics.

Method of administration

• Infuse only via the pump of an extracorporeal blood purification device, which is intended by its manufacturer for infusion of a 100 mmol/l calcium chloride solution and includes appropriate fluid volume balancing.
• Infuse only into the extracorporeal blood circuit or, if recommended by the instructions for use of the extracorporeal blood purification device, via an independent central venous access. Calrecia is not intended for intramuscular or subcutaneous use.
• Follow the handling instructions provided by the manufacturer of the extracorporeal blood purification device and associated tubing.

The solution is not intended for addition of any medicinal product or for peripheral intravenous infusion.

Handling

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

1. Separate the two bags at the seal.
2. Remove the outer wrapping only immediately before use. Check the solution bag (label, expiry date, clarity of solution) and ensure that neither the bag nor the wrapping is damaged.

Plastic containers may occasionally be damaged during transport from the manufacturer to the dialysis clinic or hospital, or within the facility itself. This may lead to contamination and bacterial or fungal growth in the solution. Therefore, careful inspection of the bag and solution before use is essential. Special attention must be paid to even the slightest damage to the closure, seals, and corners of the bag. The solution should only be used if it is colourless and clear, and if the bag and connector are intact and undamaged.

1. Hang the bag by its hanging hole on the appropriate support.
2. To connect, remove the protective cap from the connector. The connector is designed to fit only with its matching counterpart to prevent incorrect connections. Do not touch the exposed part, especially the top of the connector. The inner part of the connector is sterile and cannot be reused in further treatments with chemical disinfectants. Connect the connector to the appropriate counterpart and press and turn clockwise against resistance until it stops. A "click" may be heard when the connection is secured.

Proceed with additional steps as indicated in the treatment instructions.