Package leaflet: Information for the patient

Calrecia, 100 mmol/l, solution for infusion
Calcium chloride dihydrate
Please read all of this leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any further questions, please consult your doctor or nurse.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or nurse immediately. See section 4.

Contents of the leaflet:

What Calrecia is and what it is used for
Important information before using Calrecia
How to use Calrecia
Possible side effects
How to store Calrecia
Contents of the pack and other information

1. What Calrecia is and what it is used for

Calrecia is an infusion solution containing calcium chloride dihydrate as the active substance. This medicinal product is indicated for use in adults and children during continuous renal replacement therapies (CRRT), sustained low efficiency (daily) dialysis (SLEDD), and therapeutic plasma exchange (TPE), in order to maintain blood calcium concentration within the desired range.

2. Important information before using Calrecia

When not to take Calrecia

if blood calcium levels are very high;
if blood chloride levels are very high.

Warnings and precautions
Before starting treatment with Calrecia, discuss this with your doctor.
Inform your doctor before using Calrecia:

if the patient is taking medicines used for heart conditions (e.g. digitalis glycosides);
if the patient has other diseases affecting calcium metabolism and calcium excretion, such as calcium salt deposition in the kidneys, increased calcium excretion in urine, or vitamin D overdose. The treating physician:
will check the bag and solution before administration;
will regularly monitor whether blood clots are forming at the site where Calrecia is infused into the blood circuit;
will ensure maintenance of normal calcium concentration and strict monitoring of calcium levels during the procedure;
will monitor parathyroid hormone levels and other bone metabolism parameters;
will regularly monitor electrolytes and acid-base balance.

Calrecia and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Possible interactions may occur with the following medicines:

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine. There are insufficient data on the use of Calrecia in pregnant women. Calrecia may be used during pregnancy only if the doctor considers it absolutely necessary. Breastfeeding is permitted during treatment with Calrecia.

3. How to use Calrecia

Calrecia will be administered in a hospital. The dose will be determined by your doctor.
Use of a higher than recommended dose of Calrecia
Since this medicine will be given by a doctor, it is unlikely that too small or too large a dose will be administered. However, if the patient believes they have received too high a dose, they should inform their doctor or nurse immediately.

Symptoms of overdose may include signs of high calcium levels in the blood, such as fatigue, tingling sensations, lack of energy, disorientation, increased reflexes, nausea, vomiting, constipation, tendency to develop gastrointestinal ulcers, accelerated, slowed or irregular heartbeat with possible cardiac arrest, high blood pressure, changes in electrocardiogram, fainting, increased urine output, thirst, loss of water without loss of electrolytes, calcium deposits in the kidneys, taste disturbances, hot flushes, blood vessel dilation with low blood pressure.

In the case of very high calcium levels, i.e. hypercalcemic crisis, the following symptoms may occur: vomiting, colic, loss of intestinal muscle tone, intestinal obstruction, generalized weakness, disturbances of consciousness, initially increased urine output, followed by decreased urine output or cessation of urination.

If the patient notices any of the symptoms listed above, they should immediately inform their doctor or nurse.

If there is any uncertainty regarding the use of this medicine, the patient should consult their doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse symptoms may occur as a result of the procedure itself:

low body temperature
excessive or insufficient fluid levels in the body
high or low blood calcium levels
high blood acidity or high blood alkalinity
electrolyte disturbances (e.g. low blood potassium or phosphate levels)
low blood pressure.

The following adverse reactions may occur during treatment with Calrecia:

incorrect administration of the medicine may cause irritation at the infusion site, leakage of blood or fluid into tissues, which may lead to burning sensation, necrosis, tissue breakdown, connective tissue inflammation, and soft tissue sclerosis
high blood calcium levels caused by administration of an excessive dose of this medicine.

The exact frequency of these reactions is unknown (cannot be estimated from the available data).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the "national reporting system" listed in Annex V. Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Calrecia medicine

Keep this medicine out of the 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 the word "EXP". The expiry date refers to the last day of the stated month.
The contents must be used immediately after opening.
The solution is for single use only. Any unused residues of the solution and any damaged container must be discarded.

6. Contents of the packaging and other information

What Calrecia contains

The active substance is calcium chloride dihydrate. 1000 ml of solution contains 14.7 g calcium chloride dihydrate, corresponding to 100 mmol calcium and 200 mmol 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 ready-to-use solution.
The solution is clear and colourless, 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
Marketing Authorisation 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
Distributor:
Fresenius Medical Care Polska SA,
tel.: +48 61 83 92 600
Information intended exclusively for healthcare professionals:
1000 ml of solution contains:
Calcium chloride dihydrate 14.7 g
Ca 100 mmol
Cl 200 mmol
Theoretical osmolarity: 300 mOsm/l
pH: 5.0 – 7.0
The solution should only be used if it is clear and colourless and the bag and connector are undamaged. The solution is for single use only. Any unused solution should be discarded.
Dosage
Dosage of the medicinal product Calrecia requires monitoring through regular measurements of systemic ionised calcium. Based on these measurements, the infusion rate of the medicinal product Calrecia should be adjusted to achieve the target range of systemic ionised calcium.
A maximum dose of 3 litres per day is recommended, assuming that treatment is not chronic.
Detailed information is provided in the Summary of Product Characteristics.

Instructions for use

Infusion only via the pump of an extracorporeal blood purification device, which is intended by its manufacturer for infusion of calcium chloride 100 mmol/l solution and has the capability for appropriate fluid volume balancing.
Infusion only into the extracorporeal blood circuit or, if indicated in the instructions for use of the extracorporeal blood purification device, via a separate central venous access. The medicinal product Calrecia is not intended for intramuscular or subcutaneous administration.
The manufacturer's instructions for the extracorporeal blood purification device and catheters must also be followed. The solution is not intended for dilution of any medicinal products or for infusion into peripheral veins.

Handling of the product
Before using the solution bag, proceed as follows:

Separate the bags along the seam.
Remove the outer packaging only immediately before use of the solution. Check the solution bag (label, expiry date, clarity of solution, absence of damage to the bag and outer packaging). Plastic containers may occasionally be damaged during transport from the manufacturer to dialysis centres or hospitals or within the hospital itself. As a result, contamination and growth of bacteria or fungi in the solution may occur. Therefore, the bag and solution should be carefully inspected before use. Particular attention should be paid to any damage, even minor, to closures, seams and corners of the bag. This solution may only be used if it is clear and colourless and the bag and connector are undamaged and intact.
Hang the bag on the designated hook using the hanging hole.
To connect, remove the protective cap from the connector. The connector fits only with its matching counterpart to prevent incorrect connections. Do not touch the unprotected parts, especially the top of the connector. The inner part of the connector is sterile and is not intended for subsequent contact with chemical disinfectants. Connect the connector to its counterpart, press together firmly until it clicks clockwise against resistance to the end point. A click may be heard when the connection is closed.
Proceed with subsequent steps according to the procedure instructions.