100 mmol / liter infusion solution 
of calcium chloride dihydrate

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information, see section 4.

In this leaflet: 
1. What Calrecia is and what it is used for 
2. What you need to know before you use Calrecia 
3. How to use Calrecia 
4. Possible side effects 
5. How to store Calrecia 
6. Contents of the packaging and other information 

1. What Calrecia is and what it is used for

Calrecia is an infusion solution containing active substance calcium chloride dihydrate. This drug is intended for the treatment of adults and children in continuous renal replacement therapy (CRRT), in prolonged slow daily dialysis(SLEDD), and in therapeutic plasma exchange (TPE) to keep calcium levels in the blood within the desired range.

2. What you need to know before you use Calrecia

Do not use Calrecia:

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

Warnings and cautions

Talk to your doctor before using Calrecia.

Before taking Calrecia, tell your doctor

  • you are being treated with medicines used to treat heart problems (eg digitalis glycosides )
  • you suffer from other diseases that affect calcium metabolism and calcium excretion, such as precipitation of calcium salts in the kidneys, increased calcium excretion in the urine, and overdose of vitamin D.

Your doctor will:

  • check the bag and solution before use
  • Regularly check the infusion site where Calrecia is infused into the bloodstream to detect any possible blood clots.
  • Ensure that calcium levels are properly and closely monitored during your treatment
  • monitor the levels of parathyroid hormones and other parameters of bone metabolism
  • Check the electrolyte and acid-base balance regularly.

Other medicines and Calrecia

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Interaction is possible with:

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

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

There are not enough data from the use of Calrecia in pregnant women. If you are pregnant, only use Calrecia if your doctor considers it absolutely necessary.

Breast-feeding is possible while you need treatment with Calrecia.

3. How to use Calrecia

Calrecia will be given in a hospital or clinic. Dose one is determined by your doctor.

If you use more Calrecia than you should

Because Calrecia will only be given to you by a doctor, it is unlikely that you will receive too little or too much. If you still think you have been given too much of this medicine, talk to your doctor or nurse.

Signs of an overdose can be symptoms of too high calcium levels in the blood e.g. fatigue, irritability, lack of energy, disorientation, the overreaction of reflexes, nausea, vomiting, constipation, tendency to develop gastrointestinal ulcers, rushing heartbeat, slow heartbeat, and irregular heartbeat with the risk of cardiac arrest, high blood pressure, changes in electrocardiograms, swim, larger amounts of urine than normal, thirst, water loss without loss of electrolytes , precipitation of calcium in the kidneys, chalk taste, swelling, dilation of blood vessels with low blood pressure.

At very high calcium levels, also called a hypercalcemic crisis, the following signs appear vomiting, colic, lack of muscle tension in the intestine, intestinal blockage, general weakness, loss of consciousness, initially higher than normal amounts of urine followed by less or no amount at all.

Tell your doctor or nurse immediately if you experience any of the above symptoms.

If you have any further questions on the use of this product, 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
  • too much or too little fluid in the body
  • high or low calcium levels in the blood
  • the blood is too acidic or alkaline
  • electrolyte disturbances (eg low potassium levels in the blood, low levels of phosphate in the blood)
  • low blood pressure

The following side effects may occur while using Calrecia:

  • Improper application can cause irritation at the infusion site, blood or fluid entering the tissue which can cause burning, gangrene, tissue death, cellulite, and hardening of the soft tissues.
  • high calcium levels in the blood due to too much of this drug being added.

The exact frequency of such side effects is not known (can not be calculated from the available data).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Calrecia

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

Store in a cold place. Do not freeze.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.

The contents must be used immediately after opening.

For single use only. Leftover solution and damaged packaging must be discarded.

6. Contents of the packaging and other information

Content declaration

  • The active substance is calcium chloride dihydrate. 
    1000 ml of 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 the medicine looks like and the contents of the pack

Calrecia is supplied in a sachet of 1500 ml of reconstituted solution.

The solution is clear, colorless, and free of visible particles.

Each bag is equipped with a connecting hose and coupling 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 vdH, Germany

Manufacturer

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

Local representative

Fresenius Medical Care Sverige AB,

Sollentuna,

Tel: + 46 8 594 776 00

Muhammad Nadeem

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