Patient leaflet - Calrecia 100 mmol/l solution for infusion
what it is used for
Calrecia® is a solution for infusion which contains
the active substance calcium chloride dihydrate. This
medicine is intended to be used in adults and children
during continous renal replacement therapies (CRRT),
sustained low efficiency (daily) dialysis (SLEDD) and
therapeutic plasma exchange (TPE) to keep calcium
levels in the blood in the desired range.
2. What you need to know before
you use Calrecia®
Do not use Calrecia®
- if you have a high level of calcium in your blood
- if you have a high level of chloride in your blood.
Warnings and precautions
Talk to your doctor before using Calrecia®.
Check with your doctor before you are given Calrecia® if:
you are treated with medicines used to treat heart
problems (e.g. digitalis glycosides)
you suffer from additional diseases affecting
calcium metabolism and calcium excretion such as
deposition of calcium salts in the kidneys, increased
calcium excretion with the urine and overdose of
vitamin D.
Your doctor will:
- check the bag and the solution before use
- check the site of Calrecia® infusion into the blood tubing regularly for blood clots
- ensure that the calcium level is correct and closely monitored during your treatment
monitor parathyroid hormone levels and other
parameters of bone metabolism
control 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.
Interactions are possible 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 some antibiotics (e.g. tetracyclines, ceftriaxone) and specific salts (e.g. inorganic
phosphate, carbonates).
Pregnancy and breast-feeding
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 starting treatment with this medicine.
There are not enough data from the use of Calrecia® in pregnant women. Calrecia® should only be used during pregnancy if your doctor considers treatment absolutely necessary. Breastfeeding is possible if you need treatment with Calrecia® during that time.
3. How to use Calrecia®
Calrecia® will be given in a hospital or clinic. The dosage will be determined by your doctor.
If you use more Calrecia® than you should
As Calrecia® will only be given to you by a doctor, it is unlikely that you will be given too little or too much. However, if you think you have been given too much of this medicine, please tell your doctor or nurse.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. 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 includes any possible side effects not listed in this leaflet. See section 4.
Package leaflet: Information for the user
Calrecia®
100 mmol/l solution for infusion calcium chloride dihydrate
Calrecia®
Freigabeversion vom: 05.10.23 jd 0875661/01
The signs of an overdose may be symptoms of high
calcium levels in your blood e.g. tiredness, tingling,
lack of energy, disorientation, overresponsive reflexes,
nausea, vomiting, constipation, tendency to develop
gastrointestinal ulcers, racing heart beat, slow heartbeat
and irregular heartbeat with a possibility of cardiac arrest,
high blood pressure, alterations in electrocardiogram,
fainting, passing more urine than normal, thirst, water
loss without electrolyte loss, calcium deposits in your
kidneys, a chalky taste, hot flushes, widening of the
blood vessels with low blood pressure.
In case of very high calcium levels, also called
hypercalcaemic crisis, the following signs are present:
vomiting, colic, lack of intestinal muscle tone, bowel
obstruction, generalised weakness, disturbance of
consciousness, initially passing more urine than normal,
then often passing less or not passing urine.
If you get any of the above mentioned symptoms please
tell your doctor or nurse immediately.
If you have any further questions on 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 the treatment in general:
- low body temperature
- too much or too low fluid in your body
- high or low blood calcium levels
- high blood acidity or high blood alkalinity
electrolyte disturbances (e.g. low blood levels of
potassium or phosphate)
- low blood pressure.
The following side effects may occur when
Calrecia® is used:
wrong application can cause irritation at the site of
infusion, escape of blood or fluid into tissue which
can cause burning, gangrene, sloughing of tissue,
cellulitis and soft tissue hardening
high blood calcium levels due to administration of
too much of this medicine.
The exact frequency of such events is not known
(cannot be estimated from the available data).
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Calrecia®
Keep this medicine out of the sight and reach of children. Do not refrigerate or freeze.
Do not use this medicine after the expiry date which is stated on the bag and box label after EXP. The expiry date refers to the last day of that month.
The content must be used immediately after opening. The solution is for single use only. Any unused solution and damaged container should be discarded.
6. Contents of the pack and other
information
What Calrecia® contains
- The active substance is calcium chloride dihydrate. 1000 ml 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 provided in a bag with 1500 ml ready-to-use solution.
The solution is clear and colourless and practically free from particles.
Each bag is equipped with a connective tubing and a connector and is covered by 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
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Fresenius Medical Care (UK) Ltd.,
Tel: 0800 001 4499.
This leaflet was last revised in 07/2023.
Handling
The following points prior to the use of the solution bag have to be considered:
- 1. Separate the two bags at the peal seam.
- 2. Remove the overwrap only immediately before using the solution. Check the solution bag (label, expiry date, clearness of the solution, bag and overwrap not damaged). Plastic containers may occasionally be damaged during transport from the manufacturer to the dialysis clinic or hospital clinic or within the clinic itself. This can lead to contamination and the growth of bacteria or a fungus in the solution. Therefore careful inspection of the bag and the solution before use is essential. Particular attention should be paid to even the slightest damage to the closure of the bag, the welding seams and the corners of the bag. The solution should only be used if colourless and clear and if the bag and connector are undamaged and intact.
- 3. Put the bag on the dedicated attachment by its hanger hole.
- 4. For connection remove the protection cap from the connector. The connector only fits to its counterpart to prevent misconnection. Do not touch the unprotected part especially do not touch on top of the connector. The inner part of the connector is sterile and is not intended to be further treated with chemical disinfectants. Put together the connector with the appropriate counterpart and press together until you can turn it clockwise against the resistance to the stop point. You may hear a “click” sound when the connection is fixed.
- 5. Proceed with the further steps as indicated in the treatment description.