Calrecia 100 mmol/l, solution for infusion

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Calcium chloride dihydrate

Διαθέσιμο από:

Fresenius Medical Care Deutschland GmbH

Φαρμακολογική κατηγορία (ATC):

B05XA; B05XA07

INN (Διεθνής Όνομα):

Calcium chloride dihydrate

Δοσολογία:

100 mmol/L

Φαρμακοτεχνική μορφή:

Solution for infusion

Θεραπευτική περιοχή:

Electrolyte solutions; calcium chloride

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2019-04-12

Φύλλο οδηγιών χρήσης

1/5
PACKAGE LEAFLET: INFORMATION FOR THE USER
CALRECIA,
100 mmol/l, solution for infusion
calcium chloride dihydrate
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.
WHAT IS 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 pack and other information
1. WHAT CALRECIA IS AND 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 tube regularly for
blood clots
•
ensure that the calcium level is correct and closely monitored during
your treatment
•
monitor parathyroid hormone levels and other parame

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
12 October 2023
CRN00DWHQ
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calrecia 100 mmol/l, solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Calrecia is provided in a bag with 1500 ml ready-to-use solution.
1000 ml solution contains:
Calcium chloride dihydrate 14.7 g
Ca
2+
100 mmol
Cl
-
200 mmol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
The solution is clear and colourless and practically free from
particles.
Theoretical osmolarity: 300 mOsm/l
pH: 5.0 – 7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calrecia is used for calcium substitution in continuous renal
replacement therapies (CRRT), sustained low efficiency (daily)
dialysis (SLEDD) and therapeutic plasma exchange (TPE) using citrate
for anticoagulation.
Calrecia is indicated in adults and children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Application of Calrecia should take place only based on the
prescription of a physician familiar with citrate anticoagulation in
the specific mode of CRRT, SLEDD and TPE.
Posology
_ADULTS _
Calrecia is applied in an amount adequate to keep the systemic ionised
calcium concentration in the desired range. If not
otherwise prescribed, the normal range for systemic ionised calcium
should be targeted. The target range must not be below
0.9 mmol/l systemic ionised calcium.
The amount of Calrecia needed to keep the systemic ionised calcium
concentration within the desired range depends on:

Calcium removed during CRRT, SLEDD and TPE.

The amount of calcium required to compensate effects of citrate
reaching the systemic circulation, which can
originate from the citrate solution used for regional anticoagulation
or from plasma preparations used as
substitution solution in TPE.

Calcium shifts between the plasma and other compartments of the
patient's body.

Any intended change of the baseline systemic calcium concentration.
Health Products Regulatory Authority
12 October