Calrecia Solution for Infusion 100mmol/l

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

CALCIUM CHLORIDE, DIHYDRATE

Beschikbaar vanaf:

Fresenius Medical Care Deutschland GmbH D-61346 Bad Homburg, Germany

ATC-code:

B05XA07

INN (Algemene Internationale Benaming):

CALCIUM CHLORIDE DIHYDRATE 14.7 g

farmaceutische vorm:

SOLUTION FOR INFUSION

Samenstelling:

CALCIUM CHLORIDE DIHYDRATE 14.7 g

Prescription-type:

POM

Therapeutisch gebied:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Autorisatie-status:

Withdrawn

Autorisatie datum:

2018-12-11

Bijsluiter

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 parameters

Productkenmerken

Page 1 of 8
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 contain:
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 free from visible 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.
Page 2 of 8
-
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.
-
Any impact on patient’s ionised calcium concentration by other
medicinal interventions.
When estima