Regiocit Solution for haemofiltration

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Sodium citrate; Sodium chloride

Beszerezhető a:

Baxter Holding B.V.

ATC-kód:

B05ZB

INN (nemzetközi neve):

Sodium citrate; Sodium chloride

Gyógyszerészeti forma:

Solution for haemofiltration

Terápiás terület:

Hemofiltrates

Engedélyezési státusz:

Marketed

Engedély dátuma:

2014-11-14

Betegtájékoztató

1/6
PACKAGE LEAFLET: INFORMATION FOR THE USER
REGIOCIT SOLUTION FOR HAEMOFILTRATION
CITRATE, SODIUM, CHLORIDE
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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What this medicine is and what it is used for
2.
What you need to know before you use this medicine
3.
How to use this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1.
WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
This medicine is a solution for haemofiltration and prevents blood
clotting during continuous renal
replacement therapy (CRRT), which is a form of dialysis treatment.
This medicine is used for critically ill
patients, particularly when the normal medicine used to prevent blood
clotting (heparin) is inappropriate.
Citrate provides anticoagulation by binding to calcium in the blood.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE THIS MEDICINE
_ _
DO NOT USE THIS MEDICINE IN CASE OF:
Allergy to the active substances or to any of the other ingredients
(listed in section 6)
Severely impaired liver function
Severely decreased blood flow in the muscles
WARNING AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using this medicine.
This medicine is not for direct intravenous infusion. It should be
used only with a machine capable of
performing continuous renal replacement therapy (CRRT), which is a
type of dialysis specifically for
critically ill patients with kidney failure. The CRRT machine must be
suitable for citrate anticoagulation.
Regiocit may be warmed to 37°C to enhance patient comfort. Warming of
the solution prior to use should be
done with dry heat only. Solutions should not be heated in water or

Termékjellemzők

Health Products Regulatory Authority
20 February 2024
CRN00DLH3
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Regiocit Solution for haemofiltration
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition:
Sodium chloride 5.03 g/l
Sodium citrate 5.29 g/l
Sodium, Na
+
140 mmol/l
Chloride, Cl
-
86 mmol/l
Citrate, C
6
H
5
O
7
3-
18 mmol/l
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for haemofiltration
The solution is sterile, clear and colourless and free from bacterial
endotoxins.
Theoretical osmolarity: 244 mOsm/l
pH ≈ 7.4
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Regiocit is indicated as replacement fluid for continuous renal
replacement therapy (CRRT) using regional citrate
anticoagulation. Citrate is particularly relevant when systemic
anticoagulation with heparin is contraindicated, for example in
patients with increased bleeding risks.
In paediatric patients, Regiocit is indicated in all age groups
provided that the equipment used is adapted to the weight of the
child.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The rate at which Regiocit is administered depends on the targeted
citrate dose and the prescribed blood flow rate (BFR). The
prescription of Regiocit must consider the flow rates of the effluent
and other therapeutic fluids, the patient's fluid removal
requirements, additional fluid inputs and outputs, and the desired
acid-base and electrolyte balance. Regiocit should be
prescribed and administration (dose, infusion rate, and cumulative
volume) should be established only by a physician
experienced in critical care medicine and CRRT.
The pre-filter infusion rate of Regiocit must be prescribed and
adapted relative to the blood flow rate to achieve target blood
citrate concentration of 3 to 4 mmol/l of blood.
Flow rate for anticoagulation of the extracorporeal circuit should be
titrated to achieve a post-filter concentration of ionized
calcium in the range 0.25 to 0.35 mmol/l. The patient's systemic
ionized calcium con