Regiocit Solution for haemofiltration

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium citrate; Sodium chloride

Available from:

Gambro Lundia AB

ATC code:

B05ZB

INN (International Name):

Sodium citrate; Sodium chloride

Dosage:

18/140 mmol/L

Pharmaceutical form:

Solution for haemofiltration

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Hemofiltrates

Authorization status:

Not marketed

Authorization date:

2014-11-14

Patient Information leaflet

07-19-00-0586
Regiocit
UK, IE, MT
The following information is intended
for healthcare professionals only
.......................................15
HU
Az alábbi információk kizárólag
egészségügyi szakembereknek szólnak ...........................17
RO
Următoarele informaţii sunt destinate
numai profesioniştilor din domeniul sănătăţii
.....................19
BG
Посочената по-долу информация е
предназначена
само за медицински специалисти
..................................21
UK, IE, MT
Package leaflet: Information for the user
.............................3
HU
Betegtájékoztató: Információk a felhasználó számára ........6
RO
Prospect: Informaţii pentru utilizator
....................................9
BG
Листовка: Информация за потребителя
........................12
BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: 07-19-00-0586
Date: 28-MAR-2019
Proofread No.: 01
Designer: GSB
Page: 1 of 24
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BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: 07-19-00-0586
Date: 28-MAR-2019
Proofread No.: 01
Designer: GSB
Page: 2 of 24
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Colour Reference:
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PACKAGE LEAFLET: INFORMATION FOR THE USER
3
07-19-00-0586
UK
IE
MT
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.
Content

Summary of Product characteristics

Health Products Regulatory Authority
31 January 2020
CRN008TSZ
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 conc