Regiocit Solution for Haemofiltration

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SODIUM CHLORIDE, SODIUM CITRATE

Available from:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

ATC code:

B05ZB

INN (International Name):

SODIUM CHLORIDE 5.03 g/l SODIUM CITRATE 5.29 g/l SODIUM 140 mmol/l CHLORIDE 86 mmol/l

Pharmaceutical form:

SOLUTION FOR HAEMOFILTRATION

Composition:

SODIUM CHLORIDE 5.03 g/l SODIUM CITRATE 5.29 g/l SODIUM 140 mmol/l CHLORIDE 86 mmol/l

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Authorization date:

2014-11-13

Patient Information leaflet

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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
w

Summary of Product characteristics

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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
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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 concentration should be maintained in the nor