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REGIOCIT SOLUTION FOR HAEMOFILTRATION

Active substance(s): SODIUM CHLORIDE / SODIUM CITRATE

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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 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.
If the overwrap or solution bag is
damaged, the solution may become
contaminated and must not be
used. Besides this medicine, the
treatment involves other fluids that
are infused. The composition or
rate of administration of these other
fluids may need to be adjusted to
be compatible with this medicine.
Your doctor will closely monitor
your haemodynamic status, fluid
balance, glucose level, electrolyte
and acid/base balance before and
during treatment. Adjustments to
the therapy will be made if needed.
Special attention will be paid to the
blood level of sodium, calcium and
magnesium (electrolytes). Infusion
of sodium may be needed to compensate for sodium loss. Infusion
of calcium is standard practice.
Infusion of magnesium may also be
needed.
Your doctor will pay special attention to the citrate infusion rate.
Too much citrate causes low blood
levels of calcium and high blood
pH, which may lead to neurologic
and cardiac complications. High
blood pH can be corrected by
adjusting dialysis settings and by
infusing 0.9% sodium chloride solution post-filter. Low blood levels of
calcium can be treated by infusion
of calcium.
Special attention is required by
your doctor if you suffer from liver
failure or shock. The metabolism of
citrate may be markedly reduced
resulting in accumulation of citrate
acompanied by low blood pH. Your
doctor will decide if your treatment
has to be adjusted. If the total/ionized calcium ratio rises above 2.3,
the citrate buffer should be reduced
or stopped.

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The instructions for use must be
strictly followed. Incorrect use of
the access ports or other restrictions to fluid flow might lead to
incorrect patient weight loss and
may result in machine alarms. Continuing treatment without resolving
the originating cause may result in
patient injury or death.
This medicine is for single use
only. Any unused solution must be
discarded.
Use only if the solution is clear and
free from visible particles.
OTHER MEDICINES AND
REGIOCIT
Tell your doctor, pharmacist or
nurse if you are taking, or have
recently taken, any other medicines, including medicines obtained
without a prescription. This is
because the concentration of other
medicines may be reduced during
dialysis treatment. Your doctor will
decide if any changes in the dosage of your medicines should be
made. In particular, tell your doctor
if you are using medicinal product
containing any of the following:
•• Calcium; as they may increase
the calcium level in your blood
and/or
•• Sodium hydrogen carbonate; as
they may increase the hydrogen
carbonate level in your blood.
PREGNANCY, BREAST-FEEDING
AND FERTILITY
Fertility:
No effects on fertility are anticipated, since sodium, chloride and
citrate are normal constituents of
the body.
Pregnancy and breast-feeding:
There are no documented clinical
data on the use of this medicine
during pregnancy and breastfeeding. This medicine should only
be administered to pregnant and
breast-feeding women if clearly
needed.
DRIVING AND USING MACHINES
This medicine is not known to
affect your ability to drive or use
machines.

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3. HOW TO USE THIS
MEDICINE
For intravenous use. This medicine
is to be used in hospitals and
administered by medical professionals only. The volume used, and
therefore the dose of this medicine,
will depend on your condition. The
dose volume will be determined by
your doctor.
The recommended flow rates for this
medicine in adults and adolescents:
•• In continuous veno-venous
haemofiltration: 1 – 2.5 l/h
with a blood flow rate between
100 and 200 ml/min.
•• In continuous veno-venous
haemodiafiltration: 1 – 2 l/h
with a blood flow rate between
100 and 200 ml/min.
Use in older people:
The recommended flow rates are the
same as for adults and adolescents.
Use in children:
For neonates to toddlers
(0 to 23 months) Regiocit should
target a dose of 3 mmol citrate
per litre of blood flow in continuous veno-venous haemofiltration
or haemodiafiltration. For children
(2 to 11 years) dosage should be
adapted to both the weight of the
patient and the blood flow rate.
Liver failure or shock:
In these conditions, the initial
starting dose of citrate should be
reduced.
INSTRUCTIONS FOR USE
Regiocit will be given to you in a
hospital. Your doctor will know how
to use Regiocit.

NOT KNOWN: FREQUENCY
CANNOT BE ESTIMATED FROM
THE AVAILABLE DATA
•• Imbalance in the level of fluid in
the body (dehydration, retention
of fluid in the body)
•• Decreased blood pressure*
•• Feeling sick*, vomiting*
•• Cramps*
* Side effects related to the dialysis
treatment rather than this medicine.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects
directly via
United Kingdom:
Via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Republic of Ireland:
Via HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517;
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
Malta:
Via The Medicines Authority, PostLicensing Directorate, 203, Level 3,
Rue D’Argens, GZR 1368 Gzira
Website:
www.medicinesauthority@gov.mt
Email:
postlicensing.medicinesauthority@
gov.mt
By reporting side effects you can
help provide more information on
the safety of this medicine.

For instructions for use see the end
of this leaflet.

5. HOW TO STORE THIS
MEDICINE

4. POSSIBLE SIDE EFFECTS

Keep this medicine out of the sight
and reach of children.

Like all medicines, this medicine
can cause side effects, although
not everybody gets them. Your
blood will be regularly controlled
by a doctor or nurse in order to find
possible side effects. Use of this
solution could cause:
COMMON: MAY AFFECT
UP TO 1 IN 10 PEOPLE
•• Acid/base imbalance in the blood
•• Imbalances in the level of electrolytes in the blood (e.g. drop
in the calcium, sodium, and/or
magnesium level in the blood or
increase in the calcium level in
the blood)

4

This medicinal product does not
require any special storage conditions.
Do not freeze.
Do not use this medicine after the
expiry date which is stated on the
label and the packaging. The expiry
date refers to the last day of that
month.
Do not use this medicine if you
notice damage to the product or
visible particles in the solution.
The solution can be disposed of
via wastewater without harming the
environment.

6. CONTENTS OF THE PACK
AND OTHER INFORMATION
WHAT THIS MEDICINE
CONTAINS
Composition:
Sodium chloride
Sodium citrate

5.03 g/l
5.29 g/l

The active substances are:
Sodium, Na+
140 mmol/l
Chloride, Cl-
86 mmol/l
Citrate, C6H5O73-
18 mmol/l
Theoretical osmolarity: 244 mOsm/l
pH ≈ 7.4
The other ingredients are:
•• Dilute hydrochloric acid
(for pH adjustment) E507
•• Water for injections
WHAT THIS MEDICINE
LOOKS LIKE AND CONTENTS
OF THE PACK
This medicine is a clear and colourless solution for haemofiltation
packed in a one-compartment bag
made of a multilayer film containing polyolefins and elastomers.
The solution is sterile and free from
bacterial endotoxins. Each bag
contains 5000 ml solution and the
bag is overwrapped with a transparent film. Each box contains two
bags and one package leaflet.
MARKETING AUTHORISATION
HOLDER
Gambro Lundia AB
Magistratsvägen 16
226 43 Lund
Sweden
MANUFACTURER
Gambro Dasco S.p.A.
Via Stelvio, 94
23035 Sondalo (SO)
Italy
This medicinal product is authorised in the Member States of the
EEA under the following names:
Austria, Belgium, Croatia, Cyprus,
Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
the Netherlands, Norway, Poland,
Portugal, Romania, Slovakia,
Slovenia, Spain, Sweden, United
Kingdom: Regiocit
Bulgaria: Regiocit (Региоцит)
This leaflet was last revised in
03/2016

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The following information is intended
for healthcare professionals only

POSOLOGY
The pre-filter infusion rate of
Regiocit must be prescribed and
adapted relative to the blood flow
rate. 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 acidbase and electrolyte balance.
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 normal physiologic range by
adjustment of calcium supplementation.
Flow rates for Regiocit in adult and
adolescents:
•• In continuous veno-venous
haemofiltration: 1 – 2.5 l/h
with a blood flow rate between
100 and 200 ml/min.
•• In continuous veno-venous
haemodiafiltration: 1 – 2 l/h
with a blood flow rate between
100 and 200 ml/min.
Paediatric population:
For neonates to toddlers
(0 to 23 months) Regiocit should
target a dose of 3 mmol citrate
per litre of blood flow in continuous veno-venous haemofiltration
or haemodiafiltration. For children
(2 to 11 years) dosage should be

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adapted to both the weight of the
patient and the blood flow rate.
Special populations:
In the elderly population there is no
specific modification of the dosage
compared to adults.

PREPARATION
AND/OR HANDLING
The solution can be disposed of
via wastewater without harming the
environment.

Hepatic impairment or shock:
In case of liver failure (including
e.g. liver cirrhosis or acute liver
failure) or shock, initial starting
dose of citrate should be reduced
as metabolism may be inadequate.

Remove the overwrap from the
bag immediately before use.
Aseptic technique should be used
throughout administration to the patient. The solution should be used
immediately after opening to avoid
microbiological contamination.

OVERDOSE

I

Undesirable administration of
too high volumes of replacement
solution may lead to an overdose,
which can cause a life threatening
situation for the patient. This may
result in pulmonary oedema and
congestive heart failure in relation
with fluid overload and in hypocalcaemia and metabolic alkalosis
due to citrate overload in relation to
the blood flow. This derangement
needs to be corrected immediately
by stopping/lowering the amount
of replacement solution and by
the intravenous administration of
calcium.
In patients with poor citrate
metabolism (liver failure or shock)
citrate may accumulate. Metabolic
acidosis and ionized hypocalcaemia may ensue. Regiocit should
thus be either reduced or stopped.
To correct for metabolic acidosis,
hydrogen carbonate has to be
replaced. Continuous renal replacement therapy can be continued
without anticoagulation or other
means of anticoagulation have to
be considered.

II

If the luer connector is used,
remove the cap with a twist
and pull motion. Connect the
male luer lock on the pre-blood
pump line to the female luer
connector on the bag using a
push and twist motion. Ensure
that the connection is fully
seated and tighten. The connector is now open. Verify that
the fluid is flowing freely.
(See figure I below.)
When the pre-blood pump line
is disconnected from the luer
connector, the connector will
close and the flow of the solution will stop. The luer is a needle-less and swabbable port.
If the injection connector (or
spike connector) is used, remove the snap-off cap. Introduce the spike through the rubber septum. Verify that the fluid
is flowing freely.
(See figure II below.)

II

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Gambro and Regiocit are trademarks of Baxter International Inc., or its subsidiaries
Gambro Lundia AB
P.O. Box 10101
SE-220 10 Lund
Sweden
Visiting address: Magistratsvägen 16, Lund
Tel: +46 46 16 90 00
www.gambro.com

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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