Cifoban 136 mmol/l solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Available from:

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

ATC code:

B05ZB

INN (International Name):

SODIUM CITRATE 40 g

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

SODIUM CITRATE 40 g

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Withdrawn

Authorization date:

2022-02-23

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Cifoban 136 mmol/l solution for infusion
sodium citrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 Cifoban is and what it is used for
2.
What you need to know before you are given Cifoban
3.
How Cifoban is given
4.
Possible side effects
5.
How to store Cifoban
6.
Contents of the pack and other information
1.
WHAT CIFOBAN IS AND WHAT IT IS USED FOR
Cifoban is a solution for infusion, which contains the active
substance sodium citrate.
For infusion in the extracorporeal (outside the body) circuit only.
This medicine is used as anticoagulant (to make your blood thinner)
during regional citrate
anticoagulation in the following kidney replacement and plasma
exchange therapies:
•
continuous venovenous haemodialysis (CVVHD)
•
continuous venovenous haemodiafiltration (CVVHDF)
•
sustained low efficiency (daily) dialysis (SLEDD)
•
therapeutic plasma exchange (TPE) (removes and replaces a patient´s
blood plasma).
This medicine is intended to be used in adults and children of all age
groups (except premature
babies).
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CIFOBAN
YOU MUST NOT BE GIVEN CIFOBAN
•
if you are allergic to sodium citrate
•
if a recent treatment with Cifoban was stopped because your body was
insufficiently able to
break down the required dose of Cifoban and as a result citrate
accumulated in your blood.
WARNINGS AND PRECAUTIONS
Talk to your doctor before you are given Cifoban.
Your doctor will:
Page 2 of 7
•
ensure that any reduced liver function, a decrease of oxygen in the
blood, or disturbed oxygen
utilisation in the body tissues are known before starting the
treatme

Summary of Product characteristics

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CIFOBAN
136 mmol/l solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cifoban is provided in a bag with 1500 ml ready-to-use solution.
1000 ml solution contains:
Sodium citrate
40.0 g
Na
+
408 mmol
Citrate
3-
136 mmol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
Extracorporeal use. To be infused into the extracorporeal blood
circuit only.
The solution is clear and colourless and practically free from
particles.
Theoretical osmolarity:
544 mOsm/l
pH:
7.1 – 7.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cifoban is used for regional citrate anticoagulation (RCA) in
continuous venovenous haemodialysis
(CVVHD), continuous venovenous haemodiafiltration (CVVHDF), sustained
low efficiency (daily)
dialysis (SLEDD) and therapeutic plasma exchange (TPE) via membrane
plasma separation.
Cifoban is indicated in adults and children of all age groups (except
preterm newborn infants).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cifoban should be prescribed only by a physician competent in the
application of RCA in the specific
treatment mode of CVVHD, CVVHDF, SLEDD and/or TPE. For the paediatric
population, Cifoban
should be prescribed and monitored by physicians competent in the
aforementioned treatment modes
in children.
Page 2 of 12
Posology
_ADULTS _
The pre-filter infusion rate of Cifoban should be titrated
proportional to the blood flow of the
extracorporeal circuit to achieve a sufficient suppression of ionised
calcium of the blood within the
filter as per applied RCA protocol. Generally, a post-filter ionised
calcium concentration below 0.3-
0.35 mmol/l should be targeted, which is usually achieved with dosing
of 4-5 mmol citrate per litre
treated blood. The required Cifoban flow (in ml/min) can be calculated
by multiplying this intended
citrate
dosing
with
the
blood
flow
(in
ml/min)
and
dividing
by
136
mmol/l
(i.e.,
the
citrate
concentration of Cifoban). The patient’