Fresenius Medical Care Ci-Ca Dialysate K2 Instructions D'utilisation page 3

Ci-Ca Dialysate K2
INSTRUCTIONS FOR USE
Please read the following instructions carefully.
GENERAL INFORMATION
General description of the product
Ci-Ca Dialysate K2 is free of bacterial endotoxins and is a
sterile, clear and colourless bicarbonate buffered dialysate
solution for continuous veno-venous haemodialysis (CVVHD)
and post-dilution continuous veno-venous haemodiafiltration
(postCVVHDF) with citrate for regional anticoagulation (RCA).
Each unit consists of a bag with 5,000 mL solution and an
injection port and there is a HF connector and a Luer-Lock
connector for connection to the tubing system of the blood
processing device. The bag system is sterilized using steam. It
is a calcium-free dialysis solution.
COMPOSITION
Ci-Ca Dialysate K2 is supplied as a double-chamber bag
with a total volume of 5,000 mL. The ready-to-use dialysis
solution is obtained by mixing both compartments immediately
prior to the application. The small compartment contains
250 mL acidic solution with 15 mmol/L Mg
- +
72 mmol/L Cl , an H -excess of 2 mmol/L (equivalent to a pH
of about 2.7) and 111 mmol/L glucose. The large compartment
contains 4,750 mL of a solution with 140 mmol/L Na
-
118.84 mmol/L Cl and 21.16 mmol/L HCO
Each litre of the ready-to-use solution contains:
Sodium chloride
Sodium hydrogen carbonate
Potassium chloride
Magnesium chloride hexahydrate
Glucose monohydrate
Theoretical osmolarity
pH
Excipients: Water for injections, hydrochloric acid 25%
Ion and glucose concentration in each litre of the ready-to
use solution:
K
+
Na
+
Mg
2+
-
Cl
-
HCO
3
Glucose, anhydrous
INTENDED PURPOSE AND RELATED
DEFINITIONS
Intended purpose
Correction of blood electrolytes and acid-base balance in an
extracorporeal dialysis treatment.
Medical indication
Acute kidney injury, fluid overload or intoxications requiring CRRT
Intended patient population
Ci-Ca Dialysate K2 is intended for use in adult patients
requiring CRRT:
- continuous veno-venous haemodialysis (CVVHD) or
- post-dilution continuous veno-venous haemodiafiltration
(postCVVHDF).
Intended user group and intended environment
Ci-Ca Dialysate solutions must only be used by health care
professionals who are sufficiently trained in CRRT and in
the application of the involved products. The CRRT devices
must be operated in an intensive care unit or under similar
conditions, with close medical supervision and continuous
monitoring. Ci-Ca Dialysate solutions must be used with CRRT
devices that have dedicated pumps for the administration of
citrate and calcium and a therapy program supporting RCA,
such as Fresenius Medical Care CRRT devices multiFiltrate
and multiFiltratePRO.
SIDE EFFECTS
Side effects related to the product and treatment:
Organ class
(IMDRF)
Nervous
system
Blood and
lymphatic
system
Immune
system
2+ +
, 40 mmol/L K ,
Vascular
system
+
,
Heart
-
.
3
Respiratory
system
6.604 g/L
Gastro-
1.68 g/L intestinal
system
0.1491 g/L
0.1525 g/L
Metabolism
and nutrition
1.1 g/L
278 mOsm/L
7.0 – 7.6
2 mmol/L
Musculo-
133 mmol/L
skeletal
system
0.75 mmol/L
116.5 mmol/L
Infections
20 mmol/L
5.55 mmol/L
Other/
generalised
disorders
*Side effect predominantly related to the treatment mode
For further information on these side effects, see MEDICAL
WARNINGS AND PRECAUTIONS as well as INTERACTIONS.
Additional side effects may be specific to other devices or
drugs used in the therapy.
Reporting of serious incidents
If any serious incident occurs in relation to the device, including
those not listed in this leaflet, the treating physician shall be
informed immediately. Within the EU the user and/or patient
must report any serious incident that has occurred in relation to
the device to the manufacturer according to labelling (
the competent authority of the EU Member State in which the
user and/or patient is established.
A serious incident can be any incident that directly or indirectly
leads to the death of a patient, user or other person; to the
temporary or permanent serious deterioration of a patient's,
user's or other person's state of health; or a serious public
health threat.
Side effects
Seizures, cerebral oedema, demyelination
Anaemia*, coagulation disorders (incl.
thrombocytopaenia)*, hypovolaemia and
hypovolaemic shock (through blood
loss, excess ultrafiltration)*, (sustained)
hypervolaemia and oedema*, haemolysis*
Hypersensitivity/allergic reactions
(leading to e.g., dyspnea, hypotension,
urticaria, fever and chills, flushes,
unconsciousness, abdominal pain)
Bleeding/blood loss* (also: catheter-
related), air embolism*, thrombosis and
thrombo-embolism*
Cardiac arrhythmia, cardiac arrest
Bronchospasm, respiratory arrest
Vomiting*, abdominal pain*
Removal of nutrients*, acidosis (e.g.,
from citrate accumulation), alkalosis
(e.g., from citrate overload), electrolyte
imbalance (including hypokalaemia
when using low-potassium solutions
[K2/K2 Plus], hypophosphataemia and/
or hypomagnesaemia, especially when
using phosphate-free solutions [K2/K4]),
glucose imbalance (e.g., in patients with
diabetes mellitus)
Cramps/muscle spasms, bone fractures
Bacterial infection (also: catheter-related)
leading to sepsis
Hypotension*, hypothermia*, headache
MEDICAL WARNINGS AND
PRECAUTIONS
(to prevent Side Effects)
- A pre-existing ionized hypocalcaemia may have to be
treated before initiating the CRRT procedure to reduce the
risk of any clinically relevant hypocalcaemia during the first
hours of treatment.
- To avoid severe disturbances, the fluid balance, acid-base
status, and serum electrolytes (e.g., Ca
inorganic phosphate), as well as blood glucose must be
monitored at regular intervals prior to and during treatment.
If necessary, the prescription should be adapted, and a
severe imbalance must be managed using established
medical practices.
- Severe dysnatraemia generally requires a slow serum
sodium normalisation, as severe complications could
otherwise result, e.g., demyelination or cerebral oedema.
- In patients with reduced citrate metabolism, e.g., in patients
with reduced hepatic function, hypoxemia or a disturbed
oxygen metabolism, regional citrate anticoagulation
can lead to citrate accumulation. Signs include ionized
hypocalcaemia, an increased need for calcium substitution,
an increased ratio of total ionized calcium (above 2.25),
or metabolic acidosis. It may then become necessary to
increase the Ci-Ca Dialysate flow, reduce the blood flow,
or stop using sodium citrate 4% for anticoagulation and to
use an alternative blood anticoagulation agent. Intensified
monitoring is recommended.
- Under RCA, loss of filter performance (i.e. clogging) limits
removal of uremic toxins and may lead to citrate overload.
Signs of citrate overload include metabolic alkalosis,
hypernatraemia and hypercalcaemia. In these cases, the
extracorporeal circuit should be replaced.
- Patients in a prolonged immobilized position may undergo
bone remodelling/demineralisation, ultimately leading to
bone fractures. Under RCA, early indications of an ionized
hypercalcaemia may be masked by a decrease in the
calcium infusion rate. In patients under RCA for longer than
2 weeks or whose calcium infusion rate is progressively
decreasing, bone turnover markers should be closely
monitored.
Additional medical warnings and precautions may be specific
to other devices or drugs used in the therapy.
CONTRAINDICATIONS
Product-specific contraindications
- Hypersensitivity to any constituents of the product
- Hypokalaemia
Treatment-related contraindications
- Inability to establish vascular access
- Known severely impaired citrate metabolism (for
further information, see MEDICAL WARNINGS AND
PRECAUTIONS)
Relative treatment-related contraindications
(predictors for poor treatment outcome – treatment
decision on an individual basis)
- Mitochondrial dysfunction potentially leading to impaired
citrate metabolism (e.g., paracetamol and metformin
intoxications).
- The need to have treatment effects reached more rapidly,
e.g., certain intoxications, than the CRRT treatment can
accomplish. Intermittent HD may be more appropriate in
these cases.
) and
- Terminal disease with no reasonable expectations of
recovery.
- Severe dysnatraemias might be better managed with
a different anticoagulation method in which it is more
straightforward to modify the impact on serum sodium
concentration.
- The need to extend the treatment beyond 4 weeks
continuously.
en
, Na , K , Mg ,
2+ + + 2+