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PRISMASOL 2 MMOL/L POTASSIUM SOLUTION FOR HAEMODIALYSIS/HAEMOFILTRATION

Active substance(s): CALCIUM CHLORIDE DIHYDRATE / GLUCOSE ANHYDROUS / LACTIC ACID / MAGNESIUM CHLORIDE HEXAHYDRATE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE / CALCIUM CHLORIDE DIHYDRATE / GLUCOSE ANHYDROUS / LACTIC ACID / MAGNESIUM CHLORIDE HEXAHYDRATE / POTASSI

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Prismasol 2 mmol/l Potassium solution for haemodialysis/haemofiltration

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Prismasol 2 mmol/l Potassium is presented in a two compartment bag containing in
the smaller compartment A, the electrolyte solution, and in the larger compartment B,
the buffer solution. The final reconstituted solution is obtained after breaking the
frangible pin or peel seal and mixing both solutions.
BEFORE RECONSTITUTION
1 000 ml of electrolyte solution (small compartment A) contains:
active substances:
Calcium chloride dihydrate
5.145 g
Magnesium chloride hexahydrate
2.033 g
Glucose anhydrous
22.00 g
(as glucose monohydrate)
(S)-Lactic acid
5.400 g
(as lactic acid solution 90 %w/w)
1 000 ml of buffer solution (large compartment B) contains:
active substances:
Sodium chloride
6.45 g
Potassium chloride
0.157 g
Sodium hydrogen carbonate
3.090 g
A+B
0.257 g
0.102 g
1.100 g
0.270 g
6.128 g
0.149 g
2.936 g

Calcium chloride, 2 H2O
Magnesium chloride, 6 H2O
Glucose anhydrous
Lactic acid
Sodium chloride
Potassium chloride
Sodium hydrogen carbonate

AFTER RECONSTITUTION
1 000 ml of the reconstituted solution contains:
Active substances
Calcium
Magnesium
Sodium
Chloride
Lactate
Hydrogen carbonate
Potassium

Ca2+
Mg2+
Na+
ClHCO3K+

mmol/l
1.75
0.5
140
111.5
3
32
2

mEq/l
3.50
1.0
140
111.5
3
32
2

Glucose

6.1

Each litre of the final reconstituted solution corresponds to 50 ml of electrolyte
solution A and 950 ml of buffer solution B.
For the full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM
Solution for haemodialysis/haemofiltration
Clear reconstituted solution with a slightly yellow colour.
Theoretical Osmolarity: 297 mOsm/l
pH of the reconstituted solution: 7.0 – 8.5

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications
Prismasol 2 mmol/l Potassium is used in the treatment of renal failure, as
substitution solution in haemofiltration and haemodiafiltration and as dialysis
solution in continuous haemodialysis or continuous haemodiafiltration.
Prismasol 2 mmol/l Potassium solution may also be used in case of drug
poisoning with dialysable or filterable substances.
Prismasol 2 mmol/l Potassium solution is indicated in patients who have
tendency to hyperkalaemia.

4.2

Posology and method of administration
Posology:
The volume of Prismasol 2 mmol/l Potassium used will depend on the clinical
condition of the patient and the target fluid balance. The dose volume is therefore at
the discretion of the responsible physician.
Flow rates for the substitution solution in haemofiltration and haemodiafiltration are:
Adult and adolescents:
500 - 3000 ml/hour
Children:
15 - 35 ml/kg/hour
Flow rates for the dialysis solution (dialysate) in continuous haemodialysis and
continuous haemodiafiltration are:
Adult and adolescents:
500 - 2500 ml/hour
Children:
15 - 30 ml/kg/hour
Commonly used flow rates in adults are about 2000 ml/h which correspond to a daily
amount of 55 l.

Method of administration
Intravenous use and for haemodialysis.
Prismasol 2 mmol/l Potassium, when used as a substitution solution is administered
into the circuit before (pre-dilution) or after the haemofilter (post-dilution).
For further information on the use of the medicinal product see section 6.6 Special
precautions for disposal and other handling.

4.3

Contraindications
Solution dependent contraindications
• Hypokalaemia
• Metabolic alkalosis
Haemofiltration/- dialysis dependent contraindications
• Renal failure with pronounced hypercatabolism, if the uraemic symptoms
cannot be corrected with haemofiltration,
• Insufficient arterial pressure in the vascular access.
• Systemic anticoagulation (high risk of haemorrhage).

4.4

Special warnings and precautions for use
The solution should be used only by, or under the direction of, a physician competent
in renal failure treatments using haemofiltration, haemodiafiltration and continuous
haemodialysis.
Warnings:
Check that the solutions are clear and that all seals are intact before mixing.
Carefully follow the instructions for use.
The electrolyte solution must be mixed with the buffer solution before use to obtain
the reconstituted solution suitable for haemofiltration / haemodiafiltration /
continuous haemodialysis.
Do not administer the solution unless it is clear. Aseptic technique must be used
during connection / disconnection of the line sets.
Use only with an appropriate extra-renal replacement equipment.
Special precautions for use:
Heating of this solution to body temperature (+37°C) must be carefully controlled
verifying that the solution is clear and without particles.
Haemodynamic status, fluid balance, electrolyte and acid-base balance should be
closely monitored throughout the procedure.
Close monitoring of serum potassium levels must be carried out to enable the correct
selection of the most appropriate potassium concentration.

The inorganic phosphate concentration should be measured regularly.
Inorganic phosphate must be substituted in cases of hypophosphataemia.
Blood glucose concentration should be closely monitored, especially in diabetic
patients.
In case of fluid imbalance (example: cardiac failure, head trauma…), the clinical
situation must be carefully monitored and balancing must be restored.
The use of contaminated haemofiltration and haemodialysis solution may cause
sepsis, shock and death.

4.5

Interaction with other medicinal products and other forms of interaction
The blood concentration of filterable/dialysable drugs may be reduced during
treatment. Corresponding corrective therapy should be instituted if necessary.
Interactions with other medicaments can be avoided by correct dosage of the solution
for haemofiltration and haemodialysis and precise monitoring.
However, the following interactions are conceivable:
• The risk of digitalis-induced cardiac arrhytmia is increased during hypokalaemia;
• Vitamin D and medicinal products containing calcium, e.g. calcium carbonate as
phosphate binder, can increase the risk of hypercalcaemia;
• Additional sodium hydrogen carbonate substitution may increase the risk of
metabolic alkalosis.

4.6

Pregnancy and lactation
There are no adequate data from the use of Prismasol 2 mmol/l Potassium in
pregnant or lactating woman. The prescriber should consider the benefit/risk
relationship before administering Prismasol 2 mmol/l Potassium to pregnant or
breast-feeding woman.

4.7

Effects on ability to drive and use machines
Not relevant.

4.8

Undesirable effects
Undesirable effects can result from the solution used or the treatment.
The following undesirable effects may occur:

System Organ Class
Metabolism and

Undesirable effects
Fluid retention

nutrition disorders

Gastrointestinal
disorders
Musculoskeletal and
connective tissue
disorders
Vascular disorders

Dehydration
Electrolyte imbalance
Hypophosphataemia
Hyperglycaemia
Metabolic alkalosis.
Nausea
Vomiting
Muscle spasms

Hypotension

* undesirable effects related to the dialysis treatments (haemofiltration and
haemodialysis)

4.9

Overdose
Overdose with Prismasol 2 mmol/l Potassium, should not occur if the
procedure is carried out correctly and the fluid balance, electrolyte and acidbase balance of the patient are carefully monitored.
However, overdose will result in fluid overload in patients with renal failure.
Continued application of haemofiltration will remove excess fluid and
electrolytes. In case of hyperhydration, the ultrafiltration must be increased
and the rate of administration of the solution for haemofiltration reduced. In
the case of a severe dehydration it is necessary to cease ultrafiltration and to
increase the inflow of solution for haemofiltration appropriately.
Overdose could lead to severe consequences, such as congestive heart failure,
electrolyte or acid-base disturbances.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Hemofiltrates.
ATC code: B05ZB
Prismasol 2 mmol/l Potassium, solution for haemofiltration and haemodialysis
is pharmacologically inactive. The sodium, calcium, magnesium, potassium,
chloride ions and glucose are present at concentrations similar to physiological
levels in plasma.

The solution is used to replace water and electrolytes removed during
haemofiltration and haemodiafiltration or to serve as a suitable exchange
medium for use during continuous haemodiafiltration or continuous
haemodialysis.
Hydrogen carbonate is used as an alkalising buffer.

5.2

Pharmacokinetic properties
Not relevant.
The active ingredients are pharmacologically inactive and are present at
concentrations similar to physiological plasma levels.

5.3

Preclinical safety data
All the ingredients of the solution are physiological components in animal and
human plasma. Toxic effects are not expected at therapeutic doses.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Electrolyte solution (small compartment A): Water for injections
Buffer solution (large compartment B):
Water for injections, Carbon
dioxide

6.2

Incompatibilities
In the absence of compatibility studies, this product must not be mixed with
other medicinal products.
It is the responsibility of the physician to judge the incompatibility of an
additive medication with the Prismasol 2 mmol/l Potassium solution by
checking for eventual colour change and/or eventual precipitation, insoluble
complexes or crystals. The Instructions for Use of the medication to be added
must be consulted.
Before adding a drug, verify it is soluble and stable in water at the pH of
Prismasol 2 mmol/l Potassium (pH of reconstituted solutions is 7.0 to 8.5).

The compatible medication must be added to the reconstituted solution and the
solution must be administered immediately.

6.3

Shelf life
PVC: 1 year as packaged for sale.
Polyolefin: 18 months as packaged for sale.
Chemical and physical in-use stability of the reconstituted solution has been
demonstrated for 24 hours at +22o C. From a chemical point of view, the reconstituted
solution should be used immediately. If not used immediately in-use storage times
and conditions prior to use are the responsibility of the user and should not normally
be longer than 24 hours including the duration of the treatment.

6.4

Special precautions for storage
Do not store below +4°C.
For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5

Nature and contents of container
The container made in Poly(vinyl chloride) (PVC) or polyolefin is a twocompartment bag. The 5000 ml bag is comprised of a small compartment (250 ml)
and a large compartment (4750 ml). The two compartments are separated by a
frangible pin or a peel seal.
The large compartment B is fitted with an injection connector (or spike connector)
made of polycarbonate (PC), which is closed with a rubber disc covered by a cap as
well as a luer connector (PC) with a frangible pin (PC) or a valve made of silicone
rubber for the connection of the bag with a suitable replacement solution line
or dialysis line. The bag is over wrapped with a transparent overwrap made of
multilayer polymer film.
Each two compartment bag contains 5000 ml.
Pack size: 2 x 5000 ml in a box

6.6 Special precautions for disposal and other handling
The electrolyte solution (small compartment A) is added to the buffer solution (large
compartment B) after breaking the frangible pin or opening the peel seal immediately
before use.

A patient information leaflet with detailed instruction for use is enclosed in the box.
Aseptic technique should be used throughout administration to the patient:
Do not remove unit from overwrap until ready for use.
If a frangible pin separates the two compartments of the bag and a frangible pin is
located in the luer connector the following instructions for use should be followed:
I Remove the overwrap from the bag and the sheet between the folded compartments.
Open the seal by breaking the frangible pin between the two compartments of the
bag. The frangible pin will remain in the bag.
II Make sure all the fluid from the small compartment A is transferred into the large
compartment B.
III Rinse the small compartment A twice by pressing the mixed solution back into
the small compartment and then back into the large compartment B.
IV When the small compartment A is empty: shake the large compartment B so that
contents mix completely.
The solution is now ready for use.
V If the luer connector is used, first connect the replacement or dialysis line and then
break the frangible pin in the luer connector.
The bag should hang in all three hanging holes when used.
Connect the substitution fluid/dialysis line.
The reconstituted solution should be used immediately. If not used immediately, the
reconstituted solution should be used within 24 hours including the duration of the
treatment after addition of the electrolyte solution to the buffer solution.
The reconstituted solution is for single use only.
Do not use if container is damaged or if solution is not clear.
Discard any unused solution immediately after use.
If a frangible pin separates the two compartments of the bag and a valve is located in
the luer connector the following instructions for use shall be followed:
I
Remove the over wrap from the bag immediately before use and discard any
other packaging materials. Open the seal by breaking the frangible pin
between the two compartments of the bag. The frangible pin will remain in
the bag.
II
Make sure all the fluid from the small compartment A is transferred into the
large compartment B.
III
Rinse the small compartment A twice by pressing the mixed solution back
into the small compartment A and then back into the large compartment B.
IV
When the small compartment A is empty: shake the large compartment B so
that the contents mix completely. The solution is now ready for use and the
bag can be hung on the equipment.
V
The dialysis or replacement line may be connected to either of the two access
ports.
Va
If the luer access is used, remove the cap with a twist and pull motion, and
connect the male luer lock on the dialysis or replacement line to the female
luer receptor 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.

Vb

When the dialysis or replacement line is disconnected from the luer connector,
the connector will close and the flow of the solution will stop. The luer port is
a needle-less and swabbable port.
If the injection port is used, first remove the snap-off cap. Then introduce the
spike through the rubber septum. Verify that the fluid is flowing freely.

The reconstituted solution is for single use only.
Do not use if container is damaged or if solution is not clear.
Discard any unused solution immediately after use.
If a peel seal separates the two compartments of the bag and a frangible pin is located
in the luer connector the following instructions for use should be followed:
I
Immediately before use remove the over wrap from the bag and mix the solutions
in the two different compartments. Hold the small compartment with both hands
and squeeze it until an opening is created in the peel seal between the two
compartments.
II
Push with both hands on the large compartment until the peel seal between the
two compartments is entirely open.
III Secure complete mixing of the solution by shaking the bag gently. The solution is
now ready for use, and can be hung on the equipment.
IV The dialysis line may be connected to either of the two access ports.
IVa If the luer access is used, remove the cap and connect the male luer lock on the
dialysis line to the female luer receptor on the bag; tighten. Using thumb and
fingers, break the coloured frangible pin at its base, and move it back and forth.
Do not use a tool. Verify that the pin is completely separated and that the fluid is
flowing freely. The pin will remain in the luer port during the treatment.
IVb If the injection port is used, first remove the snap-off cap. Then introduce the
spike through the rubber septum. Verify that the fluid is flowing freely.
The reconstituted solution should be used immediately. If not used immediately, the
reconstituted solution should be used within 24 hours, including the duration of the
treatment, after addition of the electrolyte solution to the buffer solution.
The reconstituted solution is for single use only. Do not use if container is damaged
or if solution is not clear. Discard any unused portion.
If a peel seal separates the two compartments of the bag and a valve is located in the
luer connector the following instructions for use shall be followed:
I
Remove the over wrap from the bag immediately before use and discard any
other packaging materials. Open the seal by holding the small compartment with
both hands and squeezing it until an opening is created in the peel seal between
the two compartments.
II
Push with both hands on the large compartment until the peel seal between the
two compartments is entirely open.
III Secure complete mixing of the solution by shaking the bag gently. The solution is
now ready for use, and can be hung on the equipment.
IV The dialysis or replacement line may be connected to either of the two access
ports.
IVa If the luer access is used, remove the cap with a twist and pull motion, and
connect the male luer lock on the dialysis or replacement line to the female luer

receptor 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.
When the dialysis or replacement line is disconnected from the luer connector,
the connector will close and the flow of the solution will stop. The luer port is a
needle-less and swabbable port.
IVb If the injection port is used, first remove the snap-off cap. Then introduce the
spike through the rubber septum. Verify that the fluid is flowing freely
The reconstituted solution should be used immediately. If not used immediately, the
reconstituted solution should be used within 24 hours, including the duration of the
treatment, after addition of the electrolyte solution to the buffer solution.
The reconstituted solution is for single use only. Do not use if container is damaged
or if solution is not clear. Discard any unused portion.

7

MARKETING AUTHORISATION HOLDER
Gambro Lundia AB
Magistratsvägen 16
SE-220 10 Lund
SWEDEN

8.

MARKETING AUTHORISATION NUMBER
PL 14983/0013

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22/07/2012

10

DATE OF REVISION OF THE TEXT
30/11/2012

Expand Transcript

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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