Skip to Content


PDF options:  View Fullscreen   Download PDF

PDF Transcript



MONOSOL, Solution for haemofiltration, haemodialysis
and haemodiafiltration
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor.

In this leaflet:
1. What MONOSOL is and what it is used for
2. Before MONOSOL is given
3. How MONOSOL is given
4. Possible side effects
5 How to store MONOSOL
6. Further information

measure the lactate level in your blood before
prescribing to you MONOSOL solutions.
check the level of potassium in your blood to ensure
that you receive the correct strength of MONOSOL.
check the acidity or alkalinity of your blood especially if you have liver
and heart problems.
check your blood glucose very carefully, especially if you are diabetic.

Taking other medicines
Inform your doctor if you are taking other medicines, even those not prescribed.
Taking MONOSOL may affect and interact with other medicines.
• If you are diabetic your glucose level will be carefully measured.
Your insulin dose will be adjusted as needed as this solution contains

Pregnancy and breast-feeding
Tell your doctor if you are pregnant or breast-feeding. He will determine the
benefit versus the risk of using MONOSOL.

MONOSOL is a solution for haemofiltration, haemodialysis and


MONOSOL is prescribed to you if you have kidney failure.
Depending on your therapy, your doctor will administer MONOSOL solution by
way of the tubing from the dialysis machine
The treatment by haemofiltration, haemodialysis or haemodiafiltration that you
receive will depend upon your clinical diagnosis, physical examination findings,
laboratory results and response to treatment.
Your doctor will determine the right formulation and amount of MONOSOL
solutions for your clinical condition.

It purifies your blood of waste products; it corrects the acidity or alkalinity and
the level of salts in your blood. As a replacement fluid in haemodiafiltration and
haemofiltration, it can also be used as a source of salts and water for hydration.
MONOSOL solutions must only be used by or under the direction of a doctor.


How much and how often?
Your doctor will decide and adjust the flow rate and volume of the solution to be
The amount of fluid required depends upon how MONOSOL is being used.
MONOSOL should be used as indicated and needed until your doctor decides to
stop the treatment.

Before starting the therapy, your doctor will ensure that you have a good access
to your vein and artery. He will also ensure that you do not present a high risk
of bleeding.
MONOSOL solutions are available in different potassium concentrations. Your
blood level of potassium will be monitored very closely to ensure that the most
appropriate MONOSOL formulation is used.

Do not take MONOSOL solution and tell your doctor if you


do not have good access to the veins and/or arteries.
have an excessive risk of bleeding during therapy.
have a potassium blood level too low, unless you are simultaneously
receiving potassium supplementation.
have a clinical condition in which your body is not able to metabolise
lactate normally.
If your doctor has not prescribed treatment by haemofiltration,
haemodialysis or haemodiafiltration.

Like all medicines MONOSOL solutions can cause side effects, but not everyone
gets them.
You may experience possible side effects. They may not all be due to the
solutions or treatment. The potential undesirable effects that may occur are:
• Disturbance in the different salts level in your blood (e.g. disturbance
in sodium, potassium, calcium in your blood).
• Disturbance in the fluid balance in your body
• Reduction (hypovolaemia) or increase (hypervolaemia) in body fluid
• Reduction (hypotension) or increase (hypertension) in blood pressure
• Muscle cramps.
If you experience any of the side effects listed above, or any other side effects,
please inform your doctor.

Take special care with MONOSOL
MONOSOL can only be used by or under the direction of a doctor who has
experience with the haemofiltration, haemodialysis and haemodiafiltration
Your doctor will
• measure the acidity, different salts and waste product levels in your
• ensure that their levels are correct and closely monitored during your
• ensure that the fluid balance of your body is well maintained. Your
weight will be recorded regularly to ensure that you receive the right
quantity of fluid.



Keep out of the reach and sight of children.
Do not store above 25°C.
Do not keep in a refrigerator or in a freezer.
Do not use MONOSOL after the expiry date stated on the label and carton after
Exp. The expiry date refers to the last day of that month.
The doctor will check if the solution is clear and the container undamaged.

Name of the Medicinal Product
MONOSOL, Solution for haemofiltration, haemodialysis and haemodiafiltration

The composition of the solution MONOSOL is:
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Sodium chloride
Sodium lactate
Glucose monohydrate

MONOSOL solution
0.257 g/l
0.152 g/l
6.43 g/l
3.36 g/l
1.1 g/l

The other Ingredient is Water for Injections.

What MONOSOL looks like and Contents of the pack
MONOSOL is supplied in a carton box containing two units of 5 litres PVC bags.
Each bag is over-wrapped in its overpouch.
The solution in the bag is sterile, clear and colourless.

Marketing Authorisation Holder:
Nikkiso Belgium bvba
Industriepark, 6
3300 Tienen
Phone (Belgium): +32 (0)16 781770
Phone (United Kingdom): +44 (0)1483 212151

Baxter Healthcare S.A.
Moneen Road
County Mayo – Ireland

This leaflet was last approved in:
Monosol is a trademark of Nikkiso Co., Ltd.



The following information is intended for Medical or Healthcare professionals only

MONOSOL, Solution for haemofiltration, haemodialysis and haemodiafiltration


4.4. Special Warnings and Special Precautions for Use
• These solutions are to be used only by or under the direction of a
physician who should have a sound experience of intensive care
nursing and/or haemofiltration and haemodiafiltration techniques.
• When using, high volumes of fluid, either as a replacement fluid or
dialysate, consideration should be given to the fact that the lactate
uptake to blood may exceed the metabolic capabilities to convert it
into bicarbonate.
• Very special care must be devoted to ensuring proper fluid balance.
An accurate fluid balance record must be kept and the weight of the
patient must be closely monitored to avoid fluid balance problems
which may lead to life-threatening complications such as congestive
heart failure or hypovolaemic shock due to excessive volume
• Close monitoring of kalaemia must be performed to enable
selection of the appropriate potassium concentration and thus avoid
hyperkalaemia or hypokalaemia.
• Special attention must be paid to acid-base equilibium, especially in
those patients with liver impairment and cardiogenic shock. Serum
lactate and pH must be closely monitored.
• Glycaemia, phosphataemia, calcaemia and magnesaemia should also
be frequently monitored, together with the levels of urea and other
waste products.
• Care should be taken when the solution is used in patients with
hypercatabolism associated with acute renal failure, hepatic
insufficiency with lactate acidosis and serious cardiac insufficiency.
• Due to the fact that the solution may be infused into the blood path of
the extracorporeal circuit, special care must be devoted to keeping the
infusion path sterile. The dialysate circuit must also be kept sterile,
since backfiltration may easily occur in CAVHD, CVVHD, CAVHDF and

Solution for haemofiltration, haemodialysis and haemodiafiltration


Composition in g/l
Glucose monohydrate
Sodium chloride
Calcium chloride (2H2O)
Magnesium chloride (6H2O)
Sodium lactate

1.1 g/l
6.43 g/l
0.257 g/l
0.152 g/l
3.36 g/l

Composition in mmol/l

140 mmol/l
0.75 mmol/l
1.75 mmol/l
115 mmol/l
30 mmol/l
5.55 mmol/l


293 mOsm/l

For a full list of excipients, see section 6.1.


Solution for haemofiltration, haemodialysis and haemodiafiltration.
MONOSOL is a sterile, non-pyrogenic, clear solution.


4.5. Interactions with Other Medicinal Products and Other Forms of
When prescribing the solution to be used for an individual patient, consideration
should be given to the potential interaction between treatment with MONOSOL
and therapy directed at other existing illnesses. For example: rapid potassium
removal may create arrhythmias in cardiac patients using digitalis or similar
drugs; digitalis toxicity may be asked by elevated potassium or magnesium,
and by hypocalcaemia. Correction of electrolytes may precipitate signs and
symptoms of digitalis excess. Conversely, toxicity may occur at suboptimal
doses of digitalis if potassium is low or calcium is high.
Chloride plasma levels should be monitored as the chloride concentration in the
solution is higher than in normal plasma.
Diabetics require careful monitoring of insulin requirements during and
following treatment with glucose containing solutions.

4.1. Therapeutic Indications
As substitution solution in continuous hemofiltration and hemodiafiltration and
as dialysis solution in continuous hemodialysis and hemodiafiltration for acute
renal failure.
4.2. Posology and Method of Administration
Substitution fluid may be infused either in pre or post-dilutional mode, according
to the physicians prescription. The amount of substitution fluid is determined
so as to ensure a proper negative balance, according to each individual case,
between the fluids infused and the fluids lost by ultrafiltration.
The solution can be used as a dialysate fluid with any type of dialysis membrane
or fluid with any type of dialysis membrane or hemofilter. Dialysate fluid must
be properly circulated from dialysate inlet to dialysate outlet, as in conventional
haemodialysis. The usual dialysate flow rate in CAVHD or CVVHD is much lower
than in conventional dialysis, ranging from 15 ml/min to 30 ml/min.

4.6. Pregnancy and Lactation
The safety of these solutions for use in human pregnancy has not been
established. These solutions should only be administered to pregnancy women
if clearly needed.

• Haemodialysis: via the dialysis compartment of the dialyser
• Haemofiltration: via the arterial or venous blood line

4.7. Effects on Ability to Drive and Use Machines
Not applicable.

4.3. Contraindications
Solution dependent contra-indications
• Hypokalaemia,
• Severe metabolic acidosis,
• Impaired metabolism of lactate.
Haemofiltration / haemodialysis dependent contra-indications
• Inadequate blood flow from vascular access,
• All states with elevated risk of haemorrhage on account of systemic



4.8. Undesirable Effects
The undesirable effects below listed reflect the type of undesirable effects that
may be reported with haemofiltration or haemodialysis solutions.


6.1. List of Excipients
Water for Injections

System Organ Class
Metabolism and nutrition disorders

Preferred Term
Electrolyte imbalance
Fluid imbalance
Vascular disorders
Musculoskeletal, connective tissue and bone disorders Muscle cramping

6.2. Incompatibilities
• Additives should not be added to the solution when acting as a
dialysate fluid.
• Additives may be added to the solution when acting as a substitution
fluid, but only those additives for which compatibility has been
documented should been used.
• Never add bicarbonate to the solution as precipitation of calcium and
magnesium carbonate will occur.
• Bicarbonate solutions, if required, must be infused separately.

4.9. Overdose
The infusion rate of the substitution fluid should be properly prescribed in order
to obtain an appropriate fluid, electrolyte and acid/ base balance and to avoid
fluid overload.


6.3. Shelf Life
The shelf life is 2 years in the overpouch. The product, once removed from its
individual overpouch, should be used immediately.
6.4. Special Precautions for Storage
Do not store above 25°C. Do not refrigerate or freeze.


5.1. Pharmacodynamic Properties
Haemodialytics and Haemofiltrates (B05Z)
As dialysates, the solutions remove metabolic waste products and help to
manage serum electrolyte and / or fluid imbalances during continuous renal
replacement therapies in the treatment of acute renal failure. As a replacement
fluid the solution serves as an alkalinising agent and provides a continuous
source of water for hydration, electrolytes and calories.

6.5. Nature and Contents of Container
The solution is packaged in flexible plasticised (poly vinyl chloride) bags of
5000 ml size, containing 5000 ml of solution. Each unit is sealed inside a high
density polyethylene overpouch.
Pack size: Each box contains two single 5L bags.
6.6. Special Precautions for Disposal
• Follow directions of attending physician and package leaflet
accompanying the product.
• Remove the container from the overwrap.
• Check for minute leaks by squeezing the bag firmly. If leaks are
found discard the solution as sterility may be impaired. Occasionally
condensation does occur between the overpouch and the bag due to
the manufacturing process and is not necessarily indicative of a leak.
In addition, do not use the solution if the fluid is cloudy or the blue tip
protector is missing.
• If the resealable rubber plug on the medication port is missing or
partially removed, do not use product if medication is to be added.
• Once the bag has been removed from the overpouch, it should be
used immediately.
• Remove the blue tip protector from the port, hang the bag onto either
a drip stand or weighing scales (if using an automated machine) and
insert the giving set into the bag.
• The product is for single use only.
• Discard any damaged or partially used container.

5.2. Pharmacokinetic Properties
Insignificant amounts of the solutions are absorbed by patients utilising them as
dialysates. There is only an exchange between the dialysate and the patient’s
serum resulting in the removal of excess body fluid, electrolytes and metabolic
waste products.
Solution used to adjust blood volume is absorbed directly into the blood stream
where each component of the solution is essential in the maintenance of
Most of the components of the solution are excreted predominantly in the urine;
consequently, during acute renal failure, normal extracellular fluid levels of each
product component must be maintained trough the use of continuous renal
replacement therapies. Lactate is a biological precursor of bicarbonate.
5.3. Preclinical Safety Data
All ingredients are physiological components in animal and human plasma.
Within the therapeutic dosage range toxic effects are not to be expected under
the condition of clinical application.



Nikkiso Belgium bvba
Industriepark, 6
3300 Tienen
Phone (Belgium): +32 (0)16 781770
Phone (United Kingdom): +44 (0)1483 212151


PL 44204/0004
Monosol is a trademark of Nikkiso Co., Ltd.



+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.