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MONOSOL-K WITH 4MEQ POTASSIUM/L

Active substance(s): CALCIUM CHLORIDE DIHYDRATE / GLUCOSE MONOHYDRATE / MAGNESIUM CHLORIDE HEXAHYDRATE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM LACTATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MONOSOL-K with 4 mEq Potassium/l,
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-K with 4 mEq Potassium/l is and what it
is used for
2. Before MONOSOL-K with 4 mEq Potassium/l is given
3. How MONOSOL-K with 4 mEq Potassium/l is given
4. Possible side effects
5 How to store MONOSOL-K with 4 mEq Potassium/l
6. Further information




Taking other medicines
Inform the doctor if you are taking other medicines, even those not prescribed.
Taking MONOSOL-K with 4 mEq Potassium/l may affect and interact with
medicines.
• If you are diabetic your glucose level will be carefully measured.
Your insulin dose will be adjusted as needed as this solution contains
glucose.

1. WHAT MONOSOL-K with 4 mEq Potassium/l IS AND
WHAT IT IS USED FOR

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-K with 4 mEq Potassium/l.

MONOSOL-K with 4 mEq Potassium/l is a solution for haemofiltration,
haemodialysis and haemodiafiltration.
MONOSOL-K with 4 mEq Potassium/l is prescribed to you if you have kidney
failure.

3. HOW MONOSOL-K with 4 mEq Potassium/l is given

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.

Depending on your therapy, your doctor will administer MONOSOL-K with
4 mEq Potassium/l 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-K
with 4 mEq Potassium/l for your clinical condition.

MONOSOL solutions must only be used by or under the direction of a doctor.

2. BEFORE MONoSOL-K with 4 mEq Potassium/l IS given

How much and how often?

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.

Your doctor will decide and adjust the flow rate and volume of the solution to be
administered.
The amount of fluid required depends upon how MONOSOL-K with 4 mEq
Potassium/l is being used.
MONOSOL should be used as indicated and needed until your doctor decides to
stop the treatment.

Do not take MONOSOL-K with 4 mEq Potassium/l solution and
tell your doctor if you






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.
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.

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 high.
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.

4. POSSIBLE SIDE EFFECTS
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
volume
• 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-K with 4 mEq Potassium/l
MONOSOL-K with 4 mEq Potassium/l can only be used by, or under
the direction of a doctor who has experience with the haemofiltration,
haemodialysis and haemodiafiltration techniques.
Your doctor will
• measure the acidity, different salts and waste product levels in your
blood.
• ensure that their levels are correct and closely monitored during your
treatment.
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5. HOW TO STORE MONOSOL-K with 4 mEq Potassium/l
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-K with 4 mEq Potassium/l 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.

6. FURTHER INFORMATION
Name of the Medicinal Product
MONOSOL-K with 4 mEq Potassium/l, Solution for haemofiltration,
haemodialysis and haemodiafiltration

The composition of the solution MONOSOL-K with 4 mEq
Potassium/l is:
Ingredients
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Sodium chloride
Sodium lactate
Glucose monohydrate
Potassium chloride

MONOSOL-K with 4 mEq Potassium/l

0.257 g/l

0.152 g/l

6.43 g/l

3.36 g/l

1.1 g/l

0.298 g/l

The other Ingredient is Water for Injections.

What MONOSOL-K with 4 mEq Potassium/l looks like and
Contents of the pack
MONOSOL-K with 4 mEq Potassium/l 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:
Baxter Healthcare Ltd.
Caxton Way
Thetford, Norfolk
IP24 3SE, United Kingdom
Phone: + 44 (0) 1635 206345

Manufacturer:
Baxter Healthcare S.A.
Moneen Road
Castlebar
County Mayo – Ireland

This leaflet was last approved in: March 2009

Baxter and Monosol are trademarks of Baxter International Inc.

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The following information is intended for Medical or Healthcare professionals only

INFORMATION FOR THE HEALTHCARE PROFESSIONAL
MONOSOL-K with 4 mEq Potassium/l,
Solution for haemofiltration, haemodialysis and haemodiafiltration
1. NAME OF THE MEDICINAL PRODUCT

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
depletion.
• 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
CVVHDF.

MONOSOL-K with 4 mEq Potassium/l
Solution for haemofiltration, haemodialysis and haemodiafiltration
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition in g/l
Glucose monohydrate
Sodium chloride
Potassium chloride
Calcium chloride (2H2O)
Magnesium chloride (6H2O)
Sodium lactate








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

Composition in mmol/l
Sodium
Potassium
Magnesium
Calcium
Chloride
Lactate
Glucose









140 mmol/l
4 mmol/l
0.75 mmol/l
1.75 mmol/l
119 mmol/l
30 mmo/l
5.55 mmol/l

Osmolarity



301 mOsm/l

For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for haemofiltration, haemodialysis and haemodiafiltration.
MONOSOL-K with 4 mEq Potassium/l is a sterile, non-pyrogenic, clear solution.

4.5. Interactions with Other Medicinal Products and Other Forms of
Interaction
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. CLINICAL PARTICULARS
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.

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

6.4. Special Precautions for Storage
Do not store above 25°C. Do not refrigerate or freeze.
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.

System Organ Class
Metabolism and nutrition disorders

Preferred Term
Electrolyte imbalance
Fluid imbalance
Hypervolaemia
Hypovolaemia
Vascular disorders
Hypertension
Hypotension
Musculoskeletal, connective tissue and bone disorders Muscle cramping

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.

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.
5. Pharmacological Properties
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.
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
homeostasis.
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.

7. MARKETING AUTHORISATION HOLDER
Baxter Healthcare Ltd.
Caxton Way
Thetford, Norfolk
IP24 3SE, United Kingdom
Phone: +44 (0) 1635 206345
8. MARKETING AUTHORISATION NUMBER
PL 00116/0250
PA 167/104/2

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.

Baxter and Monosol are trademarks of Baxter International Inc.

6. Pharmaceutical Particulars
6.1. List of Excipients
Water for Injections
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.
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.

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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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