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POTASSIUM CHLORIDE 0.15 % W/V SODIUM CHLORIDE 0.18 % W/V AND GLUCOSE 4% W/V SOLUTION FOR INFUSION

Active substance(s): GLUCOSE / POTASSIUM CHLORIDE / SODIUM CHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Potassium Chloride 0.15% w/v, Sodium Chloride 0.18% w/v
and Glucose 4% w/v Solution for Infusion
Active substances: potassium chloride, sodium chloride and glucose monohydrate
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.

It is used to prevent and treat the following conditions:
• if you do not have enough potassium, sodium
and chloride in your blood. This can occur when
gastrointestinal (stomach) fluid is lost. This can
happen if:
– you have vomiting
– you have diarrhoea
– a wound is drained after surgery (by collecting
body fluid in a bag)
– you have gastric (stomach) suction to empty the
stomach contents
– part of your digestive system has been diverted so
that food does not pass through the small bowel.
This procedure is called small intestinal bypass
– you have a hole in the small bowel (small bowel
fistula)
• if you take too many laxatives (drugs to empty your
bowels)
• if you have a malabsorption syndrome (you cannot
absorb enough nutrients)
• if you have a tumour in your small intestine that
produces mucus (mucus secreting villous adenoma)
• if you have kidney problems that cause you to lose
too much salt
• if you take too many diuretics (water tablets that
increase urine production)
• if you cannot eat so that you need more energy

Throughout this leaflet, Potassium Chloride 0.15% w/v,
Sodium Chloride 0.18% w/v and Glucose 4% w/v,
Solution for Infusion will be called Potassium chloride,
Sodium chloride & Glucose Infusion
What is in this leaflet:
1. What Potassium chloride, Sodium chloride &
Glucose Infusion is and what it is used for
2. What you need to know before you are given
Potassium chloride, Sodium chloride & Glucose
Infusion
3. How you will be given Potassium chloride, Sodium
chloride & Glucose Infusion
4. Possible side effects
5. How to store Potassium chloride, Sodium chloride
& Glucose Infusion
6. Content of the pack and other information

1. What Potassium chloride,
Sodium chloride & Glucose
Infusion is and what it is used
for
Potassium chloride, Sodium chloride & Glucose Infusion
is a solution of potassium chloride, sodium chloride and
glucose monohydrate in water. Potassium chloride and
sodium chloride are chemicals (often called “salts”)
found in the blood.

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Your doctor will take special care when
giving you Potassium chloride, Sodium
chloride & Glucose Infusion

2. What you need to know before
you are given Potassium
chloride, Sodium chloride &
Glucose Infusion

Potassium chloride, Sodium chloride & Glucose Infusion
is a hypertonic (concentrated) solution.
Once administered, the solution becomes hypotonic due
to its low sodium content.
Your doctor will take this into account when calculating
how much to give you.

Do NOT receive Potassium chloride,
Sodium chloride & Glucose Infusion if you
are suffering from any of the following
conditions

Warnings and precautions
Please tell your doctor if you have or have had any of the
following medical conditions:
• any type of heart disease including heart failure (heart
problems that can cause shortness of breath and
ankle swelling)
• any condition that causes you to have high blood
potassium (hyperkalaemia) such as:
– poor kidney function
– adrenocortical insufficiency. This is a disease that
affects the hormones that control the concentration
of chemicals in the body.
– acute dehydration (a rapid loss of water from the
body, e.g. from vomiting or diarrhoea)
– extensive tissue damage (as can occur in severe
burns)
• high blood pressure (hypertension)
• a build up of fluid under the skin (peripheral oedema),
particularly around the ankles
• a build up of fluid in the lungs (pulmonary oedema)
• high blood pressure during pregnancy (pre-eclampsia)
• any condition associated with sodium retention (when
the body has too much sodium), such as treatment
with steroids (drugs that reduce inflammation) (See
also below “Other medicines and Potassium chloride,
Sodium chloride & Glucose Infusion”).
• diabetes, where insulin treatment may need to be
changed because of the glucose (a type of sugar) in
the solution.
• allergy to corn (Potassium chloride, Sodium chloride &
Glucose Infusion contains sugar derived from corn)”.

• higher levels of potassium in the blood than normal
(hyperkalaemia)
• higher levels of chloride in the blood than normal
(hyperchloraemia)
• severe kidney failure (when your kidneys do not work
well and you require dialysis)
• uncompensated heart failure. This is heart failure that
is not adequately treated and causes symptoms such
as:
– shortness of breath
– swelling of the ankles
• Addison’s disease (poor function of the adrenal gland.
The adrenal gland produces hormones that help to
control the concentrations of the chemicals in the
body).
• diabetes that is not adequately treated, allowing
your blood sugar levels to rise above normal
(uncompensated diabetes)
• states of glucose intolerance, for example:
– metabolic stress (when the body’s metabolism
does not function correctly, e.g. due to severe
illness)
– hyperosmolar coma (unconsciousness). This is a
type of coma that can occur if you have diabetes
and do not receive enough medicine.
– a higher amount of sugar in the blood than normal
(hyperglycaemia)
– a higher amount of lactate in the blood than normal
(hyperlactataemia)
• recent stroke
• head injury within the last 24 hours
• if you are allergic to potassium chloride, sodium
chloride and glucose monohydrate or any other
ingredients of this medicine (listed in Section 6).

If you have any of these conditions, you will need
additional tests to monitor your health. Your doctor will
take blood and urine samples to monitor the amount of
chemicals in your blood (your plasma electrolytes). You
will also have a heart tracing (ECG).
You might have changes made to your other medicines.

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Children

There is a small possibility that if you are given
Potassium chloride, Sodium chloride & Glucose Infusion
during labour, glucose could affect the unborn baby by
causing:
• hyperglycemia (high blood sugar, which causes severe
thirst, dry mouth and frequent urination)
• hyperinsulinaemia (high levels of insulin, the hormone
that regulates blood sugar. Blood glucose (sugar)
levels can become too low.)
• acidosis (an imbalance in blood chemistry) that can
lead to low blood sugar and jaundice (yellow colour of
the skin or whites of the eyes)
However, the relationship between glucose infusion and
these effects is not proven.

Potassium chloride, Sodium chloride & Glucose Infusion
should be given with special care in children.
In newborns, especially born premature and with low
birth weight are at increased risk of developing a too
low or too high level of sugar in the blood (hypo or
hyperglycemia) due to infusion of glucose solutions.
Low level of sugar in the newborn can cause prolonged
seizures, coma and brain damage. High level of sugar
has been associated with bleeding into the brain,
late onset bacterial and fungal infection, infection in
the intestinal track (necrotizing enterocolitis), affects
eyes (retinopathy of prematurity), lungs problems
(bronchopulmonary dysplasia), prolonged length of
hospital stay, and death.

If another medicine is to be added to your solution for
infusion during pregnancy or breast-feeding you should:
• consult your doctor
• read the Package Leaflet of the medicine that is to be
added.

Other medicines and Potassium chloride,
Sodium chloride & Glucose Infusion
Tell your doctor or nurse if you are taking, have recently
taken or might take any other medicines.

Driving and using machines

It is particularly important that you inform your doctor if
you are taking:
• medicines that increase the amount of potassium in
your blood, such as:
– potassium-sparing diuretics (some water tablets,
e.g. amiloride, spironolactone, triamterene)
– angiotensin converting enzyme (ACE) inhibitors
(used to treat high blood pressure)
– cyclosporin (used to prevent rejection of a
transplant)
– medicines that contain potassium (e.g. potassium
supplements, salt substitutes containing potassium
and some types of penicillin)
• corticosteroids (anti-inflammatory medicines)

The infusion does not affect your ability to drive or use
machines.

3. How you will be given Potassium
chloride, Sodium chloride &
Glucose Infusion
The infusion will be given to you by a doctor or nurse.
Your doctor will decide on how much you need and when
it is to be given. This will depend on your age, weight,
clinical and biological conditions (your state of health). It
will also depend on the other medicines that you take.
The usual dose of Potassium chloride, Sodium chloride &
Glucose Infusion in patients with mild low potassium is
up to 1.25 litres daily. In cases of severe low potassium,
the dose is up to 500 ml in 2 to 3 hours. The maximum
daily dose is approximately 50 ml to 75 ml per kilogram
body weight. This should be given at about 11 ml to
18 ml per kilogram body weight per hour.

If you need a blood transfusion at the same time as your
infusion, you will be given the blood into another vein.

Potassium chloride, Sodium chloride &
Glucose Infusion with food and drink
You should ask your doctor about what you can eat or
drink.

Your infusion must not be given to you faster than 1
litres per hour.

Pregnancy, breast-feeding and fertility
Ask your doctor or nurse for advice before taking this
medicine.

If you require a large volume or rapid infusion of
Potassium chloride, Sodium chloride & Glucose Infusion,
your doctor will monitor your ECG (heart tracing).

If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or nurse for advice before taking this medicine.

The infusion will usually be given to you through a
plastic tube attached to a needle in a vein. Usually a vein
in your arm is used to give you the infusion. However,
your doctor may use another method.
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During treatment, your doctor will take blood tests to
monitor your blood levels of:
• potassium
• other electrolytes (such as sodium, and chloride)

4. Possible side effects
Like all medicines, Potassium chloride, Sodium chloride
& Glucose Infusion can cause side effects, although not
everybody gets them.

If you suffer from poor kidney function, you will receive
a lower dose.

The side effects that may occur due to the administration
method include:
• fever (febrile response)
• infection at the site of infusion
• local pain or reaction (redness or swelling) at the site
of the infusion
• irritation and inflammation of the vein into which the
solution is infused (phlebitis). This can cause redness,
pain or burning, and swelling of the vein
• the formation of a clot in the injected vein (venous
thrombosis), which causes pain, swelling or redness.
• escape of the infusion solution (extravasation) into the
tissues around the vein. This can damage the tissues
and cause scarring.
• too much fluid in the blood vessels (hypervolaemia)
• hypersensitivity reactions, including a serious allergic
reaction called anaphylaxis (potential manifestation in
patients with allergy to corn)
• chills
• Hyponatremia (low level of sodium in body fluids)

If you receive more Potassium chloride,
Sodium chloride & Glucose Infusion than
you should
If you are given too much Potassium chloride, Sodium
chloride & Glucose Infusion (over-infusion), this may lead
to the following symptoms:
• pins and needles (paresthesia) in the arms and legs
• muscle weakness
• an inability to move your muscles (paralysis)
• irregular heartbeat (cardiac arrhythmia)
• heart block (a very slow heartbeat)
• cardiac arrest (the heart stops beating; a lifethreatening condition)
• confusion
• fluid collection in the lungs (pulmonary oedema)
making it difficult to breathe
• fluid collection under the skin (peripheral oedema),
particularly around the ankles
• acidification of the blood (acidosis, which has a wide
range of effects).

If a medicine has been added to the solution for infusion,
the added medicine may also cause side effects. These
side effects will depend on the medicine that has been
added. You should read the Package Leaflet of the added
medicine for a list of possible symptoms.

These symptoms are more likely in people with poor
kidney function.
If you develop any of these symptoms you must inform
your doctor immediately. Your infusion will be stopped
and you will be given treatment depending on the
symptoms.
If a medicine has been added to the Potassium chloride,
Sodium chloride & Glucose Infusion

If you get any side effects talk to your doctor or nurse.
This includes any possible side effects not listed in this
leaflet.

5. How to store Potassium chloride,
Sodium chloride & Glucose
Infusion

and you receive more than you should, the added
medicine may also cause side effects. You should read
the Package Leaflet of the added medicine for a list of
possible symptoms.

Potassium chloride, Sodium chloride & Glucose
Infusion does not require any special storage conditions.
Keep this medicine out of the sight and reach of
children.

Stop receiving your Potassium chloride,
Sodium chloride & Glucose Infusion
Your doctor will decide when to stop giving you this
infusion.
If you have any further questions on the use of this
product, ask your doctor.

The Potassium chloride, Sodium chloride & Glucose
Infusion should NOT be given to you after the expiry date
which is stated on the bag after EXP. The expiry date
refers to the last day of that month.

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SA-30-01-840

Potassium chloride, Sodium chloride & Glucose Infusion
can be made at any of these addresses:

You should not be given Potassium chloride, Sodium
chloride & Glucose Infusion, if:
• there are particles in the solution
• the solution changes colour, or
• the container is damaged in any way.

Baxter Healthcare Limited
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom

6. Contents of the pack and other
information

Bieffe Medital SA
Ctra de Biescas-Senegüé
22666 Sabiñánigo (Huesca)
Spain

This leaflet does not contain all the information about
this medicine. If you have any questions or are not sure
about anything, ask your healthcare professional.

This medicinal product is authorised in the Member
States of the EEA under the following names:

What Potassium chloride, Sodium chloride &
Glucose Infusion contains
The active substances are potassium chloride (1.5 g per
litre), sodium chloride (1.8 g per litre) and glucose (40 g
per litre, equivalent to 44 g glucose as monohydrate).
The only other ingredient is water for injection

Ireland:



Potassium Chloride 0.15% w/v,
Sodium Chloride 0.18% w/v and
Glucose 4% w/v, Solution for Infusion

Spain:


Viaflo Glucosalino Potásico solución
para perfusion

United Kingdom: Potassium Chloride 0.15% w/v,

Sodium Chloride 0.18% w/v and

Glucose 4% w/v, Solution for Infusion

What Potassium chloride, Sodium chloride &
Glucose Infusion looks like and contents of
the pack

This leaflet was last revised August 2013.

For information about Potassium
chloride, Sodium chloride & Glucose
infusion or to request this leaflet
in formats such as audio or large
print please contact the Marketing
Authorisation Holder:
Tel: +44 (0)1635 206345.

Potassium chloride, Sodium chloride & Glucose Infusion,
is a clear solution, free from visible particles. It is
supplied in polyolefin/polyamide plastic bags (VIAFLO).
Each bag is wrapped in a sealed, protective, outer plastic
bag.
The bag sizes are:
• 500 ml
• 1000 ml
The bags are supplied in cartons. Each carton contains
one of the following quantities:
• 20 bags of 500 ml
• 10 bags of 1000 ml
Not all pack sizes may be marketed

Marketing Authorisation Holder and
Manufacturers:
Baxter Healthcare Ltd
Caxton Way
Thetford Norfolk IP24 3SE
United Kingdom
Send all enquires to this address
Baxter and Viaflo are trademarks of
Baxter International lnc.

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Potassium Chloride 0.15% w/v, Sodium Chloride 0.18% w/v
and Glucose 4% w/v Solution for Infusion

The following information is intended
for healthcare professionals only:

1. Opening
a. Remove the VIAFLO container from the
overpouch just before use.
b. Check for minute leaks by squeezing the
inner bag firmly. If leaks are found, discard
the solution, as the solution may no longer be
sterile.
c. Check the solution for limpidity and absence of
foreign matters. If the solution is not clear or
contains foreign matter, discard the solution.

Handling and Preparation
Use only if the solution is clear, without visible
particles and if the container is undamaged. Administer
immediately following the insertion of infusion set.
Do not remove unit from overwrap until ready for use.
The inner bag maintains the sterility of the product.
Do not use plastic containers in series connections.
Such use could result in air embolism due to residual
air being drawn from the primary container before the
administration of the fluid from the secondary container
is completed.

2. Preparation for administration
Use sterile material for preparation and administration.
a. Suspend the container from the eyelet support.
b. Remove the plastic protector from the outlet
port at the bottom of the container:
– grip the small wing on the neck of the port
with one hand,
– grip the large wing on the cap with the
other hand and twist,
– the cap will pop off.
c. Use an aseptic method to set up the infusion.
d. Attach the administration set. Refer to the
complete directions accompanying the
set for connection, priming of the set and
administration of the solution.

Pressurizing intravenous solutions contained in flexible
plastic containers to increase flow rates can result in air
embolism if the residual air in the container is not fully
evacuated prior to administration.
Use of a vented intravenous administration set with the
vent in the open position could result in air embolism.
Vented intravenous administration sets with the vent in
the open position should not be used with flexible plastic
containers.
The solution should be administered with sterile
equipment using an aseptic technique.
The equipment should be primed with the solution to
prevent air entering the system.

3. Techniques for injection of additive
medications

Additives may be introduced before infusion or during
infusion through the resealable medication port.

Warning: Additives may be incompatible (see paragraph
5 “Incompatibilities of additive medications” below).

When additive is used, verify tonicity prior to parenteral
administration. Thorough and careful aseptic mixing of
any additive is mandatory. Solutions containing additives
should be used immediately after preparation, unless
preparation has taken place in controlled and validated
aseptic conditions.

To add medicinal product before administration
a. Disinfect medication site.
b. Using syringe with 19 to 22 gauge needle,
puncture resealable medication port and inject.
c. Mix solution and medication thoroughly. For
high-density medication such as potassium
chloride, tap the ports gently while ports are
upright and mix.
Caution: Do not store bags containing added
medications.

Adding other medication or using an incorrect
administration technique might cause the appearance
of fever reactions due to the possible introduction of
pyrogens. In case of adverse reaction, infusion must be
stopped immediately.
Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.
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To add medicinal product during administration
a. Close clamp on the set.
b. Disinfect medication port.
c. Using syringe with 19 to 22 gauge needle,
puncture resealable medication port and inject.
d. Remove container from IV pole and/or turn to
an upright position.
e. Evacuate both ports by tapping gently while the
container is in an upright position.
f. Mix solution and medication thoroughly.
g. Return container to in use position, re-open the
clamp and continue administration

Glucose should not be administered through the same
infusion equipment as whole blood as haemolysis and
clumping can occur.
Those additives known to be incompatible should not
be used.

4. In-use shelf life (Additives)
Chemical and physical stability of any additive
medication at the pH of Potassium chloride,
Sodium chloride & Glucose Infusion in the VIAFLO
container should be established prior to use. From a
microbiological point of view, the diluted product must
be used immediately unless dilution has taken place in
controlled and validated aseptic conditions.
If not used immediately, in-use storage times and
conditions are the responsibility of the user.

5. Incompatibilities of additive medications
As with all parenteral solutions, before adding
medications, compatibility of these additives with the
solution in the VIAFLO container must be assessed.
It is the responsibility of the physician to judge the
incompatibility of an additive medication with Potassium
chloride, Sodium chloride & Glucose Infusion by checking
for eventual colour change and/or eventual precipitate,
insoluble complexes or the appearance of crystals.
The Instructions for Use of the medication to be added
must be consulted.
Before adding a drug, verify that it is soluble and stable
in water at the pH of Potassium chloride, Sodium
chloride & Glucose Infusion. When a compatible
medication is added to this formulation, the solution
must be administered immediately, unless dilution
has taken place in controlled and validated aseptic
conditions.
As a guide, the following medications are incompatible
with Potassium chloride, Sodium chloride & Glucose
Infusion, although this list is not exhaustive:
• Amphotericin B
• Dobutamine

Baxter and Viaflo are trademarks of
Baxter International lnc.

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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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