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POTASSIUM CHLORIDE 0.3% AND GLUCOSE 5% SOLN FOR INFUSION BP

Active substance(s): GLUCOSE MONOHYDRATE / POTASSIUM CHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Potassium Chloride 0.3% w/v & Glucose 5%w/v
Solution for Infusion BP
Active substances: potassium chloride and glucose monohydrate
- extensive skin loss, as can occur in severe burns

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.

2. What you need to know before
you are given Potassium 0.3 &
Glucose Infusion
Do NOT receive Potassium 0.3 & Glucose
Infusion if you are suffering from any of the
following conditions

What is in this leaflet:
1. What Potassium 0.3 & Glucose Infusion is and what
it is used for
2. What you need to know before you are given
Potassium 0.3 & Glucose Infusion
3. How you will be given Potassium 0.3 & Glucose
Infusion
4. Possible side effects
5. How to store Potassium 0.3 & Glucose Infusion
6. Content of the pack and other information

• 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)
• if you are allergic to potassium chloride and glucose
monohydrate or any other ingredients of this medicine
(listed in Section 6).

1. What Potassium 0.3 & Glucose
Infusion is and what it is used
for
Potassium 0.3 & Glucose Infusion is a solution of
potassium chloride and glucose in water. Potassium
chloride is a chemical substance (often called a “salt”)
found in the blood.
Glucose is one of the body’s sources of energy. This
solution for infusion provides 200 kilocalories per litre.
Potassium 0.3 & Glucose Infusion is used as a source of
carbohydrate (sugar) in the prevention and treatment of:
• a loss of potassium from the body (potassium
depletion, e.g. after treatment with certain diuretics
[water tablets])
• a low level of potassium in the blood (hypokalaemia)
in situations that may cause potassium chloride and
water loss including:
- when you cannot eat or drink, due to illness or
after surgery
- pronounced sweating due to high fever
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Warning and precautions

Children

Potassium 0.3 & Glucose Infusion is a hypertonic
(concentrated) solution. Your doctor will take this into
account when calculating how much solution to give
you.
Please tell your doctor if you have or have had any of the
following medical conditions.
• heart failure
• respiratory failure (lung disease)
• any type of heart disease or poor heart function
• poor kidney function
(special monitoring may be required in the above
conditions)
• adrenocortical insufficiency (this disease of the
adrenal gland affects hormones that control the
concentration of chemicals in the body).
• a loss of water from the body (acute dehydration, e.g.
from vomiting or diarrhoea)
• extensive tissue damage (as can occur in severe
burns)
• head injury within the past 24 hours
• a high pressure within the skull (intracranial
hypertension)
• if you have recently had a stroke
• allergy to corn (Potassium 0.3 & Glucose Infusion
contains sugar derived from corn, see section 4)
When you are given this infusion, your doctor will take
blood and urine samples and monitor:
• the amount of fluid in your body
• the amount of sugar (glucose)
• your vital signs
• the amount of chemicals such as sodium and
potassium in your blood (your plasma electrolytes)
• the blood concentration of a substance called
creatinine (your plasma creatinine)
• the blood concentration of a substance called urea
(your BUN levels)
• the acidity of your blood and urine (your acid-base
balance)
• your heart tracing (ECG)
Your doctor will take into account if you are receiving
parenteral nutrition (nutrition given by infusion into a
vein). During long term treatment with Potassium 0.3 &
Glucose Infusion you may need to be given extra nutrition

Potassium 0.3 & Glucose Infusion should be given with
special care in children.

As Potassium 0.3 & Glucose Infusion contains sugar
(glucose), it can cause a high level of sugar in the blood
(hyperglycaemia). If this occurs, your doctor may:
• adjust the speed of infusion
• give you insulin to reduce the blood sugar levels
This is particularly important if you are diabetic.

Potassium & Glucose Infusion must not be added
or given through the same needle with citrate
anticoagulated/preserved blood. This can damage the
red blood cells or cause them to clump together.

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
hyperglycaemia) 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.
Paediatric patients should be closely monitored. In
cases where normal regulation of the water content
of the blood is disturbed due to increased secretion
of Antidiuretic Hormone (ADH), the infusion of fluids
with a low concentration of sodium chloride (hypotonic
fluids) may result in a low level of sodium in the blood
(hyponatraemia). This can lead to headache, nausea,
seizures, lethargy, coma, swelling of the brain (cerebral
oedema) and death; therefore these symptoms (acute
symptomatic hyponatraemic encephalopathy) are
considered a medical emergency.

Other medicines and Potassium 0.3 &
Glucose Infusion

Tell your doctor or nurse if you are taking, have recently
taken or might take any other medicines.
It is particularly important that you inform your doctor if
you are taking medicines that increase the concentration
of potassium in the blood, such as:
• potassium-sparing diuretics (certain water tablets,
e.g. amiloride, spironolactone, triamterene)
• angiotensin converting enzyme (ACE) inhibitors (used
to treat high blood pressure)
• angiotensin II receptor antagonists (used to treat high
blood pressure)
• cyclosporin (used to prevent rejection of a transplant)
• tacrolimus (used to prevent rejection of a transplant
and to treat some skin diseases)
• medicines that contain potassium (e.g. potassium
supplements, salt substitutes containing potassium)

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Potassium 0.3 & Glucose Infusion with food
and drink

When you are given Potassium 0.3 & Glucose Infusion,
your doctor will perform blood tests to monitor your
blood levels of:
• potassium
• other electrolytes (such as sodium, and chloride) and other
chemical substances that are normally in your blood like
creatinine (a breakdown product from the muscles)

You should ask your doctor about what you can eat or drink.

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

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

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.

Any unused solution should be thrown away. You should
NOT be given an infusion of Potassium 0.3 & Glucose
Infusion from a bag that has been partly used.

Changes in the potassium levels in your blood can affect
how well your heart and your unborn baby’s heart work.
Your doctor will therefore carefully monitor the levels of
the chemicals in your blood.

If you receive more Potassium 0.3 & Glucose
Infusion than you should

Potassium 0.3 & Glucose Infusion can be given during
pregnancy. The amount you are given must be carefully
controlled by your doctor.

If you are given too much Potassium 0.3 & Glucose
Infusion (over-infusion), this may lead to the following
symptoms:
• pins and needles in the arms and legs (paraesthesia)
• muscle weakness
• an inability to move (paralysis)
• an irregular heartbeat (cardiac arrhythmias)
• heart block (a very slow heartbeat)
• cardiac arrest (the heart stops beating; a lifethreatening situation)
• confusion
• acidification of the blood (acidosis) leading to tiredness,
confusion, lethargy and increased breathing rate

However, 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.

Driving and using machines
Potassium 0.3 & Glucose Infusion does not affect your
ability to drive or use machines.

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.

3. How you will be given Potassium
0.3 & Glucose Infusion
Potassium 0.3 & Glucose 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, condition, state of hydration
(the amount of water in your body) and the reason
for treatment. The amount you are given may also be
affected by other treatments you are receiving.

If a medicine has been added to your Potassium 0.3
& Glucose Infusion before over-infusion occurs, that
medicine may also cause symptoms. You should read
the Package Leaflet of the added medicine for a list of
possible symptoms.

Stop receiving your Potassium 0.3 & Glucose
Infusion

You should NOT be given Potassium 0.3 & Glucose
Infusion if there are particles floating in the solution or
if the pack is damaged in any way.

Your doctor will decide when to stop giving you this
infusion.

The speed of infusion will be decided by your doctor.

If you have any further questions on the use of this
product, ask your doctor.

If you require a large volume or rapid infusion of
Potassium 0.3 & Glucose Infusion, your doctor may
monitor your ECG (heart tracing).

4. Possible side effects

Potassium 0.3 & Glucose 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
to give you the medicine.

Like all medicines, Potassium 0.3 & Glucose Infusion can
cause side effects, although not everybody gets them.
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The side effects that may occur due to the administration
technique include:
• fever (febrile response)
• infection at the site of infusion
• local pain or reaction (redness or swelling at the site
of infusion)
• irritation and inflammation of the vein into which the
solution is infused (phlebitis). This can cause redness,
pain or burning and swelling along the path of the
vein into which the solution is infused.
• the formation of a blood clot (venous thrombosis) at
the site of infusion, which causes pain, swelling or
redness in the area of the clot
• escape of the infusion solution into the tissues around
the vein (extravasation). This can damage the tissues
and cause scarring.
• an excess of fluid in the blood vessels (hypervolaemia)
• hypersensitivity reactions, including a serious allergic
reaction called anaphylaxis (potential manifestation in
patients with allergy to corn)
• chills

5. How to store Potassium 0.3 &
Glucose Infusion
Keep this medicine out of the sight and reach of
children.
Potassium 0.3 & Glucose Infusion does not require
special storage conditions.
Potassium 0.3 & 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.
You should not be given Potassium 0.3 & Glucose
Infusion, if there are particles floating in the solution or if
the unit is damaged in any way.

6. Contents of the pack and other
information
What Potassium 0.3 & Glucose Infusion
contains

Reporting of side effects

The active substances are:
• potassium chloride: 3 g per litre.
• glucose (as monohydrate): 50 g per litre.

If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the national reporting system listed
below. By reporting side effects you can help provide
more information on the safety of this medicine.

The other ingredients are
• hydrochloric acid, concentrated
• water for injections

United Kingdom:
Via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

What Potassium 0.3 & Glucose Infusion
looks like and contents of the pack

Ireland:
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.

Potassium 0.3 & 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 overpouch
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

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Marketing Authorisation Holder and
Manufacturers
Marketing Authorisation Holder:
Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom
Manufacturers:
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium
Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom
Bieffe Medital Sabiñánigo
Ctra de Biescas, Senegüé
22666 Sabiñánigo (Huesca)
Spain

This leaflet was last revised in 10/2015
For information about Potassium 0.3 & 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.

Baxter and Viaflo are trademarks of
Baxter International lnc.

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Potassium Chloride 0.3% w/v & Glucose 5% w/v
Solution for Infusion BP

The following information is intended
for healthcare professionals only:

medicines to neonates, a bag of fluid should not be left
connected to the syringe.
When using an infusion pump all clamps on the
intravenous administration set must be closed before
removing the administration set from the pump, or
switching the pump off. This is required regardless of
whether the administration set has an anti free flow
device.

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 intravenous infusion device and administration
equipment must be frequently monitored.

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.

Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.

1. Opening

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.

a. Remove the Viaflo container from the overpouch
just before use.
b. Check for minute leaks by squeezing inner bag
firmly. If leaks are found, discard solution, as
sterility may be impaired.
c. Check the solution for limpidity and absence
of foreign matters. If solution is not clear or
contains foreign matters, discard the solution.

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.

2. Preparation for administration

The solution should be administered with sterile
equipment using an aseptic technique. The equipment
should be primed with the solution in order to prevent air
entering the system.

Use sterile material for preparation and administration.
a. Suspend container from eyelet support.
b. Remove plastic protector from outlet port at
bottom of 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 administration set. Refer to complete
directions accompanying set for connection,
priming of the set and administration of the
solution.

Additives may be introduced before infusion or during
infusion through the re-sealable medication port. When
additive is used, verify isotonicity prior to parenteral
administration. Thorough and careful aseptic mixing of
any additive is mandatory. Solutions containing additives
should be used immediately and not stored unless
dilution has taken place in controlled and validated
aseptic conditions.
Adding 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.
Paediatric population
In order to avoid potentially fatal over infusion of
intravenous fluids to the neonate, special attention
needs to be paid to the method of administration. When
using a syringe pump to administer intravenous fluids or

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3. Techniques for injection of additive
medications

5. Incompatibilities of additive medications
As with all parenteral solutions, before adding
medications, compatibility of these additives with the
solution in Viaflo container must be assessed.
It is the responsibility of the physician to judge the
incompatibility of an additive medication with the
Potassium 0.3 & Glucose Infusion, by checking for
eventual colour change and/or eventual appearance of
precipitate, 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/or stable
in water at the pH of the P Potassium 0.3 & Glucose
Infusion (pH: 3.5 to 6.5).

The solution should not be administered in the atrium or
ventricle to avoid localised hyperkalaemia, but in large
peripheral or central vein to diminish the risk of causing
sclerosis.
Warning: Additives may be incompatible (see paragraph
5 “Incompatibilities of additive medications” below).
To add medication before administration
a. Disinfect medication port.
b. Using syringe with 19 gauge (1.10 mm) to 22
gauge (0.70 mm) needle, puncture re-sealable
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.

As a guidance the following medications are
incompatible with Potassium 0.3 & Glucose Infusion
(non-exhaustive listing):
• Amphotericin B
• Dobutamine

To add medication during administration
a. Close clamp on the set.
b. Disinfect medication port.
c. Using syringe with 19 gauge (1.10 mm) to 22
gauge (0.70 mm) needle, puncture re-sealable
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 the Potassium 0.3 & 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.

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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