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POTASSIUM CHLORIDE 0.3% SODIUM CHLORIDE 0.18% & GLUCOSE 4%

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Potassium Chloride 0.3% w/v, Sodium Chloride 0.18% w/v
and Glucose 4% w/v
Solution for Infusion BP
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.

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DATE 05 September 2013
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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

2nd DRAFT

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)

ARTWORK APPROVAL

Throughout this leaflet, Potassium Chloride 0.3%,
Sodium Chloride 0.18% and Glucose 4%, Solution
for Infusion BP will be called Potassium chloride,
Sodium chloride & Glucose Infusion

EUROPEAN LABELLING CENTRE

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.

Name

1. What Potassium chloride,
Sodium chloride & Glucose
infusion is and what it is
used for

• 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

– 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).

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

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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

EUROPEAN LABELLING CENTRE

Warnings and precautions

RA TO APPROVE LAYOUT
AND FORMAT

• 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)

DATE 05 September 2013
PLANT APPROVAL
HALLE ONLY
N/A

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.

2nd DRAFT

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

Name

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

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)

• 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)
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).

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.

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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.
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)

ARTWORK APPROVAL

Ask your doctor or nurse for advice before taking
this medicine.

EUROPEAN LABELLING CENTRE

Pregnancy, breast-feeding and fertility

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 enterocolitits), affects
eyes (retinopathy of prematurity), lungs problems
(bronchopulmonary dysplasia), prolonged length of
hospital stay, and death.

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Children

Name

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

Country

You might have changes made to your other
medicines.

2nd DRAFT

Potassium chloride, Sodium chloride &
Glucose Infusion with food and drink

RA TO APPROVE LAYOUT
AND FORMAT

DATE 05 September 2013
PLANT APPROVAL
HALLE ONLY
N/A

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

During treatment, your doctor will take blood tests
to monitor your blood levels of:
• potassium
• other electrolytes (such as sodium, and
chloride)

However, the relationship between glucose
infusion and these effects is not proven.
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.

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

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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.

N/A

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

N/A

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
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.

Signature

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

Name

These symptoms are more likely in people with
poor kidney function.

Country

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.

RA TO APPROVE LAYOUT
AND FORMAT

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.

DATE 05 September 2013
PLANT APPROVAL
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N/A

3. How you will be given
Potassium chloride, Sodium
chloride & Glucose infusion

2nd DRAFT

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).

ARTWORK APPROVAL

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

EUROPEAN LABELLING CENTRE

If you receive more Potassium chloride,
Sodium chloride & Glucose Infusion
than you should

Driving and using machines

Stop receiving your Potassium chloride,
Sodium chloride & Glucose Infusion

5. How to store 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.

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

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

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.

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

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

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.

N/A

The only other ingredient is water for injection

Signature

The active substances are potassium chloride
(3 g per litre), sodium chloride (1.8 g per litre) and
glucose monohydrate (44 g per litre, equivalent to
40 g anhydrous glucose).

Country

What Potassium chloride, Sodium
chloride & Glucose Infusion contains

ARTWORK APPROVAL

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.

EUROPEAN LABELLING CENTRE

6. Contents of the pack and
other information

RA TO APPROVE LAYOUT
AND FORMAT

DATE 05 September 2013
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N/A

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.

2nd DRAFT

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)

Name

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.

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

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DATE 05 September 2013
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N/A

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F

Signature

Baxter and Viaflo are trademarks of
Baxter International lnc.

Country

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: 01635 206345.

RA TO APPROVE LAYOUT
AND FORMAT

This leaflet was last revised in August 2013.

2nd DRAFT

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

ARTWORK APPROVAL

Baxter SA
Boulevard Rene Branquart, 80
7860 Lessines
Belgium

EUROPEAN LABELLING CENTRE

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

Name

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

b

Potassium Chloride 0.3% w/v, Sodium Chloride 0.18% w/v
and Glucose 4% w/v
Solution for Infusion BP

The following information
is intended for healthcare
professionals only:

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.

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.

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.

Do not remove unit from overwrap until ready for
use.
The inner bag maintains the sterility of the product.

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N/A

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

N/A

The equipment should be primed with the solution
to prevent air entering the system.

Signature

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.

The solution should be administered with sterile
equipment using an aseptic technique.

Name

2. Preparation for administration

ARTWORK APPROVAL

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.

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.

EUROPEAN LABELLING CENTRE

1. Opening

Country

Do not reconnect partially used bags.

2nd DRAFT

Discard any unused portion.

RA TO APPROVE LAYOUT
AND FORMAT

DATE 05 September 2013
PLANT APPROVAL
HALLE ONLY
N/A

Discard after single use.

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.

5. Incompatibilities of additive
medications

d. Attach the administration set. Refer to the
complete directions accompanying the
set for connection, priming of the set and
administration of the solution.

As with all parenteral solutions, before adding
medications, compatibility of these additives
with the solution in the VIAFLO container must be
assessed.

3. Techniques for injection of additive
medications

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.

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

Baxter and Viaflo are trademarks of
Baxter International lnc.

F
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per RA SOP CE-RAPV-009

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Product Information proofread as

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N/A

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.

Signature

4. In-use shelf life (Additives)

Country

Those additives known to be incompatible should
not be used.

RA TO APPROVE LAYOUT
AND FORMAT

Glucose should not be administered through
the same infusion equipment as whole blood as
haemolysis and clumping can occur.

DATE 05 September 2013
PLANT APPROVAL
HALLE ONLY
N/A

As a guide, the following medications are
incompatible with Potassium chloride, Sodium
chloride & Glucose Infusion, although this list is not
exhaustive:
• Amphotericin B
• Dobutamine

2nd DRAFT

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

ARTWORK APPROVAL

Caution: Do not store bags containing added
medications.

EUROPEAN LABELLING CENTRE

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.

Name

The Instructions for Use of the medication to be
added must be consulted.

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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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