Skip to Content

UK Edition. Click here for US version.

POTASSIUM CHLORIDE 0.15% W/V & SODIUM CHLORIDE 0.9% W/V SOLUTION FOR INFUSION - BP

Active substance(s): POTASSIUM CHLORIDE / SODIUM CHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v
Solution for Infusion BP
Active substances: potassium chloride & sodium chloride
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 or pharmacist.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

1. What Potassium 0.15 & Sodium 0.9
Infusion is and what it is used for
Potassium 0.15 & Sodium 0.9 Infusion is a solution
of potassium chloride and sodium chloride in
water. Potassium chloride and sodium chloride are
chemical substances (often called “salts”) found in
the blood.
Potassium 0.15 & Sodium 0.9 Infusion is used to
prevent and treat:
• 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 sodium chloride and
water loss including:
• when you cannot eat or drink, due to illness or
after surgery
• pronounced sweating due to high fever
• extensive skin loss, as can occur in severe burns.

This medicine is called Potassium Chloride 0.15% w/v
& Sodium Chloride 0.9% w/v Solution for Infusion BP,
but will be referred to as Potassium 0.15 & Sodium
0.9 Infusion throughout the remainder of this leaflet.
In this leaflet:
1. What Potassium 0.15 & Sodium 0.9 Infusion
is and what it is used for
2. Before you use Potassium 0.15 & Sodium 0.9
Infusion
3. How to use Potassium 0.15 & Sodium 0.9
Infusion
4. Possible side effects
5. How to store Potassium 0.15 & Sodium 0.9
Infusion
6. Further information

2. Before you use Potassium 0.15 &
Sodium 0.9 Infusion
You must NOT receive Potassium 0.15 &
Sodium 0.9 Infusion if you are suffering
from any of the following conditions
• higher levels of potassium in the blood than
normal (hyperkalaemia)
• higher levels of chloride in the blood than normal
(hyperchloraemia)
• higher levels of sodium in the blood than normal
(hypernatraemia)
• 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
1

• 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).

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
0.15 & Sodium 0.9 Infusion you may need to be given
extra nutrition.

Take special care with Potassium 0.15 &
Sodium 0.9 Infusion

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.

Potassium 0.15 & Sodium 0.9 Infusion is a hypertonic
(concentrated) solution. Your doctor will take this
into account when calculating how much solution to
give you.

It is particularly important that you inform your
doctor if you are taking:
• cardiac glycosides (cardiotonics) used to treat
heart failure, such as digitalis or digoxin
• 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)
• corticosteroids (anti-inflammatory medicines).

Please tell your doctor if you have or have had any of
the following medical conditions:
• any type of heart disease or poor heart function
• poor kidney function
• 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)
• if you are on treatment with cardiac glycosides
(also called cardiotonics), such as digitalis or
digoxin. These medicines are used to treat
heart disease. Regular monitoring of the level of
potassium in the blood must be performed
• high blood pressure (hypertension)
• build up of fluid under the skin, particularly
around the ankles (peripheral oedema)
• build up of fluid in the lungs (pulmonary
oedema)
• high blood pressure during pregnancy
(pre-eclampsia)
• any other condition associated with sodium
retention (when the body retains too much
sodium), such as treatment with steroids (See
also below “Taking other medicines”).

Using Potassium 0.15 & Sodium 0.9
Infusion with food and drink
You should ask your doctor about what you can eat
or drink.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.

When you are given this infusion, your doctor will
take blood and urine samples to monitor:
• the amount of fluid in your body
• 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 acidbase balance)
• your heart tracing (ECG).

Tell your doctor if you are pregnant or breast-feeding.
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.
Potassium 0.15 & Sodium 0.9 Infusion can be given
during pregnancy. The amount you are given must be
carefully controlled by your doctor.

2

If you receive more Potassium 0.15 &
Sodium 0.9 Infusion than you should

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 Patient Information Leaflet of the
medicine that is to be added.

If you are given too much Potassium 0.15 & Sodium
0.9 Infusion (over-infusion), this may lead to the
following symptoms:
• pins and needles in the arms and legs
(paresthesia)
• 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
life-threatening situation)
• confusion
• fluid collection in the lungs making it difficult to
breathe (pulmonary oedema)
• fluid collection under the skin, particularly
around the ankles (peripheral oedema).
• acidification of the blood (acidosis) leading to
tiredness, confusion, lethargy and increased
breathing rate.

Driving and using machines
Potassium 0.15 & Sodium 0.9 Infusion does not
affect your ability to drive or use machines.

3. How to use Potassium 0.15 &
Sodium 0.9 Infusion
Potassium 0.15 & Sodium 0.9 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 and state of hydration (the
amount of water in your body). The amount you are
given may also be affected by other treatments you
are receiving.

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.

You should NOT be given Potassium 0.15 & Sodium
0.9 Infusion if there are particles floating in the
solution or if the pack is damaged in any way.
The speed of infusion will be decided by your doctor.

If a medicine has been added to your Potassium 0.15
& Sodium 0.9 Infusion before over-infusion occurs,
that medicine may also cause symptoms. You should
read the Patient Information Leaflet of the added
medicine for a list of possible symptoms.

If you require a large volume or rapid infusion of
Potassium 0.15 & Sodium 0.9 Infusion, your doctor
may monitor your ECG (heart tracing).
Potassium 0.15 & Sodium 0.9 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.

Stopping your Potassium 0.15 & Sodium
0.9 Infusion
Your doctor will decide when to stop giving you this
infusion.

When you are given Potassium 0.15 & Sodium
0.9 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).

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

4. Possible side effects
Like all medicines, Potassium 0.15 & Sodium
0.9 Infusion can cause side effects, although not
everybody gets them.
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)

If you suffer from poor kidney function, you may
receive a lower dose.
Any unused solution should be thrown away. You
should NOT be given an infusion of Potassium 0.15 &
Sodium 0.9 Infusion from a bag that has been partly
used.

3

What Potassium Chloride 0.15% w/v &
Sodium Chloride 0.9% w/v Solution for
Infusion looks like and contents of the pack

• 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).

Potassium Chloride 0.15% w/v & Sodium Chloride
0.9% w/v Solution for 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.

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
Patient Information Leaflet of the added medicine for
a list of possible symptoms.

Marketing Authorisation Holder and
Manufacturers

Please tell your doctor or nurse if you notice any
listed or unlisted side effects. If any side effects
occur, the infusion must be stopped.

Marketing Authorisation Holder:
Send all enquiries to this address
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

5. How to store Potassium 0.15 &
Sodium 0.9 Infusion
Keep out of the reach and sight of children.
Potassium 0.15 & Sodium 0.9 Infusion does not
require special storage conditions.
Potassium 0.15 & Sodium 0.9 Infusion should NOT
be given to you after the expiry date which figures
on the bag. The expiry date refers to the last day of
that month.
You should not be given Potassium 0.15 & Sodium
0.9 Infusion, if there are particles floating in the
solution or if the unit is damaged in any way.

6. Further information
What Potassium 0.15 & Sodium 0.9
Infusion contains

This leaflet was approved in 10/2012

The active substances are:
• potassium chloride: 1.5 g per litre
• sodium chloride: 9 g per litre.
The only other ingredient is water for injections.

For information about Potassium 0.15 &
Sodium 0.9 Infusion or to request this
leaflet in formats such as audio or large
print please contact the
Marketing Authorisation Holder:
Tel: 01635 206345.
Baxter and Viaflo are trademarks of
Baxter International lnc.
4

F

TH-30-01-437

Potassium Chloride 0.15% w/v & Sodium Chloride 0.9% w/v
Solution for Infusion BP
The following information is
intended for medical or healthcare
professionals only:

1. Opening
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.

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

2. Preparation for administration
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.

5

3. Techniques for injection of additive
medications

5. Incompatibilities of additive
medications

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.

As with all parenteral solutions, incompatibility of
the additive medications with the solution must be
assessed before addition.
In the absence of compatibility studies, this solution
must not be mixed with other medicinal products.
It is the responsibility of the physician to judge the
incompatibility of an additive medication with the
Potassium Chloride 0.15% & Sodium Chloride 0.9%
solution, 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 Potassium Chloride
0.15% & Sodium Chloride 0.9% solution
(pH: 4.5 to 7.0).
Those additives known to be incompatible should not
be used.

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.
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.

4. In-use shelf-life (Additives)
Chemical and physical stability of any additive
medication at the pH of the Potassium Chloride
0.15% & Sodium Chloride 0.9% solution 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.

F

6

b

PACKAGE LEAFLET: INFORMATION FOR THE USER

Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v
Solution for Infusion BP
Active substances: potassium chloride and sodium chloride
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 or pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

1. What Potassium 0.15 & Sodium
0.9 Infusion is and what it is
used for
Potassium 0.15 & Sodium 0.9 Infusion is a solution
of potassium chloride and sodium chloride in
water. Potassium chloride and sodium chloride are
chemical substances (often called “salts”) found in
the blood.
Potassium 0.15 & Sodium 0.9 Infusion is used to
prevent and treat:
• 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 sodium chloride and
water loss including:
• when you cannot eat or drink, due to illness or
after surgery
• pronounced sweating due to high fever
• extensive skin loss, as can occur in severe
burns.

This medicine is called Potassium Chloride 0.15%
w/v and Sodium Chloride 0.9% w/v Solution for
Infusion BP, but will be referred to as Potassium
0.15 & Sodium 0.9 Infusion throughout the
remainder of this leaflet.
In this leaflet:
1. What Potassium 0.15 & Sodium 0.9 Infusion
is and what it is used for
2. Before you use Potassium 0.15 & Sodium
0.9 Infusion
3. How to use Potassium 0.15 & Sodium 0.9
Infusion
4. Possible side effects
5. How to store Potassium 0.15 & Sodium 0.9
Infusion
6. Further information

1a

• a loss of water from the body (acute
dehydration, e.g. from vomiting or diarrhoea)
• extensive tissue damage (as can occur in
severe burns)
• if you are on treatment with cardiac glycosides
(also called cardiotonics), such as digitalis or
digoxin. These medicines are used to treat
heart disease. Regular monitoring of the level
of potassium in the blood must be performed
• high blood pressure (hypertension)
• build up of fluid under the skin, particularly
around the ankles (peripheral oedema)
• build up of fluid in the lungs (pulmonary
oedema)
• high blood pressure during pregnancy
(pre-eclampsia)
• any other condition associated with sodium
retention (when the body retains too much
sodium), such as treatment with steroids (See
also below “Taking other medicines”).

2. Before you use Potassium 0.15 &
Sodium 0.9 Infusion
You must NOT receive Potassium 0.15 &
Sodium 0.9 Infusion if you are suffering
from any of the following conditions
• higher levels of potassium in the blood than
normal (hyperkalaemia)
• higher levels of chloride in the blood than
normal (hyperchloraemia)
• higher levels of sodium in the blood than
normal (hypernatraemia)
• 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).

When you are given this infusion, your doctor will
take blood and urine samples to monitor:
• the amount of fluid in your body
• 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 acidbase balance)
• your heart tracing (ECG).

Take special care with Potassium 0.15 &
Sodium 0.9 Infusion
Potassium 0.15 & Sodium 0.9 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:
• any type of heart disease or poor heart
function
• poor kidney function
• adrenocortical insufficiency (this disease of the
adrenal gland affects hormones that control
the concentration of chemicals in the body)

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 0.15 & Sodium 0.9 Infusion you
may need to be given extra nutrition.

2a

Taking other medicines

Potassium 0.15 & Sodium 0.9 Infusion can be
given during pregnancy. The amount you are given
must be carefully controlled by your doctor.

Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without a
prescription.

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 Patient Information Leaflet of the
medicine that is to be added.

It is particularly important that you inform your
doctor if you are taking:
• cardiac glycosides (cardiotonics) used to treat
heart failure, such as digitalis or digoxin
• 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)
• corticosteroids (anti-inflammatory medicines).

Driving and using machines
Potassium 0.15 & Sodium 0.9 Infusion does not
affect your ability to drive or use machines.

3. How to use Potassium 0.15 &
Sodium 0.9 Infusion
Potassium 0.15 & Sodium 0.9 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 and state of hydration (the
amount of water in your body). The amount you
are given may also be affected by other treatments
you are receiving.
You should NOT be given Potassium 0.15 &
Sodium 0.9 Infusion if there are particles floating
in the solution or if the pack is damaged in any
way.

Using Potassium 0.15 & Sodium 0.9
Infusion with food and drink

The speed of infusion will be decided by your
doctor.

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

If you require a large volume or rapid infusion of
Potassium 0.15 & Sodium 0.9 Infusion, your doctor
may monitor your ECG (heart tracing).

Pregnancy and breast-feeding

Potassium 0.15 & Sodium 0.9 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.

Ask your doctor or pharmacist for advice before
taking any medicine.
Tell your doctor if you are pregnant or breastfeeding.
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.

3a

Stopping your Potassium 0.15 & Sodium
0.9 Infusion

When you are given Potassium 0.15 & Sodium 0.9
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).

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.

4. Possible side effects

If you suffer from poor kidney function, you may
receive a lower dose.
Any unused solution should be thrown away. You
should NOT be given an infusion of Potassium 0.15 &
Sodium 0.9 Infusion from a bag that has been partly
used.

Like all medicines, Potassium 0.15 & Sodium
0.9 Infusion can cause side effects, although not
everybody gets them.
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).

If you receive more Potassium 0.15 &
Sodium 0.9 Infusion than you should
If you are given too much Potassium 0.15 &
Sodium 0.9 Infusion (over-infusion), this may lead
to the following symptoms:
• pins and needles in the arms and legs
(paresthesia)
• 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
• fluid collection in the lungs making it difficult
to breathe (pulmonary oedema)
• fluid collection under the skin, particularly
around the ankles (peripheral oedema)
• acidification of the blood (acidosis) leading to
tiredness, confusion, lethargy and increased
breathing rate.

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
Patient Information Leaflet of the added medicine
for a list of possible symptoms.

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.

Please tell your doctor or nurse if you notice any
listed or unlisted side effects. If any side effects
occur, the infusion must be stopped.

If a medicine has been added to your Potassium
0.15 & Sodium 0.9 Infusion before over-infusion
occurs, that medicine may also cause symptoms.
You should read the Patient Information Leaflet
of the added medicine for a list of possible
symptoms.
4a

Marketing Authorisation Holder and
Manufacturers

5. How to store Potassium 0.15 &
Sodium 0.9 Infusion

Marketing Authorisation Holder:

Keep out of the reach and sight of children.

Send all enquiries to this address

Potassium 0.15 & Sodium 0.9 Infusion does not
require special storage conditions.

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

Potassium 0.15 & Sodium 0.9 Infusion should NOT
be given to you after the expiry date which figures
on the bag. The expiry date refers to the last day of
that month.

Manufacturers:
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium

You should not be given Potassium 0.15 & Sodium
0.9 Infusion, if there are particles floating in the
solution or if the unit is damaged in any way.

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

6. Further information
What Potassium 0.15 & Sodium 0.9
Infusion contains

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

The active substances are:
• potassium chloride: 1.5 g per litre
• sodium chloride: 9 g per litre
The only other ingredient is water for injections.

This leaflet was approved in 10/2012

What Potassium Chloride 0.15% w/v &
Sodium Chloride 0.9% w/v Solution for
Infusion looks like and contents of the
pack

For information about Potassium
0.15 & Sodium 0.9 Infusion or to
request this leaflet in formats
such as audio or large print please
contact the Marketing Authorisation
Holder:
Tel: 01635 206345.

Potassium Chloride 0.15% w/v & Sodium Chloride
0.9% w/v Solution for 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.

5a

b

Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v
Solution for Infusion BP
1. Opening
The following information
a. Remove the Viaflo container from the
is intended for medical or
overpouch just before use.
healthcare professionals only:
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.

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

2. Preparation for administration
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.

1b

3. Techniques for injection of
additive medications

4. In-use shelf-life: (Additives)
Chemical and physical stability of any additive
medication at the pH of the Potassium Chloride
0.15% and Sodium Chloride 0.9% solution 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.

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.

5. Incompatibilities of additive
medications
As with all parenteral solutions, incompatibility of
the additive medications with the solution must be
assessed before addition.
In the absence of compatibility studies, this
solution must not be mixed with other medicinal
products.
It is the responsibility of the physician to judge
the incompatibility of an additive medication with
the Potassium Chloride 0.15% & Sodium Chloride
0.9% solution, 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 Potassium Chloride
0.15% & Sodium Chloride 0.9% solution
(pH: 4.5 to 7.0).
Those additives known to be incompatible should
not be used.

Caution: Do not store bags containing added
medications.
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.

Baxter and Viaflo are trademarks of
Baxter International lnc.

F

2b

Expand view ⇕

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.

Hide