Skip to Content

SODIUM CHLORIDE 0.18% & GLUCOSE 4% SOLUTION FOR INFUSION BP

Active substance(s): GLUCOSE MONOHYDRATE / SODIUM CHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: information for the user
Sodium Chloride 0.18% w/v & Glucose 4% w/v
Solution for Infusion BP
Active substances: sodium chloride, glucose.
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. See section 4.
This medicine is called Sodium chloride 0.18% w/v
& Glucose 4% w/v Solution for Infusion BP, but will
be referred to as Sodium chloride 0.18 & Glucose 4
Infusion throughout the remainder of this leaflet.

Sodium chloride 0.18 & Glucose 4 Infusion is used:
• as a source of carbohydrate (sugar).
• to treat a loss of body water (dehydration) and
chemicals (e.g. by heavy sweating, kidney
disorders)
• to treat you, if the volume of blood in your blood
vessels is low (hypovolaemia).

2. What you need to know before you are
given Sodium chloride 0.18 & Glucose 4
Infusion
Do NOT receive Sodium chloride 0.18 & Glucose
4 Infusion if you are suffering from any of the
following conditions

What is in this leaflet:
1. What Sodium chloride 0.18 & Glucose 4 Infusion
is and what it is used for
2. What you need to know before you are given
Sodium chloride 0.18 & Glucose 4 Infusion
3. How you will be given Sodium chloride 0.18 &
Glucose 4 Infusion
4. Possible side effects
5. How to store Sodium chloride 0.18 & Glucose 4
Infusion
6. Contents of the pack and other information

• when you know you are allergic to the product
• when there is too much fluid in the spaces around
the cells of the body (extracellular hyperhydration)
• when there is a larger volume of blood in
the blood vessels than there should be
(hypervolaemia)
• more fluid and sodium than normal in the body
(fluid and sodium retention)
• severe kidney problems that mean you produce
less urine than usual or none at all (oliguria or
anuria)
• uncompensated heart failure. This is heart
failure that is not adequately treated and causes
symptoms such as:
– shortness of breath
– swelling of the ankles.
• lower levels of sodium in the blood than normal
(hyponatraemia)
• lower levels of chloride in the blood than normal
(hypochloraemia)
• build up of fluid under the skin, affecting all parts
of the body (general oedema)
• liver disease that causes fluid to build up within
the abdomen (ascitic cirrhosis)

1. What Sodium chloride 0.18 & Glucose 4
Infusion is and what it is used for
Sodium chloride 0.18 & Glucose 4 Infusion is a
solution of the following substances in water:
• sugar (glucose)
• sodium chloride (salt).
Glucose is one of the body’s sources of energy.
This solution for infusion provides 200 kilocalories
per litre. Sodium and chloride are chemical
substances found in the blood.

1

TH-30-01-808

death. Acute hyponatraemic encephalopathy is a
serious complication. Some patients are at higher
risk for hyponatraemia. In general this applies to

• diabetes that is not adequately treated, allowing
your blood sugar levels to rise above normal
(uncompensated diabetes)
• other 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 very high amount of sugar in the blood
(significant hyperglycaemia)
– higher levels of lactate in the blood than
normal (hyperlactataemia)

– young and old people
– women
– anyone with a condition such as
low levels of oxygen in your blood
(hypoxemia), drinking a lot due to a dry
mouth (psychogenic polydipsia).
– If you have recently been operated on.
• changes in the concentrations of the chemicals in
the blood (electrolyte disturbances)
• a build up of fluid under the skin, affecting all
parts of the body (general oedema), around
the ankles (peripheral oedema) or in the lungs
(pulmonary oedema)

Warnings and precautions

When you are given this infusion, your doctor will take
blood and urine samples to monitor:
• the amount of chemicals such as sodium and
chloride in your blood (your plasma electrolytes)
• the amount of sugar (glucose)

Please tell your doctor if you have or have had any of
the following medical conditions.
• conditions associated with sodium retention,
fluid overload and oedema, such as
aldosteronism (a disease that causes high levels
of a hormone called aldosterone) associated with
high blood pressure (hypertension)
• heart failure
• poor liver function or liver disease that causes
fluid to build up within the abdomen (ascitic
cirrhosis)
• poor kidney function
• high blood pressure during pregnancy (preeclampsia)
• taking certain medications, See below, “other
medicines and Sodium chloride 0.18 & Glucose 4
Infusion”).
• a disorder in which the blood becomes too
alkaline (metabolic alkalosis)
• muscle weakness and periodic paralysis due to
low thyroid activity (thyrotoxic periodic paralysis)
• rapid loss of water from the body e.g. due to
vomiting or diarrhoea
• being on a low potassium diet for a long time
• allergy, in particular to corn (Sodium chloride
0.18 & Glucose 4 Infusion contains sugar derived
from corn)
The infusion may cause
• lower levels of sodium in the blood than normal
(hyponatraemia). Hyponatraemia can lead to
headache, nausea, seizures, lethargy, coma,
swelling of the brain (cerebral oedema) and

As Sodium chloride 0.18 & Glucose 4 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
• if you have not been eating well or have been
drinking too much alcohol for a long time
• if you have recently had a stroke (acute
ischaemic stroke). High levels of sugar in the
blood can worsen the effects of stoke and affect
recovery
• if you have had head injury within the past 24
hours
Your doctor will take into account if you are receiving
parenteral nutrition (nutrition given by infusion into
a vein). During long-term treatment with Sodium
chloride 0.18 & Glucose 4 Infusion, you may need
to be given extra nutrition. Your doctor should also
monitor the level of potassium in your blood to avoid
this becoming lower than normal (hypokalaemia).

2

TH-30-01-808

Children

Sodium chloride 0.18 & Glucose 4 Infusion with
food, drink and alcohol

Special care should be taken when giving this
solution to children, infants, and newborns (especially
premature babies and those with low birth weight).
Children, infants and newborns may not have a good
ability to handle the chemicals in the solution.

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

Pregnancy, breast-feeding and fertility
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.
Sodium chloride 0.18 & Glucose 4 Infusion can be
used during breastfeeding.
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 Leaflet of the medicine that is to
be added.

Younger children are at an increased risk of
developing levels of sugar in the blood that are
either too high or too low, and therefore need close
monitoring during treatment to ensure that sugar
levels are controlled. Low sugar levels in the newborn
can cause prolonged seizures, coma and brain
damage. High sugar levels have been associated with
bleeding into the brain, bacterial and fungal infection,
damage to the eye (retinopathy of prematurity),
infections in the intestinal tract, lung problems,
prolonged length of hospital stay and death.
Children are at higher risk for having or developing
a too low sodium concentration in their blood
(hyponatraemia). Hyponatraemia can lead to
headache, nausea, seizures, lethargy, coma,
swelling of the brain (cerebral oedema) and death.
Acute hyponatraemic encephalopathy is a serious
complication, especially in children.

Driving and using machines

Your doctor knows this and will closely monitor
the amount of chemicals such as glucose (sugar),
sodium and chloride in your child’s blood (plasma
electrolytes)

You will be given Sodium chloride 0.18 & Glucose 4
Infusion 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 and
the reason for treatment. The amount you are given
may also be affected by other treatments you are
receiving.

Sodium chloride 0.18 & Glucose 4 Infusion does not
affect your ability to drive or use machines.

3. How you will be given Sodium chloride
0.18 & Glucose 4 Infusion

Other medicines and Sodium chloride 0.18 &
Glucose 4 Infusion
Tell your doctor or nurse if you are taking or have
recently taken any other medicines.
It is particularly important that you inform your doctor
if you are taking:
• corticosteroids (anti-inflammatory medicines)
These medicines can cause the body to accumulate
sodium and water, leading to:
• tissue swelling due to fluid collection under the
skin (oedema)
• high blood pressure (hypertension).

You should NOT be given Sodium chloride 0.18 &
Glucose 4 Infusion if there are particles floating in
the solution or if the pack is damaged in any way.
Sodium chloride 0.18 & Glucose 4 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.
Any unused solution should be thrown away. You
should NOT be given an infusion of Sodium chloride
0.18 & Glucose 4 Infusion from a bag that has been
partly used.

Other medicines that can affect or be affected by
Sodium chloride 0.18 & Glucose 4 Infusion:
• lithium (used to treat psychiatric illnesses)
• insulin (used to treat diabetes)
• water tablets (diuretics)
• beta blockers (heart tablets)

If you receive more Sodium chloride 0.18 &
Glucose 4 Infusion than you should
If you are given too much Sodium chloride 0.18 &
Glucose 4 Infusion (over-infusion) or if it is given
3

TH-30-01-808

• local pain or reaction (pain or vesicles at the site
of infusion)
• irritation and inflammation of the vein into which
the solution is infused (phlebitis). This can cause
redness, pain , swelling or vesicles along the path
of the vein into which the solution is infused.

too fast, this may lead to the following symptoms:
• high levels of sugar in the blood (hyperglycemia)
Symptoms include:

– dry mouth due to lack of water in body
tissues (dehydration)
– thirst
– fatigue
– frequent urination due to increased
urine production (osmotic diuresis)
– blurred vision

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.

• low levels of sodium in the blood (hyponatraemia).
Hyponatraemia can lead to headache, nausea,
seizures, lethargy, coma, swelling of the brain
(cerebral oedema) and death
• build-up of fluid in the body causing swelling
(oedema).
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 your Sodium chloride
0.18 & Glucose 4 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.

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

Stop receiving your Sodium chloride 0.18 &
Glucose 4 Infusion
Your doctor will decide when to stop giving you this
infusion.
If you have any further questions on the use of this
medicine, ask your doctor or nurse.

Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them
The side effects can be related to Sodium chloride
0.18 & Glucose 4 Infusion itself. This includes:
• hypersensitivity reactions, including a serious
allergic reaction called anaphylaxis (potential
manifestation in patients with allergy to corn)
• high level of sugar in the blood (hyperglycaemia)
• low levels of sodium in the blood (hyponatraemia)
The side effects can be related to the administration
technique. This includes:
• fever (febrile response)
• chills
• itching (pruritus) or rash

5. How to store Sodium chloride 0.18 &
Glucose 4 Infusion
Keep this medicine out of the sight and reach of
children.
Sodium chloride 0.18 & Glucose 4 Infusion does not
require special storage conditions.
Sodium chloride 0.18 & Glucose 4 Infusion should NOT
be given to you after the expiry date which is stated
4

TH-30-01-808

Manufacturers:

on the bag after EXP. The expiry date refers to the last
day of that month.
You should not be given Sodium chloride 0.18 &
Glucose 4 Infusion, if there are particles floating in the
solution or if the unit is damaged in any way.

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

6. Contents of the pack and other
information

Baxter SA
Boulevard Rene Branquart, 80
B7860 Lessines
Belgium

What Sodium chloride 0.18 & Glucose 4 Infusion
contains

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

The active substances are:
• sugar (glucose): 40 g per litre
• sodium chloride: 1.8 g per litre

The only other ingredient is water for injections.

The leaflet was last revised in March 2016

What Sodium chloride 0.18 & Glucose 4 Infusion
looks like and contents of the pack

For information about Sodium chloride
0.18 & Glucose 4 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.

Sodium chloride 0.18 & Glucose 4 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:
• 250 ml
• 500 ml
• 1000 ml.
The bags are supplied in cartons. Each carton
contains one of the following quantities:
• 30 bags of 250 ml
• 20 bags of 500 ml
• 10 bags of 1000 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Send all enquiries to this address
Baxter Healthcare Ltd.
Caxton Way
Thetford, Norfolk,
IP24 3SE
United Kingdom

5

TH-30-01-808

Baxter and Viaflo are trademarks of
Baxter International lnc.

6

TH-30-01-808

Sodium Chloride 0.18% w/v & Glucose 4% w/v
Solution for Infusion BP
The following information is intended
for healthcare professionals only:

controlled and validated aseptic conditions.
Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.

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.
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 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 tonicity prior to
parenteral administration.
From a physico-chemical viewpoint, solution
containing additives should be used immediately
unless chemical and physical in-use stability has
been established.
From a microbiological point of view, solutions
containing additives should be used immediately.
If not used immediately, in-use storage times and
conditions prior to use are the responsibility of the
user and should normally not be longer than 24
hours at 2 to 8°C, unless addition has taken place in

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.

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.

3. Techniques for injection of additive medicinal
products
Warning: Additives may be incompatible (see
Paragraph 5 “Incompatibilities of additive medicinal
products” below).
To add medicinal products 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.
7

TH-30-01-808

Before adding a drug, verify it is soluble and stable in
water at the pH of Sodium chloride 0.18 & Glucose 4
Infusion (pH 3.5 – 6.5).
When a compatible medicinal product is added to
the Sodium chloride 0.18 & Glucose 4 Infusion, the
solution must be administered immediately, unless
chemical and physical in-use stability has been
established.
As guidance the following medicinal products are
incompatible with the Sodium chloride 0.18 & Glucose
4 Infusion (non-exhaustive listing):
• Ampicillin sodium
• Mitomycin
• Erythromycin lactobionate
• Human insulin

c. Mix solution and medicinal product thoroughly.
For high-density medicinal products such as
potassium chloride, tap the ports gently while
ports are upright and mix.
Caution: for storage of bags containing additives, refer
to In-use shelf-life instructions in section 4.
To add medicinal products 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 medicinal product thoroughly.
g. Return container to in use position, re-open the
clamp and continue administration.

Because of the presence of glucose, Sodium chloride
0.18 & Glucose 4 Infusion 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
The chemical and physical stability of any additive at
the pH of Sodium chloride 0.18 & Glucose 4 Infusion
in the Viaflo container should be established prior to
use.
From a physico-chemical viewpoint, solution
containing additives should be used immediately
unless chemical and physical in-use stability has
been established.
From a microbiological point of view, the diluted
product must be used immediately. If not used
immediately, in-use storage times and conditions
prior to use are the responsibility of the user and
would normally not be longer than 24 hours at 2 to
8°C unless dilution has taken place in controlled and
validated aseptic conditions.

5. Incompatibilities of additive medicinal
products
As with all parenteral solutions, before adding
medicinal products, 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 medicinal product with
the Sodium chloride 0.18 & Glucose 4 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.

Baxter and Viaflo are trademarks of
Baxter International lnc.

8

TH-30-01-808

Package leaflet: information for the user
Sodium Chloride 0.18% w/v and Glucose 4% w/v
Solution for Infusion BP
Active substances: sodium chloride, glucose.
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. See section 4.
This medicine is called Sodium chloride 0.18% w/v &
Glucose 4% w/v Solution for Infusion BP, but will be
referred to as Sodium chloride 0.18 & Glucose 4 Infusion
throughout the remainder of this leaflet.






as a source of carbohydrate (sugar).
to treat a loss of body water (dehydration) and
chemicals (e.g. by heavy sweating, kidney
disorders)
to treat you, if the volume of blood in your blood
vessels is low (hypovolaemia).

2. What you need to know before
you are given Sodium chloride
0.18 & Glucose 4 Infusion
Do NOT receive Sodium chloride 0.18 &
Glucose 4 Infusion if you are suffering from
any of the following conditions

What is in this leaflet:
1. What Sodium chloride 0.18 & Glucose 4 Infusion is
and what it is used for
2. What you need to know before you are given
Sodium chloride 0.18 & Glucose 4 Infusion
3. How you will be given Sodium chloride 0.18 &
Glucose 4 Infusion
4. Possible side effects
5. How to store Sodium chloride 0.18 & Glucose 4
Infusion
6. Contents of the pack and other information








1. What Sodium chloride 0.18 &
Glucose 4 Infusion is and what it
is used for



Sodium chloride 0.18 & Glucose 4 Infusion is a solution
of the following substances in water:
• sugar (glucose)
• sodium chloride (salt).
Glucose is one of the body’s sources of energy. This
solution for infusion provides 200 kilocalories per litre.
Sodium and chloride are chemical substances found in
the blood.
Sodium chloride 0.18 & Glucose 4 Infusion is used:





when you know you are allergic to the product
when there is too much fluid in the spaces around
the cells of the body (extracellular hyperhydration)
when there is a larger volume of blood in the blood
vessels than there should be (hypervolaemia)
more fluid and sodium than normal in the body
(fluid and sodium retention)
severe kidney problems that mean you produce less
urine than usual or none at all (oliguria or anuria)
uncompensated heart failure. This is heart failure
that is not adequately treated and causes symptoms
such as:
– shortness of breath
– swelling of the ankles.
lower levels of sodium in the blood than normal
(hyponatraemia)
lower levels of chloride in the blood than normal
(hypochloraemia)
build up of fluid under the skin, affecting all parts of
the body (general oedema)
liver disease that causes fluid to build up within
the abdomen (ascitic
cirrhosis)

SA-30-02-101
1a





diabetes that is not adequately treated, allowing
your blood sugar levels to rise above normal
(uncompensated diabetes)
other 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 very high amount of sugar in the blood
(significant hyperglycaemia)
– higher levels of lactate in the blood than normal
(hyperlactataemia)




– women
– anyone with a condition such as low levels of
oxygen in your blood (hypoxemia), drinking a lot
due to a dry mouth (psychogenic polydipsia).
– If you have recently been operated on.
changes in the concentrations of the chemicals in
the blood (electrolyte disturbances)
a build up of fluid under the skin, affecting all parts
of the body (general oedema), around the ankles
(peripheral oedema) or in the lungs (pulmonary
oedema)

When you are given this infusion, your doctor will take
blood and urine samples to monitor:
• the amount of chemicals such as sodium and
chloride in your blood (your plasma electrolytes)
• the amount of sugar (glucose)

Warnings and precautions
Please tell your doctor if you have or have had any of the
following medical conditions.
• conditions associated with sodium retention, fluid
overload and oedema, such as aldosteronism (a
disease that causes high levels of a hormone called
aldosterone) associated with high blood pressure
(hypertension)
• heart failure
• poor liver function or liver disease that causes fluid
to build up within the abdomen (ascitic cirrhosis)
• poor kidney function
• high blood pressure during pregnancy (preeclampsia)
• taking certain medications, See below, “other
medicines and Sodium chloride 0.18 & Glucose 4
Infusion”).
• a disorder in which the blood becomes too alkaline
(metabolic alkalosis)
• muscle weakness and periodic paralysis due to low
thyroid activity (thyrotoxic periodic paralysis)
• rapid loss of water from the body e.g. due to
vomiting or diarrhoea
• being on a low potassium diet for a long time
• allergy, in particular to corn (Sodium chloride 0.18
& Glucose 4 Infusion contains sugar derived from
corn)

As Sodium chloride 0.18 & Glucose 4 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
• if you have not been eating well or have been
drinking too much alcohol for a long time
• if you have recently had a stroke (acute ischaemic
stroke). High levels of sugar in the blood can worsen
the effects of stoke and affect recovery
• if you have had head injury within the past 24 hours
Your doctor will take into account if you are receiving
parenteral nutrition (nutrition given by infusion into a
vein). During long-term treatment with Sodium chloride
0.18 & Glucose 4 Infusion, you may need to be given
extra nutrition. Your doctor should also monitor the level
of potassium in your blood to avoid this becoming lower
than normal (hypokalaemia).

Children
Special care should be taken when giving this solution
to children, infants, and newborns (especially premature
babies and those with low birth weight). Children, infants
and newborns may not have a good ability to handle the
chemicals in the solution.
Younger children are at an increased risk of developing
levels of sugar in the blood that are either too high or
too low, and therefore need close monitoring during
treatment to ensure that sugar levels are controlled.
Low sugar levels in the newborn can cause prolonged
seizures, coma and brain damage.

The infusion may cause
• lower levels of sodium in the blood than normal
(hyponatraemia). Hyponatraemia can lead to
headache, nausea, seizures, lethargy, coma,
swelling of the brain (cerebral oedema) and death.
Acute hyponatraemic encephalopathy is a serious
complication. Some patients are at higher risk for
hyponatraemia. In general this applies to
– young and old people

SA-30-02-101
2a

Driving and using machines

High sugar levels have been associated with bleeding
into the brain, bacterial and fungal infection, damage
to the eye (retinopathy of prematurity), infections in
the intestinal tract, lung problems, prolonged length of
hospital stay and death.

Sodium chloride 0.18 & Glucose 4 Infusion does not
affect your ability to drive or use machines.

3. How you will be given Sodium
chloride 0.18 & Glucose 4 Infusion

Children are at higher risk for having or developing a too
low sodium concentration in their blood (hyponatraemia).
Hyponatraemia can lead to headache, nausea, seizures,
lethargy, coma, swelling of the brain (cerebral oedema)
and death. Acute hyponatraemic encephalopathy is a
serious complication, especially in children.

You will be given Sodium chloride 0.18 & Glucose 4
Infusion 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 and the reason
for treatment. The amount you are given may also be
affected by other treatments you are receiving.

Your doctor knows this and will closely monitor the
amount of chemicals such as glucose (sugar), sodium
and chloride in your child’s blood (plasma electrolytes)

You should NOT be given Sodium chloride 0.18 &
Glucose 4 Infusion if there are particles floating in the
solution or if the pack is damaged in any way.

Other medicines and Sodium chloride 0.18 &
Glucose 4 Infusion
Tell your doctor or nurse if you are taking or have
recently taken any other medicines.
It is particularly important that you inform your doctor if
you are taking:
• corticosteroids (anti-inflammatory medicines)
These medicines can cause the body to accumulate
sodium and water, leading to:
• tissue swelling due to fluid collection under the skin
(oedema)
• high blood pressure (hypertension).
Other medicines that can affect or be affected by Sodium
chloride 0.18 & Glucose 4 Infusion:
• lithium (used to treat psychiatric illnesses)
• insulin (used to treat diabetes)
• water tablets (diuretics)
• beta blockers (heart tablets)

Sodium chloride 0.18 & Glucose 4 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.
Any unused solution should be thrown away. You should
NOT be given an infusion of Sodium chloride 0.18 &
Glucose 4 Infusion from a bag that has been partly used.

If you receive more Sodium chloride 0.18 &
Glucose 4 Infusion than you should
If you are given too much Sodium chloride 0.18 &
Glucose 4 Infusion (over-infusion) or if it is given too fast,
this may lead to the following symptoms:
• high levels of sugar in the blood (hyperglycemia)
Symptoms include:
– dry mouth due to lack of water in body tissues
(dehydration)
– thirst
– fatigue
– frequent urination due to increased urine
production (osmotic diuresis)
– blurred vision
• low levels of sodium in the blood (hyponatraemia).
Hyponatraemia can lead to headache, nausea,
seizures, lethargy, coma, swelling of the brain
(cerebral oedema) and death
• build-up of fluid in the body causing swelling
(oedema).
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.

Sodium chloride 0.18 & Glucose 4 Infusion
with food, drink and alcohol
You should ask your doctor about what you can eat or
drink.

Pregnancy, breast-feeding and fertility
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.
Sodium chloride 0.18 & Glucose 4 Infusion can be used
during breastfeeding.
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 Leaflet of the medicine that is to be
added.

SA-30-02-101
3a

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.

If a medicine has been added to your Sodium chloride
0.18 & Glucose 4 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 Sodium chloride 0.18 &
Glucose 4 Infusion
Your doctor will decide when to stop giving you this
infusion.
If you have any further questions on the use of this
medicine, ask your doctor or nurse.

Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them
The side effects can be related to Sodium chloride 0.18 &
Glucose 4 Infusion itself. This includes:
• hypersensitivity reactions, including a serious
allergic reaction called anaphylaxis (potential
manifestation in patients with allergy to corn)
• high level of sugar in the blood (hyperglycaemia)
• low levels of sodium in the blood (hyponatraemia)
The side effects can be related to the administration
technique. This includes:
• fever (febrile response)
• chills
• itching (pruritus) or rash
• local pain or reaction (pain or vesicles at the site of
infusion)
• irritation and inflammation of the vein into which
the solution is infused (phlebitis). This can cause
redness, pain , swelling or vesicles along the path of
the vein into which the solution is infused.
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.

5. How to store Sodium chloride
0.18 & Glucose 4 Infusion
Keep this medicine out of the sight and reach of children.
Sodium chloride 0.18 & Glucose 4 Infusion does not
require special storage conditions.
Sodium chloride 0.18 & Glucose 4 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 Sodium chloride 0.18 & Glucose
4 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 Sodium chloride 0.18 & Glucose 4
Infusion contains
The active substances are:
• sugar (glucose): 40 g per litre
• sodium chloride: 1.8 g per litre
The only other ingredient is water for injections.

Reporting of side effects

What Sodium chloride 0.18 & Glucose 4
Infusion looks like and contents of the pack

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.

Sodium chloride 0.18 & Glucose 4 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:
• 250 ml
• 500 ml
SA-30-02-101

United Kingdom:
Via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
4a

• 1000 ml.
The bags are supplied in cartons. Each carton contains
one of the following quantities:
• 30 bags of 250 ml
• 20 bags of 500 ml
• 10 bags of 1000 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Send all enquiries to this address
Baxter Healthcare Ltd.
Caxton Way
Thetford, Norfolk, IP24 3SE
United Kingdom
Manufacturers:
Baxter Healthcare Limited
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom
Baxter SA
Boulevard Rene Branquart, 80
B7860 Lessines
Belgium
Bieffe Medital SA
Ctra de Biescas-Senegüé
22666 Sabiñánigo (Huesca)
Spain

The leaflet was last revised in March 2016

For information about Sodium
chloride 0.18 & Glucose 4 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.

SA-30-02-101
5a

Baxter and Viaflo are trademarks of
Baxter International lnc.

SA-30-02-101
6a

Sodium Chloride 0.18% w/v & Glucose 4% w/v
Solution for Infusion BP
The following information
is intended for healthcare
professionals only:

Do not reconnect partially used bags.

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.
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 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 tonicity prior to parenteral
administration.
From a physico-chemical viewpoint, solution containing
additives should be used immediately unless chemical
and physical in-use stability has been established.
From a microbiological point of view, solutions containing
additives should be used immediately. If not used
immediately, in-use storage times and conditions prior to
use are the responsibility of the user and should normally
not be longer than 24 hours at 2 to 8°C, unless addition
has taken place in controlled and validated aseptic
conditions.
Discard after single use.
Discard any unused portion.

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.

3. Techniques for injection of additive
medicinal products
Warning: Additives may be incompatible (see Paragraph 5
“Incompatibilities of additive medicinal products” below).
To add medicinal products 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 medicinal product thoroughly. For
high-density medicinal products such as potassium
chloride, tap the ports gently while ports are upright
and mix.
Caution: for storage of bags containing additives, refer to
In-use shelf-life instructions in section 4.

SA-30-02-101
1b

• Erythromycin lactobionate
• Human insulin
Because of the presence of glucose, Sodium chloride
0.18 & Glucose 4 Infusion 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.

To add medicinal products 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 medicinal product thoroughly.
g. Return container to in use position, re-open the clamp
and continue administration.

4. In-use shelf-life: Additives
The chemical and physical stability of any additive at the
pH of Sodium chloride 0.18 & Glucose 4 Infusion in the
Viaflo container should be established prior to use.
From a physico-chemical viewpoint, solution containing
additives should be used immediately unless chemical
and physical in-use stability has been established.
From a microbiological point of view, the diluted product
must be used immediately. If not used immediately,
in-use storage times and conditions prior to use are the
responsibility of the user and would normally not be
longer than 24 hours at 2 to 8°C unless dilution has taken
place in controlled and validated aseptic conditions.

5. Incompatibilities of additive medicinal
products
As with all parenteral solutions, before adding medicinal
products, 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 medicinal product with the
Sodium chloride 0.18 & Glucose 4 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 stable in
water at the pH of Sodium chloride 0.18 & Glucose 4
Infusion (pH 3.5 – 6.5).
When a compatible medicinal product is added to the
Sodium chloride 0.18 & Glucose 4 Infusion, the solution
must be administered immediately, unless chemical and
physical in-use stability has been established.
As guidance the following medicinal products are
incompatible with the Sodium chloride 0.18 & Glucose 4
Infusion (non-exhaustive listing):
• Ampicillin sodium
• Mitomycin

Baxter and Viaflo are trademarks of
Baxter International lnc.

SA-30-02-101
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