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SODIUM CHLORIDE 0.45%W/V & GLUCOSE 2.5% W/V SOLUTION FOR INFUSION BP

Active substance(s): GLUCOSE MONOHYDRATE / SODIUM CHLORIDE

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Package leaflet: Information for the user
Sodium Chloride 0.45% w/v & Glucose 2.5% 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.

• sodium chloride (salt).
Glucose is one of the body’s sources of energy.
This solution for infusion provides 100 kilocalories
per litre.
Sodium and chloride are chemical substances
found in the blood.

• 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.

Sodium Chloride 0.45 & Glucose 2.5 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).

This medicine is called ‘Sodium Chloride 0.45%
w/v & Glucose 2.5% w/v Solution for Infusion BP’,
but will be referred to as ‘Sodium Chloride 0.45 &
Glucose 2.5 Infusion’ throughout the remainder of
this leaflet.

2. What you need to know before
you are given Sodium Chloride
0.45 & Glucose 2.5 Infusion

What is in this leaflet:
1. What Sodium Chloride 0.45 & Glucose 2.5
Infusion is and what it is used for
2. What you need to know before you are
given Sodium Chloride 0.45 & Glucose 2.5
Infusion
3. How you will be given Sodium Chloride 0.45
& Glucose 2.5 Infusion
4. Possible side effects
5. How to store Sodium Chloride 0.45 &
Glucose 2.5 Infusion
6. Contents of the pack and other information

Do NOT receive Sodium Chloride 0.45 &
Glucose 2.5 Infusion if you are suffering
from any of the following conditions
• 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)

1. What Sodium Chloride 0.45
& Glucose 2.5 Infusion is and
what it is used for
Sodium Chloride 0.45 & Glucose 2.5 Infusion is a
solution of the following substances in water:
• sugar (glucose)

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1a

• 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)
• 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)








medicines and Sodium Chloride 0.45 &
Glucose 2.5 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
0.45 & Glucose 2.5 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 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
– 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.

Warnings and precautions

• changes in the concentrations of the chemicals
in the blood (electrolyte disturbances)

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

• 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)

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headache, nausea, seizures, lethargy, coma,
swelling of the brain (cerebral oedema) and death.
Acute hyponatraemic encephalopathy is a serious
complication, especially in children.

As Sodium Chloride 0.45 & Glucose 2.5 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

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)

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

Other medicines and Sodium Chloride
0.45 & Glucose 2.5 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)
• or high blood pressure (hypertension).

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 0.45 & Glucose 2.5 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).

Other medicines that can affect or be affected by
Sodium Chloride 0.45 & Glucose 2.5 Infusion:
• lithium (used to treat psychiatric illnesses)
• insulin (used to treat diabetes)
• water tablets (diuretics)
• beta blockers (heart tablets)

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.

Sodium Chloride 0.45 & Glucose 2.5
Infusion with food, drink and alcohol
You should ask your doctor about what you can eat
or drink.

Pregnancy, breast-feeding and fertility

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.

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 0.45 & Glucose 2.5 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.

Children are at higher risk for having or developing
a too low sodium concentration in their blood
(hyponatraemia). Hyponatraemia can lead to

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Driving and using machines

(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).

Sodium Chloride 0.45 & Glucose 2.5 Infusion does
not affect your ability to drive or use machines.

3. How you will be given Sodium
Chloride 0.45 & Glucose 2.5
Infusion

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 0.45 & Glucose 2.5 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.

You will be given Sodium Chloride 0.45 & Glucose
2.5 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.

Stop receiving your Sodium Chloride
0.45 & Glucose 2.5 Infusion

You should NOT be given Sodium Chloride 0.45 &
Glucose 2.5 Infusion if there are particles floating
in the solution or if the pack is damaged in any
way.

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

Sodium Chloride 0.45 & Glucose 2.5 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.

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

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them

Any unused solution should be thrown away.
You should NOT be given an infusion of Sodium
Chloride 0.45 & Glucose 2.5 Infusion from a bag
that has been partly used.

The side effects can be related to Sodium Chloride
0.45 & Glucose 2.5 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)

If you receive more Sodium Chloride
0.45 & Glucose 2.5 Infusion than you
should
If you are given too much Sodium Chloride 0.45 &
Glucose 2.5 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

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)

SA-30-02-100
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• 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.

6. Contents of the pack and
other information
What Sodium Chloride 0.45 & Glucose
2.5 Infusion contains

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.

The active substances are:
• sugar (glucose): 25 g per litre
• sodium chloride: 4.5 g per litre
The only other ingredient is water for injections.

What Sodium Chloride 0.45 & Glucose
2.5 Infusion looks like and contents of
the pack

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.

Sodium Chloride 0.45 & Glucose 2.5 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.

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.

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
Manufacturers

5. How to store Sodium Chloride
0.45 & Glucose 2.5 Infusion

Marketing Authorisation Holder:
Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom

Keep this medicine out of the sight and reach of
children.
Sodium Chloride 0.45 & Glucose 2.5 Infusion does
not require special storage conditions.

Manufacturers:

Sodium Chloride 0.45 & Glucose 2.5 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.

Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium

You should not be given Sodium Chloride 0.45 &
Glucose 2.5 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
5a

SA-30-02-100

Bieffe Medital Sabiñánigo
Ctra de Biescas, Senegüé
22666 Sabiñánigo (Huesca)
Spain
Baxter Healthcare S.A.
Moneen Road
Castlebar
County Mayo
Ireland

This leaflet was last revised in March 2016

For information about Sodium Chloride
0.45 & Glucose 2.5 Infusion or to request
this leaflet in formats such as audio or
large print please contact the Marketing
Authorisation Holder:
Tel: +44 (0)1635 206345.

Baxter and Viaflo are trademarks of
Baxter International lnc.

SA-30-02-100
6a

Sodium Chloride 0.45% w/v & Glucose 2.5% w/v
Solution for Infusion BP
The following information
is intended for healthcare
professionals only:

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.
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 inuse stability has been established.
• From a microbiological point of view,
solutions containing additives should be used
immediately. If not used immediately, in-use

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.

SA-30-02-100
1b

3. Techniques for injection of additive
medicinal products

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.

Warning: Additives may be incompatible (see
Paragraph 5 “Incompatibilities of additive
medicinal products” below).

5. Incompatibilities of additive
medicinal products

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.

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 0.45 & Glucose 2.5
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.

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.

Before adding a drug, verify it is soluble and stable
in water at the pH of Sodium Chloride 0.45 &
Glucose 2.5 Infusion (pH 3.5 – 6.5).
When a compatible medicinal product is added to
the Sodium Chloride 0.45 & Glucose 2.5 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 0.45 &
Glucose 2.5 Infusion (non-exhaustive listing):
• Ampicillin sodium
• Mitomycin
• Erythromycin lactobionate
• Human insulin
Because of the presence of glucose, Sodium
chloride 0.45 & Glucose 2.5 Infusion should not be
administered through the same infusion equipment
as whole blood, as haemolysis and clumping can
occur.

4. In-use shelf-life: Additives
The chemical and physical stability of any additive
at the pH of Sodium Chloride 0.45 & Glucose
2.5 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

Those additives known to be incompatible should
not be used.
Baxter and Viaflo are trademarks of
Baxter International lnc.

SA-30-02-100
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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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