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SODIUM CHLORIDE 0.45% W/V AND GLUCOSE 5% W/V IV INFUSION BP

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Sodium Chloride 0.45% w/v and Glucose 5% w/v
Solution for Infusion BP
Active substances: sodium chloride, glucose

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.

Glucose is one of the body’s sources of energy.
This solution for infusion provides 200 kilocalories
per 1000 ml.
Sodium and chloride are chemical substances
found in the blood.
Sodium Chloride 0.45 & Glucose 5 Infusion is used:
• as a source of carbohydrate (sugar)
• to treat a loss of body water (dehydration) and
chemicals, particularly sodium (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
and Glucose 5% w/v Solution for Infusion BP but
will be called Sodium Chloride 0.45 & Glucose 5
Infusion throughout the remainder of this leaflet.

2. Before you are given Sodium Chloride 0.45 &
Glucose 5 Infusion
You must NOT receive Sodium Chloride 0.45 &
Glucose 5 Infusion if you are suffering from any
of the following conditions:
• 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 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.
• lower levels of sodium in the blood than normal
(hyponatraemia)
• lower levels of chloride in the blood than
normal (hypochloraemia)

In this leaflet:
1. What Sodium Chloride 0.45 & Glucose 5
Infusion is and what it is used for
2. Before you are given Sodium Chloride 0.45 &
Glucose 5 Infusion
3. How you will be given Sodium Chloride 0.45
& Glucose 5 Infusion
4. Possible side effects
5. How Sodium Chloride 0.45 & Glucose 5
Infusion is stored
6. Further information
1. What Sodium Chloride 0.45 & Glucose 5
Infusion is and what it is used for
Sodium Chloride 0.45 & Glucose 5 Infusion is a
solution of the following substances in water:
• sugar (glucose)
• sodium chloride.

1

• 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)
• states of glucose intolerance, for example:
– metabolic stress (when the body’s
metabolism does not function correctly,
e.g. due to severe illness)
• hyperosmolar coma (unconsciousness). This
is a type of coma that can occur if you have
diabetes and do not receive enough medicine
• a higher amount of sugar in the blood than
normal (hyperglycaemia)
• higher levels of lactate in the blood than normal
(hyperlactataemia).

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).
Sodium Chloride 0.45 & Glucose 5 Infusion must
not be given through the same needle as a blood
transfusion. This can damage the red blood cells or
cause them to clump together.
Sodium Chloride 0.45 & Glucose 5 Infusion should
be given with special care to premature babies and
babies less than 3 months of age.
Sodium Chloride 0.45 & Glucose 5 Infusion should
be given with special care in the first 24 hours
after a head injury. Your doctor should monitor
your blood glucose levels if you have raised
blood pressure within your skull (intracranial
hypertension).
As Sodium Chloride 0.45 & Glucose 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 will take special care when giving
you Sodium Chloride 0.45 & Glucose 5 Infusion
Please tell your doctor if you have or have had any
of the following medical conditions.
• heart failure
• respiratory failure (lung disease)
(special monitoring may be required in the
above conditions)
• poor kidney function
• 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”)
• diabetes (your blood sugar levels will be
monitored closely and your insulin treatment
may need to be modified)
• stroke due to a clot in a blood vessel in the
brain (ischaemic stroke).

This is particularly important:
• if you are diabetic
• 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 are being treated for low blood volume
(hypovolaemia). Your doctor should adjust the
rate of infusion to avoid causing raised blood
sugar levels.
If you are diabetic or have had kidney problems
(renal insufficiency), your doctor should carefully
monitor your blood glucose levels. Your need for
insulin or potassium may change while you are
being given Sodium Chloride 0.45 & Glucose 5
Infusion.

2

During long-term treatment with Sodium Chloride
0.45 & Glucose 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).

3. How you will be given Sodium Chloride 0.45
& Glucose 5 Infusion
You will be given Sodium Chloride 0.45
& Glucose 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, clinical and biological conditions and
the reason for treatment. The amount you are
given may also be affected by other treatments
you are receiving.

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.

You should NOT be given Sodium Chloride 0.45
& Glucose 5 Infusion if there are particles in the
solution or if the pack is damaged in any way.

It is particularly important that you inform your
doctor if you are taking:
• corticosteroids (anti-inflammatory medicines)
• carbenoxolone (an anti-inflammatory medicine
used to treat stomach ulcers).

Sodium Chloride 0.45 & Glucose 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.

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).
Using Sodium Chloride 0.45 & Glucose 5 Infusion
with food and drink

Any unused solution should be thrown away.
You should NOT be given an infusion of Sodium
Chloride 0.45 & Glucose 5 Infusion from a bag that
has been partly used.

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

If you receive more Sodium Chloride 0.45
& Glucose 5 Infusion than you should

Pregnancy and breast-feeding

If your kidneys are less able to remove sodium
from your blood than normal, Sodium Chloride 0.45
& Glucose 5 Infusion may cause an increase in
your blood levels of sodium (hypernatraemia). This
can lead to:
• build up of fluid under the skin, particularly
around the ankles (peripheral oedema)
• build up of fluid in the lungs (pulmonary
oedema).

Ask your doctor or pharmacist for advice before
taking any medicine.
Tell your doctor if you are pregnant or
breast-feeding.
Sodium Chloride 0.45 & Glucose 5 Infusion can be
used safely during pregnancy or breast-feeding.
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.

High blood levels of sodium are rare with normal
use of Sodium Chloride 0.45 & Glucose 5 Infusion. If
they occur, the most serious effect is a reduction in
the water content of the brain (dehydration of the
brain). This causes drowsiness and confusion and
may lead to fits (convulsions), unconsciousness
(coma), stopping breathing (respiratory failure) and
even death. Other symptoms include:
• thirst
• dry mouth and eyes
• fever

Driving and using machines
Sodium Chloride 0.45 & Glucose 5 Infusion does
not affect your ability to drive or use machines.

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rapid heart rate (tachycardia)
high blood pressure (hypertension)
headache
dizziness
restlessness
irritability
weakness.

4. Possible Side Effects
Like all medicines, Sodium Chloride 0.45
& Glucose 5 Infusion can cause side effects,
although not everybody gets them.
The side effects are listed according to their
frequencies. The side effects can be related to
Sodium Chloride 0.45 & Glucose 5 Infusion itself.
This includes:

If you are given too much Sodium Chloride 0.45
& Glucose 5 Infusion, your blood may become
too acidic. This may lead to tiredness, confusion,
lethargy and increased breathing rate.

Very common (occurring in more than 1 of every
10 patients)
• changes in the concentrations of the chemicals
in the blood (electrolyte disturbances)

If you are given too much Sodium Chloride 0.45 &
Glucose 5 Infusion, or large amounts are infused
too quickly you may develop:
• increased concentration of the salts in the
blood (hyperosmolarity)
• lack of water in the body tissues (dehydration)
• high levels of sugar in the blood
(hyperglycaemia)
• sugar in the urine (hyperglucosuria)
• an increase in the amount of urine you produce
(osmotic diuresis).

If you suffer from heart disease or fluid in the
lungs (pulmonary oedema):
• too much fluid in the body (hyperhydration)
which may lead to more frequent urination
(polyuria)
• heart failure.
Uncommon (occurring in less than 1 of every
100 patients but in more than 1 of every 1,000
patients)
• low levels of sodium in the blood
(hyponatraemia).

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. Your doctor will also
make the necessary examinations. You may need
hospital treatment if the symptoms are dangerous.

Not known (cannot be estimated from the
available data)
• The side effects can be related to the
administration technique:
– 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 in the injection
vein (venous thrombosis) 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 a medicine has been added to your Sodium
Chloride 0.45 & Glucose 5 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.
Stopping your Sodium Chloride 0.45 & Glucose 5
Infusion
Your doctor will decide when to stop giving you
this infusion.
If you have any further questions on the use of this
product, ask your doctor.

4

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.

The solution is supplied in a plastic VIAFLEX
infusion bag made from PVC. The bag contains
either 500 ml or 1000 ml and is sealed in a
protective plastic overpouch. The bags are
supplied in cartons. Each carton contains one of
the following quantities: 20 bags of 500 ml
10 bags of 1000 ml.

If any side effects occur, the infusion must be
stopped. Please tell your doctor or nurse if you
notice any side effect listed or not listed in this
leaflet.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturers
Marketing Authorisation Holder:

5. How Sodium Chloride 0.45 & Glucose 5
Infusion is stored

Baxter Healthcare Ltd.
Caxton Way
Keep out of the reach and sight of children.
Thetford
Sodium Chloride 0.45 & Glucose 5 Infusion does
Norfolk
not require special storage conditions, apart from a IP24 3SE
storage temperature below 25°C.
United Kingdom
Sodium Chloride 0.45 & Glucose 5 Infusion should Send all enquiries to this address.
NOT be given to you after the expiry date shown
Manufacturers
on the bag. The expiry date refers to the last day of
Baxter Healthcare Ltd.
that month.
Caxton Way
You should not be given Sodium Chloride 0.45
Thetford
& Glucose 5 Infusion, if there are particles floating Norfolk
in the solution or if the unit is damaged in any way. IP24 3SE
United Kingdom
6. Further Information
Baxter S.A.
Boulevard René Branquart, 80
This leaflet does not contain all the information
7860 Lessines
about this medicine. If you have any questions or
Belgium
are not sure about any thing, ask your healthcare
Baxter Healthcare S.A.
professional.
Moneen Road
What Sodium Chloride 0.45 & Glucose 5 Infusion
Castlebar
contains
County Mayo
The active substances are:
Ireland
• sugar (glucose) 50 g per litre
This leaflet was last approved in
12/2011
• sodium chloride 4.5 g per litre.

For information about Sodium
Chloride 0.45 & Glucose 5
Infusion or to request this leaflet
in formats such as audio or
large print please contact the
Marketing Authorisation Holder:
Tel: 01635 206345.

The other ingredients are:
• water for injections
• hydrochloric acid (for pH adjustment).
What Sodium Chloride 0.45 & Glucose 5 Solution
for Infusion looks like and contents of the pack
Sodium Chloride 0.45 & Glucose 5 Solution for
Infusion is a clear solution, free from visible
particles.
5

Baxter and Viaflex are trademarks of
Baxter International Inc.

Regulations

Compliance with National

per RA SOP CE-RAPV-009

Product Information proofread as

Storage Conditions and Shelf-Life

cited in the product information

Consistency check with all figures

(API & excipients)

Product name,strength,composition

RA Proofreading Checklist

Barcodes, Symbols and Reimbursement Information

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ARTWORK APPROVAL

06

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TH-30-01-398
6

Sodium Chloride 0.45% w/v and Glucose 5% w/v
Solution for Infusion BP
The following information is intended for medical
or healthcare professionals only:

c. Check the solution for limpidity and absence
of foreign matter. If solution is not clear or
contains foreign matter, 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 injection 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.
Adding other medications or using incorrect
administration technique might cause the
appearance of fever reactions due to the possible
introduction of pyrogens. In case of an adverse
reaction, infusion must be stopped immediately.
Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.
1. Opening
a. Remove the Viaflex 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.

2. Preparation for administration
Use sterile material for preparation and
administration.
a. Suspend container from base eyelet support.
b. Use an aseptic technique to prepare the
administration set.
c. Remove blue protector from outlet port.
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
medications
Warning: Additives may be incompatible.
To add medication before administration
a. Disinfect the medication port.
b. Using a syringe with a 20 gauge (0.9 mm) to
22 gauge (0.70 mm) needle, puncture
re-sealable medication port and inject.
c. Mix the solution and medication thoroughly.
For high density medications such as
potassium chloride, tap the ports gently while
ports are upright and mix.
To add medication during administration
a. Close clamp on the set.
b. Disinfect medication port.
c. Using a syringe with a 20 gauge (0.9 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.
7

4. In-use shelf-life: Additives
From a microbiological point of view, unless
the method of opening precludes the risk of
microbial contamination, the product should be
used immediately. If not used immediately, in-use
storage times and conditions are the responsibility
of the user.
5. Incompatibilities of additive medicinal
products
In the absence of compatibility studies, this
solution must not be mixed with other medicinal
products.
The Instructions for Use of the medicinal product
to be added must be consulted.
Before adding a drug, verify it is soluble and stable
in water at the pH of Sodium Chloride 0.45 and
Glucose 5 solution (pH: 3.5 – 6.5).
As a guidance the following medicinal products
are incompatible with the Sodium Chloride 0.45 &
Glucose 5 Infusion (non-exhaustive listing):
• Ampicillin sodium
• Mitomycin
• Erythromycin lactobionate.
• Amphotericin B
Those additives known to be incompatible should
not be used.
Because of the presence of glucose, Sodium
Chloride 0.45 & Glucose 5 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.
Baxter and Viaflex are trademarks of
Baxter International Inc.

8

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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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