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SODIUM CHLORIDE 0.9% AND GLUCOSE 5% SOLUTION FOR INFUSION BP

Active substance(s): GLUCOSE MONOHYDRATE / SODIUM CHLORIDE

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Package Leaflet: Information for the user
Sodium Chloride 0.9% w/v & Glucose 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.
• 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.

1. What Sodium Chloride 0.9
& Glucose 5 Infusion is and
what it is used for
Sodium Chloride 0.9 & Glucose 5 Infusion is a
solution of the following substances in water:
• sugar (glucose)
• sodium chloride.
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.

This medicine is called ‘Sodium Chloride 0.9%
w/v & Glucose 5% w/v Solution for Infusion BP’,
but will be referred to as ‘Sodium Chloride 0.9
& Glucose 5 Infusion’ throughout the remainder
of this leaflet.

Sodium Chloride 0.9 & Glucose 5 Infusion is
used:
• as a source of carbohydrate (sugar).
• to treat a loss of sodium from the blood and
the body (sodium depletion)
• to treat a loss of body water, for example
after being sick or having diarrhoea
(extracellular dehydration)
• to treat you, if the volume of blood in your
blood vessels is low (hypovolaemia).

What is in this leaflet:
1. What Sodium Chloride 0.9 & Glucose 5
Infusion is and what it is used for
2. What you need to know before you are
given Sodium Chloride 0.9 & Glucose 5
Infusion
3. How you will be given Sodium Chloride
0.9 & Glucose 5 Infusion
4. Possible side effects
5. How to store Sodium Chloride 0.9 &
Glucose 5 Infusion
6. Contents of the pack and other
information

2. What you need to know
before you are given Sodium
Chloride 0.9 & Glucose 5
Infusion
Do NOT receive Sodium Chloride 0.9 &
Glucose 5 Infusion if you are suffering
from any of the following conditions
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• 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.
• higher levels of sodium in the blood than
normal (hypernatraemia)
• higher levels of chloride in the blood than
normal (hyperchloraemia)
• 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)

• 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
• taking certain medications, See below,
“Other medicines and Sodium Chloride 0.9
& Glucose 5 Infusion”.
• a disorder in which the blood becomes too
acidic (metabolic acidosis)
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 poor liver function or liver
disease that causes fluid to build up within
the abdomen (ascitic cirrhosis)
• high blood pressure (hypertension)
• heart failure
• poor kidney function
• high blood pressure during pregnancy (preeclampsia)
• any other condition associated with sodium
retention (when the body retains too much
sodium), such as treatment with steroids
(See also below, “Other medicines and
Sodium Chloride 0.9 & Glucose 5 Infusion”).
• allergy, in particular to corn (Sodium
Chloride 0.9 & Glucose 5 Infusion contains
sugar derived from corn)
The infusion may cause
• changes in the concentrations of the
chemicals in the blood (electrolyte
disturbances)
• 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)
• a higher amount of sugar in the blood than
normal (hyperglycaemia)

Warnings and precautions
Please tell your doctor if you have or have had
any of the following medical conditions.

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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)

treatment with intravenous solutions containing
glucose to ensure adequate control of the
sugar levels in order to avoid potential long
term adverse effects. 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, late
onset bacterial and fungal infection, damage to
the eye (retinopathy of prematurity), infections
in the intestinal track (necrotizing enterocolitis),
lung problems (bronchopulmonary dysplasia),
prolonged hospital stay and death.

As Sodium Chloride 0.9 & 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

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. Your doctor knows
this and will closely monitor the amount of
chemicals such as 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 stroke
and affect recovery
• if you have had head injury within the past
24 hours

Other medicines and Sodium Chloride
0.9 & Glucose 5 Infusion

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 0.9 & 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).

Tell your doctor if you are using, have recently
used or might use 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).

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.

Other medicines that can affect or be affected
by Sodium Chloride 0.9 & Glucose 5 Infusion:





Newborns – especially those born premature
and with low birth weight - are at increased
risk of developing a too low or too high level of
sugar in the blood (hypo- or hyperglycaemia)
and therefore need close monitoring during

lithium (used to treat psychiatric illnesses)
insulin (used to treat diabetes)
water tablets (diuretics)
beta blockers (heart tablets)
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Sodium Chloride 0.9 & 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 0.9 & Glucose 5 Infusion will
usually be given to you through a plastic tube
attached to a needle in a vein. However, your
doctor may use another method to give you the
medicine.

Sodium Chloride 0.9 & Glucose 5
Infusion with food and drink

Any unused solution should be thrown away.
You should NOT be given an infusion of Sodium
Chloride 0.9 & Glucose 5 Infusion from a bag
that has been partly used.

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

Pregnancy and breast-feeding

If you receive more Sodium Chloride 0.9
& Glucose 5 Infusion than you should

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 0.9 & Glucose 5 Infusion can
be used during breastfeeding.

If you are given too much Sodium Chloride 0.9
& Glucose 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
(hyperglycaemia) 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
– fatigue

if another medicine is to be added to your
solution for infusion during pregnancy or
breast-feeding you should:
• consult your doctor
• read the Package Leaflet of the medicine
that is to be added.

Driving and using machines
Sodium Chloride 0.9 & Glucose 5 Infusion does
not affect your ability to drive or use machines.

• 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.

3. How you will be given
Sodium Chloride 0.9 &
Glucose 5 Infusion

• High blood levels of sodium
(hypernatraemia). 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
– rapid heart rate (tachycardia)

You will be given Sodium Chloride 0.9 &
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, condition and the reason
for treatment. The amount you are given may
also be affected by other treatments you are
receiving.
You should NOT be given Sodium Chloride
0.9 & Glucose 5 Infusion if there are particles
floating in the solution or if the pack is
damaged in any way.

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high blood pressure (hypertension)
headache
dizziness
restlessness
irritability
weakness.
build-up of fluid in the body causing
swelling (oedema).

• 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 or burning
and swelling along the path of the vein into
which the solution is infused.

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 0.9 & Glucose 5 Infusion before overinfusion occurs, that medicine may also cause
symptoms. You should read the Package Leaflet
of the added medicine for a list of possible
symptoms.

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.

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.

Stop receiving your Sodium Chloride
0.9 & Glucose 5 Infusion
Your doctor will decide when to stop giving you
this infusion.

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

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

4. Possible side effects

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.

Like all medicines, Sodium Chloride 0.9 &
Glucose 5 Infusion can cause side effects,
although not everybody gets them.
The side effects can be related to Sodium
Chloride 0.9 & Glucose 5 Infusion itself. This
includes:
• hypersensitivity reactions, including a
serious allergic reaction called anaphylaxis
(potential manifestation in patients with
allergy to corn)
• higher levels of sodium in the blood than
normal (hypernatraemia)
• higher levels of sugar in the blood than
normal (hyperglycaemia)

5. How to store Sodium
Chloride 0.9 & Glucose 5
Infusion
Keep this medicine out of the sight and reach
of children.
Sodium Chloride 0.9 & Glucose 5 Infusion does
not require special storage conditions.

The side effects can be related to the
administration technique. This includes:
• fever (febrile response)

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Marketing Authorisation Holder and
Manufacturers

Sodium Chloride 0.9 & Glucose 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.

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

You should not be given Sodium Chloride 0.9
& Glucose 5 Infusion, if there are particles
floating in the solution or if the unit is damaged
in any way.

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

6. Contents of the pack and
other information
What Sodium Chloride 0.9 & Glucose 5
Infusion contains

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

The active substances are:
• sugar (glucose): 50 g per litre
• sodium chloride: 9 g per litre

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

The only other ingredient is water for
injections.

What Sodium Chloride 0.9 & Glucose 5
Infusion looks like and contents of the
pack

This leaflet was last revised in March 2016

For information about Sodium Chloride
0.9 & Glucose 5 Infusion or to request
this leaflet in formats such as audio
or large print please contact the
Marketing Authorisation Holder:
Tel: +44 (0)01635 206345.

Sodium Chloride 0.9 & Glucose 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
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.

Baxter and Viaflo are trademarks of
Baxter International lnc.

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Sodium Chloride 0.9% w/v & Glucose 5% w/v
Solution for Infusion BP
The following information
is intended for healthcare
professionals only:

Paediatric population
In order to avoid potentially fatal over infusion of
intravenous fluids to the neonate, special attention
needs to be paid to the method of administration.
When using a syringe pump to administer
intravenous fluids or medicines to neonates, a
bag of fluid should not be left connected to the
syringe.
When using an infusion pump all clamps on the
intravenous administration set must be closed
before removing the administration set from the
pump, or switching the pump off. This is required
regardless of whether the administration set has
an anti free flow device.
The intravenous infusion device and
administration equipment must be frequently
monitored.
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. Thorough and careful
aseptic mixing of any additive is mandatory.
Solutions containing additives should be used
immediately and not stored.

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,
TH-30-01-806
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– 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.

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
medications

3. Techniques for injection of additive
medications

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

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

It is the responsibility of the physician to judge
the incompatibility of an additive medication with
the Sodium Chloride 0.9 & Glucose 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.

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 medication thoroughly.
For high-density medication such as
potassium chloride, tap the ports gently
while ports are upright and mix.

Before adding a drug, verify it is soluble and
stable in water at the pH of Sodium Chloride 0.9 &
Glucose 5 Infusion (pH 3.5 – 6.5).
When a compatible medication is added to the
Sodium Chloride 0.9 & Glucose 5 Infusion, the
solution must be administered immediately.

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.

As a guidance the following medications are
incompatible with the Sodium Chloride 0.9 &
Glucose 5 Infusion (non-exhaustive listing):
• Ampicillin sodium
• Mitomycin
• Amphotericin B
• Erythromycin lactobionate.

4. In-use shelf-life: Additives

Baxter and Viaflo are trademarks of
Baxter International lnc.

Because of the presence of glucose, Sodium
Chloride 0.9 & 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.

The chemical and physical stability of any additive
at the pH of Sodium Chloride 0.9 & Glucose
5 Infusion in the Viaflo container should be
established prior to use.

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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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