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SODIUM CHLORIDE 0.3%W/V AND GLUCOSE 3.3%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 0.3% w/v & Glucose 3.3% 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 0.3% w/v & Glucose 3.3% w/v Solution for Infusion BP’, but will
be referred to as ‘Sodium Chloride 0.3 & Glucose 3.3 Infusion’ throughout the remainder of this leaflet.
What is in this leaflet
1. What Sodium Chloride 0.3 & Glucose 3.3 Infusion is and what it is used for
2. What you need to know before you are given Sodium Chloride 0.3 & Glucose 3.3 Infusion
3. How you will be given Sodium Chloride 0.3 & Glucose 3.3 Infusion
4. Possible side effects
5. How to store Sodium Chloride 0.3 & Glucose 3.3 Infusion
6. Contents of the pack and other information

1.

What Sodium Chloride 0.3 & Glucose 3.3 Infusion is and what it is used for

Sodium Chloride 0.3 & Glucose 3.3 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 132 kilocalories per litre.
Sodium and chloride are chemical substances found in the blood.
Sodium Chloride 0.3 & Glucose 3.3 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 0.3 & Glucose 3.3 Infusion

Do NOT receive Sodium Chloride 0.3 & Glucose 3.3 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)
- 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)
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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)

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 (pre-eclampsia)
- taking certain medications, See below, “Other medicines and Sodium Chloride 0.3 & Glucose 3.3
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 0.3 & Glucose 3.3 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.
- 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)
As Sodium Chloride 0.3 & Glucose 3.3 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

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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 0.3 & Glucose 3.3 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. 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.
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)
Other medicines and Sodium Chloride 0.3 & Glucose 3.3 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).

Other medicines that can affect or be affected by Sodium Chloride 0.3 & Glucose 3.3 Infusion:
- lithium (used to treat psychiatric illnesses)
- insulin (used to treat diabetes)
- water tablets (diuretics)
- beta blockers (heart tablets)
Sodium Chloride 0.3 & Glucose 3.3 Infusion with food and 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 0.3 & Glucose 3.3 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.
Driving and using machines
Sodium Chloride 0.3 & Glucose 3.3 Infusion does not affect your ability to drive or use machines.

3.

How you will be given Sodium Chloride 0.3 & Glucose 3.3 Infusion
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You will be given Sodium Chloride 0.3 & Glucose 3.3 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 0.3 & Glucose 3.3 Infusion if there are particles floating in
the solution or if the pack is damaged in any way.
Sodium Chloride 0.3 & Glucose 3.3 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 0.3
& Glucose 3.3 Infusion from a bag that has been partly used.
If you receive more Sodium Chloride 0.3 & Glucose 3.3 Infusion than you should
If you are given too much Sodium Chloride 0.3 & Glucose 3.3 Infusion (over-infusion) or if it is given too
fast, this may lead to the following symptoms:
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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.
If a medicine has been added to your Sodium Chloride 0.3 & Glucose 3.3 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 0.3 & Glucose 3.3 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.

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 0.3 & Glucose 3.3 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)
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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.

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 nurse. This includes any possible side effects not listed in
this leaflet. If any side effects occur, the infusion must be stopped.
You can also report side effects directly (see details 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
5.

How to store Sodium Chloride 0.3 & Glucose 3.3 Infusion

Keep this medicine out of the sight and reach of children.
Sodium Chloride 0.3 & Glucose 3.3 Infusion does not require special storage conditions.
Sodium Chloride 0.3 & Glucose 3.3 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 0.3 & Glucose 3.3 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 0.3 & Glucose 3.3 Infusion contains
The active substances are:
- sugar (glucose): 33 g per litre
- sodium chloride: 3 g per litre
The only other ingredient is water for injections.
What Sodium Chloride 0.3 & Glucose 3.3 Infusion looks like and contents of the pack
Sodium Chloride 0.3 & Glucose 3.3 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.
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Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder:
Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom
Manufacturers:
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium
Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom
Bieffe Medital S.A.
Ctra de Biescas, Senegüé
22666 Sabiñanigo (Huesca)
Spain
Baxter Manufacturing Sp. z.o.o.
42 B Wojciechowska Str.
20-704 Lublin
Poland
This leaflet was last revised in March 2016
For information about Sodium Chloride 0.3 & Glucose 3.3 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.
--------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
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.
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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.
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.

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.
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.

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4.

In-use shelf-life: Additives
The chemical and physical stability of any additive at the pH of Sodium Chloride 0.3 & Glucose 3.3
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 0.3 & Glucose 3.3 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 0.3 &
Glucose 3.3 Infusion (pH 3.5 – 6.5).
When a compatible medicinal product is added to the Sodium Chloride 0.3 & Glucose 3.3 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 0.3 &
Glucose 3.3 Infusion (non-exhaustive listing):


Ampicillin sodium



Mitomycin



Erythromycin lactobionate



Human insulin

Because of the presence of glucose, Sodium Chloride 0.3 & Glucose 3.3 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.

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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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