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SODIUM CHLORIDE 0.45% W/V SOLUTION FOR INFUSION

Active substance(s): SODIUM CHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Chloride 0.45 % Solution for Infusion
Active substance: sodium chloride
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.

2. What you need to know before you
are given Sodium 0.45 Infusion
Do NOT receive Sodium 0.45 Infusion
if you are suffering from any of the
following conditions
• lower levels of chloride in the blood than normal
(hypochloraemia)
• lower levels of sodium in the blood than normal
(hyponatraemia)
• severe kidney problems causing lower than
normal or no urine production (oliguria or anuria)
• higher than normal levels of water or sodium in
the blood (fluid or sodium retention)
• uncompensated heart failure. This is heart
failure that is not adequately treated and causes
symptoms such as:
– shortness of breath
– swelling of the ankles
• 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).

This medicine is called `Sodium Chloride 0.45%
Solution for Infusion’, but will be referred to as
`Sodium 0.45 Infusion’ throughout the remainder of
this leaflet.
What is In this leaflet:
1. What Sodium 0.45 Infusion is and what it is
used for
2. What you need to know before you are given
Sodium 0.45 Infusion
3. How you will be given Sodium 0.45 Infusion
4. Possible side effects
5. How to store Sodium 0.45 Infusion
6. Contents of the pack and other information.

If a medicine has been added to Sodium 0.45
Infusion, the Package Leaflet of the added medicine
must be consulted to determine whether or not you
can receive the solution.

1. What Sodium 0.45 Infusion is and
what it is used for

Warnings and precautions

Sodium 0.45 Infusion is a solution of sodium chloride
in water. Sodium chloride is a chemical substance
(often called “salt”) found in the blood.

Please tell your doctor if you have or have had any of
the following medical conditions.
• any type of heart disease or poor heart function
• poor kidney function
• respiratory failure (lung disease)
• (special monitoring may be required in the above
conditions)

Sodium 0.45 Infusion is used to treat:
• a loss of body water, for example after being
sick or having diarrhoea (hypertonic extracellular
dehydration)
• a lower than normal volume of blood in the body
(hypovolaemia)
Sodium 0.45 infusion may also be used to deliver or
to dilute other medicines for infusion.

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• consult your doctor
• read the Package Leaflet of the medicine that is
to be added.

• raised production of the hormone aldosterone
(aldosteronism)
• when there is a larger volume of blood in
the blood vessels than there should be
(hypervolaemia)
• high blood pressure (hypertension)
• high blood pressure during pregnancy (preeclampsia)
• any other condition associated with sodium and
fluid retention (when the body retains too much
sodium or water), such as treatment with steroids
(See also below “Taking other medicines”).

Driving and using machines
Ask your doctor or nurse for advice before driving or
using machines.

3. How you will be given Sodium 0.45
Infusion
Sodium 0.45 Infusion will be given to you 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, the reason for treatment
and whether or not the infusion is being used to
deliver or dilute another medicine

Some patients are at higher risk for having or
developing a too low sodium concentration in your
blood (hyponatraemia). In general this applies to
young and old people, women and 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. With certain diseases of the nervous system
or when you are taking certain antiepileptic and
psychiatric medicines.

The amount you are given may also be affected by
other treatments you are receiving.
You should NOT be given Sodium 0.45 Infusion if
there are particles floating in the solution or if the
pack is damaged in any way.

Other medicines and Sodium 0.45 Infusion

Sodium 0.45 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.

Please tell your doctor or nurse if you are taking, have
recently taken or might take any other medicines.
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)
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).
• Lithium (used to treat psychiatric illness)

When you are given Sodium 0.45 Infusion, your doctor
will take blood and urine samples and monitor:
• the amount of fluid in your body
• your vital signs
• the amount of electrolytes (such as sodium, and
chloride) and other chemical substances that are
normally in your blood
This is especially important for children as they have
a limited ability to regulate fluids and electrolytes.
Any unused solution should be thrown away. You
should NOT be given an infusion of Sodium 0.45
Infusion from a bag that has been partly used.

Sodium 0.45 Infusion with food and drink
You should ask your doctor about what you can eat
or drink.

If you receive more Sodium 0.45 Infusion
than you should

Pregnancy and breast-feeding
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.

If you are given too much Sodium 0.45 Infusion (overinfusion), or it is given too fast, this may lead to the
following symptoms:
• build up of water in the body (oedema)
• too much water in the blood (haemodilution)
• heart problems
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However, if another medicine is to be added to your
solution for infusion during pregnancy or breastfeeding you should:
2a

• 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 (venous thrombosis)
at the site of infusion, 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.

• acidification of the blood (acidosis), leading to
tiredness, confusion, lethargy and increased
breathing rate.
If Sodium 0.45 infusion is given too fast when
you have higher than normal levels of salts in the
blood (hypertonicity), swelling of the brain (brain
oedema) is possible, especially if you often have
higher than normal levels of sodium in the blood
(hypernatraemia).
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.

Other side effects noted with similar products
(sodium chloride containing solutions) include:
• Acidification of the blood (hyperchloraemic
metabolic acidosis)
• Reactions with the following symptoms have
been reported:
– hives (urticaria) which may be localised to a
part of the body or widespread
– fever (pyrexia)
– skin rash
– chills
– itching (pruritus)
– decreased blood pressure
• Other infusion site reactions
– hives at the infusion site.
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.

If a medicine has been added to your Sodium 0.45
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.

If you stop receiving your Sodium 0.45
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, Sodium 0.45 Infusion can cause
the following side effects, although not everybody
gets them.
• too much fluid in the body (overhydration) which
may lead to more frequent urination (polyuria)
• changes in the concentrations of the chemicals in
the blood (electrolyte disturbances)
• heart failure, if you suffer from heart disease or
fluid in the lungs (pulmonary oedema)
• 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. Acute hyponatraemic encephalopathy is
a serious complication, especially in children,
whom have a higher risk for developing
symptomatic hyponatraemia.

Reporting of side effects
If you get any side effect, talk to your doctor or nurse.
This includes any possible side effect 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.
If any side effects occur, the infusion must be
stopped.
United Kingdom:
Via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

The side effects that may occur due to the
administration technique include:
• fever (febrile response)

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Marketing Authorisation Holder and
Manufacturers

Ireland
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.

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

Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.

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

5. How to store Sodium 0.45 Infusion
Keep this medicine out of the sight and reach of
children.

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

Sodium 0.45 Infusion does not require special storage
conditions.
Sodium 0.45 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.

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

You should not be given Sodium 0.45 Infusion, if there
are particles floating in the solution or if the unit is
damaged in any way.

Baxter Healthcare S.A.
Moneen Road
Castlebar
County Mayo
Ireland

6. Contents of the pack and other
information

This medicinal product is authorised in
the Member States of the EEA under the
following names:

What Sodium 0.45 Infusion contains
The active substance is sodium chloride: 4,5 g per
litre.

Ireland, UK: Sodium Chloride 0.45 % Solution for
Infusion
Finland: Natriumklorid Baxter Viaflo 4,5 mg/ml
infuusioneste, liuos

The only other ingredient is water for injections

What Sodium Chloride 0.45% Infusion
looks like and contents of the pack

This leaflet was last approved in

Sodium Chloride 0.45% Solution for 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.

July 2015

For information about Sodium Chloride 0.45% 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 bag size is 500 ml
The bags are supplied in cartons. Each carton
contains 20 bags of 500 ml

Baxter and Viaflo are trademarks of
Baxter International lnc.

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F

Sodium Chloride 0.45 % Solution for Infusion
1. Opening

The following information is
intended for medical or healthcare
professionals only:

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.
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 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 medication or using an incorrect
administration technique might cause the appearance
of fever reactions due to the possible introduction of
pyrogens. In case of adverse reaction, infusion must
be stopped immediately.
Do not mix or administer Sodium Chloride 0.45%
Solution through the same administration set with
whole blood or cellular blood components.
Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.

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
medications
Warning: Additives may be incompatible (see
paragraph 5 “Incompatibilities of additive
medications” below).
To add medication before administration
a. Disinfect medication port.
b. Using syringe with 19 (1.10 mm) to 22 (0.70
mm) gauge 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.
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1b

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 (1.10 mm) to 22 (0.70
mm) gauge 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

4. In-use shelf life (Additives)
Chemical and physical stability of any additive
medication at the pH of the Sodium Chloride 0.45%
solution in the Viaflo container should be established
prior to use. 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
As with all parenteral solutions, incompatibility of
the additive medications with the solution in Viaflo
container must be assessed before addition.
Those additives known to be incompatible should not
be used.
In the absence of compatibility studies, this solution
must not be mixed with other medicinal products.
It is the responsibility of the healthcare professional
to judge the incompatibility of an additive medication
with the Sodium Chloride 0.45% solution, 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.

Before adding a drug, verify it is soluble and/or stable
in water at the pH of the Sodium Chloride 0.45%
solution (pH 4.5 to 7.0).

F
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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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