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SODIUM CHLORIDE INTRAVENOUS INFUSION BP 0.9% W/V

Active substance(s): SODIUM CHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Sodium Chloride Intravenous Infusion BP 0.9% w/v
Active substance: sodium chloride
Read all of this leaflet carefully before you
are given this medicine because it contains
important information for you.

• pronounced sweating due to high fever
• extensive skin loss, as can occur in severe
burns.

• 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 0.9 infusion may also be used to deliver or
to dilute other medicines for infusion.
2. What You Need to Know Before You Are Given
Sodium 0.9 Infusion

Do NOT receive Sodium 0.9 Infusion if you
are suffering from any of the following
conditions

This medicine is called Sodium Chloride
Intravenous Infusion BP 0.9% w/v, but will be
referred to as Sodium 0.9 Infusion throughout the
remainder of this leaflet.

• higher levels of chloride in the blood than
normal (hyperchloraemia)
• higher levels of sodium in the blood than
normal (hypernatraemia)
If a medicine has been added to Sodium 0.9
Infusion, the Package Leaflet of the added
medicine must be consulted to determine whether
or not you can receive the solution.

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

Warnings and precautions
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
• acidification of the blood (acidosis)
• when there is a larger volume of blood in
the blood vessels than there should be
(hypervolaemia)
• 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)
• liver disease (eg cirrhosis)
• high blood pressure during pregnancy
(pre-eclampsia)
• raised production of the hormone aldosterone
(aldosteronism)

1. What Sodium 0.9 Infusion Is And What It Is
Used For
Sodium 0.9 Infusion is a solution of sodium chloride
in water. Sodium chloride is a chemical substance
(often called “salt”) found in the blood.
Sodium 0.9 Infusion is used to treat:
• a loss of body water (dehydration)
• a loss of sodium from the body (sodium
depletion)
Situations that may cause sodium chloride and
water loss include:
• when you cannot eat or drink, due to illness or
after surgery

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

• 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
0.9 Infusion”).

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

When you are given this infusion, your
doctor will take blood and urine samples to
monitor:

3. How You Will Be Given Sodium 0.9 Infusion

• the amount of fluid in your body
• your vital signs
• the amount of chemicals such as sodium
and potassium in your blood (your plasma
electrolytes)

Sodium 0.9 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.

This is especially important for children and
(premature) babies as they can retain too much
sodium due to their immature kidney function

The amount you are given may also be affected by
other treatments you are receiving.

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 0.9 Infusion you may need to be given
extra nutrition.

You should NOT be given Sodium 0.9 Infusion if
there are particles floating in the solution or if
the pack is damaged in any way.
Sodium 0.9 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.

Other medicines and Sodium 0.9 Infusion
Tell your doctor or nurse 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) and high blood pressure
(hypertension).
• lithium (used to treat psychiatric illness)

When you are given Sodium 0.9 Infusion, your
doctor will perform blood tests to monitor your
blood levels of:
• electrolytes (such as sodium, and chloride) and
other chemical substances that are normally in
your blood like creatinine (a breakdown product
from the muscles)

Sodium 0.9 Infusion with food and drink

Any unused solution should be thrown away. You
should NOT be given an infusion of Sodium 0.9
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 0.9 Infusion
than you should

Pregnancy, breast-feeding and fertility

If you are given too much Sodium 0.9 Infusion
(over-infusion), this may lead to the following
symptoms:
• nausea (feeling sick)
• vomiting
• diarrhoea (loose stools)
• stomach cramps
• thirst
• dry mouth
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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.
However, if another medicine is to be added to
your solution for infusion during pregnancy or
breast-feeding you should:
• consult your doctor
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dry eyes
sweating
fever
rapid heart rate (tachycardia)
raised blood pressure (hypertension)
kidney failure (renal failure)
fluid collection in the lungs making it difficult to
breathe (pulmonary oedema)
fluid collection under the skin, particularly
around the ankles (peripheral oedema)
stopping breathing (respiratory arrest)
headache
dizziness
restlessness
irritability
weakness
muscular twitching and stiffness
convulsions
acidification of the blood (acidosis), leading to
tiredness, confusion, lethargy and increased
breathing rate.
higher levels of sodium in the blood than
normal (hypernatraemia), which can lead to
seizures, coma, swelling of the brain (cerebral
edema) and death

tremor
decreased blood pressure
hives (urticaria)
skin rash
itching (pruritus)

The side effects that may occur due to the
administration technique include:
• 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.
• an excess of fluid in the blood vessels
(hypervolaemia)
• itching at the site of infusion (urticaria)
• fever (pyrexia)
• chills

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
(other sodium containing solutions) include:
• higher levels of sodium in the blood than
normal (hypernatraemia)
• lower levels of sodium in the blood than normal
(hypornatraemia)

If a medicine has been added to your Sodium 0.9
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 0.9 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 or nurse.
4. Possible Side Effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them. The
frequency of the side-effects is unknown
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• acidification of the blood linked with a higher
level of chloride in the blood than normal
(hyperchloremic metabolic acidosis)

free from visible particles. It 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.

Reporting of side effects

Not all pack sizes may be marketed

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.

Marketing Authorisation Holder and
Manufacturers
Marketing Authorisation Holder:

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

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

Send all enquiries to this address.
Sodium chloride 0.9 Infusion can be made at any
of these addresses:

If any side effects occur, the infusion must be
stopped.

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

5. How to Store Sodium 0.9 Infusion
Keep this medicine out of the sight and reach of
children.

Baxter Healthcare S.A.
Boulevard René Branquart, 80
7860 Lessines, Belgium

VIAFLEX containers should be stored within their
overpouch at a temperature below 25°C.

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

You should NOT be given this medicine after
the expiry date which is stated on the bag after
EXP The expiry date refers to the last day of that
month.

This leaflet was last revised in October 2015

For information about Sodium
Chloride 0.9%w/v Solution for
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.

You should not be given this medicine 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 0.9 Infusion contains
The active substance is sodium chloride
(9 g per litre).

Baxter and Viaflex are trademarks of Baxter
International Inc.

The other ingredients are:
• hydrochloric acid
• water for injections
• sodium hydroxide.

What Sodium Chloride 0.9 Infusion looks
like and contents of the pack
Sodium chloride 0.9 Infusion is a clear solution,
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Sodium Chloride Intravenous Infusion BP 0.9% w/v
Preparation for Administration

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

The VIAFLEX container has an outlet port designed
for an administration set with a short single
Handling and Preparation
connector. If an administration set with a combined
The solution for infusion should be visually
air inlet/fluid path connector has to be used,
inspected prior to use.
ensure the air inlet tube is always clamped off.
Use only if the solution is clear, without visible
1. Opening
particles and if the container is undamaged.
Administer immediately following the insertion of
a. Remove the protective overpouch by tearing
infusion set.
down from notch and remove container.
Do not remove unit from overwrap until ready for
b. Carefully straighten hanger and ports, if
use.
necessary.
The inner bag maintains the sterility of the product. c. Squeeze container and inspect for minute leaks
Do not use plastic containers in series
and examine solution for visible particles or
connections. Such use could result in air embolism
cloudiness by viewing along seam.
due to residual air being drawn from the primary
d. Discard unit if leaks, particles or cloudiness are
container before the administration of the fluid
evident.
from the secondary container is completed.
2. Preparation for administration
Pressurizing intravenous solutions contained
Use sterile material for preparation and
in flexible plastic containers to increase flow
administration.
rates can result in air embolism if the residual
a. Suspend container from base eyelet support.
air in the container is not fully evacuated prior to
b. Use an aseptic technique to prepare the
administration.
administration set.
The solution should be administered with sterile
c.
Remove blue protector from outlet port and
equipment using an aseptic technique. The
insert
set connector well into port.
equipment should be primed with the solution in
d. Prime set and regulate administration as
order to prevent air entering the system.
required.
Additives may be introduced before infusion or
e.
If administration set becomes blocked do not
during infusion through the re-sealable medication
pump
contents back into container but replace
port. When additive is used, verify isotonicity prior
equipment.
to parenteral administration. Thorough and careful
f. Discard any unused portion and equipment
aseptic mixing of any additive is mandatory.
after use. Do not store or reconnect partly used
Solutions containing additives should be used
containers.
immediately and not stored.
3.
Techniques for injection of additive
Adding medication or using an incorrect
medications
administration technique might cause the
The VIAFLEX container has a second port with
appearance of fever reactions due to the possible
a self-sealing rubber medication port designed
introduction of pyrogens. In case of adverse
for the addition of medication using a syringe.
reaction, infusion must be stopped immediately.
This is the only port for adding medication.
Discard after single use.
Warning: Additives may be incompatible.
Discard any unused portion.
To add medication before administration
Do not reconnect partially used bags.

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a. Swab the medication port with the appropriate
anti-bacterial fluid in line with current
recommended practice and procedure.
b. Using a syringe with a 20 – 22 gauge needle,
puncture re-sealable medication port and
inject. Do not leave the syringe and needle in
the port once the medication has been injected.
c. Shake and squeeze the VIAFLEX container so
that the solution and medication are thoroughly
mixed. For high density medications such
as potassium chloride, squeeze both ports
while upright and invert the container several
times while shaking and squeezing to ensure
thorough mixing.

4. In-use shelf life
Chemical and physical stability of any additive
medication at the pH of the Sodium chloride
0.9 Infusion in the VIAFLEX container should be
established prior to use.
From a microbiological point of view, the diluted
product should 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 reconstitution has taken place in
controlled and validated aseptic conditions.
5. Incompatibilities of additive medications
WARNING: Additives may be incompatible. The
introduction of additives to any solution, regardless
of type of container, requires special attention to
assure that no incompatibilities result.

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 a syringe with a 20 – 22 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.

While some incompatibilities are readily observed,
it is important to be aware that subtle physical,
chemical and pharmacological incompatibilities
can occur. The medical literature, the additive
package insert and other available sources
of information should be reviewed for a more
thorough understanding of possible incompatibility
problems.
If, in the informed judgment of the physician, it is
deemed advisable to introduce additives into this
solution, aseptic technique must be employed.
It is recommended that medication is added only
under Pharmaceutical supervision.

Cautions
a. Do not vent.
b. Do not administer unless the solution is clear
and container undamaged.
c. Do not use in series connections as this could
result in air embolism due to residual air being
drawn from the primary container before
administration of fluid from the secondary
container is completed.
d. Discontinue infusion if adverse reaction occurs.
e. Rapid infusion may be harmful.
f. It is recommended that the intravenous
administration set be replaced at least once
every 24 hours. Details of the use of the set can
be recorded – record labels are available from
Baxter Healthcare Ltd.

Do not add medication before hanger and ports
have been straightened and the container
inspected.
Do not store solutions with added medication.
Before adding a drug, verify it is soluble
and stable in water at the pH of the Sodium
chloride 0.9 Infusion.
Those additives known to be incompatible should
not be used.
Baxter and Viaflex are trademarks of Baxter
International Inc.

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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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