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SODIUM CHLORIDE 0.9% W/V INTRAVENOUS INFUSION BP

Active substance(s): SODIUM CHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Chloride 0.9%w/v Intravenous Infusion BP
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.

Situations that may cause sodium chloride and water
loss include:
• when you cannot eat or drink, due to illness or
after surgery
• pronounced sweating due to high fever
• extensive skin loss, as can occur in severe burns.
Sodium 0.9 infusion may also be used to deliver or to
dilute other medicines for infusion.

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

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

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

• 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.

Warnings and precautions

1. What Sodium 0.9 Infusion Is And
What It Is Used For

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)

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)

1

TH-30-01-697

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

• high blood pressure during pregnancy (preeclampsia)
• raised production of the hormone aldosterone
(aldosteronism)
• 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:
• 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)

3. How You Will Be Given Sodium 0.9
Infusion
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.
The amount you are given may also be affected by
other treatments you are receiving.

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

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)

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

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.

2

TH-30-01-697

If you receive more Sodium 0.9 Infusion
than you should

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.

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
• 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

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
• 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
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)
• acidification of the blood linked with a higher
level of chloride in the blood than normal
(hyperchloremic metabolic acidosis)

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 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.
3

TH-30-01-697

Reporting of side effects

6. Contents of the Pack and Other
Information

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.

What Sodium 0.9 Infusion contains
The active substance is sodium chloride: 9 g per litre
The only other ingredient is water for injections

What Sodium Chloride 0.9%w/v Solution
for Infusion looks like and contents of the
pack

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

Sodium Chloride 0.9%w/v 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.

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.

The bag sizes are:
• 50 ml
• 100 ml
• 250 ml
• 500 ml
• 1000 ml

Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt

Pack sizes:
• 50 bags of 50 ml per carton
• 1 bag of 50 ml
• 50 bags of 100 ml per carton
• 1 bag of 100 ml
• 30 bags of 250 ml per carton
• 1 bag of 250 ml
• 20 bags of 500 ml per carton
• 1 bag of 500 ml
• 10 bags of 1000 ml per carton
• 1 bag of 1000 ml

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

5. How to Store Sodium 0.9 Infusion
Keep this medicine out of the sight and reach of
children.
50 ml and 100 ml bags: Do not store above 30°C.
250 ml, 500 ml and 1000 ml bags:

Not all pack sizes may be marketed

This medicine does not require any special storage
conditions.
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.

Marketing Authorisation Holder and
Manufacturers
Marketing Authorisation Holder:
Send all enquiries to this address

You should not be given this medicine if there are
particles floating in the solution or if the unit is
damaged in any way.

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

4

TH-30-01-697

Manufacturers:
Baxter S.A.
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 Sabiñánigo (Huesca)
Spain
Baxter Healthcare S.A.
Moneen Road
Castlebar
County Mayo
Ireland
Bieffe Medital S.P.A.
Via Nuova Provinciale
23034 Grosotto (SO)
Italy
Baxter Manufacturing Sp. z o.o.
42 B Wojciechowska Str.
20-704 Lublin
Poland
This leaflet was last revised in 11/2014

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.

5

TH-30-01-697

Baxter and Viaflo are trademarks of
Baxter International lnc.

F

6

TH-30-01-697

Sodium Chloride 0.9%w/v Intravenous Infusion BP
The following information is
intended for medical or healthcare
professionals only:

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.

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.

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.

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.

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 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.

Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.

7

TH-30-01-697

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

4. In-use shelf life (Additives)
Chemical and physical stability of any additive
medication at the pH of the Sodium Chloride 0.9%
solution in the VIAFLO container should be established
prior to use. From a microbiological point of view,
the diluted product must be used immediately unless
dilution has taken place in controlled and validated
aseptic conditions.
If not used immediately, in-use storage times and
conditions are the responsibility of the user.

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.
In the absence of compatibility studies, this solution
must not be mixed with other medicinal products.
It is the responsibility of the physician to judge the
incompatibility of an additive medication with the
Sodium Chloride 0.9% 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.
Before adding a drug, verify it is soluble and/or stable
in water at the pH of the Sodium Chloride 0.9%
solution.
Those additives known to be incompatible should not
be used.

Baxter and Viaflo are trademarks of
Baxter International lnc.

F

8

TH-30-01-697

b

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Chloride 0.9%w/v Intravenous Infusion BP
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.

Situations that may cause sodium chloride and water
loss include:
• when you cannot eat or drink, due to illness or
after surgery
• pronounced sweating due to high fever
• extensive skin loss, as can occur in severe burns.
Sodium 0.9 infusion may also be used to deliver or to
dilute other medicines for infusion.

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

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

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

• 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.

Warnings and precautions

1. What Sodium 0.9 Infusion Is And
What It Is Used For

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)

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)

SA-30-01-938
1a

Pregnancy, breast-feeding and fertility

• 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 (preeclampsia)
• raised production of the hormone aldosterone
(aldosteronism)
• 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”).

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

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:
• 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)

3. How You Will Be Given Sodium 0.9
Infusion
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.
The amount you are given may also be affected by
other treatments you are receiving.

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

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)

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

SA-30-01-938
2a

If you receive more Sodium 0.9 Infusion
than you should

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.

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
• 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

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
• 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
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)
• acidification of the blood linked with a higher
level of chloride in the blood than normal
(hyperchloremic metabolic acidosis)

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 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.

SA-30-01-938
3a

Reporting of side effects

6. Contents of the Pack and Other
Information

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.

What Sodium 0.9 Infusion contains
The active substance is sodium chloride: 9 g per litre
The only other ingredient is water for injections

What Sodium Chloride 0.9%w/v Solution
for Infusion looks like and contents of the
pack

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

Sodium Chloride 0.9%w/v 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.

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.

The bag sizes are:
• 50 ml
• 100 ml
• 250 ml
• 500 ml
• 1000 ml

Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt

Pack sizes:
• 50 bags of 50 ml per carton
• 1 bag of 50 ml
• 50 bags of 100 ml per carton
• 1 bag of 100 ml
• 30 bags of 250 ml per carton
• 1 bag of 250 ml
• 20 bags of 500 ml per carton
• 1 bag of 500 ml
• 10 bags of 1000 ml per carton
• 1 bag of 1000 ml

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

5. How to Store Sodium 0.9 Infusion
Keep this medicine out of the sight and reach of
children.
50 ml and 100 ml bags: Do not store above 30°C.
250 ml, 500 ml and 1000 ml bags:

Not all pack sizes may be marketed

This medicine does not require any special storage
conditions.
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.

Marketing Authorisation Holder and
Manufacturers
Marketing Authorisation Holder:
Send all enquiries to this address

You should not be given this medicine if there are
particles floating in the solution or if the unit is
damaged in any way.

Baxter Healthcare Ltd.
Caxton Way
Thetford Norfolk IP24 3SE
United Kingdom
SA-30-01-938
4a

Manufacturers:
Baxter S.A.
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 Sabiñánigo (Huesca)
Spain
Baxter Healthcare S.A.
Moneen Road
Castlebar
County Mayo
Ireland
Bieffe Medital S.P.A.
Via Nuova Provinciale
23034 Grosotto (SO)
Italy
Baxter Manufacturing Sp. z o.o.
42 B Wojciechowska Str.
20-704 Lublin
Poland
This leaflet was last revised in 11/2014

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.

SA-30-01-938
5a

Baxter and Viaflo are trademarks of
Baxter International lnc.

F

SA-30-01-938
6a

b

Sodium Chloride 0.9%w/v Intravenous Infusion BP

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

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.

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.

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.

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.

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 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.

Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.

SA-30-01-938
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 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

4. In-use shelf life (Additives)
Chemical and physical stability of any additive
medication at the pH of the Sodium Chloride 0.9%
solution in the VIAFLO container should be established
prior to use. From a microbiological point of view,
the diluted product must be used immediately unless
dilution has taken place in controlled and validated
aseptic conditions.
If not used immediately, in-use storage times and
conditions are the responsibility of the user.

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.
In the absence of compatibility studies, this solution
must not be mixed with other medicinal products.
It is the responsibility of the physician to judge the
incompatibility of an additive medication with the
Sodium Chloride 0.9% 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.
Before adding a drug, verify it is soluble and/or stable
in water at the pH of the Sodium Chloride 0.9%
solution.
Those additives known to be incompatible should not
be used.

Baxter and Viaflo are trademarks of
Baxter International lnc.

F
SA-30-01-938

2b

PACKAGE LEAFLET: INFORMATION FOR THE USER
Sodium Chloride 0.9%w/v Intravenous Infusion BP
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.

• 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
01961
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)
• 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”).

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

When you are given this infusion, your doctor will take blood and urine
samples to monitor:
• 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)
This is especially important for children and (premature) babies as they
can retain too much sodium due to their immature kidney function
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.

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.

Other medicines and Sodium 0.9 Infusion

Sodium 0.9 Infusion is used to treat:
• a loss of body water (dehydration)
• a loss of sodium from the body (sodium depletion)

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)

Situations that may cause sodium chloride and water loss include:
• when you cannot eat or drink, due to illness or after surgery
• pronounced sweating due to high fever
• extensive skin loss, as can occur in severe burns.
Sodium 0.9 infusion may also be used to deliver or to dilute other
medicines for infusion.

Sodium 0.9 Infusion with food and drink
You should ask your doctor about what you can eat or drink.

2. What You Need to Know Before You Are Given
Sodium 0.9 Infusion

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.

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

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 Package Leaflet of the medicine that is to be added.

• 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.

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

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),

CB-30-01-961
1

If a medicine has been added to your Sodium 0.9 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.

3. How You Will Be Given Sodium 0.9 Infusion
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.
The amount you are given may also be affected by other treatments
you are receiving.

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.

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.

4. Possible Side Effects

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.

Like all medicines, this medicine can cause side effects, although not
everybody gets them. The frequency of the side-effects is unknown
• tremor
• decreased blood pressure
• hives (urticaria)
• skin rash
• itching (pruritus)

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)

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

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.

If you receive more Sodium 0.9 Infusion than you should
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
• 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

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)
• acidification of the blood linked with a higher level of chloride in
the blood than normal (hyperchloremic metabolic acidosis)

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

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.

CB-30-01-961
2

Marketing Authorisation Holder and Manufacturers

Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt

Marketing Authorisation Holder:
Send all enquiries to this address
Baxter Healthcare Ltd.
Caxton Way
Thetford Norfolk IP24 3SE
United Kingdom

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

Manufacturers:

5. How to Store Sodium 0.9 Infusion

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

Keep this medicine out of the sight and reach of children.
50 ml and 100 ml bags: Do not store above 30°C.
250 ml, 500 ml and 1000 ml bags:

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

This medicine does not require any special storage conditions.
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.

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

You should not be given this medicine 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
What Sodium 0.9 Infusion contains
The active substance is sodium chloride: 9 g per litre
The only other ingredient is water for injections

What Sodium Chloride 0.9%w/v Solution for Infusion
looks like and contents of the pack

Bieffe Medital S.P.A.
Via Nuova Provinciale
23034 Grosotto (SO)
Italy

Sodium Chloride 0.9%w/v 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.

Baxter Manufacturing Sp. z o.o.
42 B Wojciechowska Str.
20-704 Lublin
Poland

The bag sizes are:
• 50 ml
• 100 ml
• 250 ml
• 500 ml
• 1000 ml

This leaflet was last revised in 11/2014

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.

Pack sizes:
• 50 bags of 50 ml per carton
• 1 bag of 50 ml
• 50 bags of 100 ml per carton
• 1 bag of 100 ml
• 30 bags of 250 ml per carton
• 1 bag of 250 ml
• 20 bags of 500 ml per carton
• 1 bag of 500 ml
• 10 bags of 1000 ml per carton
• 1 bag of 1000 ml
Not all pack sizes may be marketed

CB-30-01-961
3

01961

Baxter and Viaflo are trademarks of
Baxter International lnc.

F

4

CB-30-01-961

Sodium Chloride 0.9%w/v Intravenous Infusion BP
The following information is intended for
medical or healthcare professionals only:

3. Techniques for injection of additive medications
Warning: Additives may be incompatible (see paragraph 5
“Incompatibilities of additive medications” below).

Handling and Preparation

To add medication 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.

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.

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

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.

4. In-use shelf life (Additives)
Chemical and physical stability of any additive medication at the pH
of the Sodium Chloride 0.9% solution in the VIAFLO container should
be established prior to use. From a microbiological point of view, the
diluted product must be used immediately unless dilution has taken
place in controlled and validated aseptic conditions.
If not used immediately, in-use storage times and conditions are the
responsibility of the user.

Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.

1. Opening

5. Incompatibilities of additive medications

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.

As with all parenteral solutions, incompatibility of the additive
medications with the solution in VIAFLO container must be assessed
before addition.
In the absence of compatibility studies, this solution must not be mixed
with other medicinal products. It is the responsibility of the physician
to judge the incompatibility of an additive medication with the Sodium
Chloride 0.9% 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.
Before adding a drug, verify it is soluble and/or stable in water at the
pH of the Sodium Chloride 0.9% solution.
Those additives known to be incompatible should not be used.

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.

CB-30-01-961
5

Baxter and Viaflo are trademarks of
Baxter International lnc.

F

6

CB-30-01-961

Expand view ⇕

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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