Skip to Content

SODIUM CHLORIDE INTRAVENOUS INFUSION BP 0.9% W/V

Active substance(s): SODIUM CHLORIDE / SODIUM CHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
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
• 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
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)
1

Applicable for pages ___ to ___

Date

(and pages ___ to ___ for TIL)

Date:
Date:

Comments:

Sign:
Sign:

Signature

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
• 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.

Name

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

Errors: Yes / No PR2:

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

Country

Date: 09-DEC-2016

• 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
02261
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)
• 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”).
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.
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 with food and drink
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.
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.
Driving and using machines
Ask your doctor or nurse for advice before driving or using
machines.
CB-30-02-261

EMEA ARTWORK DESIGN CENTRE

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

ARTWORK APPROVAL
1st DRAFT
LAYOUT AND FORMAT
PLANT APPROVAL
APPROVAL
HALLE ONLY

Active substance: sodium chloride

Errors: Yes / No PR1:

Artworker: Federico Repiso

Draft: 1st
Version: 00
ARTWORK DESIGN CENTRE

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

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.

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.

CB-30-02-261
2

(and pages ___ to ___ for TIL)
Applicable for pages ___ to ___

Date

Signature
Date:
Sign:

Country

Name
Date:
Sign:

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

Version: 00

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

EMEA ARTWORK DESIGN CENTRE

Like all medicines, this medicine can cause side effects,
although not everybody gets them. The frequency of the sideeffects 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
(hyponatraemia)
• 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.

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)
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
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.

ARTWORK APPROVAL
1st DRAFT
LAYOUT AND FORMAT
PLANT APPROVAL
APPROVAL
HALLE ONLY

4. Possible Side Effects

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.

5. How to Store Sodium 0.9 Infusion
Keep this medicine out of the sight and reach of children.
VIAFLEX containers should be stored within their overpouch at a
temperature below 25°C.
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.
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

Baxter Healthcare S.A.

Boulevard René Branquart, 80
7860 Lessines, Belgium

CB-30-02-261
3

Date:

Baxter and Viaflex are trademarks of Baxter International Inc.

Sign:

Version: 00

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.

Date:

Moneen Road, Castlebar,
County Mayo, Ireland
This leaflet was last revised in October 2015

Sign:

Baxter Healthcare S.A.

Applicable for pages ___ to ___

(and pages ___ to ___ for TIL)

Caxton Way, Thetford
Norfolk, IP24 3SE
United Kingdom

Date

Signature

Baxter Healthcare Ltd.

Name

EMEA ARTWORK DESIGN CENTRE

What Sodium Chloride 0.9 Infusion looks like and contents of
the pack
Sodium chloride 0.9 Infusion is a clear solution, 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.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder:
Baxter Healthcare Ltd.
Caxton Way, Thetford
Norfolk,
IP24 3SE
United Kingdom
Send all enquiries to this address.
Sodium chloride 0.9 Infusion can be made at any of these
addresses:

Country

ARTWORK APPROVAL
1st DRAFT
LAYOUT AND FORMAT
PLANT APPROVAL
APPROVAL
HALLE ONLY

What Sodium 0.9 Infusion contains
The active substance is sodium chloride
(9 g per litre).
The other ingredients are:
• hydrochloric acid
• water for injections
• sodium hydroxide.

4

CB-30-02-261

Date:
Date:

Sign:

Sign:

Version: 00

02261

Applicable for pages ___ to ___

Date

Signature

Name

Country

(and pages ___ to ___ for TIL)

ARTWORK APPROVAL
1st DRAFT
LAYOUT AND FORMAT
PLANT APPROVAL
APPROVAL
HALLE ONLY

EMEA ARTWORK DESIGN CENTRE

5

Date:
Sign:

Applicable for pages ___ to ___

(and pages ___ to ___ for TIL)

Date:
Sign:

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.
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
CB-30-02-261
should be established prior to use.

Version: 00

Cautions

Date

Signature

Name

The solution for infusion should be visually inspected prior to
use.
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.
Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.
Preparation for Administration
The VIAFLEX container has an outlet port designed for
an administration set with a short single connector. If an
administration set with a combined air inlet/fluid path connector
has to be used, ensure the air inlet tube is always clamped off.
1. Opening
a. Remove the protective overpouch by tearing down from
notch and remove container.
b. Carefully straighten hanger and ports, if necessary.
c. Squeeze container and inspect for minute leaks and examine
solution for visible particles or cloudiness by viewing along
seam.
d. Discard unit if leaks, particles or cloudiness are evident.
2. Preparation for administration
Use sterile material for preparation and administration.
a. Suspend container from base eyelet support.
b. Use an aseptic technique to prepare the administration set.
c. Remove blue protector from outlet port and insert set
connector well into port.
d. Prime set and regulate administration as required.

Country

Handling and Preparation

EMEA ARTWORK DESIGN CENTRE

e. If administration set becomes blocked do not pump contents
back into container but replace equipment.
f. Discard any unused portion and equipment after use. Do not
store or reconnect partly used containers.
3. Techniques for injection of additive medications
The VIAFLEX container has a second port with a selfsealing rubber medication port designed for the addition of
medication using a syringe. This is the only port for adding
medication.
Warning: Additives may be incompatible.
To add medication before administration
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.
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 resealable 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 following information is intended for medical or healthcare
professionals only:

ARTWORK APPROVAL
1st DRAFT
LAYOUT AND FORMAT
PLANT APPROVAL
APPROVAL
HALLE ONLY

Sodium Chloride Intravenous Infusion BP 0.9% w/v

CB-30-02-261
6

(and pages ___ to ___ for TIL)
Applicable for pages ___ to ___

Date

Signature
Date:
Sign:

Name
Date:
Sign:

Country
Version: 00

EMEA ARTWORK DESIGN CENTRE

ARTWORK APPROVAL
1st DRAFT
LAYOUT AND FORMAT
PLANT APPROVAL
APPROVAL
HALLE ONLY

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.
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.
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.

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.

Hide