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SODIUM CHLORIDE INJECTION BP / SODIUM CHLORIDE 0.9% W/V FOR INTRAVENOUS INFUSION BP.

Active substance(s): SODIUM CHLORIDE / SODIUM CHLORIDE / SODIUM CHLORIDE

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Transcript
INSTRUCTIONS FOR USE

SODIUM CHLORIDE

is intended
The following informationFOR
INSTRUCTIONS
USEfor
healthcare professionals only:

INJECTION BP/ SODIUM CHLORIDE 0.9%w/v INTRAVENOUS INFUSION BP

Sterile, apyrogenic solutions for Intravenous Infusion

Visual Inspection
1

Ensure that the infusion fluid complies with the written prescription.

2

If ANY fluid is present inside the overwrap, regard the integrity of the pack as suspect and discard the
solution.

3

Visually examine the fluid which should be clear and free from particles. If any particles are present, regard
the integrity of the pack as suspect and discard the solution.

4

Read all precautionary notes and check the expiry date.

5

Do NOT reconnect partially used bags.

Pack Preparation
1

Remove the pack from the protective overwrap by tearing downwards from the
serrated edge.

2

Carefully straighten hanger and ports if necessary.

3

The sterile giving port is protected by a removable section of the port plug. To
remove this protector, twist off the top section while holding the bottom
section.

4

Insert the giving set fully to produce a leak proof connection and suspend the
pack from the infusion stand.

5

Prime and regulate the giving set in accordance with the manufacturer's
instructions. If giving set becomes blocked do not pump contents back into
pack but replace equipment.

6

An air inlet is not required.

7

Discard any unused portion. Do not store partly used packs.

8

Discard all packs and equipment after use.

Addition of Drugs
This pack has an additive port with a self-sealing septum designed for the addition of drugs using a syringe and needle, or
drug transfer device. This is the only site for adding drugs.
Where possible, ready made solutions should be used. Check the drug/solution compatibility. Drugs should only be added
immediately prior to use and strict aseptic technique employed throughout the procedure. Do not add drugs until the
hanger and ports have been straightened and the container inspected.
1

Swab the drug additive site with the appropriate anti-bacterial fluid in accordance with current recommended
practice and procedure.

2

Using a syringe and needle or drug transfer device, puncture the site and transfer the vial contents. Do not leave the
needle or device in the site once the drug has been transferred. Removing the needle allows the rubber to reseal.

3

Ensure the adequate mixing of the contents before use. Observe the fluid for any changes which may indicate
incompatibility.

4

Ensure that the addition has been recorded on the pack in accordance with routine procedure. The drug additive
port should then be covered by an additive port cap to prevent further addition.

5

This presentation is latex free.

Terumo BCT Ltd., Larne, BT40 2SH, U.K.
Tel: (028) 2827 3631

Sodium chloride
Read all of this leaflet carefully before you start taking
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
pharmacist.
• This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your doctor. This
includes any possible side effects not listed in this leaflet.
See section 4.
The name of your medicine is Sodium Chloride Injection BP /
Sodium chloride 0.9% w/v for Intravenous Infusion BP,
which will be referred to as sodium chloride 0.9%
throughout this leaflet.
What is in this leaflet
1. What sodium chloride 0.9% is and what it is used for
2. What you need to know before you are given sodium
chloride 0.9%
3. How you are given sodium chloride 0.9%
4. Possible side effects
5. How to store sodium chloride 0.9%
6. Contents of the pack and other information
1. WHAT SODIUM CHLORIDE 0.9% IS AND WHAT
IT IS USED FOR
Sodium chloride 0.9% is a sterile fluid for infusion into a
vein. Your doctor has prescribed sodium chloride 0.9% to
treat water loss (dehydration) and to correct salt (electrolyte)
loss. Sodium chloride 0.9% is also used in the treatment of
Addison's disease, which causes salt to be lost in the urine.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
SODIUM CHLORIDE 0.9%
Do not take sodium chloride if you have high levels of
sodium in your blood (hypernatremia) or high levels of
chloride (hyperchloremia).
Warnings and precautions
Tell your doctor if you have any of the following conditions:
• heart failure,
• high blood pressure (hypertension),
• a kidney disorder,
• fluid under the skin (peripheral oedema),
• water on the lungs (pulmonary oedema).
Young children and the elderly should not be given longterm treatment.
Other medicines and sodium chloride 0.9%
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Pregnancy and breast-feeding
Please tell your doctor if you are pregnant, think you are
pregnant or breast-feeding.
Sodium chloride 0.9% will only be given in pregnancy and
lactation under close medical supervision. Your doctor will
take special care if you have toxaemia of pregnancy (high
blood pressure and protein in the urine). This can be
detected by a test carried out by a doctor.
Driving and using machines
Sodium chloride solution for injection has no effect on
driving or using machines.
Important information about some of the ingredients of
Sodium chloride 0.9%
Sodium chloride 0.9% contains sodium. This will be taken
into consideration for patients on a controlled sodium diet.
3. HOW YOU ARE GIVEN SODIUM CHLORIDE 0.9%
Sodium chloride 0.9% will be given to you as an infusion
(IV) in hospital by a doctor or a nurse.

Adults:
The normal dose is 1 litre over 6-8 hours, increasing to
a maximum of 1 litre per hour.
Children:
The dosage depends on body weight and condition of the
patient. Sodium chloride 0.9% should not be given for long
periods.
Elderly:
The dosage depends on the condition of the patient.
Sodium chloride 0.9% should not be given for long periods.
If you are given more Sodium chloride than you should
It is very unlikely that you will be given too much, as your
doctor will know the correct amount to give you. However,
tell your doctor if you have any concerns.
Symptoms of overdose include restlessness, weakness, thirst,
dry mouth and eyes, swollen tongue, flushing of the skin,
fever, dizziness, headache, reduced urine, low blood
pressure, fast heart rate, being delirius, panting and stopped
breathing.
If overdose occurs, a doctor will correct the fluid and
electrolyte imbalance.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Sodium chloride 0.9% can cause side
effects, although not everybody gets them.
Swelling of the vein cause by a blood clot is possible with an
infusion. If sodium chloride leaks into the tissue it may cause
swelling and skin damage.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you
can help provide more information on the safety of this
medicine.
5. HOW TO STORE SODIUM CHLORIDE 0.9%
Keep this medicine out of the sight and reach of children.
Your doctor and hospital pharmacist are responsible for the
correct storage, use and disposal of sodium chloride 0.9%
solution.
Store below 25°C. Do not refrigerate.
Do not use after the expiry date. Any unused solution should
be discarded.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Sodium Chloride 0.9% contains:
Each 100 ml contains 0.9 g of sodium chloride.
The only excipient is Water for Injections BP
What Sodium Chloride 0.9% looks like and contents of
the pack.
Sodium chloride 0.9% comes in PVC bags in the following
sizes: 2000 ml, 1000 ml, 500 ml, 250 ml 100 ml, 70 ml and
50 ml. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Terumo BCT Ltd.
Old Belfast Road
Millbrook
Lame
Northern Ireland
BT40 2SH
United Kingdom
For any information about this medicinal product, please
contact Marketing Authorisation Holder.
This leaflet was last approved in June 2016

LEAF/101/4

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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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