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SODIUM CHLORIDE 0.9% INTRAVENOUS INFUSION

Active substance(s): SODIUM CHLORIDE / SODIUM CHLORIDE

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1. What Sodium Chloride infusion is and what it is used for
PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Chloride 0.18%
solution for infusion
Sodium Chloride 0.45%
solution for infusion
Sodium Chloride 0.9%
solution for infusion
Sodium Chloride 1.8%
solution for infusion
Sodium Chloride 2.7%
solution for infusion
Sodium Chloride 5%
solution for infusion
Read all of this leaflet carefully before you are given 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.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Sodium Chloride infusion is and what it is used for
2. What you need to know before you are given Sodium Chloride infusion
3. How you are given Sodium Chloride infusion
4. Possible side effects
5. How to store Sodium Chloride infusion
6. Contents of the pack and other information

The full names of the medicines covered by this leaflet are:
Sodium Chloride 0.18% solution for infusion
Sodium Chloride 0.45% solution for infusion
Sodium Chloride 0.9% solution for infusion
Sodium Chloride 1.8% solution for infusion
Sodium Chloride 2.7% solution for infusion
Sodium Chloride 5% solution for infusion
In this leaflet they are jointly referred to as Sodium Chloride infusion.
Sodium Chloride (salt) helps to maintain the correct balance of fluid in and
around the body´s cells and tissues. Sodium Chloride infusion is given by Intravenous (into
a vein) infusion to patients suffering from water loss or lack of sodium.
Sodium Chloride 0.18% infusion and Sodium Chloride 0.45% infusion are used in patients
where there has been water loss from the body and too much sodium in the blood.
Sodium Chloride 0.9% infusion is used to correct water and Sodium Chloride loss.
Sodium Chloride 1.8% infusion, Sodium Chloride 2.7% infusion and Sodium Chloride 5%
infusion are used in patients where there has been a sudden fall in the sodium
concentration of the blood caused by water overload.

2. What you need to know before you are given Sodium
Chloride infusion
You should not receive Sodium Chloride infusion if:
• you are allergic (hypersensitive) to sodium chloride or any of the
ingredients of Sodium Chloride infusion mentioned in section 6
You should not receive Sodium Chloride (0.9%, 1.8%, 2.7%, 5%) infusion if
• you have very high sodium levels. Your doctor will check this.
You may not receive Sodium Chloride (0.18%, 0.45%) infusion if


you have kidney or heart disorders. Your doctor will check this.

Take special care with Sodium Chloride infusion if:
• you suffer from any type of heart or kidney disorders
• you suffer from hypertension (high blood pressure)
• you suffer from oedema (swelling of organs from excess liquid)
• you are pregnant and have been told you have complications in your pregnancy called
eclampsia (symptoms include: convulsions, increased blood pressure, circulatory problems,
severe headaches, vision problems, pain in your upper abdomen, vomiting, sudden
swelling of your feet, ankles, face and hands and excessive weight gain).
The doctor or nurse will ensure that the infusion is not given to you too rapidly
as this may cause heart and circulation problems.
You may lose potassium from your blood when treated with Sodium Chloride
intravenous infusions. Your doctor may give you potassium supplements.

V004/KU
U15774/A GB

Your doctor or nurse will ensure the solution is clear and free from particles before use.

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KOREKTA: 1

Akceptuję do druku(treść / kolorystyka / układ graficzny)

WERSJA: A
DATA: 09.01.2017

SODIUM CHLORIDE 0,9% SOLUTION FOR INFUSION

(data, czytelny podpis)

Sposób pakowania:

Rodzaj surowca:

INDEKS, WYDANIE ULOTKI: U15774/A GB
WYMIAR: 210 x 148 mm
WIELKOŚĆ CZCIONKI: 12/8/7,5/7 pt
PHARMACODE: 223 I I I I I I I
ZAPROJEKTOWAŁ: KATARZYNA STĘPNIEWSKA-BĄK

KOLOR:

Wymiar po złożeniu:

Inne uwagi:

Pantone Black U

UWAGA: Pola oznaczone zielonym wypełnia klient.

Other medicines and Sodium Chloride infusion
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The following drugs should not be mixed with any of the Sodium Chloride infusion:
• amiodarone (used for heart rhythm disorders)
• amphotericin B (for fungal infections)
• amsacrine (a chemotherapy drug)
• sodium nitroprusside (a drug used to reduce very high blood pressure)
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.This is especially
important if you have been told that you have complications in your pregnancy called
eclampsia. Your doctor will decide if you should be given Sodium Chloride infusion.
Driving and using machines
Sodium Chloride infusion has no effect on driving or using machines.

3. How you are given Sodium Chloride Infusion
Sodium Chloride infusion will be given to you in hospital.
You will receive your medicine by intravenous infusion (IV drip). The amount and rate at which
the infusion is given depends on your requirements. Your doctor will decide on the correct dose
for you to receive. For Sodium Chloride 0.18%, 0.45%, and 0.9% infusions your doctor will be
able to check the effect of the treatment on dehydration by the relief of your symptoms,
monitoring your blood pressure, and by measuring the volume and concentration of your urine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very
rare. If you get any of the following symptoms after receiving this medicine you
should contact your doctor immediately:
• skin rash
• swelling of the face, lips or mouth
• difficulty breathing
• Thrombosis (the formation of a clot) may occur in the vein where the infusion is given.
The symptoms of thrombosis include:
• pain, swelling and redness at the blood clot site
• an itchy rash at the clot site
• warm skin around the clot
• a mild fever
• major veins which stand out from your skin
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 infusion
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 infusion.
Sodium Chloride infusion should be stored between 2°C and 25°C.
Do not use this medicine after the expiry date which is stated on the label.
The expiry date refers to the last day of that month.
Any solution remaining after treatment should be disposed of using the
approved hospital procedures.

6. Contents of the pack and other information
What Sodium Chloride infusion contains:
The active substance is sodium chloride.
The concentration of sodium chloride in the infusion can be seen in the name of
the product.
The following concentrations are available:
Sodium Chloride 0.18% solution for infusion
Sodium Chloride 0.45% solution for infusion
Sodium Chloride 0.9% solution for infusion
Sodium Chloride 1.8% solution for infusion
Sodium Chloride 2.7% solution for infusion
Sodium Chloride 5% solution for infusion
The other ingredients are water for injections, hydrochloric acid and sodium hydroxide.
What Sodium Chloride infusion looks like and contents of the pack.
Sodium Chloride infusion are clear solutions of sodium chloride in water.
The solutions are contained in a sealed tube-shaped plastic container,
known as a Polyfusor®. Sodium Chloride 0.9% infusion is also available in a sealed plastic
container known as KabiPac® bottle.
Sodium Chloride 0.9% is also available in a polypropylene bottle in a sealed plastic container
known as KabiClear® bottle.
All six strengths are available as 500 ml. Sodium Chloride 0.9% infusion is also available
as 50, 100, 250 and 1000 ml volumes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Limited
Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire, WA7 1NT. UK.

Manufacturer:
Fresenius Kabi Polska Sp. z o.o.
Wytwórnia Płynów Infuzyjnych
ul. Sienkiewicza 25
99-300 Kutno, Poland

This leaflet was last revised in November 2016.

Skład w:
UWAGA! Teksty i układ graficzny na wydruku są obowiązujące.
Dopuszcza się wystąpienie odchyleń kolorystyki
ze względu na wymagania technologii druku.
KOREKTA: 1

Akceptuję do druku(treść / kolorystyka / układ graficzny)

WERSJA: A
DATA: 09.01.2017

SODIUM CHLORIDE 0,9% SOLUTION FOR INFUSION

(data, czytelny podpis)

Sposób pakowania:

Rodzaj surowca:

INDEKS, WYDANIE ULOTKI: U15774/A GB
WYMIAR: 210 x 148 mm
WIELKOŚĆ CZCIONKI: 12/8/7,5/7 pt
PHARMACODE: 223 I I I I I I I
ZAPROJEKTOWAŁ: KATARZYNA STĘPNIEWSKA-BĄK

KOLOR:

Wymiar po złożeniu:

Inne uwagi:

Pantone Black U

UWAGA: Pola oznaczone zielonym wypełnia klient.

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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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