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SODIUM CHLORIDE 0.9% INTRAVENOUS INFUSION

Active substance(s): SODIUM CHLORIDE

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0687521_01_UK_PB 21.02.2014 11:56 Seite 1

PACKAGE LEAFLET: INFORMATION FOR THE USER

1. WHAT SODIUM CHLORIDE INTRAVENOUS
INFUSION IS AND WHAT IT IS USED FOR

Sodium Chloride 0.18%
Intravenous Infusion

Sodium Chloride (salt) helps to maintain the correct balance of fluid in and
around the body s cells and tissues. Sodium Chloride Intravenous Infusions are
given by Intravenous (into a vein) injection to patients suffering from water loss
or lack of sodium.

Sodium Chloride 0.45%
Intravenous Infusion

Sodium Chloride 0.18% Intravenous Infusion and Sodium Chloride 0.45%
Intravenous 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%
Intravenous Infusion
Sodium Chloride 1.8%
Intravenous Infusion
Sodium Chloride 2.7%
Intravenous Infusion
Sodium Chloride 5%
Intravenous Infusion
Read all of this leaflet carefully before you start taking this medicine.
• 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 symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Sodium Chloride Intravenous Infusion is and what it is used for
2. Before you are given Sodium Chloride Intravenous Infusion
3. How you are given Sodium Chloride Intravenous Infusion
4. Possible side effects
5. How Sodium Chloride Intravenous Infusion is stored
6. Further information

Sodium Chloride 0.9% Intravenous Infusion is used to correct water and
Sodium Chloride loss.
Sodium Chloride 1.8% Intravenous Infusion, Sodium Chloride 2.7%
Intravenous Infusion and Sodium Chloride 5% Intravenous Infusion are used in
patients where there has been a sudden fall in the sodium concentration of
the blood caused by water overload.

2. BEFORE YOU ARE GIVEN SODIUM CHLORIDE
INTRAVENOUS INFUSION
You should not receive Sodium Chloride Intravenous Infusion if:
• you are allergic (hypersensitive) to sodium chloride or any of the
ingredients of Sodium Chloride Intravenous Infusion mentioned in section 6
(for symptoms of an allergic reaction, please refer to section 4).
You should not receive Sodium Chloride (0.9%, 1.8%, 2.7%, 5%)
Intravenous Infusion if
• you have very high sodium levels. Your doctor will check this.
You may not receive Sodium Chloride (0.18%, 0.45%) Intravenous Infusion if
• you have kidney or heart disorders. Your doctor will check this.
Take special care with Sodium Chloride Intravenous Infusions 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.
Your doctor or nurse will ensure the solution is clear and free from particles
before use.

0687521/01 UK

1

2

0687521_01_UK_PB 21.02.2014 11:56 Seite 3

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
The following drugs should not be mixed with any of the Sodium Chloride
Intravenous Infusions:
• 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
You should tell your doctor if you are pregnant, if you think you are pregnant or
you are planning to be pregnant, if you are breastfeeding your baby. 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 Intravenous Infusion.
Driving and using machines
Sodium Chloride Intravenous Infusion has no effect on driving or using machines.

3. HOW YOU ARE GIVEN SODIUM CHLORIDE INTRAVENOUS INFUSION
Sodium Chloride Intravenous Infusion will be given to you in hospital.
You will receive your medicine by 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 Intravenous Infusion 0.18%,
0.45%, and 0.9% 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 product, ask your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines Sodium Chloride Intravenous Infusion 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
The following side effect has been reported:
• Thrombosis (the formation of a clot) may occur in the vein where the
infusion is given.




a mild fever
major veins which stand out from your skin

If any of the side effects get serious or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE SODIUM CHLORIDE INTRAVENOUS INFUSION
Keep out of the reach and sight of children
Your doctor and hospital pharmacist are responsible for the correct storage,
use and disposal of Sodium Chloride Intravenous Infusions.
Sodium Chloride Intravenous Infusions should be stored between 2°C and 25°C.
The solution must not be used after the expiry date shown 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. FURTHER INFORMATION
What Sodium Chloride Intravenous Infusions contain:
The infusions contain sodium chloride, water for injections, hydrochloric acid,
and sodium hydroxide.
What Sodium Chloride Intravenous Infusion looks like and contents
of the pack.
Sodium Chloride Intravenous Infusions 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% Intravenous Infusion is also
available in a sealed plastic container known as KabiPac® bottle.
All six strengths are available as 500 ml. Sodium Chloride 0.9% Intravenous
Infusion is also available as 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 Deutschland
61346 Bad Homburg v.d.H.
Germany
This leaflet was last revised in February 2014.

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

3

4

V001/FB

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Chloride 0.18%
Intravenous Infusion
Sodium Chloride 0.45%
Intravenous Infusion
Sodium Chloride 0. 9%
Intravenous Infusion
Sodium Chloride 1.8%
Intravenous Infusion
Sodium Chloride 2. 7%
Intravenous Infusion
Sodium Chloride 5%
Intravenous Infusion
Read all of this leaflet carefully before you start taking this medicine.
• 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 symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Sodium Chloride Intravenous Infusion is and what it is used for
2. Before you are given Sodium Chloride Intravenous Infusion
3. How you are given Sodium Chloride Intravenous Infusion
4. Possible side effects
5. How Sodium Chloride Intravenous Infusion is stored
6. Further information

1. WHAT SODIUM CHLORIDE INTRAVENOUS
INFUSION IS AND WHAT IT IS USED FOR
Sodium Chloride (salt) helps to maintain the correct balance of fluid in and
around the body's cells and tissues. Sodium Chloride Intravenous Infusions are
given by Intravenous (into a vein) injection to patients suffering from water loss
or lack of sodium.
Sodium Chloride 0.18% Intravenous Infusion and Sodium Chloride 0.45%
Intravenous 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% Intravenous Infusion is used to correct water and
Sodium Chloride loss.
Sodium Chloride 1.8% Intravenous Infusion, Sodium Chloride 2.7%
Intravenous Infusion and Sodium Chloride 5% Intravenous Infusion are used in
patients where there has been a sudden fall in the sodium concentration of
the blood caused by water overload.

2. BEFORE YOU ARE GIVEN SODIUM CHLORIDE
INTRAVENOUS INFUSION
You should not receive Sodium Chloride Intravenous Infusion if:
• you are allergic (hypersensitive) to sodium chloride or any of the
ingredients of Sodium Chloride Intravenous Infusion mentioned in section 6
(for symptoms of an allergic reaction, please refer to section 4).
You should not receive Sodium Chloride (0.9%, 1.8%, 2.7%, 5%)
Intravenous Infusion if
• you have very high sodium levels. Your doctor will check this.
You may not receive Sodium Chloride (0.18%, 0.45%) Intravenous Infusion if
• you have kidney or heart disorders. Your doctor will check this.
Take special care with Sodium Chloride Intravenous Infusions 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.
Your doctor or nurse will ensure the solution is clear and free from particles
before use.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
The following drugs should not be mixed with any of the Sodium Chloride
Intravenous Infusions:
•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
You should tell your doctor if you are pregnant, if you think you are pregnant or
you are planning to be pregnant or if you are breastfeeding your baby. 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 Intravenous Infusion.
Driving and using machines
Sodium Chloride Intravenous Infusion has no effect on driving or using machines.

3. HOW YOU ARE GIVEN SODIUM CHLORIDE INTRAVENOUS INFUSION
Sodium Chloride Intravenous Infusion will be given to you in hospital.
You will receive your medicine by 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 Intravenous Infusion 0.18%,
0.45%, and 0.9% 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 product, ask your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines Sodium Chloride Intravenous Infusion 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
The following side effect has been reported:
• 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
If any of the side effects get serious or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE SODIUM CHLORIDE INTRAVENOUS INFUSION
Keep out of the reach and sight of children
Your doctor and hospital pharmacist are responsible for the correct storage,
use and disposal of Sodium Chloride Intravenous Infusions.
Sodium Chloride Intravenous Infusions should be stored between 2°C and 25°C.
The solution must not be used after the expiry date shown 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. FURTHER INFORMATION
What Sodium Chloride Intravenous Infusions contain:
The infusions contain sodium chloride, water for injections, hydrochloric acid,
and sodium hydroxide.
What Sodium Chloride Intravenous Infusion looks like and contents
of the pack.
Sodium Chloride Intravenous Infusions 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% Intravenous Infusion is also
available in a sealed plastic container known as KabiPac® bottle.
All six strengths are available as 500 ml. Sodium Chloride 0.9% Intravenous
Infusion is also available as 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:
Terumo BCT Limited,
Old Belfast Road, Millbrook,
Larne, Co. Antrim, BT40 2SH. UK.
This leaflet was last revised in March 2014

V003/TM

Data: 12/02/2014
Formato foglio: 300

mm x 210 mm

• a mild fever
• major veins that stand out from your skin
If any of these side effects get serious of if you notice side any effects not
listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE SODIUM CHLORIDE INTRAVENOUS INFUSION
Keep out of reach and sight of children.
Your doctor and hospital pharmacist are responsible for the correct storage,
use and disposal of Sodium Chloride Intravenous Infusions.
Sodium Chloride Intravenous Infusions should be stored between 2ºC and 25ºC.
The solution must not be used after the expiry date shown 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. FURTHER INFORMATION
What Sodium Chloride Intravenous Infusions contain:
The infusion contains sodium chloride (0.9%w/v), water for injections, hydrochloric acid,
and sodium hydroxide.
What Sodium Chloride Intravenous Infusion looks like and contents
of the pack.
Sodium Chloride Intravenous Infusions are clear solutions of sodium choride
in water. The solution is contained in a sealed tube-shaped plastic container,
known as a Polyfusor®. Sodium Chloride 0.9% Intravenous Infusion is also
available in a sealed plastic container known as a KabiPac® bottle.
Sodium Chloride 0.9% Intravenous Infusion is available as 100, 250, 500 ml 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(s)
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
I - 37063 Isola della Scala, Verona, Italy
This leaflet was last revised in February 2014
V002/IS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Chloride 0.9%
Intravenous Infusion
Read all of this leaflet carefully before you start taking this medicine.
• 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 symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Sodium Chloride Intravenous Infusion is and what it is used for
2. Before you are given Sodium Chloride Intravenous Infusion
3. How you are given Sodium Chloride Intravenous Infusion
4. Possible side effects
5. How to store Sodium Chloride Intravenous Infusion
6. Further information

Data: 12/02/2014
Formato foglio: 300

1. WHAT SODIUM CHLORIDE INTRAVENOUS
INFUSION IS AND WHAT IT IS USED FOR
Sodium Chloride (salt) helps to maintain the correct balance of fluid in and
around the body’s cells and tissues. Sodium Chloride Intravenous Infusions are
given by intravenous (into a vein) injection to patients suffering from water loss
or lack of sodium.
Sodium Chloride 0.9% Intravenous Infusion is used to correct water and
Sodium Chloride loss.

2.BEFORE YOU ARE GIVEN SODIUM CHLORIDE
INTRAVENOUS INFUSION
You should not receive Sodium Chloride Intravenous Infusion if:
• you are allergic (hypersensitive) to sodium chloride or any of the
ingredients of Sodium Chloride Intravenous Infusion mentioned in section 6
(for symptoms of an allergic reaction, please refer to section 4).
• you have very high sodium levels. Your doctor will check this.
Take special care with Sodium Chloride Intravenous Infusions 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 abodomen, 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.
Your doctor or nurse will ensure the solution is clear and free from particles
before use.

mm x 210 mm

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
The following drugs should not be mixed with any of the Sodium Chloride
Intravenous Infusions:
• 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
You should tell your doctor if you are pregnant, if you think you are pregnant or
you are planning to be pregnant or if you are breastfeeding your baby. 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 Intravenous Infusion.
Driving and using machines
Sodium Chloride Intravenous Infusion has no effect on driving or using machines.

3. HOW YOU ARE GIVEN SODIUM CHLORIDE INTRAVENOUS INFUSION
Sodium Chloride Intravenous Infusion will be given to you in hospital.
You will receive your medicine by 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. 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 product, ask your
doctor or pharmacist.

4.POSSIBLE SIDE EFFECTS
Like all medicines Sodium Chloride Intravenous Infusion 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 and mouth
• difficulty breathing
The following side effect has been reported:
• 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

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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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