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SODIUM CHLORIDE 0.18% AND GLUCOSE 4% INFUSION BP POLYFUSOR AS STERIFLEX NO. 18 OR FREEFLEX

Active substance(s): GLUCOSE MONOHYDRATE FOR PARENTERAL USE / SODIUM CHLORIDE INJECTION

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14.07.2015

14:06 Uhr

Seite 1

6. CONTENTS OF THE PACK AND OTHER INFORMATION

PACKAGE LEAFLET: INFORMATION FOR THE USER

What Sodium Chloride and Glucose Solution for Infusion contains:
The infusions contain sodium chloride, glucose, water for injections,
hydrochloric acid, and sodium hydroxide. The concentration of each
active ingredient can be seen in the name of product.

Sodium Chloride 0.9% and
Glucose 5% Solution for Infusion

What Sodium Chloride and Glucose Solution for Infusion looks like
and contents of the pack
Sodium Chloride and Glucose Solution for Infusion is a clear solution
of sodium chloride and glucose in water.

Sodium Chloride 0.18% and
Glucose 4% Solution for Infusion

The solution is contained in a sealed plastic container known as a
Steriflex® bag or in a freeflex® infusion bag. It is available in 500 ml
and 1000 ml bags.
Not all pack sizes may be marketed.

Sodium Chloride and Glucose

Marketing Authorisation Holder
Fresenius Kabi Limited
Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire, WA7 1NT. UK.

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.

Manufacturer:
Fresenius Kabi Deutschland GmbH
Werk Friedberg
Freseniusstraβe 1
61169 Friedberg
Germany

What is in this leaflet:
1. What Sodium Chloride and Glucose Solution for Infusion is and what it is used for
2. What you need to know before you are given Sodium Chloride and
Glucose Solution for Infusion
3. How you are given Sodium Chloride and Glucose Solution for Infusion
4. Possible side effects
5. How Sodium Chloride and Glucose Solution for Infusion is stored
6. Contents of the pack and other information

Terumo BCT Limited,
Old Belfast Road, Millbrook,
Larne, Co. Antrim, BT40 2SH. UK.
For any information about this medicinal product, please contact
the local representative of the Marketing Authorisation Holder:

1. WHAT SODIUM CHLORIDE AND GLUCOSE
SOLUTION FOR INFUSION IS AND WHAT
IT IS USED FOR

Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
UK
+44 (0) 1928 533 533

Sodium Chloride and Glucose Solution for Infusion is a clear solution
of sodium chloride and glucose in water.
The solution is contained in a sealed plastic container known as Steriflex® or freeflex®.
Two strengths of solution are available:
Sodium Chloride 0.9%, Glucose 5%
Sodium Chloride 0.18%, Glucose 4%

V002 / FB

This leaflet was last revised in month YYYY.

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068 9931/ 02 UK

0689931_02_UK_Sodium:0689931_02_UK_Sodium

0689931_02_UK_Sodium:0689931_02_UK_Sodium

14.07.2015

14:06 Uhr

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Sodium chloride (salt) helps to maintain the correct balance of fluid in and
around the body’s cells and tissues. Sodium chloride is given by intravenous
(into a vein) infusion to patients suffering from water loss or lack of sodium.
Glucose is a simple sugar, which provides a source of energy. Sodium Chloride
and Glucose Solution for Infusion is used where there has been excessive fluid
loss from the body (dehydration) with carbohydrate loss.

2. WHAT YOU NEED TO KNOW BEFORE
YOU ARE GIVEN SODIUM CHLORIDE AND
GLUCOSE SOLUTION FOR INFUSION
You should not receive Sodium Chloride and Glucose Solution for Infusion if you have:
– a known allergy (hypersensitivity) to sodium chloride, glucose or any of the other
ingredients of Sodium Chloride and Glucose Solution for Infusion (listed in section 6)
– severely reduced kidney function
– worsening of existing heart failure
– reduced liver function
– too much fluid in the spaces around the cells of body (hyperhydration)
– a loss of water from the body (dehydration) with low levels of sodium
– had a stroke resulting in permanent brain injury
– had a head injury within the last 24 hours
– very low levels of sodium
– routine rehydration or fluid maintenance therapy.

Other medicines and Sodium Chloride and Glucose Solution for Infusion
Tell your doctor or nurse if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
It is particularly important that you inform your doctor or nurse if you are taking
the following medicine as it can cause the body to accumulate sodium and water,
leading to tissue swelling (oedema) and high blood pressure (hypertension):
• Corticosteroids
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 using this medicine.
The doctor will then decide whether you should receive Sodium chloride and
Glucose Solution for Infusion.
Driving and using machines
Sodium Chloride and Glucose Solution for Infusion has no effect on your ability
to drive or use machines.

3. HOW YOU WILL BE GIVEN SODIUM CHLORIDE
AND GLUCOSE SOLUTION FOR INFUSION
Sodium Chloride and Glucose Solution for Infusion will be given to you in hospital.
You will receive your medicine by infusion (an injection into a vein).

Your doctor will check for this.
Warnings and precautions
Talk to your doctor or nurse before being given Sodium Chloride and
Glucose Solution for Infusion if you have:
– reduced kidney function
– heart failure
– high blood pressure (hypertension)
– build-up of fluid in the tissues, particularly around the ankles
(peripheral oedema)
– build-up of fluid in the lungs (pulmonary oedema)
– high blood pressure during pregnancy (pre-eclampsia)
– any other condition associated with sodium retention
(where the body retains too much sodium)
– diabetes
– a potassium deficiency
When you are given this infusion, your doctor or nurse will take blood
and urine samples and monitor:
– the amount of fluid in your body
– your vital signs
– the amount of chemicals such as sodium, potassium, calcium
and chlorides in your blood (plasma electrolytes).
Your doctor or nurse will ensure the solution is clear and free from
particles before use.

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Dosage
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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Sodium Chloride and Glucose Solution for Infusion
can cause side effects, although not everybody gets them.
If you have a side effect that is not mentioned in this leaflet or if any
side effect gets serious, please tell your doctor or nurse.
Reactions due to the administration technique:
• fever
• infection at the site of the 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
• escape of the infusion solution into the tissues around the vein (extravasation).
This can damage the tissues and cause scarring
• increase in blood volume.
Other possible side effects:
• Thrombosis (the formation of a clot) may occur in the vein where the infusion is given.
• Loss of potassium from the blood may be increased with the use of a sodium
chloride-containing infusion. Your doctor may therefore decide to give you
potassium supplements
• Reduced sodium levels.
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

If you have any further questions on the use of this medicine,
ask your doctor or nurse.

By reporting side effects you can help provide more information
on the safety of this medicine.

If you receive more Sodium Chloride and Glucose Solution for Infusion than you should
It is very unlikely you will receive more solution than you should as this medicine
will be given to you by a doctor or nurse and you will be closely monitored during
treatment. If you are given too much Sodium Chloride and Glucose Solution for
Infusion or you are given your infusion too quickly, this may lead to the following symptoms:
• water and/or sodium overload with build-up of fluid in the tissues (oedema) causing swelling
• headache
• nausea or vomiting
• diarrhoea or constipation
• abdominal cramping
• dark, concentrated urine
• irregular heartbeat
• fatigue or weakness
• convulsions or seizures
• muscle pain or weakness
• mood changes such as irritability, confusion, depression
• increased thirst
• frequent need to urinate.

5. HOW SODIUM CHLORIDE AND GLUCOSE
SOLUTION FOR INFUSION IS STORED

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Keep this medicine out of the sight and reach of children.
Your doctor, pharmacist or nurse are responsible for the correct storage,
use and disposal of Sodium Chloride and Glucose Solution for Infusion.
Sodium Chloride and Glucose Solution for Infusion should be stored below 25 °C.
The solution must not be used 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.

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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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