PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Chloride 0.9% Intravenous Infusion BP as Steriflex® No. 1 or freeflex®

Sodium Chloride 0.45% Intravenous Infusion BP as Steriflex® No. 2 or freeflex®

•    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 gets 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 receive 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

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 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 BP (Steriflex® No.'ll is used to correct water and Sodium Chloride loss.

Sodium Chloride 0.45% Intravenous Infusion BP (Steriflex® No.2) are used in patients where there has been water loss from the body and too much sodium in the blood.

2. BEFORE YOU RECEIVE SODIUM CHLORIDE INTRAVENOUS INFUSION

You should not receive Sodium Chloride 0.9% Intravenous Infusion BP (Steriflex® No.1) if:

•    you have very high sodium levels. Your doctor will check these.

You may not receive Sodium Chloride 0.45% Intravenous Infusion BP (Steriflex No.2) if:

•    you have kidney or heart disorders. Your doctor will check these. Take care with Sodium Chloride Intravenous Infusion

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

Sodium Chloride 0.9% Intravenous Infusions BP (Steriflex® No.1)

is not suitable for a long term use if there is a continued loss of electrolytes (salts) from the blood.

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 Infusions: amiodarone (used for heart rhythm disorders), amphotericin B (for fungal infections), amsacrine (a chemotherapy drug) and 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. The doctor will decide whether you should receive Sodium Chloride Intravenous Infusion.

Driving and using machines

Sodium Chloride Intravenous Infusion has no effect on driving or using machines.

3.    HOW TO TAKE 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.

If you have any further questions on the use of this product ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Thrombosis (the formation of a clot) may occur in the vein where the infusion is given.

The symptons of thrombosis include:

•    pain, swelling and redness at the blood clot site

•    an itchy rash at the clot site

•    warm skin around the clot

•    major veins that stand out from your skin

If the side effects get serious please tell your doctor or pharmacist

5.    HOW TO STORE SODIUM CHLORIDE INTRAVENOUS INFUSION

Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Sodium Chloride Intravenous Infusion . Sodium Chloride Solution should be stored between 2°C and 25°C.

The solution must not be used after the expiry date shown on the label. Any solution remaining after treatment should be disposed of using the approved hospital procedures.

Keep out of the reach and sight of children.

6. FURTHER INFORMATION

What Sodium Chloride intravenous infusions contain:

The infusions contain sodium chloride, water for injections, hydrochloric acid, and sodium hydroxide.

Sodium Chloride Intravenous Infusion 0.45% (Steriflex® No.2) contains sodium chloride 0.45 % w/v.

Sodium Chloride Intravenous Infusion 0.9% (Steriflex® No. 1) contains: sodium chloride 0.9 % w/v.

What Sodium Chloride intravenous infusion looks like and contents of the pack.

Sodium Chloride Intravenous Infusion BP is a clear solution of sodium chloride in water. The solution is contained in a sealed plastic container, known as a Steriflex® bag.

Sodium Chloride Intravenous Infusion 0.9% (Steriflex® No. 1) is available in 50,100, 250, 500, and 1000 ml bags.

Sodium Chloride Intravenous Infusion 0.45% (Steriflex® No.2) is available in 500 ml bags.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Fresenius Kabi Limited Cestrian Court, Eastgate Way,

Manor Park, Runcorn,

Cheshire, WA7 1 NT. UK.

Manufacturer:

Terumo BCT Limited,

Old Belfast Road, Millbrook,

Larne, Co. Antrim, BT40 2SH. UK.

This leaflet was last revised in February 2013.

tjJw FRESENIUS III KABI