4

6. FURTHER INFORMATIONWhat Sodium Chloride 0.9% Intravenous Infusions contain:The infusions contain sodium chloride (0.9% w/v), water for injections, hydrochloric acid, and sodium hydroxide.

What Sodium Chloride 0.9% 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 or freeflex bag, or freeflex+ bag.

Sodium Chloride Intravenous Infusion 0.9% is available in 50, 100, 250, 500, and 1000 ml bags.

Not all pack sizes may be marketed.

Marketing Authorisation HolderFresenius Kabi LimitedCestrian Court, Eastgate Way,Manor Park, Runcorn,Cheshire, WA7 1NT. UK.

Manufacturer:Fresenius Kabi Deutschland GmbHWerk FriedbergFreseniusstraße 161169 Friedberg, Germany

This leaflet was last revised in Sep 2015

V00

4/F

B

1

• 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 for2. Before you receive Sodium Chloride Intravenous Infusion3. How you are given Sodium Chloride Intravenous Infusion4. Possible side effects5. How to store Sodium Chloride Intravenous Infusion6. Further information

1. WHAT SODIUM CHLORIDE 0.9% 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 is used to correct water and Sodium Chloride loss.

068

8911

/02

UK

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Chloride 0.9%Intravenous Infusion BP asSteriflex® No. 1 or freeflex or freeflex+

0688911_02 UK_Sodium:0688911_02 UK_Sodium 21.09.2015 12:24 Uhr Seite 1

2

2. BEFORE YOU RECEIVE SODIUM CHLORIDE 0.9% INTRAVENOUS INFUSION

You should not receive Sodium Chloride 0.9% Intravenous Infusion BP 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 these.

Take care with Sodium Chloride 0.9% Intravenous InfusionThe 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.

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

Taking other medicinesPlease 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-feedingYou 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 machinesSodium Chloride Intravenous Infusion has no effect on driving or using machines.

3. HOW YOU ARE GIVEN SODIUM CHLORIDE 0.9% 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 EFFECTSLike 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– major veins that stand out from the skin

If the side effects gets serious please tell your doctor or pharmacist.

5. HOW TO STORE SODIUM CHLORIDE 0.9% 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.

3

0688911_02 UK_Sodium:0688911_02 UK_Sodium 21.09.2015 12:24 Uhr Seite 3

I

Instructions for use

1 2

3

4

1

2

3

4

1. IV Solution Container

2. Transfer Adapter

3. Protective Cap

4. Precision Swab

– Check the IV container solution composition,lot number and expiry date.

– Inspect the container for damage or solution leakage. Ifdamaged, do not use!

– Check the solution for visible particles orcloudiness. Do not use unless the solution is clear.

– Using the pre-cut corner tabs peel open the overwrapto remove the primary bag. The overwrap adheresslightly to the primary bag to improve handling evenwhen wearing disposable gloves.

1. PREPARATION FOR ADMINISTRATION

– Identify the dark blue infusion port. re-check thesolution for visible particles or cloudiness.

– Break off the dark blue tamper-evident cap from theinfusion port.

V

WARNINGS1. Do not remove the freeflex® IV container from its overwrap until immediately before use. 2. Do not administer unless the solution is clear, free from particles and the freeflex® IV container is undamaged.3. Discontinue the infusion if adverse reaction occurs.4. Do not vent.5. It is recommended that administration sets are changed at least once every 24 hours.6. Partially used freeflex® IV container must be discarded.7. Additives may be incompatible and expert advice should be sought before adding medication to a freeflex® IV

container. If the physician decides to add medication, aseptic technique must be employed – Additions must bemade by an authorised person.

2

3

1

4. DISINFECTION OF THE INJECTION PORT

The injection port is sterile under the tamper evidentbreakoff cap. The precision swab is only necessary ifmore than one syringe or transfer adapter is used.

– After removing the first syringe or transfer adapter it ismandatory to disinfect the port in order to remove anydrug remains. Take the precision swab and soak it withdisinfectant.

– Use the moistened precision swab to disinfect the cavity of the injection port. After that a second syringeor transfer adapter can be used.

– After finishing the drug reconstitution the red protectivecap can be clipped over the injection port to indicatethat a drug addition has been made.

VI

V00

1/

FB

073

0691

/00

UK

0730691_00_UK_Instruction_for_use:0730691_00_UK_Instruction_for_use 22.09.2015 9:14 Uhr Seite 1

IV

1

2

3

4

3. NEEDLE-FREE DRUG PREPARATION WITH A LUER-LOCK SYRINGE

Using an aseptic technique, prepare a syringe with aluer-lock, no needle is needed

– Follow steps 1 and 2 (see Chapter 1). Identify the lightblue injection port.

– Break off the light blue tamper evident cap from theinjection port. Membrane below cover is

sterile – disinfection of the membrane is not necessary!

– Hold the light blue injection port with your fingersbehind the finger guard. Connect the luer-lock of the syringe with the injection port of the and inject the medication into the bag. The rigid port construction supports a safe and convenient handling.

– Mix the medication thoroughly by agitation. The redprotective cap can be clipped over the injection port to indicate that a drug addition has been made.

II

5

1

2

3

2. NEEDLE-FREE RECONSTITUTION WITH THETRANSFER ADAPTER

– Use a non-vented giving set or, if using a vented set,close the air inlet. Grip the base of the infusion portwith your fingers behind the guard. Push and twist thegiving set firmly into the port. A slight resistance shouldbe felt, as the port membrane is broken. To preventleaks, insert the spike until the clear plastic collar of theport meets the shoulder of the spike.

The IV container is compatible with monovialtransfer systems

– Follow steps 1 and 2 (see Chapter 1). Identify the lightblue injection port.

– Break off the light blue tamper-evident cap from theinjection port.

– Connect the luer-lock of the transfer adapter with the luer compatible injection port of the bag. The injection port is now opened; therefore hold the injection port in an upright position to avoid leakage.

III

6

5

7

8

4

– Then push the medication vial on the adapter.

– To fix the vial to the adapter push the blue safety ringtowards the vial. Make sure that the safety ring snapsinto place, so that the connection between medicationvial and transfer adapter is fixed.

– With the vial hanging downwards, squeeze and releasethe IV container to transfer solution into thevial. Shake to dissolve the medication.

– Invert the IV container and press air from the bag into the vial to transfer the solution from the vial into the bag. Agitate thoroughly to mix medication.Remove Transfer Adapter.

– The red protective cap can be clipped over the injection port to indicate that a drug addition has been made.

0730691_00_UK_Instruction_for_use:0730691_00_UK_Instruction_for_use 22.09.2015 9:14 Uhr Seite 4

4468-3.qxp_Mise en page 1 19/01/2017 15:35 Page1

4468-3.qxp_Mise en page 1 19/01/2017 15:35 Page2

V001/LV

Freeflex Instruction Uk_Mise en page 1 22/08/2016 16:51 Page1

Freeflex Instruction Uk_Mise en page 1 22/08/2016 16:51 Page2