PACKAGE LEAFLET: INFORMATION FOR THE USER

Glucose Intravenous Infusion BP 5%, as Steriflex® No 6 or freeflex®

Glucose Intravenous Infusion BP 10%, as Steriflex® No 7 or freeflex® Glucose Intravenous Infusion BP 20%, as Steriflex® No 31 or freeflex® Glucose Intravenous Infusion BP 40%, as Steriflex® No 33 or freeflex®

Glucose Intravenous Infusion BP 50%, as Steriflex® No 34 or freeflex®

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 nurse.

•    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 nurse.

In this leaflet:

1.    What glucose intravenous infusion is and what it is used for

2.    Before you are given glucose intravenous infusion

3.    How you are given glucose intravenous infusion

4.    Possible side effects

5.    How glucose intravenous infusion is stored

6.    Further information

1. WHAT GLUCOSE INTRAVENOUS INFUSION IS AND WHAT IT IS USED FOR

Glucose intravenous infusions are clear solutions of glucose BP in water for injections.

Glucose intravenous infusions are used where there has been excessive water loss from the body (dehydration), where there is low blood sugar, or where there is loss of consciousness caused by an extremely low blood sugar level. These infusions may also be used to temporarily increase the blood volume in haemorrhage (blood loss) or shock.

The higher strength glucose infusions, 20% and above, may be combined with amino acid (protein) solutions and given when intravenous feeding is necessary.

The Glucose 5% solution in the smaller container size is also used to dilute certain drugs.

This leaflet covers five different solution strengths. Detailed concentration information for the solutions can be found in section 6.

These solutions will collectively be referred to as glucose intravenous infusion in this leaflet.

2. BEFORE YOU ARE GIVEN GLUCOSE INTRAVENOUS INFUSION

You should not receive glucose intravenous infusion if you have:

•    Diabetes (except as a treatment for hypoglycaemia -low blood sugar)

•    Liver or kidney disorders Your doctor will check these.

Take special care with glucose intravenous infusion

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

Taking other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The following items should not be combined with glucose intravenous infusion:

•    blood

•    frusemide (a diuretic -causes water loss)

•    hydralazine (used to reduce high blood pressure)

•    cyanocobalamin (used to treat anaemia)

•    kanamycin, novobiocin (antibiotics)

•    warfarin (a blood thinner)

Pregnancy and breast-feeding

It is safe to receive glucose intravenous infusion during pregnancy and breast-feeding. You will be monitored by your doctor during treatment.

Driving and using machines

Glucose intravenous infusion has no effect on driving or using machines.

3. HOW YOU ARE GIVEN GLUCOSE INTRAVENOUS INFUSION

Glucose 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 nurse.

if you receive more medicine than you should

It is very unlikely that you will receive more solution than you should as this medicine will be given to you in a hospital and you will be closely monitored during treatment. If an overdosage occurs, your doctor or nurse will be able to help you.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, glucose intravenous infusion can cause side effects, although not everybody gets them.

•    Large volumes of these solutions given too quickly may lead to fluid overload (too much fluid in your body)

•    Infusion over a long period can cause dehydration (water loss)

•    Low blood sugar may occur after the use of concentrated solutions of glucose

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

You will be monitored by your doctor during treatment

If any of the side effect gets serious doctor or nurse will be able to help you.

If the side effects worry you talk to the doctor or nurse.

5.    HOW GLUCOSE INTRAVENOUS INFUSION IS STORED

Keep out of the reach and sight of children

Your doctor and hospital pharmacist/nurse are responsible for the correct storage, use and disposal of glucose intravenous infusion.

Glucose intravenous infusion should be stored between 2°C and 25°C. The solutions 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.

6.    FURTHER INFORMATION

What glucose intravenous infusion contains:

Glucose intravenous infusion is a solution of glucose in water for injections. The solution also contains small amounts of hydrochloric acid and sodium hydroxide.

The concentration of glucose in each of the solution types can be seen in the name of each product. They are:

•    Glucose Intravenous Infusion BP 5%, as Steriflex® No 6 orfreeflex®

•    Glucose    Intravenous Infusion    BP 10%, as Steriflex® No    7 or freeflex®

•    Glucose    Intravenous Infusion    BP 20%, as Steriflex® No    31 or freeflex®

•    Glucose    Intravenous Infusion    BP 40%, as Steriflex® No    33 or freeflex®

•    Glucose    Intravenous Infusion    BP 50%, as Steriflex® No    34 or freeflex®

What glucose intravenous infusion looks like and contents of the pack.

Glucose intravenous infusion is a clear solution contained in a sealed plastic container known as a Steriflex® bag or a freefle^ bag. The solutions are available in 500 ml and 1000 ml bags. The glucose 5% solution is also available in 50,100,150 and 250ml bag sizes.

Not all 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.

For any information about this medicinal product, please contact the local representative of the MArketing Authorisation Holder.

UK: +44 (0)1928 533 533

This leaflet was last revised in February 2013.

Ufl FRESENIUS III KABI