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Glucose 10% Intravenous Infusion

Document: leaflet MAH GENERIC_PL 08828-0019 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Chloride 0.18% and Glucose 10% 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 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 and glucose infusion is and what it is used for

2.    Before you are given sodium chloride and glucose infusion

3.    How you are given sodium chloride and glucose infusion

4.    Possible side effects

5.    How sodium chloride and glucose infusion is stored

6.    Further information

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

Sodium Chloride 0.18% and Glucose 10% Infusion, is a clear solution of sodium chloride and glucose in water.

The solution is contained in a sealed plastic container known as either Steriflex®, freeflex® or Kabipac®. The strength of the solution is: sodium chloride 0.18%, glucose 10%.

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 infusions are used where there has been excessive fluid loss from the body (dehydration) with carbohydrate loss.

2.    BEFORE YOU ARE GIVEN SODIUM CHLORIDE AND GLUCOSE INFUSION

You should not receive this sodium chloride and glucose infusion if:

•    You have a kidney, heart, or liver disorder. Your doctor will check this.

•    You are in an insulin coma.

Take special care with this sodium chloride and glucose infusion

Tell your doctor if you have any type of kidney, heart, or liver disorder. Sodium chloride and glucose infusion may not be suitable for longterm use if there is a continued loss of electrolytes (salts) from the blood. Sodium chloride and glucose infusion should not be given too rapidly, particularly in infants and the elderly. Your doctor will make sure that they are given correctly.

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.

Pregnancy and breast-feeding

You should tell your doctor if you are pregnant, if you think you are pregnant or if you are breastfeeding.

Driving and using machines

Sodium chloride and glucose infusion has no effect on driving or using machines.

3.    HOW YOU ARE GIVEN SODIUM CHLORIDE AND GLUCOSE INFUSION

Sodium chloride and glucose 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 and glucose infusion can cause side effects, although not everybody gets them.

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.

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

5.    HOW SODIUM CHLORIDE AND GLUCOSE INFUSION IS STORED

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 and glucose infusion solution.

Sodium chloride and glucose infusion solution 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 thrown away.

6.    FURTHER INFORMATION

What sodium chloride and glucose infusions contain:

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

What sodium chloride and glucose infusion looks like and contents of the pack.

Sodium chloride and glucose infusion is a clear solution of sodium chloride and glucose in water. The solution is contained in a sealed plastic container known as a Steriflex® orfreeflex® infusion bag or a Kabipac® bottle.

It is available in 500 ml and 1000ml volumes. 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.

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

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

+44(0)1928 533 533

This leaflet was last revised in March 2013.

FRESENIUS III KABI