PACKAGE LEAFLET: INFORMATION FOR THE USER

Glucose 70% w/v Concentrate for Solution for Infusion

Anhydrous Glucose 70% w/v

Read all of this leaflet carefully before you are given this _H 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.

Throughout this leaflet, Glucose 70% w/v Concentrate for Solution for Infusion will be called Glucose Concentrate.

What is in this leaflet

1.    What Glucose Concentrate is and what it is used for

2.    What you need to know before you are given Glucose Concentrate

3.    How you will be given Glucose Concentrate

4.    Possible side effects

5.    How Glucose Concentrate is stored

6.    Contents of the pack and other information

1 What Glucose Concentrate is and what it is used for

Glucose Concentrate is a sterile solution of concentrated glucose.

The glucose is used to provide energy and to increase the

amount of sugar in your blood.

Glucose Concentrate is used if:

•    you are unable to take enough food by mouth. It is mixed with other nutrition solutions that will be given to you by infusion through your vein.

•    you have increased fluid pressure in your skull and are unconscious due to having low blood sugar. It will provide relief from the symptoms.

2 What you need to know before you are given Glucose Concentrate

Warnings and precautions

Your doctor will take special care when giving you Glucose Concentrate if:

If you are not sure if any of the above apply to you, talk to your doctor or nurse before having Glucose Concentrate.

Children

Glucose Concentrate should be given with special care in children.

Newborns - especially those born premature and with low birth weight - are at increased risk of developing a too low or too high level of sugar in the blood (hypo- or hyperglycaemia) and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate control of the sugar levels in order to avoid potential long term adverse effects. Low sugar levels in the newborn can cause prolonged seizures, coma and brain damage. High sugar levels have been associated with bleeding into the brain, bacterial and fungal infection, damage to the eye (retinopathy of prematurity), infections in the intestinal track (necrotizing enterocolitits), lung problems (bronchopulmonary dysplasia), prolonged length of hospital stay and death.

When administered to a newborn baby, the solution bag could be connected to an infusion pump device, which allows exact delivery of the required quantity of solution across the defined time interval. Your doctor or nurse will be monitoring the device to ensure safe administration.

Having blood transfusions while you are having Glucose Concentrate

Whilst you are having Glucose Concentrate you will not be given a blood transfusion. Also, blood will not be given before or after using the same infusion tube, as this may make the blood clot.

Tests you may have with Glucose Concentrate

Your doctor may decide to do some extra tests before and during this treatment.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, please inform your doctor. They will advise you if this treatment is suitable for you.

Driving and using machines

Glucose Concentrate has no or little influence on the ability to drive or use machines. Please inform your doctor and they will advise you if you can drive or use machines.

•    you have kidney problems

•    you have diabetes.

3 How you will be given Glucose Concentrate

Glucose Concentrate will be given to you by a doctor or nurse. The usual dose

Your doctor will decide how much of the medicine you will need and for how long it will be given to you. The dose will depend on:

•    your age and weight

•    the reason you are being given the medicine.

How Glucose Concentrate is prepared and given

•    Glucose Concentrate will be diluted with other nutrition solutions before it is given to you.

•    The dilution will be done under sterile conditions by a trained and qualified person.

•    The diluted solution will be stored at 2 to 8°C and used within 24 hours of mixing.

•    It will be given to you via a plastic tube, which will be placed very carefully into your vein, usually in your chest.

Your doctor will check that any medicines added to your infusion are compatible with Glucose Concentrate.

If you are given more Glucose Concentrate than you should have

It is unlikely that you will be given more Glucose Concentrate that you should, because it will be given to you by a trained and qualified person. They would stop the infusion straightaway if too much was given.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects can include:

•    hypersensitivity reactions, including a serious allergic reaction called anaphylaxis

•    fever (pyrexia)

•    chills

Occasionally, reddening and stinging can occur at the point where your infusion was given.

Please tell your doctor or nurse if you notice any listed or unlisted side effects. If any side effects occur, the infusion must be stopped.

5 How Glucose Concentrate is stored

Keep this medicine out of the sight and reach of children.

Hospital staff will ensure that the product is stored and disposed of correctly and not used after the expiry date stated on the product. The storage conditions should you need them are given below.

•    Do not store above 25°C.

•    Store in original packaging.

•    Do not use Glucose Concentrate after the expiry date that is stated on the label. The expiry date refers to the last date of that month.

•    Glucose Concentrate must not be used if the solution is not clear or the bag is damaged.

Each bag will be used once. Any left over concentrate will be discarded.

6 Contents of the pack and other information

This leaflet does not contain all the information about for this medicine. If you have any questions or are not sure about anything, ask your healthcare professional.

What Glucose Concentrate contains

The active substance is Glucose Monohydrate 77% w/v (770 g per 1000 ml), which is equivalent to Anhydrous Glucose 70% w/v (700 g per 1000 ml).

The other ingredient is sterile water (called ‘water for Injections’). Glucose Concentrate can also sometimes contain small amount of hydrochloric acid. This is added to adjust the pH of the Concentrate.

What Glucose Concentrate looks like and contents of the pack

Glucose Concentrate is as a clear, slightly yellow solution. It is available in flexible plastic bags, which contain 500 ml, 1000 ml or 1500 ml of Concentrate. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers

The Marketing Authorisation holder is:

Baxter Healthcare Ltd Caxton Way, Thetford Norfolk, IP24 3SE United Kingdom

Send all enquires to this address.

Glucose Concentrate can be made at either of these addresses: Baxter Healthcare Ltd    Baxter Healthcare S.A.

Caxton Way, Thetford    Castlebar, Co. Mayo

Norfolk, IP24 3SE    Ireland

United Kingdom

This leaflet was last revised in 03/2013.

For information about Glucose Concentrate or to request this leaflet in formats such as audio or large print please contact the Marketing Authorisation Holder:

Tel: 01635 206345.

Baxter is a trademark of Baxter International Inc.

TH-30-01-642

2