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Glucose 10% Intravenous Infusion

Document: leaflet MAH GENERIC_PL 12580-0007 change

NTS022E 150X210_- 21/09/15 13:33 Pagel

PACKAGE LEAFLET: INFORMATION FOR THE USER GLUCOSE 10% INTRAVENOUS INFUSION

Dextrose (glucose) monohydrate

Read all of this leaflet carefully before being given this 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. See section 4.

What is in this leaflet

1.    What Glucose 10% Intravenous Infusion is and what it is used for

2.    What you need to know before you are given Glucose 10% Intravenous Infusion

3.    How Glucose 10% Intravenous Infusion is given

4.    Possible side effects

5.    How to store Glucose 10% Intravenous Infusion

6.    Contents of the pack and other information

1. WHAT GLUCOSE 10% INTRAVENOUS INFUSION IS AND WHAT IT IS USED FOR

Glucose 10% Intravenous Infusion is a clear solution of glucose in water. The solution is stored in a sealed plastic container.

Glucose is a simple sugar which is found normally in blood, and provides a source of energy. You are being given this glucose infusion to provide your body with extra energy as glucose, by infusing the solution directly into a

Glucose infusions will be given to you in hospital by a doctor or nurse.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GLUCOSE 10% INTRAVENOUS INFUSION

You must NOT be given this solution if you:

•    have an allergy to glucose or any of the other ingredients

•    suffer from water retention

•    have suffered a stroke

•    are unable to urinate

•    have bleeding into the spine or brain

•    have delirium tremens (DTs) due to alcohol withdrawal and dehydration

Warnings and precautions Talk to your doctor or nurse if you:

•    have diabetes mellitus

•    have kidney failure

•    have severe malnutrition or thiamine (vitamin B1)deficiency

•    have liver failure

•    are pregnant or breast-feeding

Other medicines and Glucose 10% Intravenous Infusion

Tell your doctor if you are taking or have recently taken any other medicines.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or think you may be pregnant or are planning to have a baby, ask your doctor for advice before being

gTiven this medicine.

he solution should be used with care during pregnancy and breast-feeding to avoid extreme levels of glucose in the mother and the foetus or baby.

Driving and using machines

Glucose infusion has no effect on your ability to drive or use machines.

3. HOW GLUCOSE 10% INTRAVENOUS INFUSION IS GIVEN

Glucose infusion will be given to you in hospital.

You will receive the solution by infusion into a vein (usually in your chest), administered by a doctor or nurse. The amount and rate at which the infusion is given depends on your requirements such as your age, body weight and clinical condition. Your doctor will decide on the correct volume for you to receive.

Your doctor will check your response to the treatment by the relief of your symptoms, and will probably take samples of blood and urine for laboratory testing.

If you are given more glucose infusion than you should

It is unlikely you will be given too much solution as your doctor or nurse will be checking your response to the treatment. If you receive too much solution, the levels of glucose in the blood may increase and may lead to dehydration. If you are concerned about the volume of solution given, or are worried about any effects you notice, talk to your doctor or nurse.

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If you have any further questions on the use of this medicine, ask your doctor or nurse.

4.    POSSIBLE SIDE EFFECTS

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

The infusion should be stopped immediately if you experience an adverse reaction.

Glucose infusions can cause irritation and discomfort at the site of infusion.

In some cases, upset fluid and salt levels may cause patients to feel weak, drowsy, confused or nauseous.

Some diabetic patients receiving glucose solution and insulin may feel weak, drowsy or dizzy because of upset salt levels.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

By reporting side effects, you can help provide more information on the safety of this medicine.

5.    HOW TO STORE GLUCOSE 10% INTRAVENOUS INFUSION

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

Do not store above 25°C. Do not freeze. Store in the original outer container. Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

The solution should only be used if it is clear and the container is not damaged. It should be used immediately on removal from the overwrap. Any unused solution in the bag must be discarded.

Do not throw away any medicines via wastewater or household waste. The doctor or nurse will dispose of this medicine. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Glucose 10% Intravenous Infusion contains

The active substance is glucose as dextrose monohydrate. Each litre of solution contains 100g glucose.

The other ingredient is water for injections.

What Glucose 10% Intravenous Infusion looks like and contents of the pack

Glucose infusion is a clear, colourless solution. The solution is packaged in a plastic bag. It is available in sizes of 50ml, 100ml, 250ml, 500ml and 1000ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

MACO PHARMA (UK) LTD

8th Floor

Regal House

70 London Road

Twickenham

Middlesex TW1 3QS

United Kingdom

Manufacturer

Maco Productions SAS Rue Lorthiois 59420 Mouvaux France

This leaflet was last revised in 07/2015

PL 12580/0007

For information on CD, please contact the Royal National Institute of Blind People. Central free-phone number: (+44) 0800 198 5000.

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