PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Glucose Intravenous Infusion BP 15% w/v Solution for Infusion

Anhydrous Glucose 15% w/v

Read all of this leaflet carefully before you are 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.

Throughout this leaflet, Glucose Intravenous Infusion BP 15% w/v Solution for Infusion will be called Glucose Solution.

What is in this leaflet

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

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

3.    How you will be given Glucose Solution

4.    Possible side effects

5.    How Glucose Solution is stored

6.    Contents of the pack and other information

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

Glucose Solution is a sterile solution of glucose. The glucose is used to provide energy and to increase the amount of sugar in your blood.

Glucose Solution is used if:

•    you are unable to take enough food by mouth. It can be used on its own or mixed with other nutrition solutions and 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 Solution

Do NOT receive Glucose Solution if you are suffering from any of the following conditions:

•    a significantly higher level of sugar in your blood than normal (hyperclycaemia).

•    sensitivity (hypersensitivity) to glucose. The glucose in this product is derived from corn.

Warnings and precautions

Please tell your doctor if you have, or have had, any of the following medical conditions:

diabetes.

kidney disease.

an acute critical (an illness illness that has started recently and could be life-threatening).

high pressure within the skull (intracranial hypertension).

if you have had a head injury in the past 24 hours.

a stroke due to a clot in a blood vessel in the brain (ischaemic stroke).

heart disease (heart failure).

lung disease (respiratory failure).

reduced production of urine (oliguiria or anuria).

excess water in the body (water intoxication).

low level of sodium in the blood (hyponatraemia).

allergy to corn (Glucose solution contains sugar derived from corn).

precipitates. Because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in a ny parenteral nutrient admixture.

liver disorders. There have been reports of liver problems and liver failure in patients who take intravenous nutrition therapy. If you suffer symptoms such as nausea, vomiting, abdominal pain, yellowing of the skin or eyes, contact your doctor immediately.

catheter infection/sepsis. Certain medications and illnesses can increase the risk of developing infection or sepsis (bacteria in the blood). There is a particular risk of infection or sepsis when a tube (intravenous catheter) is placed in your vein. Your doctor will carefully watch you for any signs of infection. Patients who require parenteral nutrition (giving nutrition through a tube in your vein) may be more likely to develop infections from their medical conditions. Using aseptic (“germ-free”) techniques when placing and caring for the catheter and when making the nutritional formula (TPN) can reduce the risk of infection.

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

When you are given Glucose Solution, your doctor will monitor:

•    the amount of electrolytes such as sodium and potassium in your blood (your plasma electrolytes).

•    the amount of sugar (glucose).

•    the amount of fluid in your body (your fluid balance).

•    the acidity of your blood and urine (changes in acid-base balance).

Your doctor will adjust how much Glucose Solution you are given according to the results of these tests. These tests will also tell your doctor if you need extra potassium, an electrolyte (salt) in your blood. If required, this can be given into a vein.

As Glucose Solution contains sugar (glucose), it can cause a high level of sugar in your blood (hyperglycemia). If this occurs, your doctor may:

•    adjust the speed of infusion.

•    give insulin to reduce the amount of sugar in your blood.

•    if necessary, give you extra potassium.

This is particularly important:

•    if you are diabetic.

•    if your kidneys do not work as well as normal.

•    if you have recently had a stroke (acute ischaemic stroke). High levels of sugar in the blood can worsen the effects of stroke and affect recovery.

•    if you have metabolic disturbances due to starvation or due to a diet which does not provide the right proportion of the necessary nutrients (malnutrition).

•    if you have a low level of thiamine (vitamin B1). This can happen if you suffer from chronic alcoholism.

Children

Glucose Solution should be given with special care in children.

Children must be given Glucose Solution by a doctor or nurse.

The amount given must be decided by a doctor specialising in the care of children and will depend upon the child’s age, weight, and condition. If the Glucose Solution is used to deliver or dilute another medicine, or if other medicines are given at the same time, this may affect the dose.

When the Glucose Solution is given to children, the child’s doctor will take blood and urine samples to monitor the amount of electrolytes such as potassium in the blood (plasma electrolytes).

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 enterocolitis), 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.

Children (including neonates and older children) who are given Glucose Solution are at a higher risk of developing a low sodium level in the blood (hypoosmotic hyponatraemia) and a disorder affecting the brain due to low levels of sodium (hyponatraemic encephalopathy).

Other medicines and Glucose Solution

Tell your doctor or nurse if you are using, have recently used or might use other medicines. Glucose Solution and other medicines taken at the same time can affect each other.

Having blood transfusions while you are having Glucose Solution

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.

Pregnancy

Glucose solution can be used during pregnancy. However, caution should be taken when glucose solution is used during child birth.

Fertility

There are no adequate data of the effect of Glucose on fertility. Lactation

There are no adequate data of the effect of Glucose solution during breast-feeding. Glucose solutions have been used during breast-feeding.

Driving and using machines

Ask your doctor or nurse for advice before driving or using machines.

3. How you will be given Glucose Solution

Glucose Solution 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 Solution is prepared and given

•    Glucose Solution can be used on its own or diluted with other nutrition solutions before it is given to you.

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

•    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 Solution.

If you are given too much Glucose Solution (over-infusion) or it is given too fast, or too often, this may lead to the following symptoms:

•    build-up of liquid in the tissues causing swelling (oedema) or water intoxication with lower level than normal of sodium in the blood (hyponatraemia)

•    a higher amount of sugar in the blood than normal (hyperglycaemia)

•    the blood becomes too concentrated (hyperosmolarity)

•    sugar in the urine (hyperglycosuria)

•    an increase in the amount of urine you produce (osmotic diuresis)

•    a loss of water from the body (dehydration)

If you develop any of these symptoms, you must inform your doctor immediately. Your infusion will be stopped or reduced. Insulin should be administered and you will be given treatment depending on your symptoms.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although

not everybody gets them.

Side effects can include:

•    hypersensitivity reactions, including a serious allergic reaction called anaphylaxis (potential manifestation in patients with allergy to corn).

•    changes in the levels of the electrolytes (electrolyte disturbances) in the blood.

•    a high level of sugar in the blood (hyperglycaemia).

•    an excess of fluid in the blood vessels (haemodilution and hypervolaemia).

•    sugar in your urine (glycosuria).

•    reactions related to the route of administration:

-    fever, febrile reaction (pyrexia).

-    infection at the site of injection.

-    escape of the Glucose Solution into the tissues around the vein (extravasation). This can damage the tissues and cause scarring.

-    the formation of a blood clot (venous thrombosis) at the site of infusion, which causes pain, swelling and redness in the area of the clot.

-    irritation and inflammation of the vein into which the solution was infused (phlebitis). This can cause redness, pain or burning and swelling along the path of the vein into which the solution is infused.

-    local pain or reaction (redness or swelling at the site of infusion).

•    shivering.

•    sweating.

•    formation of small particles blocking lung blood vessels.

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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

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5. How Glucose Solution 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 Solution after the expiry date that is stated on the label. The expiry date refers to the last date of that month.

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

Each bag will be used once. Any left-over solution 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 Solution contains

The active substance is Glucose Monohydrate 16.5% w/v (165 g per 1000 ml), which is equivalent to Anhydrous Glucose 15% w/v (150 g per 1000 ml).

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

What Glucose Solution looks like and contents of the pack

Glucose Solution is as a clear, slightly yellow solution. It is available in flexible plastic bags, which contain 500 ml or 1000 ml of solution. 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.

If any side effects occur, the infusion must be stopped.

Baxter Healthcare Ltd

Caxton Way, Thetford Norfolk, IP24 3SE United Kingdom

NV Baxter SA Boulevard D’Houraing 7860 Lessines Belgium

This leaflet was last revised in 03/2016.

For information about Glucose Solution 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.

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