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GLUCOSE 40% W/V CONCENTRATE FOR SOLUTION FOR INFUSION.

Active substance(s): ANHYDROUS GLUCOSE / GLUCOSE MONOHYDRATE FOR PARENTERAL USE / ANHYDROUS GLUCOSE / GLUCOSE MONOHYDRATE FOR PARENTERAL USE / ANHYDROUS GLUCOSE / GLUCOSE MONOHYDRATE FOR PARENTERAL USE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Glucose 40% w/v Concentrate for Solution for Infusion
Anhydrous Glucose 40% w/v
Warnings and precautions

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.

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



If you have any further questions, ask your doctor or nurse.



diabetes.



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.



kidney disease.



an acute critical 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 Concentrate 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 any parenteral nutrient admixture.

Throughout this leaflet, Glucose 40% 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
Do NOT receive Glucose Concentrate if you are suffering from
any of the following conditions:



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.

a significantly higher level of sugar in your blood than normal If you are not sure if any of the above apply to you, talk to your
doctor or nurse before having Glucose Concentrate.
(hyperglycaemia).
When you are given Glucose Concentrate, your doctor will
sensitivity (hypersensitivity) to glucose. The glucose in this
monitor:
product is derived from corn.


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



the amount of sugar (glucose).

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



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

Children (including neonates and older children) who are
given Glucose Concentrate 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).

Your doctor will adjust how much Glucose Concentrate you are
given according to the results of these tests. These tests will also
Other medicines and Glucose Concentrate
tell your doctor if you need extra potassium, an electrolyte (salt)
in your blood. If required, this can be given into a vein.
Tell your doctor or nurse if you are using, have recently used
As Glucose Concentrate contains sugar (glucose). It can cause a or might use other medicines. Glucose Concentrate and other
high level of sugar in your blood (hyperglycaemia). If this occurs, medicines taken at the same time can affect each other.
your doctor may:
Having blood transfusions while you are having Glucose


adjust the speed of infusion.

Concentrate



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



if necessary, give you extra potassium.

This is particularly important:

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



if you are diabetic.

Pregnancy, breast-feeding and fertility



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 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



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).

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



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

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

Children

Lactation

Glucose Concentrate should be given with special care in
children.

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

Children must be given Glucose Concentrate by a doctor or nurse.
The amount given must be decided by a doctor specialising in
Driving and using machines
the care of children and will depend upon the child’s age, weight, Ask your doctor or nurse for advice before driving or using
and condition. If the Glucose Concentrate is used to deliver or
machines.
dilute another medicine, or if other medicines are given at the
same time, this may affect the dose.
3. How you will be given Glucose Concentrate
When the Glucose Concentrate 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).

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

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.

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:


the reason you are being given the medicine



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.

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your age and weight

How Glucose Concentrate is prepared and given

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.

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Your doctor will check that any medicines added to your infusion
are compatible with Glucose Concentrate.
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If you are given more Glucose Concentrate than you should have

Reporting of side effects

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

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.



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)

Yellow Card Scheme
www.mhra.gov.uk/yellowcard
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.

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

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.

Like all medicines, this medicine can cause side effects, although • Glucose Concentrate must not be used if the solution is not
clear or the bag is damaged.
not everybody gets them.
Each bag will be used once. Any left-over concentrate will be
Side effects can include:
discarded.
• hypersensitivity reactions, including a serious allergic
reaction called anaphylaxis (potential manifestation in
6. Contents of the pack and other information
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:

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 44% w/v
(440 g per 1000 ml), which is equivalent to Anhydrous Glucose
40% w/v (400 g per 1000 ml).

The other ingredient is sterile water (called ‘water for Injections’).
Glucose Concentrate can also sometimes contain small amount
–– infection at the site of injection.
of hydrochloric acid. This is added to adjust the pH of the
–– escape of the Glucose Concentrate into the tissues around Concentrate.
the vein (extravasation). This can damage the tissues and
What Glucose Concentrate looks like and contents of the pack
cause scarring.

–– fever, febrile reaction (pyrexia).

–– 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.

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

–– 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.

Marketing Authorisation Holder and Manufacturers

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

The Marketing Authorisation holder is:
Baxter Healthcare Ltd
Caxton Way, Thetford
Norfolk, IP24 3SE
United Kingdom



shivering.

Send all enquires to this address.



sweating.



formation of small particles blocking lung blood vessels.

If any side effects occur, the infusion must be stopped.
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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
NV Baxter SA
Boulevard D’Houraing
7860 Lessines
Belgium
This leaflet was last revised in 09/2016.

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.

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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