Skip to Content

GLUCOSE INTRAVENOUS INFUSION BP 15%W/V

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

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Glucose Intravenous Infusion BP 15% w/v Solution for Infusion
Anhydrous Glucose 15% 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.
• 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.

Sign:

Sign:

• kidney disease.

Date:

Date:

6. Contents of the pack and other information
1. What Glucose Solution is and what it is used for

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

• reduced production of urine (oliguiria or anuria).
• excess water in the body (water intoxication).

Name

N/A

• low level of sodium in the blood (hyponatraemia).

Signature

N/A

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

Date

N/A

• 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.

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.

• 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.

• 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 If you are not sure if any of the above apply to you, talk to your
doctor or nurse before having Glucose Solution.
(hyperclycaemia).
When you are given Glucose Solution, your doctor will monitor:
• sensitivity (hypersensitivity) to glucose. The glucose in this
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).
1

EMEA ARTWORK DESIGN CENTRE
ARTWORK APPROVAL
3rd DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

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

• 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.

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.

Comments:

high pressure within the skull (intracranial hypertension).

• lung disease (respiratory failure).

5. How Glucose Solution is stored

Draft: 3rd

• diabetes.

• heart disease (heart failure).

4. Possible side effects

Date: 07 MAR 2016
Errors: Yes / No PR2:

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

3. How you will be given Glucose Solution

Version: 04

Artworker: P. Delcourt
Errors: Yes / No PR1:

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

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

ARTWORK DESIGN CENTRE

TH-30-01-753

DATE
PLANT APPROVAL
HALLE ONLY
N/A

affecting the brain due to low levels of sodium (hyponatraemic
encephalopathy).

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

Other medicines and Glucose Solution

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.

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

As Glucose Solution contains sugar (glucose), it can cause a high
level of sugar in your blood (hyperglycemia). If this occurs, your
doctor may:
• give insulin to reduce the amount of sugar in your blood.

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.

• if necessary, give you extra potassium.

Pregnancy, breast-feeding and fertility

This is particularly important:
• if you are diabetic.

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.

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

Pregnancy

• 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.

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

• 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).

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

• adjust the speed of infusion.

Fertility

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

Lactation

Version: 04
Sign:
Sign:

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

EMEA ARTWORK DESIGN CENTRE

Driving and using machines

Glucose Solution should be given with special care in children.

Ask your doctor or nurse for advice before driving or using
Children must be given Glucose Solution by a doctor or nurse.
machines.
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
3. How you will be given Glucose Solution
another medicine, or if other medicines are given at the same
time, this may affect the dose.
Glucose Solution will be given to you by a doctor or nurse.
When the Glucose Solution is given to children, the child’s doctor
The usual dose
will take blood and urine samples to monitor the amount of
electrolytes such as potassium in the blood (plasma electrolytes). 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:
Newborns – especially those born premature and with low
birth weight – are at increased risk of developing a too low or
• your age and weight.
too high level of sugar in the blood (hypo- or hyperglycaemia)
• the reason you are being given the medicine.
and therefore need close monitoring during treatment with
intravenous glucose solutions to ensure adequate control of the
How Glucose Solution is prepared and given
sugar levels in order to avoid potential long term adverse effects.
• Glucose Solution can be used on its own or diluted with other
Low sugar levels in the newborn can cause prolonged seizures,
nutrition solutions before it is given to you.
coma and brain damage. High sugar levels have been associated
with bleeding into the brain, bacterial and fungal infection, damage • Dilution will be done under sterile conditions by a trained and
to the eye (retinopathy of prematurity), infections in the intestinal
qualified person.
track (necrotizing enterocolitis), lung problems (bronchopulmonary
• Diluted solution will be stored at 2 to 8°C and used within
dysplasia), prolonged length of hospital stay and death.
24 hours of mixing.
When administered to a newborn baby, the solution bag could
• It will be given to you via a plastic tube, which will be placed
be connected to an infusion pump device, which allows exact
very carefully into your vein, usually in your chest.
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.

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

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
2

TH-30-01-753

Date:
Date:

ARTWORK APPROVAL
3rd DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

DATE
PLANT APPROVAL
HALLE ONLY
N/A

Name

N/A

Signature

N/A

Date

N/A

If you are given more Glucose Solution than you should have

Reporting of side effects

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:

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)

Yellow Card Scheme

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

www.mhra.gov.uk/yellowcard

• the blood becomes too concentrated (hyperosmolarity)

5. How Glucose Solution is stored

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

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.

• 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
• Do not store above 25°C.
be administered and you will be given treatment depending on your
• Store in original packaging.
symptoms.

• 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although • Glucose Solution 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 solution 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:
–– 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.

What Glucose Solution contains

Name

N/A

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).

Signature

N/A

Date

N/A

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

–– 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).

Send all enquires to this address.

• shivering.
• sweating.
• formation of small particles blocking lung blood vessels.
If any side effects occur, the infusion must be stopped.

3

EMEA ARTWORK DESIGN CENTRE

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 looks like and contents of the pack

–– 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.

Date:
Date:

ARTWORK APPROVAL
3rd DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

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.

–– fever, febrile reaction (pyrexia).

Version: 04
Sign:
Sign:

TH-30-01-753

DATE
PLANT APPROVAL
HALLE ONLY
N/A

Glucose Solution can be made at either of these addresses:
Baxter Healthcare Ltd
Caxton Way, Thetford
Norfolk, IP24 3SE
United Kingdom

Baxter Healthcare S.A.
Castlebar, Co. Mayo
Ireland

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.
Version: 04
Sign:
Sign:

Date:
Date:

EMEA ARTWORK DESIGN CENTRE
ARTWORK APPROVAL
3rd DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

4

TH-30-01-753

DATE
PLANT APPROVAL
HALLE ONLY
N/A

Name

N/A

Signature

N/A

Date

N/A

Expand view ⇕

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.

Hide