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GLUCOSE 10% W/V SOLUTION FOR INFUSION

Active substance(s): GLUCOSE MONOHYDRATE

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SA-30-01-972

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Glucose 10% infusion is used to:
• provide a source of sugar (carbohydrate) alone or, as
required, for parenteral nutrition. Parenteral nutrition
is used to feed patients who are unable to eat. It is
given as a slow injection (infusion) into a vein.
• prevent or treat a low level of sugar in the blood
(hypoglycaemia, that is causing symptoms, but is not
life-threatening)
• give you extra fluid if your body does not have enough
water (you are dehydrated), and you need extra sugar
(carbohydrate)
• water down/dilute other medicines to be given into
a vein.

PLANT APPROVAL
HALLE ONLY

Glucose 10% Infusion is a solution of sugar (glucose) in
water. Glucose is one of the body’s sources of energy.
This solution for infusion provides 400 kilocalories per
litre.

DATE

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

Version: 01

What is in this leaflet:
1. What Glucose 10% Infusion is and what it is used for
2. What you need to know before you are given
Glucose 10% Infusion
3. How you will be given Glucose 10% Infusion
4. Possible side effects
5. How to store Glucose 10% Infusion
6. Contents of the pack and other information

Date: 03DEC2015

• diabetes that is not adequately treated, allowing
your blood sugar levels to rise above normal
(uncompensated diabetes)
• hyperosmolar coma (unconsciousness). This is a type
of coma that can occur if you have diabetes and do
not receive enough medicine.
• thinning of the blood due to the addition of too much
fluid (haemodilution)
• when there is too much fluid in the spaces around the
cells of the body (extracellular hyperhydration)
• when there is a larger volume of blood in the blood
vessels than there should be (hypervolaemia)
• a higher level of sugar in the blood than normal
(hyperglycaemia)
• a higher level of lactate, a chemical found in the
blood, than there should be (hyperlactataemia)
• severe kidney failure (when your kidneys do not work
well and you require dialysis)
• uncompensated heart failure. This is heart failure
that is not adequately treated and causes symptoms
such as:
–– shortness of breath
–– swelling of the ankles
• build up of fluid under the skin, affecting all parts
of the body including your brain and lungs (general
oedema)
• liver disease that causes fluid to build up within the
abdomen (ascitic cirrhosis).
• any condition which affects the way your body
controls your sugar level
• to be sensitive (hypersensitivity) to glucose. This is
potential manifestations in patients with allergy to
corn.

Artworker: Leroi C.

Do NOT receive Glucose 10% Infusion if
you are suffering from any of the following
conditions

ARTWORK DESIGN CENTRE

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

ARTWORK APPROVAL
1st DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

Active substance: glucose
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,
pharmacist 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.
This medicine is called ‘Glucose 10% w/v Solution
for Infusion’, but will be referred to as ‘Glucose 10%
infusion’ throughout the remainder of this leaflet.

EMEA ARTWORK DESIGN CENTRE

Glucose 10% w/v Solution for Infusion

Draft: 1st

PACKAGE LEAFLET: INFORMATION FOR THE USER

Please tell your doctor if you have or have had any of the
following medical conditions.
• diabetes
• kidney disease
• an acute critical illness (an illness that has started
recently and could be life-threatening).
• a high pressure within the skull (intracranial
hypertension)
• tell your doctor if you had 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 (oliguria or anuria)
• excess water in the body (water intoxication)
• low level of sodium in the blood (hyponatraemia)
• allergy to corn (Glucose 5% Infusion contains sugar
derived from corn)

Children

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This solution should not be given to you through the
same needle with a blood transfusion. This can damage
the red blood cells or cause them to clump together.

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Glucose 10% Infusion is a hypertonic (concentrated)
solution. Your doctor will take this into account when
calculating how much solution to give you.

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Warnings and precautions

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

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If another medicine is added to your solution for infusion,
always read the Package Leaflet of that medicine. This
way you can check to see if that medicine is safe for you
to take.

When this infusion 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 you are given this infusion, your doctor will
monitor:
• the amount of electrolyte 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 the blood and urine (changes in acidbase balance)
Your doctor will adjust how much solution for infusion
you are given according to the results of these tests.
These tests will also tell the doctor if you need extra
potassium, a chemical in the blood. If required, this can
be given into a vein.

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.

As Glucose 10% infusion contains sugar (glucose),
it can cause a high level of sugar in the blood
(hyperglycaemia). 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 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

Children (including neonates and older children) who
are given Glucose 10% Infusion are at higher risk of
developing a low sodium level in the blood (hypoosmotic
hyponatraemia) and a disorder affecting the brain
due to low plasma levels of sodium (hyponatraemic
encephalopathy).

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SA-30-01-972

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Children must be given Glucose 10% 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
10% is used to deliver or dilute another medicine, or if
other medicines are given at the same time, this may
also affect the dose.

01

Glucose 10% Infusion should be given with special care
in children.

Other medicines and Glucose 10% Infusion

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Do not take Glucose 10% with certain hormones
(catecholamines) including adrenaline or steroids as they
can increase the level of sugar in your blood.

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Glucose 10% Infusion will usually be given to you
through a plastic tube attached to a needle in a vein.
Usually a vein in your arm is used to give you the
infusion. However, your doctor may use another method
to give you the medicine.

Glucose 10% and other medicines taken at the same
time can affect each other.

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Tell your doctor or nurse if you are using, have recently
used or might use any other medicines.

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You should NOT be given Glucose 10% Infusion if there
are particles floating in the solution or if the pack is
damaged in any way.

When you are given Glucose 10% Infusion, your doctor
will perform regular blood tests to monitor:
• the amount of sugar in your blood
• the concentration of certain electrolytes (e.g. sodium,
potassium) in your blood.

Glucose 10% Infusion with food and drink
You should ask your doctor about what you can eat or
drink.

Pregnancy, breast-feeding and fertility

Any unused solution should be thrown away. You should
NOT be given an infusion of Glucose 10% Infusion from a
bag that has been partly used.

Pregnancy

If you receive more Glucose 10% Infusion
than you should

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

If you are given too much Glucose 10% Infusion (overinfusion) 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)

Fertility
There are no adequate data of the effect of Glucose on
fertility. However, no effect on fertility is expected.

Lactation
There are no adequate data of using Glucose solution
during breast-feeding. However, no effect on breastfeeding is expected. Glucose solution can be used during
breast-feeding.
If another medicine is to be added to your solution for
infusion during pregnancy or breast-feeding you should:
• consult your doctor
• read the Package Leaflet of the medicine that is to
be added.

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 the symptoms.

Driving and using machines

If a medicine has been added to your Glucose 10%
Infusion before over-infusion occurs, that medicine may
also cause symptoms. You should read the Package
Leaflet of the added medicine for a list of possible
symptoms.

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

3. How you will be given Glucose
10% Infusion

Stop receiving your Glucose 10% Infusion
Your doctor will decide when to stop giving you this
infusion.

Glucose 10% Infusion will be given to you by a doctor
or nurse. Your doctor will decide on how much you need
and when it is to be given. This will depend on your age,
weight, clinical condition and the reason for treatment.
The amount you are given may also be affected by other
treatments you are receiving.

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

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SA-30-01-972

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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.

01

Your doctor will also monitor your fluid intake and the
amount of urine you produce (your fluid balance).

Version:

01

Ireland:
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
Malta:
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt

If a medicine has been added to the solution for infusion,
the added medicine may also cause side effects. These
side effects will depend on the medicine that has been
added. You should read the Package Leaflet of the added
medicine for a list of possible symptoms.
If any side effects occur, the infusion must be stopped.

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Date:

United Kingdom:
Via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

Sign:

This side effects can include:
• hypersensitivity reactions, including a serious
allergic reaction called anaphylaxis (potential
manifestation in patients with allergy to corn)
–– difficulty breathing
–– swelling of the skin of the face, lips and swelling
of the throat
–– fever (pyrexia)
–– hives (urticaria)
–– skin rash
–– redness of the skin (erythema)
–– chills
• changes in the levels of the electrolytes in the blood
(electrolyte disturbances), including
–– a low level of potassium in the blood
(hypokalaemia)
–– a low level of magnesium in the blood
(hypomagnesaemia)
–– a low level of phosphate in the blood
(hypophosphataemia)
• a high level of sugar in the blood (hyperglycaemia).
• an excess of fluid in the blood vessels (haemodilution
and hypervolaemia)
• sugar in the urine (glycosuria)
• reactions related to the route of administration:
–– fever, febrile reaction (pyrexia)
–– infection at the site of injection
–– escape of the infusion 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
or redness in the area of the clot
–– irritation and inflammation of the vein into which
the solution is 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

Date:

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

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If you get any side effects, talk to your doctor or
pharmacist 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 listed
below. By reporting side effects you can help provide
more information on the safety of this medicine.

4. Possible side effects

SA-30-01-972

Marketing Authorisation Holder and
Manufacturer

5. How to store Glucose 10%
Infusion

Glucose 10% Infusion should NOT be given to you after
the expiry date which is stated on the bag and the
carton after EXP. The expiry date refers to the last day of
that month.

Date:

This medicinal product does not have any special
storage conditions.

Sign:

Baxter Healthcare Ltd.
Caxton Way
Thetford Norfolk IP24 3SE
United Kingdom
Manufacturers:

Date:

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

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Marketing Authorisation Holder:
Send all enquiries to this address

Baxter Healthcare Ltd.
Caxton Way
Thetford Norfolk IP24 3SE

You should not be given Glucose 10% Infusion if there
are particles floating in the solution or if the unit is
damaged in any way.

United Kingdom

Version:

6. Contents of the pack and other
information

01

Bieffe Medital S.A.
Ctra de Biescas-Senegüé
22666 Sabiñánigo (Huesca)
Spain

This leaflet was last revised in
July 2015

What Glucose 10% Infusion contains
The active substance is glucose (as monohydrate): 100
g per litre.
The only other ingredient is water for injections.

For information about Glucose 10% Infusion or to request
this leaflet in formats such as audio or large print please
contact the Marketing Authorisation Holder:
Tel: +44 (0)1635 206345.

Formula per 250 ml
Glucose (as monohydrate): 25 g
Formula per 500 ml
Glucose (as monohydrate): 50 g
Formula per 1000 ml
Glucose (as monohydrate): 100 g

What Glucose 10% Infusion looks like and
contents of the pack
Glucose 10% Infusion is a clear solution, free from
visible particles. It is supplied in polyolefin/polyamide
plastic bags (Viaflo). Each bag is wrapped in a sealed,
protective, outer plastic overpouch.
The bag sizes are:
• 250 ml
• 500 ml
• 1000 ml
Pack sizes:
• 30 or 36 bags of 250 ml per carton
• 1 bag of 250 ml
• 20 or 24 bags of 500 ml per carton
• 1 bag of 500 ml
• 10 or 12 bags of 1000 ml per carton
• 1 bag of 1000 ml
Not all pack sizes may be marketed.
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SA-30-01-972

Date:

Date:
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01
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Version:
Baxter and Viaflo are trademarks of
Baxter International lnc.

SA-30-01-972
6a

F

Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to
administration, whenever solution and container
permit. Use only if the solution is clear, without visible
particles and if the container is undamaged. Administer
immediately following the insertion of infusion set.

The intravenous infusion device and administration
equipment must be frequently monitored.
Discard after single use.
Discard any unused portion.

Do not remove unit from overwrap until ready for use.

Do not reconnect partially used bags.

The inner bag maintains the sterility of the product.

Do not store solutions containing additives.

Do not use plastic containers connected in series.
Such use could result in air embolism due to residual
air being drawn from the primary container before the
administration of the fluid from the secondary container
is completed.

When introducing additives to Glucose solution aseptic
technique must be used.
Mix the solution thoroughly when additives have been
introduced.

Pressurizing intravenous solutions contained in flexible
plastic containers to increase flow rates can result in air
embolism if the residual air in the container is not fully
evacuated prior to administration.

1. Opening
a. Remove the Viaflo container from the overpouch
just before use.
b. Check for minute leaks by squeezing inner bag
firmly. If leaks are found, discard solution, as
sterility may be compromised.
c. Check the solution for limpidity and absence
of foreign matter. If solution is not clear or
contains foreign matter, discard the solution

Use of a vented intravenous administration set with the
vent in the open position could result in air embolism.
Vented intravenous administration sets with the vent in
the open position should not be used with flexible plastic
containers.
The solution should be administered with sterile
equipment using an aseptic technique. The equipment
should be primed with the solution in order to prevent air
entering the system.

2. Preparation for administration
Use sterile material for preparation and administration.
a. Suspend container from eyelet support.
b. Remove plastic protector from outlet port at
bottom of container:
–– grip the small wing on the neck of the port
with one hand,
–– grip the large wing on the cap with the
other hand and twist,
–– the cap will pop off.
c. Use an aseptic method to set up the infusion.
d. Attach administration set. Refer to complete
directions accompanying set for connection,
priming of the set and administration of the
solution.

Electrolyte supplementation may be indicated according
to the clinical needs of the patient.
Additives may be introduced before infusion or during
infusion through the re-sealable medication port.
When an additive is used, verify final osmolariy prior to
parenteral administration. Thorough and careful aseptic
mixing of any additive is mandatory. Solutions containing
additives should be used immediately and not stored.
In order to avoid potentially fatal over infusion of
intravenous fluids to the neonate, special attention needs
to be paid to the method of administration.

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SA-30-01-972

Date:

The solution for infusion should be visually inspected
before use.

Date:

When using an infusion pump all clamps on the
intravenous administration set must be closed before
removing the administration set from the pump, or
switching the pump off. This is required regardless of
whether the administration set has an anti free flow
device.

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Handling and Preparation

01

When using a syringe pump to administer intravenous
fluids or medicines to neonates, a bag of fluid should not
be left connected to the syringe.

Version:

The following information is intended
for healthcare professionals only:

Sign:

Glucose 10% w/v Solution for Infusion

3. Techniques for injection of additive
medications

5. Incompatibilities of additive medications

Date:
Sign:

Incompatibility of the medicinal product to be added with
the solution in Viaflo container must be assessed before
its addition.

Date:

To add medication before administration
a. Disinfect medication port.
b. Using syringe with 19 (1.10 mm) to
22 (0.70 mm) gauge needle, puncture
resealable medication port and inject.
c. Mix solution and medication thoroughly. For
high-density medication such as potassium
chloride, tap the ports gently while ports are
upright and mix.
d. Caution: Do not store bags containing added
medications.
To add medication during administration
a. Close clamp on the set.
b. Disinfect medication port.
c. Using syringe with 19 (1.10 mm) to
22 (0.70 mm) gauge needle, puncture
re-sealable medication port and inject.
d. Remove container from IV pole and/or turn to
an upright position.
e. Evacuate both ports by tapping gently while the
container is in an upright position.
f. Mix solution and medication thoroughly.
g. Return container to in use position, re-open the
clamp and continue administration.

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Glucose solution should not be administered
simultaneously with, before or after an administration
of blood through the same infusion equipment, because
haemolysis and clumping can occur.

Warning: Additives may be incompatible.

In the absence of incompatibility studies, this solution
medicinal product must not be mixed with other
medicinal products.

When a compatible medication is added to the Glucose
10% Infusion, the solution must be administered
immediately.
Those additives known to be incompatible should not
be used.

4. In use shelf life: Additives
The chemical and physical stability of any additive at the
pH of Glucose 10% Infusion in the Viaflo container should
be established prior to use.
From a microbiological point of view, the diluted product
must be used immediately unless dilution has taken
place in controlled and validated aseptic conditions.
If not used immediately, in-use storage times and
conditions are the responsibility of the user.

Baxter and Viaflo are trademarks of
Baxter International lnc.

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SA-30-01-972

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Before adding a drug, verify if it is soluble and stable in
water at the pH range of the Glucose 10% Infusion (pH
3.5 to 6.5).

00

The instructions for use of the medicinal product to be
added must be consulted.

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.

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