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GLUCOSE 5% W/V INTRAVENOUS INFUSION BP

Active substance(s): GLUCOSE MONOHYDRATE

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Package leaflet: Information for the patient
Glucose 5% w/v Intravenous Infusion BP
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
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.

2. What you need to know before you
are given Glucose 5% Infusion
Do NOT receive Glucose 5% Infusion if you
are suffering from any of the following
conditions
• diabetes that is not adequately treated, allowing
your blood sugar levels to rise above normal
(uncompensated diabetes)
• states of glucose intolerance, for example:
when the body’s metabolism does not function
correctly, e.g. due to severe illness (metabolic
stress)
• hyperosmolar coma (unconsciousness). This is a
type of coma that can occur if you have diabetes
and do not receive enough medicine.
• a higher amount of sugar in the blood than
normal (hyperglycaemia)
• a higher level of lactate in the blood than normal
(hyperlactataemia)
• to be sensitive (hypersensitivity) to glucose. This
can happen in patients with an allergy to corn

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

1. What Glucose 5% Infusion is and
what it is used for

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.

Glucose 5% Infusion is a solution of sugar (glucose) in
water. Glucose is one of the body’s sources of energy.
This solution for infusion provides 200 kilocalories
per litre.

Warnings and precautions

Glucose 5% Infusion is used:
• as a source of fluid and sugar (carbohydrate )
• to dilute or to deliver other medicines that can be
given by infusion.

Please tell your doctor if you have or have had any of
the following medical conditions.
• excess water in the body (water intoxication)
• if you are diabetic or high level of sugar in the
blood (hyperglcaemia)
• if your kidneys do not work as well as normal
• if you have sepsis, trauma or shock
• low levels of electrolytes (sodium, potassium,
phosphorus, magnesium) in the blood
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Children

• head injury within the past 24 hours
• 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 low level of thiamine (vitamin B1) in
your body. This can happen if you suffer from
chronic alcoholism.
• allergy to corn (Glucose 5% Infusion contains
sugar derived from corn)

Glucose 5% Infusion should be given with special
care in children.
Children must be given Glucose 5% Infusion 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 5% Infusion is used to deliver
or dilute another medicine, or if other medicines are
given at the same time, this may also affect the dose.
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).

When you are given this infusion, your doctor will take
blood and urine samples to monitor:
• the amount of electrolyte such as 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
acid-base balance)

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.

As Glucose 5% 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 blood sugar levels
• if necessary, give extra potassium

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.

Glucose 5% Infusion must not be given through the
same needle as a blood transfusion. This can damage
the red blood cells or cause them to clump together.
Your doctor will take into account if you are receiving
parenteral nutrition (nutrition given by infusion into a
vein).
During long term treatment with Glucose 5% Infusion
you may need to be given extra nutrition.

Children (including neonates and older children)
who are given Glucose 5% 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).

Other medicines and Glucose 5% Infusion
Tell your doctor or nurse if you are using, have
recently used or might use any other medicines.
Glucose 5% Infusion and other medicines taken at the
same time can affect each other.
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Do not take Glucose 5% Infusion with certain
hormones (catecholamines) including adrenaline or
steroids as they can increase the level of sugar in
your blood.

receiving.

Glucose 5% Infusion with food and drink

Pregnancy, breast-feeding and fertility

Glucose 5% 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.

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.

Glucose 5% Infusion should be given slowly to
prevent you producing too much urine (osmotic
diuresis).

Pregnancy
Glucose 5% Infusion can be used during pregnancy.
However, caution should be taken when glucose
solution is used during the child birth or during the
delivery

Any unused solution should be thrown away. You
should NOT be given an infusion of Glucose 5%
Infusion from a bag that has been partly used.

You should NOT be given Glucose 5% Infusion if
there are particles floating in the solution or if the
pack is damaged in any way.

You should ask your doctor about what you can eat
or drink.

If you receive more Glucose 5% Infusion
than you should

Fertility
There are no adequate data of the effect of Glucose
5% Infusion on fertility. However, no effect on fertility
is expected.

If you are given too much Glucose 5% Infusion
(over-infusion) or it is given too fast, this may lead to
the following symptoms:
• build up of liquid in the tissues causing swelling
(oedema) or water intoxication with lower
than normal amounts of sodium in the blood
(hyponatraemia)
• an increase in the amount of urine you produce
(osmotic diuresis)
• the blood becomes too concentrated
(hyperosmolarity)
• a loss of water from the body (dehydration)
• a high blood sugar level (hyperglycaemia)
• sugar in the urine (hyperglycosuria)

Lactation
There are no adequate data of using Glucose 5%
Infusion during breast-feeding. However, no effect on
breast-feeding is expected. Glucose 5% Infusion 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
Ask your doctor or nurse for advice before driving or
using machines.

If a medicine has been added to your Glucose 5%
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.

3. How you will be given Glucose 5%
Infusion
You will be given Glucose 5% Infusion 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, condition, the reason for treatment and
whether or not the infusion is being used to deliver
or dilute another medicine The amount you are given
may also be affected by other treatments you are

Stop receiving your Glucose 5% Infusion
Your doctor will decide when to stop giving you this
infusion.
If you have any further questions on the use of this
product, ask your doctor or nurse.
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United Kingdom:
Via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

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

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.

The side effects can include:
• hypersensitivity reactions, including a serious
allergic reaction called anaphylaxis (potential
manifestation in patients with allergy to corn)
• changes in the amounts of the electrolytes
(electrolyte disturbances) in the blood
• higher than normal amounts of sugar in the blood
(hyperglycaemia)
• loss of water from the body (dehydration)
• an excess of fluid in the blood vessels
(hypervolaemia)
• excessive urination (polyuria)
• reactions due to the administration technique:
– reactions at the infusion site
– irritation of the vein into which the solution
is infused. 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)
– 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.

Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt

5. How to store Glucose 5% Infusion
Keep this medicine out of the sight and reach of
children.
50 ml and 100 ml bags: Do not store above 30°C.
250 ml, 500 ml and 1000 ml bags: This medicinal
product does not require any special storage
conditions.
Glucose 5% Infusion should NOT be given to you after
the expiry date which is stated on the bag after EXP.
The expiry date refers to the last day of that month.
You should not be given Glucose 5% Infusion, if there
are particles floating in the solution or if the unit is
damaged in any way.

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.

6. Contents of the pack and other
information
What Glucose 5% Infusion contains
• The active substance is sugar (glucose): 50 g per

Reporting of side effects
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.

litre.
The only other ingredient is water for injections.

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What Glucose 5% Infusion looks like and
contents of the pack

Baxter Healthcare S.A.
Moneen Road
Castlebar
County Mayo
Ireland

Glucose 5% 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

Bieffe Medital S.P.A.
Via Nuova Provinciale
23034 Grosotto (SO)
Italy

The bag sizes are:
• 50 ml
• 100 ml
• 250 ml
• 500 ml
• 1000 ml

Baxter Manufacturing Sp. z o.o.
42 B Wojciechowska Str.
20-704 Lublin
Poland

Pack sizes:
• 50 bags of 50 ml per carton.
• 1 bag of 50 ml.
• 50 bags of 100 ml per carton.
• 1 bag of 100 ml.
• 30 bags of 250 ml per carton.
• 1 bag of 250 ml.
• 20 bags of 500 ml per carton.
• 1 bag of 500 ml.
• 10 bags of 1000 ml per carton.
• 1 bag of 1000 ml.

This leaflet was last revised in 03/2016

For information about
Glucose 5% 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.

Not all pack sizes may be marketed

Marketing Authorisation Holder and
Manufacturers
Marketing Authorisation Holder:
Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom
Manufacturers:
Baxter S.A.
Boulevard René Branquart, 80
7860 Lessines
Belgium
Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom
Bieffe Medital. S.A.
Ctra de Biescas, Senegüé
22666 Sabiñánigo (Huesca)
Spain
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Baxter and Viaflo are trademarks of
Baxter International lnc.

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Glucose 5% w/v Intravenous Infusion BP
The following information
is intended for healthcare
professionals only:

Adding other medication or using an incorrect
administration technique might cause the appearance
of fever reactions due to the possible introduction of
pyrogens. In case of adverse reaction, infusion must
be stopped immediately.
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.
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.
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.
The intravenous infusion device and administration
equipment must be frequently monitored.

Handling and Preparation
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.
Do not remove unit from overwrap until ready for use.
The inner bag maintains the sterility of the product.
Do not use plastic containers in series connections.
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.
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.
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.
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 additive is used, verify final osmolarity prior
to parenteral administration. Thorough and careful
aseptic mixing of any additive is mandatory. Solutions
containing additives should be used immediately and
not stored.

Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.
Do not store solutions containing additives.
When introducing additives to Glucose 5% Infusion
aseptic technique must be used.
Mix the solution thoroughly when additives have
been introduced.

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 impaired.
c. Check the solution for limpidity and absence
of foreign matters. If solution is not clear
or contains foreign matters, discard the
solution.

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2. Preparation for administration

4. In-use shelf-life: Additives

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.

The chemical and physical stability of any additive at
the pH of Glucose 5% 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.

5. Incompatibilities of additive
medications
As with all parenteral solutions, before adding
medications, compatibility of these additives with the
solution in VIAFLO container must be assessed.
It is the responsibility of the physician to judge the
incompatibility of an additive medication with the
Glucose 5% Infusion by checking for eventual colour
change and/or eventual appearance of precipitate,
insoluble complexes or crystals. The Instructions for
Use of the medication to be added must be consulted.

3. Techniques for injection of additive
medications
Warning: Additives may be incompatible (see
Paragraph 5 “Incompatibilities of additive
medications” below).

Before adding a drug, verify it is soluble and stable in
water at the pH of Glucose 5% Infusion.

To add medication before administration
a. Disinfect medication port.
b. Using syringe with 19 gauge (1.10 mm) to
22 gauge (0.70 mm) needle, puncture
re-sealable 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.

When a compatible medication is added to
Glucose 5% Infusion, the solution must be
administered immediately.
Those additives known to be incompatible should not
be used.

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 gauge (1.10 mm) to
22 gauge (0.70 mm) 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.

Baxter and Viaflo are trademarks of
Baxter International lnc.

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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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