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MANNITOL INTRAVENOUS INFUSION EP 20% W/V

Active substance(s): MANNITOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Mannitol Intravenous Infusion EP 20% w/v
Active substance: mannitol

Read all of this leaflet carefully before you start
using this medicine.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your
doctor or pharmacist
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor.

Mannitol 20% Infusion is used to:
• produce an increase in your urine production
when your kidneys are not working properly.
This can help prevent your kidney disease
becoming more serious
• reduce the pressure within the skull caused by
an accumulation of liquid within the brain.
This is sometimes necessary following an
injury to the head or before brain surgery, when
the natural protective barrier between the blood
vessels in your head and your brain is intact
• reduce pressure in the eye. This may be
necessary during eye surgery, or during
attacks of glaucoma (a disease that causes eye
pressure to rise)
• treat certain types of poisoning or drug
overdose. Mannitol helps the kidney to remove
these substances from the blood. They are then
eliminated from the body in the urine.

Throughout this leaflet Mannitol Intravenous
Infusion EP 20% w/v will be called Mannitol 20%
Infusion.
In this leaflet:
1. What Mannitol 20% Infusion is and what it is
used for
2. Before you are given Mannitol 20% Infusion
3. How you will be given Mannitol 20% Infusion
4. Possible side effects
5. How Mannitol 20% Infusion is stored
6. Further information

2. Before you are given Mannitol 20% Infusion

1. What Mannitol 20% Infusion is and what it is
used for

You must NOT receive Mannitol 20% Infusion
if you are suffering from any of the following
conditions:
• if you are allergic to mannitol or any of the
other ingredients of Mannitol 20% Infusion. See
section 6.
• if you have a high concentration of salts in your
blood. This is due to an excessive loss of water
from the blood and can be caused by problems
such as:
– prolonged, profuse sweating
– excess treatment with certain medicines
such as water tablets
– kidney disease.

Mannitol 20% Infusion is a solution of mannitol
in water. Mannitol is an osmotic diuretic. Osmotic
diuretics act in the kidney to make it produce more
urine. This will reduce the amount of water in your
body. Mannitol 20% Infusion is given by infusion
into a vein.

Turn over leaflet for further information.

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• if you are severely dehydrated e.g. due to
vomiting or diarrhoea. Severe dehydration gives
you a dry mouth and makes you very thirsty
• if it is known that your kidneys cannot produce
urine
• if you have severe heart failure
• if you have a build up of fluid in the lungs
associated with heart failure
• if you have bleeding inside the skull, except
during an operation on the skull
• if the natural protective barrier between the
blood vessels in your head and your brain is
damaged. This could occur, for example, after
severe injury to the head (such as a fracture of
the skull).

This solution should not be given through the same
needle as blood transfusion. This can damage the
red blood cells or cause them to clump together.
Taking other medicines

• a low volume of blood in your blood vessels.

Certain medicines must not be added to the bag of
Mannitol 20% Infusion. These include:
• Potassium
• Sodium
• Cefepime (an antibiotic)
• Imipenem (an antibiotic)
• Cilastin (a substance given with some
antibiotics to help them work better)
• Filigratim (a medicine used to increase the
number of white cells in the blood).

Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without a
prescription.
Some medicines can affect or be affected by
Mannitol 20% Infusion. If you are taking any of
these medicines, it may be necessary to change
the dose.

The following medicines are known to affect or be
affected by Mannitol 20% Infusion. Please tell your
doctor if you are taking any of these medicines:
• diuretics (water tablets, to increase the amount
of urine you produce)
Your doctor will take special care when giving
you Mannitol 20% Infusion
• ciclosporin (used to prevent rejection of a
transplant)
Please tell your doctor if you have or have had any
of the following medical conditions:
• lithium (used for mental disorders)
• if you have kidney disease or poor kidney
• aminoglycosides (antibiotics such as amikacin,
function
gentamicin and streptomycin)
• if you are receiving medicines which may be
• depolarising neuromuscular blocking drugs.
harmful to your kidneys (for example, certain
These drugs are also known as muscle
antibiotics or anticancer medicines). Your
relaxants and may be given to you by your
doctor will know if any of the medicines you are
anaesthetist during an operation
taking could affect your kidneys
• oral anticoagulants (medicines to thin the
• a medical condition where there is inadequate
blood, for example warfarin)
supply of blood to the tissues
• digoxin (a heart medicine)
• heart failure
• methotrexate (a medicine used in the treatment
• a low level of salt in your blood
of cancer and certain diseases of the immune
system).
• not enough water in your body
When you are given this infusion, your doctor will
regularly monitor:
• how well your heart, lungs and kidneys are
working
• the amount of liquid you are receiving
• the amount of urine you are producing
• the blood pressure in the veins returning blood
to your heart
• the amount of chemicals such as sodium and
potassium in your blood and urine.

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Using Mannitol 20% Infusion with food and drink

Mannitol 20% Infusion can also be used in children
and in the elderly (over 65 years of age). Your
doctor will adjust the dose as necessary.

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

If you receive more Mannitol 20% Infusion than
you should

Pregnancy and breast-feeding
Ask your doctor or pharmacist before taking any
medicine.

If you are given too much Mannitol 20% Infusion or
it is given too fast, this may lead to the following
symptoms:
• too much blood in the blood vessels
• your blood may become too acid. The
symptoms of acidosis include drowsiness,
feeling and being sick and acetone smelling
breath
• headache
• feeling sick
• shivering, but without fever.
• confusion
• tiredness
• fits
• reduced consciousness and unconsciousness.

Please tell your doctor if you are pregnant or
breast-feeding.
It is not known whether mannitol could affect
your unborn baby or your pregnancy. It is also not
known whether mannitol could reach your baby
through your breast milk. Your doctor will therefore
only give you Mannitol 20% Infusion during
pregnancy or breast-feeding if it is essential.
Driving and using machines
Mannitol 20% Infusion does not affect your ability
to drive or use machines.
3. How you will be given Mannitol 20% Infusion

If you develop any of these symptoms, you must
inform your doctor immediately. Your infusion
will be stopped and you will be given treatment
depending on the symptoms. Your doctor will also
make the necessary examinations. You may need
hospital treatment if the symptoms are dangerous.

Mannitol 20% 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, condition and the
reason for treatment. The amount you are given
may also be affected by other treatments you are
receiving.

If a medication has been added to Mannitol 20%
Infusion before over-infusion occurs, that medicine
You should NOT be given Mannitol 20% Infusion if
may also cause symptoms. You should read the
there are particles in the solution or if the pack is
Patient Information Leaflet of the added medicine
damaged in any way.
for a list of possible symptoms.
Mannitol 20% Infusion will usually be given to
Stopping your Mannitol 20% Infusion
you through a plastic tube attached to a needle in
Your doctor will decide when to stop giving you
a vein. Usually a vein in your arm is used to give
this infusion.
you the infusion. However, your doctor may use
another method to give you the medicine.
If you have any further questions on the use of this
product, ask your doctor.
The normal speed of infusion is 30 to 50 ml per
hour. This means that the infusion of a half-litre
bag would take at least 10 hours.
4. Possible Side Effects
If your kidneys are not working properly, your
Like all medicines, Mannitol 20% Infusion can
doctor may give you a test dose of the infusion.
cause side effects, although not everybody gets
The amount of urine you produce will then be
them.
measured. If your kidneys do not respond well
enough, you will be given a different treatment.

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If you have any of the following symptoms you
should tell your doctor or nurse immediately. These
may be signs of a very severe or even fatal allergic
reaction called anaphylactic shock:









– swelling of the skin of the face and throat
– difficulty breathing
– a low blood pressure
– skin rash
– hives.






You will be given treatment depending on the
symptoms.
The other side effects are listed according to their
frequencies.

thirst
feeling sick
vomiting
hives
cramps
production of a large volume of urine
damage to the kidney caused by medicines like
mannitol. This will be diagnosed during tests on
your urine
an inability to pass water
chills
chest pain
fever.

Uncommon (occurring in less than 1 of every 100
patients but in more than 1 of every 1,000 patients)
• too much or too little liquid in the body.
Your fluid balance will be monitored during
treatment
• imbalance in the concentrations of chemicals in
the blood. Your doctor will monitor this during
treatment
• a low blood pressure. Your blood pressure will
be measured during treatment
• inflammation of the vein with redness, swelling
and pain along the path of the vein.

Very rare (occurring in less than 1 of every
10,000 patients)
• heart failure associated with fluid on the lungs
and swelling of the ankles
• sudden onset of kidney failure, seen by a
marked decrease in urine production.

Rare (occurring in less than 1 of every 1,000
patients but in more than 1 of every 10,000
patients):
• not enough water in the body. Symptoms
include thirst, loss of appetite, fatigue and chills
• fluid collecting under the skin, usually around
the ankles
• headache
• convulsions
• dizziness
• an increase in pressure within the skull
• blurred vision
• an irregular heartbeat
• a high blood pressure. Your blood pressure will
be measured during treatment
• a build up on fluid in your lungs
• runny/itchy nose
• dryness of the mouth
• death of an area of skin

VIAFLEX containers should be stored within their
overpouch at a temperature between 20°C – 30°C

If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or nurse.
5. How Mannitol 20% Infusion is stored

Keep out of the reach and sight of children.
Do not remove Mannitol 20% Infusion from the
outer plastic bag until it is to be used.
Mannitol 20% Infusion should NOT be given to you
after the expiry date shown on the bag. The expiry
date refers to the last day of that month.
You should not be given Mannitol 20% Infusion if
there are particles in the solution or if the unit is
damaged in any way.
6. Further Information
This leaflet does not contain all the information
about this medicine. If you have any questions or
are not sure about any thing, ask your healthcare
professional.

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For information about Mannitol
20% Infusion or to request this
leaflet in formats such as audio
or large print please contact the
Marketing Authorisation Holder:
Tel: 01635 206345.

What Mannitol 20% Infusion contains
The active substance is mannitol.
The other ingredients are:
• water for injections
• sodium hydroxide.
Each 1000 ml of solution contains 200 grammes of
mannitol.
What Mannitol 20% Infusion looks like and
contents of the pack
• The solution is supplied in a plastic VIAFLEX
infusion bag made from PVC. The bag contains
either 200 ml, 250 ml, 500 ml or 1000 ml and is
sealed in a protective plastic overpouch.
Not all pack sizes may be marketed.

Baxter and Viaflex are trademarks of Baxter
International Inc.

Marketing Authorisation Holder and
Manufacturers
Marketing Authorisation Holder:
Baxter Healthcare Ltd.
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom
Send all enquiries to this address.
Mannitol 20% Infusion can be made at any of
these addresses:
Baxter Healthcare Ltd.
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom
Baxter S.A.
Boulevard René Branquart, 80
7860 Lessines
Belgium
Baxter Healthcare S.A.
Moneen Road
Castlebar
County Mayo
Ireland
This leaflet was last approved in 11/2009

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Mannitol Intravenous Infusion EP 20% w/v
The following information is intended for medical
or healthcare professionals only:
Handling and Preparation
The solution for infusion should be visually
inspected prior to use.
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.
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.
Additives may be introduced before infusion or
during infusion through the re-sealable medication
port. When additive is used, verify isotonicity 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 cooler temperatures the mannitol may form
crystals. Redissolve any crystallised mannitol
by warming in a water bath heated to 50 – 70ºC,
agitating the solution vigorously periodically.
Cool to 37ºC before infusion.
Discard after single use.
Discard any unused portion.

1. Opening
a. Remove the protective overpouch by tearing
down from notch and remove container.
b. Carefully straighten hanger and ports, if
necessary.
c. Squeeze container and inspect for minute leaks
and examine solution for visible particles or
cloudiness by viewing along seam.
d. Discard unit if leaks, particles or cloudiness are
evident.
2. Preparation for administration
Use sterile material for preparation and
administration.
a. Suspend container from base eyelet support.
b. Use an aseptic technique to prepare the
administration set.
c. Remove blue protector from outlet port and
insert set connector well into port.
d. Prime set and regulate administration as
required.
e. If administration set becomes blocked do not
pump contents back into container but replace
equipment.
f. Discard any unused portion and equipment
after use. Do not store or reconnect partly used
containers.
3. Techniques for injection of additive
medications
The VIAFLEX container has a second port with a
self-sealing rubber medication port designed for
the addition of medication using a syringe. This is
the only port for adding medication.
Warning: Additives may be incompatible.

To add medication before administration
a. Swab the medication port with the appropriate
Preparation for Administration
anti-bacterial fluid in line with current
The VIAFLEX container has an outlet port designed
recommended practice and procedure.
for an administration set with a short single
b. Using a syringe with a 20-22 gauge needle,
connector. If an administration set with a combined
puncture re-sealable medication port and
air inlet/fluid path connector has to be used,
inject. Do not leave the syringe and needle in
ensure the air inlet tube is always clamped off.
the port once the medication has been injected.
TH-30-01-388/UT2
7
Do not reconnect partially used bags.

c. Shake and squeeze the VIAFLEX container so
that the solution and medication are thoroughly
mixed. For high density medications such
as potassium chloride, squeeze both ports
while upright and invert the container several
times while shaking and squeezing to ensure
thorough mixing.

would normally not be longer than 24 hours at
2 to 8°C, unless reconstitution has taken place in
controlled and validated aseptic conditions.
5. Incompatibilities of additive medications
Mannitol 20% Solution for Infusion should not be
administered simultaneously with, before, or after
administration of blood through the same infusion
equipment, due to risk of pseudoagglutination.

Caution: Do not store bags containing added
medications.

WARNING: Additives may be incompatible. The
introduction of additives to any solution, regardless
of type of container, requires special attention to
assure that no incompatibilities result.

To add medication during administration
a. Close clamp on the set.
b. Disinfect medication port.
c. Using a syringe with a 20-22 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.

While some incompatibilities are readily observed,
it is important to be aware that subtle physical,
chemical and pharmacological incompatibilities
can occur. The medical literature, the additive
package insert and other available sources
of information should be reviewed for a more
thorough understanding of possible incompatibility
problems.
If, in the informed judgment of the physician, it is
deemed advisable to introduce additives into this
solution, aseptic technique must be employed.

Cautions
a. Do not vent.
b. Do not administer unless the solution is clear
and container undamaged.
c. Do not use in series connections as this could
result in air embolism due to residual air being
drawn from the primary container before
administration of fluid from the secondary
container is completed.
d. Discontinue infusion if adverse reaction occurs.
e. Rapid infusion may be harmful.
f. It is recommended that the intravenous
administration set be replaced at least once
every 24 hours. Details of the use of the set can
be recorded – record labels are available from
Baxter Healthcare Ltd.

It is recommended that medication is added only
under Pharmaceutical supervision.
Do not add medication before hanger and ports
have been straightened and the container
inspected.
Do not store solutions with added medication.
Before adding a drug, verify it is soluble and stable
in water at the pH of the Mannitol 20% Infusion
(4.5 to 7.0).
As a guide, the following medications are
incompatible with Mannitol 20% Infusion
(non-exhaustive listing)
• Cefepime
• Imipenem
• Cilastin
• Filgrastim.

4. In-use shelf life
Chemical and physical stability of any additive at
the pH of the Mannitol 20% Infusion in the VIAFLEX
container should be established prior to use.
From a microbiological point of view, the diluted
product should be used immediately. If not used
immediately, in-use storage times and conditions
prior to use are the responsibility of the user, and

The addition of potassium or sodium chloride to
Mannitol 20% Infusion may cause precipitation of
mannitol.
Baxter and Viaflex are trademarks of Baxter
International Inc.
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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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