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Active substance(s): MANNITOL

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Mannitol 15% Infusion Solution for Infusion

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
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• 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.

• reduce pressure in the eye (intraocular
• treat certain types of poisoning or drug

2. What you need to know before
you are given Mannitol 15%









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Edge Code
Trademark Y N NA

Mannitol 15% Infusion is used to:
• produce an increase in your urine production
(diuresis) when your kidneys are not working
• reduce the pressure within the skull caused
by an accumulation of liquid within the brain
(oedema) or after a head injury.

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If you are unsure if you are affected by
any of the conditions above, please
ask your doctor.

Mannitol 15% Infusion is a solution of mannitol in

Date: 07 OCT 2015

1. What Mannitol 15% Infusion
is and what it is used for

Artworker: Elise Mahieu

What is in this leaflet:
1. What Mannitol 15% Infusion is and what it
is used for
2. What you need to know before you are
given Mannitol 15% Infusion
3. How you will be given Mannitol 15%
4. Possible side effects
5. How to store Mannitol 15% Infusion
6. Contents of the pack and other information


• if you are allergic to mannitol Mannitol 15%
• if you have a high concentration of salts in
your blood
• if you are severely dehydrated,). if your
kidneys cannot produce urine if you have
severe heart disease (heart failure)
• if you have a build-up of fluid in the lungs
(pulmonary oedema) associated with heart
• if you have bleeding inside the skull (active
intracranial bleeding) or if you have some
types of recent, severe head injury,
if you failed to respond to test dosing that your
doctor or nurse will give you (see section 3)
• if your kidney function worsen after initiating
mannitol treatment

Draft: 1st

Do not receive Mannitol 15% Infusion

Warnings and precautions


Talk to your doctor before receiving
Mannitol 15% Infusion

The following medicines are known to affect or be
affected by Mannitol 15% Infusion. Please tell your
doctor if you are taking any of these medicines:
• diuretics (water tablets, to increase the
amount of urine you produce)
• ciclosporin (used to prevent rejection of a
• lithium (used for mental disorders)
• aminoglycoside (a type of antibiotic)
• depolarising neuromuscular blocking drugs
(used during anaesthesia to cause muscle
paralysis). These will be controlled by your
• oral anticoagulants (medicines to thin the
blood, for example warfarin)
• digoxin (a heart medicine)

• if you have kidney disease or poor kidney
• if you are receiving medicines which may be
harmful to your kidneys (for example, certain
antibiotics or anticancer medicines).
• if you are severely dehydrated (a loss of water
from the body, e.g. due to vomiting, diarrhoea,
profuse sweating or certain medications).
Symptoms will include dry mouth and
• if you have been told by your doctor you
have a low level of sodium (salt) in your blood
• if you have allergy to mannitol (as mannitol
is found in the nature and is used in other
medical products you may had developed
sensitivity to this substance without having
received intravenous treatment with mannitol).
The infusion must be stopped if any signs of
hypersensitivity develop, see section 4.

Mannitol 15% Infusion with food, drink
and alcohol
You should ask your doctor about what you can eat
or drink.

Pregnancy and 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 15% Infusion during
pregnancy or breast-feeding if it is clearly needed.


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.

When monitoring is required your doctor may
want to carry out tests to ensure that your dose is
sufficient. These tests may include:
• how well your heart, lungs and kidneys are
• 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 (central venous pressure)
• the amount of chemicals such as sodium
and potassium in your blood and urine
• the acidity of your blood and urine (your acidbase balance)

Driving and using machines

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.

3. How you will be given
Mannitol 15% Infusion
Your doctor will decide on how much you need
and when it is to be given. The doctor(s) make
the decision based on your age, weight, medical
condition and the medicine(s) you are taking.

Other medicines and Mannitol 15%
Tell your doctor or pharmacist if you are using,
have recently used or might use any other

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There is no information of the effects of this
product on the ability to drive or operate other
heavy machinery.

Stopping your Mannitol 15% Infusion

Mannitol 15% Infusion will usually be given to you
through infusion line that accesses your vein. If
your kidneys are not working properly, your doctor
may give you a small amount of the solution as a
test dose. The amount of urine you produce will
then be measured. If your kidneys don’t produce
more urine as a response to the test dose, you will
be given a different treatment.

Your doctor will decide when to stop giving you
this infusion.
If you have any further questions on the use of this
medicine, ask your doctor.

4. Possible side effects

Mannitol 15% Infusion can also be used in children
and the elderly (over 65 years of age). Your doctor
will adjust the dose as needed.

Like all medicines, Mannitol 15% Infusion can
cause side effects, although not everybody gets

You should NOT be given Mannitol 15% Infusion
if there are particles floating in the solution or if
the pack is damaged in any way.

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 (hypotension)
• skin rash
• hives (urticaria)

If you receive more Mannitol 15%
Infusion than you should
If you are given too much Mannitol 15% Infusion
(over-infusion) or if it is given too fast, this may
lead to the following symptoms:
• too much blood in the blood vessels
(hypervolaemia). The symptoms include
swelling in the arms and legs (peripheral
oedema), difficulty breathing (pulmonary
oedema and dyspnea) and fluid in the
abdomen (ascites), imbalances of chemicals in
your body (electrolytes imbalance)
• your blood may become too acid (acidosis).
• headache
• feeling sick (nausea)
• shivering
• confusion
• tiredness
• fits (seizures)
• reduced consciousness (stupor) and
unconsciousness (coma).
• kidney failure (acute renal failure)



If a medication has been added to Mannitol 15%
Infusion you should read the Patient Information
Leaflet of the added medicine for a list of possible


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.


Other side effects that you may experience
• Damage to the kidney, causing difficulty with
passing water or affecting the amount of
water being passed
• Heart failure
• Shortness of breath
• Headache
• convulsions (seizures)
• Coma
• Chest pain
• High blood pressure (hypertension)
• Swelling of ankles, fingers or face due to
build-up of fluid in the body
• Dizziness
• An increase in pressure within the skull (raised
intracranial pressure), causing headaches,
feeling sick (nausea), being sick (vomiting),
back pain, blurred vision and other changes to
your sight, such as difficulty moving your eyes
(ocular palsy).
• An irregular heartbeat (cardiac arrhythmia)

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You will be given treatment depending on the

outer plastic bag until it is to be used.

• Dryness of the mouth
• Dehydration
• Fatigue and weakness
• Vomiting
• Swelling, pain, itching, rash or redness at the
infusion site or along the path of the vein
• Fever
• Chills
• Thirst
• Cramps
• Escape of the infusion solution into the tissues
around the vein (extravasation). This might
cause swelling and pain at the injection site. In
severe cases, the blood flow will be decreased
and the surrounding tissue will be injured
(compartment syndrome).

Mannitol 15% 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.
After opening, with or without additives:
From a microbiological point of view, the
product should be used immediately. If not used
immediately, in-use storage times and conditions
prior to use are the responsibility of the user.
You should not be given Mannitol 15% Infusion if
there are particles floating in the solution or if the
unit is damaged in any way.

6. Contents of the pack and
other information

If any of these side effects occur consult your
health care professional.

What Mannitol 15% Infusion contains

Reporting of side effects

The active substance is mannitol.
The only other ingredient is water for injections.
Each 1000 ml of solution contains 150 grams of

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.

5. How to store Mannitol 15%

Not all pack sizes may be marketed.

This product should not be refrigerated or frozen.
Keep this medicine out of the sight and reach and
of children.
Do not remove Mannitol 15% Infusion from the


The bags are supplied in cartons. Each carton
contains one of the following quantities:
• 50 bags of 100 ml
• 30 bags of 250 ml
• 20 bags of 500 ml

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


HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.


Mannitol 15% 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

United Kingdom:
Via the Yellow Card Scheme at:


What Mannitol 15% Infusion looks like
and contents of the pack

Marketing Authorisation Holder and
Marketing Authorisation Holder:
Baxter Healthcare Ltd.
Caxton Way
Norfolk – IP24 3SE
United Kingdom
Baxter Healthcare Ltd.
Caxton Way
Norfolk – IP24 3SE
United Kingdom
Baxter S.A.
Boulevard R. Branquart, 80
7860 Lessines
Bieffe Medital S.A.
Ctra de Biescas-Senegüé
22666 Sabiñànigo (Huesca)
Baxter Healthcare S.A.
Moneen Road
County Mayo




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For information about Mannitol 15% 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.


This leaflet was revised in August 2015







Version: 00

Baxter and Viaflo are trademarks of
Baxter International lnc.

Mannitol 15% Infusion Solution for Infusion
The following information is
intended for medical or healthcare
professionals only:

solutions have a greater tendency to crystallize.
Inspect for crystals prior to administration. If
crystals are visible, re-dissolve by warming the
solution up to 37°C, followed by gentle agitation.
Solutions should not be heated in water or in a
microwave oven due to the potential for product
contamination or damage. Allow the solution
to cool to room or body temperature before reinspection for crystals and use.
Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.

Handling and Preparation

Use only if the solution is clear, without visible
particles or discoloration and if the container is
undamaged. Administer immediately following
the insertion of infusion set which includes a final
in-line filter because of the potential for mannitol
crystals to form.
Hyperosmolar mannitol solutions may cause vein
damage. The osmolarity of the solution should be
Do not remove unit from overwrap until ready for
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 through a
sterile and non-pyrogenic administration set which
includes a filter and using an aseptic technique.
The equipment should be primed with the solution
in order to prevent air entering the system.
Additives may be incompatible with Mannitol 15%
Additives may be introduced before infusion or
during infusion through the re-sealable medication
Thorough and careful aseptic mixing of any
additive is mandatory. Solutions containing
additives should be used immediately and not
Adding other medications or using an incorrect
administration technique may cause febrile
reactions due to possible introduction of pyrogens.
In case of an adverse reaction, infusion must be
stopped immediately.

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.

Mannitol solutions may crystallize when exposed
to low temperature. At higher concentrations, the





Use sterile material for preparation and
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
d. Attach administration set. Refer to
complete directions accompanying set
for connection, priming of the set and
administration of the solution.

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2. Preparation for administration

3. Techniques for injection of additive

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

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

The Instructions for Use of the medicinal product
to be added must be consulted.
Before adding a medicinal product, verify it
is soluble and stable in water at the pH of the
mannitol solution (4.5 to 7.0). As a guide, cefepime,
imipenem, cilastin and filgrastim are incompatible
with mannitol solutions, but this list is not
The addition of potassium or sodium chloride to
Mannitol 15% Infusion may cause precipitation of

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.



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
f. Mix solution and medication thoroughly.
g. Return container to in use position,
re-open the clamp and continue


Caution: Do not store bags containing added

4. In-use shelf-life: Additives

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Chemical and physical stability of any additive at
the pH of Mannitol solution in the Viaflo 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.

5. Incompatibilities of additive
Mannitol 15% Infusion should not be administered
simultaneously with, before, or after administration
of blood through the same infusion equipment,
due to risk of pseudoagglutination. Incompatibility

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.