Skip to Content

MANNITOL 15% W/V SOLUTION FOR INFUSION

Active substance(s): MANNITOL

PDF options:  View Fullscreen   Download PDF

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER
Mannitol 15% w/v Solution for Infusion
mannitol
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 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.

Mannitol 15% Infusion is used to:
• Produce an increase in your urine
production (diuresis) when your kidneys
are not working properly
• Reduce the pressure within the skull
caused by an accumulation of liquid
within the brain (oedema) or after a head
injury
• Reduce pressure in the eye (intraocular
pressure)
• Treat certain types of poisoning or drug
overdose

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

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%
Infusion
4. Possible side effects
5. How to store Mannitol 15% Infusion
6. Contents of the pack and other
information

Do not receive Mannitol 15%
Infusion
• If you are allergic to mannitol.
• 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).

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

• if you have a build-up of fluid in the lungs
(pulmonary oedema) associated with heart
failure

Mannitol 15% Infusion is a solution of
mannitol in water.

SA-30-02-087
1a

• If you have bleeding inside the skull
(active intracranial bleeding) or if you have
some type of recent, severe head injury.

These tests may include:
• 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 (central venous
pressure).
• The amount of chemicals, such as sodium
and potassium, in your blood and urine
(electrolytes).
• The acidity of your blood and urine (your
acid-base balance).

• If you fail to respond to test dosing, which
your doctor or nurse will give you (see section
3).
• If your kidney function worsens after
initiating mannitol treatment.

If you are unsure whether you are
affected by any of the conditions
above, please ask your doctor.
Warnings and precautions

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.

Talk to your doctor before receiving
Mannitol 15% Infusion
• If you have kidney disease or poor kidney
function.
• 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 dizziness.
• If you have been told by your doctor you
have a low level of sodium (salt) in your
blood (hyponatremia).
• If you have an allergy to mannitol (as
mannitol is found in nature and is
used in other medical products, you
may have 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.

Other medicines and Mannitol 15%
Infusion
Tell your doctor or nurse if you are using,
have recently used or might use any other
medicines.
The following medicines are known to affect
or be affected by Mannitol Baxter Viaflo.
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
transplant).
• 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 anaesthetist.
• Oral anticoagulants (medicines to thin the
blood, for example warfarin).
• Digoxin (a heart medicine).

When monitoring is required your doctor may
want to carry out tests to ensure that your
dose is sufficient.

SA-30-02-087
2a

Mannitol 15% Infusion with food,
drink and alcohol

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.

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

If you receive more Mannitol 15%
Infusion than you should

Pregnancy and breast-feeding
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 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) , fluid in the
abdomen (ascites) and 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).

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.

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

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. 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.

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

Stopping your Mannitol 15% Infusion
Your doctor will decide when to stop giving
you this infusion.

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.

SA-30-02-087
3a

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






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





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:
• Difficulty breathing.
• A low blood pressure (hypotension).
• Swelling of the skin of the face and throat.
• Hives (urticaria).
• Skin rash.
You will be given treatment depending on the
symptoms.







Other side effects that you may experience
include:
• Damage to the kidneys, which might
cause difficulty with passing water or
decreased or increased amount of urine
being passed.
• Presence of blood in the urine.
• Heart failure.
• High blood pressure.
• A rapid or irregular heartbeat
(palpitations, cardiac arrhythmia).
• Excess fluid on the lungs causing
shortness of breath.
• Coma, convulsions, confusion or tiredness
(lethargy) due to damage to the central
nervous system.
• Swelling of ankles, fingers or face due to
build up of fluid in the body.
• Dehydration.
• Increased or decreased amounts of
potassium and/or sodium in your blood.



Dryness of the mouth, thirst.
Nausea, vomiting.
Feeling sick (malaise)
Increased amounts of acid in your blood
(metabolic acidosis, see “If you receive
more Mannitol Baxter Viaflo than you
should” in section 3).
Chest pain.
Chills, fever.
An increase in pressure within the skull
(raised intracranial pressure), causing
headeaches, feeling sick (nausea), being
sick (vomiting), back pain, blurred vision
and other changes to your sight, such as
difficulty moving your eyes (ocular palsy).
Dizziness, headache, fatigue and
weakness (asthenia)
Cramps.
Blurred vision.
Runny nose.
Skin necrosis.
Reactions due to the administration
technique may include swelling, pain,
itching, rash or redness at the infusion
site or along the path of the vein.
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).

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.
SA-30-02-087
4a

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

6. Contents of the pack and
other information
What Mannitol 15% Infusion
contains

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

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

5. How to store Mannitol 15%
Infusion

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 overpouch.

This product should not be refrigerated or
frozen.

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

Keep this medicine out of the sight and reach
and of children.
Do not remove Mannitol 15% Infusion from
the outer plastic bag until it is to be used.

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

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:

Not all pack sizes may be marketed.

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.

SA-30-02-087
5a

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

This leaflet was revised in
June 2016
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.
Baxter and Viaflo are trademarks of
Baxter International lnc.

SA-30-02-087
6a

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

Mannitol solutions may crystallize when
exposed to low temperatures. At higher
concentrations, the 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 re-inspection for
crystals and use.

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
considered.
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 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%
Infusion.
Additives may be introduced before infusion or
during infusion through the re-sealable medication
port.
Thorough and careful aseptic mixing of any
additive is mandatory. Solutions containing
additives should be used immediately and not
stored.
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.

Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.

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.

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.
SA-30-02-087
1b

immediately, in-use storage times and conditions
prior to use are the responsibility of the user.

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.

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

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

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
exhaustive.
The addition of potassium or sodium chloride to
Mannitol 15% Infusion may cause precipitation of
mannitol.

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.

4. In-use shelf-life: Additives
Chemical and physical stability of any additive at
the pH of Mannitol solution in the Viaflo container
should be established prior to use.

Baxter and Viaflo are trademarks of
Baxter International lnc.

From a microbiological point of view, the diluted
product should be used immediately. If not used

SA-30-02-087
2b

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide