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MANNITOL 10% SOLUTION FOR INFUSION

Active substance(s): MANNITOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Mannitol 10% Solution for Infusion BP
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.
• 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 any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.

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

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In this leaflet:
1. What Mannitol 10% Infusion is and
what it is used for
2. Before you take Mannitol 10% Infusion
3. How to use Mannitol 10% Infusion
4. Possible side effects
5. How to store Mannitol 10% Infusion
6. Further information

ARTWORK APPROVAL

This medicine is called 'Mannitol 10%
Solution for Infusion BP’, but will be referred
to as 'Mannitol 10% Infusion' throughout the
remainder of this leaflet.

EUROPEAN LABELLING CENTRE

Mannitol 10% Infusion is used to:
• produce an increase in your urine
production (a diuresis) when your kidneys
are not working properly (acute kidney
failure). 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 (oedema). 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 (intraocular
pressure). 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.

DATE 19 Sep 2011

Mannitol 10% 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.

• 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
(e.g. an injury causing a fracture of the
skull).

2. Before you take Mannitol 10%
Infusion
You must NOT receive Mannitol 10%
Infusion if you are suffering from any
of the following conditions:

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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 (central venous
pressure)
• the amount of chemicals such as sodium
and potassium in your blood and urine
(electrolytes).

EUROPEAN LABELLING CENTRE

Please tell your doctor if you have or have
had any of the following medical conditions:
• 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). Your doctor will know if any of
the medicines you are taking could affect
your kidneys
• a medical condition where there is
inadequate supply of blood to the tissues
(shock)
• heart failure
• a low level of sodium (salt) in your blood
(hyponatremia)
• not enough water in your body
(dehydration)
• a low volume of blood in your blood
vessels (hypovolaemia).

DATE 19 Sep 2011

Take special care with Mannitol 10%
Infusion

• if you are allergic (hypersensitive) to
mannitol or any of the other ingredients of
Mannitol 10% Infusion
• if you have a high concentration of salts
in your blood (hyperosmolarity). 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
(diuretics)
– kidney disease
In this situation, Mannitol can cause the
osmolarity of the blood to increase even
more.
• if you are severely dehydrated (a loss of
water from the body, 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 (anuria)
• if you have severe heart failure (heart
disease that is difficult to control with
medicines)
• if you have a build up of fluid in the lungs
(pulmonary oedema) associated with
heart failure
• if you have bleeding inside the skull
(active intracranial bleeding), except
during an operation on the skull
(craniotomy)

Using Mannitol 10% Infusion with
food and drink

Your doctor will take into account if you are
receiving parenteral nutrition (nutrition given
by infusion into a vein). During long term
treatment with Mannitol 10% Infusion you
may need to be given extra nutrition.

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

Pregnancy and breast-feeding

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.

Ask your doctor or pharmacist before taking
any medicine.
Please tell your doctor if you are pregnant or
breast-feeding.

Taking other medicines

Mannitol 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.

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

ARTWORK APPROVAL

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

EUROPEAN LABELLING CENTRE

3. How to use Mannitol 10%
Infusion

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DATE 19 Sep 2011

Mannitol 10% Infusion does not affect your
ability to drive or use machines.

The following medicines are known to affect
or be affected by Mannitol 10% 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
transplant)
• lithium (used for mental disorders)
• aminoglycosides (a type of antibiotic)
• depolarising neuromuscular blocking
drugs (drug 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)
• methotrexate (a medicine used in the
treatment of cancer and certain diseases
of the immune system).

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Driving and using machines

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Some medicines can affect or be affected by
Mannitol 10% Infusion. If you are taking any
of these medicines, it may be necessary to
change the dose.

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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 10%
Infusion during pregnancy or breast-feeding if
it is essential.

Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.

The normal speed of infusion is 30 to 50 ml
per hour. This means that the infusion of a
500 ml bag would take at least 10 hours.

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

If your kidneys are not working properly,
your doctor may give you a test dose of the
infusion. The amount of urine you produce
will then be measured. If your kidneys do
not respond well enough, you will be given a
different treatment.

Stopping your Mannitol 10% Infusion
Your doctor will decide when to stop giving
you this infusion.

Mannitol 10% Infusion can also be used in
children and in the elderly (over 65 years
of age). Your doctor will adjust the dose as
necessary.

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

4. Possible side effects

If you receive more Mannitol 10%
Infusion than you should

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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
(fluid imbalance)
• imbalance in the concentrations of
chemicals in the blood (electrolyte
imbalance)
• a low blood pressure (hypotension)

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.

1st DRAFT

The other side effects are listed according to
their frequencies.

ARTWORK APPROVAL

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 hypersensitivity (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).
You will be given treatment depending on the
symptoms.

EUROPEAN LABELLING CENTRE

If you are given too much Mannitol 10%
Infusion (over-infusion) or it is given too fast,
this may lead to the following symptoms:
• too much blood in the blood vessels
(hypervolaemia)
• your blood may become too acid
(acidosis) the symptoms of acidosis
include drowsiness, feeling and being sick
and acetone smelling breath
• headache
• feeling sick (nausea)
• shivering, but without fever.
• confusion
• tiredness
• fits
• reduced consciousness (stupor) and
unconsciousness (coma).

DATE 19 Sep 2011

Like all medicines, Mannitol 10% Infusion can
cause side effects, although not everybody
gets them.

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
(congestive heart failure)
• sudden onset of kidney failure, with a
marked decrease in urine production
(acute renal failure).

• inflammation of the vein with redness,
swelling and pain along the path of the
vein (thrombophlebitis).
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
(dehydration)
• fluid collecting under the skin, usually
around the ankles (oedema)
• headache
• convulsions (seizures)
• dizziness
• an increase in pressure within the skull
(raised intracranial pressure)
• blurred vision
• an irregular heartbeat (cardiac
arrhythmia)
• a high blood pressure (hypertension)
• pulmonary congestion
• fluid on the lung (pulmonary oedema)
• runny/itchy nose (rhinitis)
• dryness of the mouth
• death of an area of skin (skin necrosis)
• thirst
• feeling sick (nausea)
• vomiting
• hives (urticaria)
• cramps
• production of a large volume of urine
(excessive diuresis)
• damage to the kidney (osmotic nephrosis)
• an inability to pass water (urinary
retention)
• chills
• chest pain (oppressive pain in the middle
of the chest)
• fever.

Please tell your doctor or nurse if you notice
any listed or unlisted side effects. If any side
effects occur, the infusion must be stopped.

5. How to store Mannitol 10%
Infusion

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Product name,strength,composition
(API & excipients)

Consistency check with all figures
cited in the product information

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per RA SOP CE-RAPV-009

Compliance with National
Regulations

Barcodes, Symbols and Reimbursement Information

Date

Signature

Name

Country

1st DRAFT

ARTWORK APPROVAL

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

EUROPEAN LABELLING CENTRE

Mannitol 10% Infusion should NOT be given to
you after the expiry date which figures on the
bag. The expiry date refers to the last day of
that month.

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DATE 19 Sep 2011

Do not remove Mannitol 10% Infusion from
the outer plastic bag until it is to be used.

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Keep out of the reach and sight of children.

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This product should not be refrigerated or
frozen.

Baxter Healthcare Ltd.
Caxton Way
Thetford Norfolk IP24 3SE
United Kingdom
Bieffe Medital Sabiñánigo
Ctra de Biescas-Senegüé
22666 Sabiñánigo (Huesca)
Spain
Baxter Healthcare S.A.
Moneen Road
Castlebar
County Mayo
Ireland

6. Further information
What Mannitol 10% Infusion
contains
The active substance is mannitol.
The only other ingredient is water for
injections.
Each 1000 ml of solution contains
100 grammes of mannitol.

What Mannitol 10% Infusion looks
like and contents of the pack

Manufacturers:
Baxter SA
Boulevard R. Branquart, 80
7860 Lessines
Belgium

Baxter and Viaflo are trademarks of
Baxter International lnc.

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(API & excipients)

Consistency check with all figures
cited in the product information

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per RA SOP CE-RAPV-009

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Regulations

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Marketing Authorisation Holder:
Send all enquiries to this address
Baxter Healthcare Ltd.
Caxton Way
Thetford Norfolk IP24 3SE
United Kingdom

Country

Marketing Authorisation Holder and
Manufacturers

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Not all pack sizes may be marketed.

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EUROPEAN LABELLING CENTRE

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

ARTWORK APPROVAL

The bag sizes are:
• 250 ml
• 500 ml

DATE 19 Sep 2011

For information about Mannitol
10% Infusion or to request this
leaflet in formats such as audio
or large print please contact
the Marketing Authorisation
Holder:
Tel: 01635 206345.

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This leaflet was last approved in
September 2011.

Mannitol 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.

b
MANNITOL 10% W/V SOLUTION FOR INFUSION BP
The following information
is intended for medical or
healthcare professionals only:

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

In cooler temperatures the mannitol may
form crystals. Redissolve any crystallised
mannitol by warming in a water bath
heated to 50 – 70°C, agitating the solution
vigorously periodically. Cool to 37°C before
infusion.

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Regulations

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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.

EUROPEAN LABELLING CENTRE

2. Preparation for administration

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DATE 19 Sep 2011

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.

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.
Thorough and careful aseptic mixing of any
additive is mandatory. Solutions containing
additives should be used immediately and not
stored.

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1. Opening

Handling and Preparation

3. Techniques for injection of
additive medications

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.
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 would normally
not be longer than 24 hours at 2 to 8°C,
unless reconstitution has taken place in
controlled and validated aseptic conditions.

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.
Caution: Do not store bags containing added
medications.

Baxter and Viaflo are trademarks of
Baxter International lnc.

F

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Product name,strength,composition
(API & excipients)

Consistency check with all figures
cited in the product information

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Product Information proofread as
per RA SOP CE-RAPV-009

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Regulations

Barcodes, Symbols and Reimbursement Information

Date

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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.

EUROPEAN LABELLING CENTRE

Mannitol 10% 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.
Incompatibility of the medicinal product to
be added with the solution in the VIAFLO
container must be assessed before addition.
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 10% may cause precipitation of
mannitol.

DATE 19 Sep 2011

5. Incompatibilities of additive
medications

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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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