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MESNA INJECTION

Active substance(s): SODIUM MERCAPTOETHANESULPHONATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Mesna Injection
Read all of this leaflet carefully before
you are given this medicine because it
contains important information for you.

Driving and using machines

Some of the side effects of treatment with
Mesna might affect your ability to drive and use
• Keep this leaflet. You may need to read it again. machines safely. Your doctor will decide if it is
safe for you to do so.
• If you have any further questions, ask your
doctor, nurse or pharmacist.
Important information about some of
• This medicine has been prescribed for you
the ingredients of Mesna
only. Do not pass it on to others. It may harm
This medicinal product contains approximately
them, even if their signs of illness are the same 59 mg of sodium per 400 mg of Mesna. To
as yours.
be taken into consideration by patients on a
• If you get any side effects, talk to your doctor,
controlled sodium diet.
or pharmacist or nurse. This includes any
What to do if you see a different doctor,
possible side effects not listed in this leaflet.
or have to go to hospital
See section 4.
If you see any other doctor or have to go to
Throughout this leaflet, Mesna Injection will be
hospital for any reason, tell them what medicines
called Mesna.
you are taking. Do not take any other medicines
What is in this leaflet:
unless your doctor knows you are taking Mesna.
1. What Mesna is and what it is used for
3 How Mesna is given
2. What you need to know before you are given
Mesna
Taking this medicine
3. How Mesna is given
Mesna can be given as an injection or by mouth.
4. Possible side effects
• When Mesna is given by injection, it will be
5. How Mesna is stored
given to you by a doctor or nurse. They will
6. Contents of the pack and other information
check the injection solution is not discoloured,
hazy or contain any particles before it is given
1 What Mesna is and what it is used
to you.
for
• When Mesna is given by mouth, it will be mixed
in a flavoured drink such as orange juice or
The name of your medicine is Mesna.
cola which will make it taste pleasant and
Mesna is used to help reduce and prevent
easier to swallow.
bleeding in the bladder (haemorrhagic cystitis)
• While you are taking Mesna you should drink
caused by cyclophosphamide and ifosfamide.
enough fluid every day to maintain a urine
Mesna helps to protect the lining of the bladder
output of 100 ml per hour.
from damage caused by these two drugs. The
• This helps to dilute your urine and keeps a
body breaks down these two drugs to form
good flow of urine. It will help to protect your
products that can harm the bladder. Mesna works
bladder. You should pass urine (empty your
by helping to make these breakdown products
bladder) as normal when you need to. Do not
less harmful. Mesna should only be given
try to change your usual pattern.
when you are also given cyclophosphamide or
The recommended usual dose
ifosfamide.
• Your doctor will decide how much of the
The damage to your bladder may show up as
medicine you will need and when you will need
blood in your urine. Very small amounts of blood
it. Always take the medicine exactly as your
may not be seen, so your doctor or nurse will
doctor tells you.
test your urine with a ‘dipstick’ or microscope to

The dose will depend on:
check for blood. If a larger amount of blood is in

the dose and timing of your treatment
your urine, you will notice that it is red and very
with
ifosfamide or cyclophosphamide
occasionally you may be able to see blood clots

if
ifosfamide
or cyclophosphamide is
in it.
being given to you as tablets or injection
– if you suffer from water infections
2 What you need to know before you
(urinary tract infections)
are given Mesna
– if you have ever had signs of
bladder damage from Ifosfamide or
You will not be given Mesna if:
Cyclophosphamide before
• you are allergic (hypersensitive) to Mesna or
– if you have had radiation therapy near
any of the other ingredients (listed in section
your bladder.
6). An allergic reaction can include shortness
of breath, wheezing, rash, itching or swelling of Use in children
Children generally urinate more frequently
the face and lips.
than adults. For children your doctor may need
If you are not sure if you are allergic talk to your
doctor, nurse or pharmacist before having Mesna. to shorten the interval between doses and/or
increase the number of individual doses.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before
you are given Mesna if:
• you have any problems with your immune
systems called ‘autoimmune’ disease, such
as rheumatoid arthritis or lupus, where your
body’s immune system attacks itself. Patients
with an autoimmune disease treated with
cyclophosphamide and Mesna could have an
increased risk of allergic (hypersensitivity)
reactions.
• you have experienced any side effects in
the past when given a thiol-containing
compound as there could be an increased
risk of experiencing side-effects with Mesna.
Examples of thiol-containing medicines are
amifostine (used to reduce the toxicity of some
chemotherapy products), penicillamine (used to
treat rheumatoid arthritis) and captopril (used
to treat hypertension or heart failure).
If any of these applies to you your doctor will only
give you Mesna following careful consideration of
the risks and benefits to you.

Using other medicines
Mesna is given with ifosfamide and
cyclophosphamide. It does not react with these
medicines, and is not known to react with any
others.
However, always tell your doctor, nurse or
pharmacist if you are taking or have recently
taken any other medicines. This includes
medicines you have obtained without a
prescription.

If you are not sure how you will be
given your injection or when you should
drink it, ask your doctor, nurse or
pharmacist.
If you take more Mesna than you should
It is unlikely that you will be given more Mesna
as an injection than you should, because it will
be given to you by a trained and qualified person.
They would stop the injection straightaway if too
much was given.
If you are drinking it, and think you have had too
much or if a child has swallowed any of your
medicine, talk to a doctor or go to a hospital
straight away. Always take the labelled medicine
container with you whether or not there is any
medicine left.
Taking too much of Mesna can cause symptoms
such as nausea, vomiting, abdominal pain,
diarrhoea, headache, fatigue, limb and joint
pains, rash, flushing, low blood pressure, slow or
irregular heartbeat, feeling of pins and needles
like tingling, fever, and breathing difficulties.
A specific antidote treatment for Mesna overdose
is not known.

If you forget to take Mesna

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Date

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• The most severe adverse reactions associated
with use of Mesna are:
• Anaphylaxis. Signs of this would be
shortness of breath, wheezing, rash,
itching or swelling of the face and
lips (hypersensitivity). Severe allergic
reactions could lead to difficulty in
breathing or shock, with a possible
fatal outcome (anaphylactic shock,
anaphylactic/anaphylactoid reaction).

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Tell your doctor straight away, if you
notice any of the following side effects,
you may need urgent medical attention:

Country

Food does not affect the absorption and urinary
elimination of Mesna.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Some of these side effects may be caused by
cyclophosphamide or ifosfamide rather than
Mesna, as they are always taken together.

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Mesna with food, drink and alcohol

4 Possible side effects

EMEA ARTWORK DESIGN CENTRE

Mesna does not prevent the damage to the lining
of the bladder in all patients. Your doctor or nurse
will want to check your urine regularly for blood
with a special ‘dipstick’ or look at it under a
microscope.
Tell your doctor, nurse or pharmacist if you
are having any other urine tests because your
medicines can affect the results. ‘Dipstick’ and
other types of tests frequently used to monitor
diabetes can be used to detect ‘ketones’ or
Vitamin C levels in your urine. Mesna can
interfere with these types of urine tests.
Mesna can also interfere with the results
of certain laboratory tests for the creatine
phosphokinase (CPK) enzyme. Your doctor or
nurse are aware of this interference and different
test methods will be used while you are receiving
Mesna.

DATE 24 Oct 2014

It is very important to have Mesna at the times
your doctor has told you:
these times will have been carefully worked out
to make sure that your bladder is fully protected
against damage.
• If you are being given an injection by a doctor
or nurse, it is very unlikely that you will miss
Pregnancy, breast-feeding and fertility
a dose. If you think that you have missed an
Mesna is only taken with ifosfamide and
injection, talk to your doctor or nurse as soon
cyclophosphamide. If you are pregnant and your
as possible.
doctor thinks that you need treatment with these • If you are being given Mesna as drink and you
medicines, you will also need to have Mesna.
miss a dose, drink it as soon as you remember
Discuss pregnancy with your doctor before
and talk to your doctor or nearest hospital
having this medicine.
immediately for advice.
Do not breast-feed while being treated with these If you have any further questions on the use of
medicines.
this medicine, ask your doctor, pharmacist or
Tests while you are being given Mesna nurse.

5 How Mesna is stored
• Keep this medicine out of the sight and reach
of children.
• Do not use this medicine after the expiry date
which is stated on the label after EXP. The
expiry date refers to the last day of that month.
• Do not store the ampoules above 30ºC. Keep
them in the outer carton to protect them from
light.
• If Mesna has been mixed for drinking, store the
mixture in a fridge in a sealed container for no
longer than 24 hours.
Medicines should not be disposed of via
wastewater or household waste. If you have
some Mesna in a drink left over, take them back
to your hospital. These measures will help protect
the environment.

6 Contents of the pack and other
information
What Mesna contains
• The active substance is mesna and each
ampoule contains 400 mg in 4 ml or 1000 mg
in 10 ml.
• The other ingredients are: Disodium edetate,
sodium hydroxide, sterile water (called ‘water
for injections’).

What Mesna looks like and contents of
the pack
The injection is a clear, colourless, sterile solution
and is supplied in 4 ml and 10 ml clear glass
ampoules. Each carton contains 15 ampoules.

Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation holder is:
Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom
Send all enquiries to this address.
Mesna is manufactured by:
Baxter Oncology GmbH
Kantstrasse 2
33790 Halle/Westfalen
Germany

This leaflet was last revised in 07/2014
For information about Mesna Injection
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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Date

Signature

Name

ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

Country

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Baxter is a trademark of Baxter International Inc.

DATE 24 Oct 2014

Blood and Lymphatic System
• swollen/enlarged lymph nodes
(lymphadenopathy).
Metabolism and Nutrition
• decreased appetite,
• feeling dehydrated.
Psychiatric
• insomnia,
• nightmares.
Nervous System
• dizziness,
• fainting (syncope),
• sensation of tickling, tingling, burning,
pricking (paresthesia),
• increased or abnormally painful
sensitivity to touch (hyperesthesia),
• reduced sensitivity to touch
(hypoesthesia),
• disturbance in paying attention.
Eyes
• blurred sight,
• sensitivity to light,
• inflammation of the eye (conjunctivitis).
Heart and Circulation
• changes in your heartbeat (palpitation),
• faster heart beat (tachycardia),
• low blood pressure (hypotension).
Lungs
• nasal congestion,
• cough,
• severe, sharp pain when breathing in
(pleuritic pain),
• dry mouth,
• difficulty in breathing or wheezing
(bronchospasm),
• shortness of breath (dyspnea),
• vocal cord discomfort (laryngeal
discomfort),
• nosebleeds (epistaxis),
• severe difficulty breathing (respiratory
distress),
• decrease levels of oxygen in your body
(hypoxia).
Digestive system
• irritation of the lining of the mouth and
digestive system (mucosal irritation),
• flatulence,
• burning pain in the area of the stomach,
• constipation,
• bleeding gums.
Liver
• increased levels of certain proteins
produced by your liver called enzymes
(increased transaminases). Your doctor
will do blood tests to test for these.
Skin and Subcutaneous Tissue
• itching (pruritus),
• excessive sweating (hyperhidrosis),
• itchy, red rash which can develop in to
sores (erythema multiforme, erythema),
• ulceration or blistering,
• swelling of the deeper layers of the
skin, caused by a build-up of fluid
(angioedema),
• skin rash notable for pale red, raised,
itchy bumps (urticaria),
• burning sensation.
Musculoskeletal and Connective Tissue
• muscle or joint pain (myalgia, arthralgia),
• back pain,
• pain in hands or feet (pain in extremity),
• jaw pain.
Renal and Urinary
• painful urination (dysuria),
• kidney failure (acute renal failure).
General Disorders and Administrative Site
Conditions
• chills (rigors),
• chest pain,
• swelling of the face (face oedema),
• swelling of tissues, usually in the lower
limbs, due to the accumulation of fluids
(oedema peripheral),
• muscle weakness (Asthenia).
If you get any side effects, talk to your doctor,
nurse or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly (see details below). By
reporting side effects you can help provide more
information on the safety of this medicine.

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www.mhra.gov.uk/yellowcard

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Other possible side effects include:

UK

EMEA ARTWORK DESIGN CENTRE

• Bullous skin reactions which are life
threatening conditions which cause:
– rash,
– ulcers,
– sore throat,
– fever,
– conjunctivitis,
– blistering of the skin.
• Drug rash with eosinophilia and
systemic symptoms (DRESS) which is a
life threatening hypersensitivity reaction
to drugs which can cause:
– rash,
– fever,
– pain and swelling of internal organs,
– swollen and tender lymph nodes,
– changes in blood cells (eosinophilia).
• The most frequently occurring adverse
reactions associated with use of Mesna, are:
• feeling sick, headache, diarrhoea,
• fever, flushing, rash,
• infusion site reactions such as pain,
swelling, itching, redness or rash around
the injection site,
• waves of sudden abdomen or stomach
pain (colic),
• light headedness, lack of energy,
tiredness,
• flu-like illness.
If you are actually sick (vomit) after taking Mesna
as a drink, you may need to have Mesna by
injection instead.

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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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