DESFERRIOXAMINE MESILATE 500MG POWDER FOR INJECTION

Active substance: DESFERRIOXAMINE MESILATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Desferrioxamine Mesilate 500 mg Powder for Injection
Desferrioxamine Mesilate 2 g Powder for Injection
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.
In this leaflet:
1. What Desferrioxamine Mesilate Powder for Injection is and what it is
used for
2. Before you use Desferrioxamine Mesilate Powder for Injection
3. How to use Desferrioxamine Mesilate Powder for Injection
4. Possible side effects
5. How to store Desferrioxamine Mesilate Powder for Injection
6. Further information

1. WHAT DESFERRIOXAMINE MESILATE POWDER FOR INJECTION
IS AND WHAT IT IS USED FOR
Desferrioxamine mesilate is a binding agent for iron and aluminium.
Desferrioxamine mesilate is used to remove excess iron or aluminium from
the body in patients with conditions such as iron poisoning, thalassaemia
(a hereditary type of anaemia) haemochromatosis (a disorder of iron
metabolism) and aluminium overload due to kidney failure. It may also be
used to diagnose iron storage disease and some types of chronic anaemias
or aluminium overload in some patients.

2. BEFORE YOU USE DESFERRIOXAMINE MESILATE POWDER FOR
INJECTION
You should not be given desferrioxamine mesilate


if you have shown signs of hypersensitivity (severe allergy) to
desferrioxamine mesilate in the past and you have not had treatment to
prevent (desensitise you to) this reaction.
Tell your doctor or pharmacist if the above applies to you before this
medicine is used.

Take special care with desferrioxamine mesilate if




you have problems with your kidneys or are on dialysis
you have problems with fits due to high levels of aluminium in the brain
you have had problems with your sight or hearing during previous
treatments with desferrioxamine mesilate
• you are due to have a radiography scan (some radiography scans may
be spoilt if desferrioxamine mesilate is used before the scan)
• you have hyperparathyroidism (a condition affecting calcium in the
blood)
• this medicine is given to a young child (under the age of 3 years). The
doctor may want to monitor the child’s growth regularly as it may be
affected by this medicine.
• your doctor has told you that aluminium has resulted in fits. If so,
you may be given a dose of clonazepam before you are given
desferrioxamine mesilate.
Tell your doctor or pharmacist if any of the above applies to you before this
medicine is used.

Taking/using other medicines
Special care is needed if you are taking/using other medicines as some
could interact with desferrioxamine mesilate, for example:
• vitamin C supplements can help desferrioxamine mesilate remove iron
from the body, but may cause heart problems in some patients. Do not
take vitamin C supplements during the first month of desferrioxamine
treatment
• the side effects of prochlorperazine (a medicine used to treat vertigo,
nausea and some types of mental illness) or any medicine of the
same family (phenothiazines) may be made worse by desferrioxamine
mesilate
• the effectiveness of erythropoietin (a medicine used to increase the
number of red blood cells) may be changed once desferrioxamine
mesilate treatment is started
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or
breast-feeding. Your doctor will decide if you should receive this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Desferrioxamine mesilate may cause side effects such as dizziness and
problems with vision or hearing. Do not drive or use machines if you
experience any side effect which may lessen your ability to do so.

3. HOW TO USE DESFERRIOXAMINE MESILATE POWDER FOR
INJECTION
This medicine is given by injection or slow infusion (given over a period of
time rather than all in one go). It may be injected into muscle, or infused
under the skin, or into a vein or into the abdomen, for patients on peritoneal
dialysis. Rapid intravenous infusion may lead to a dangerous decrease in
blood pressure and in severe cases to flushing, rapid heart beat, collapse
and itchy rash.

Dose
Your doctor will work out the correct dose of desferrioxamine mesilate for
you and how often it must be given.
The dose will depend on your medical condition, your size, your age and
how well your kidneys are working. Your doctor will tell how well your
kidneys are working using blood or urine samples.

If you are given too much or too little desferrioxamine
mesilate
This medicine will be used according to your doctor’s instructions. It is
unlikely that you will be given too much or too little, however, tell your doctor
or nurse if you have any concerns.
If you have received too much then you may get side effects (see section 4
Possible side effects). Your doctor will be able to take action to reduce the
side effects.

4. POSSIBLE SIDE EFFECTS
Like all medicines, desferrioxamine mesilate can cause side effects,
although not everybody gets them.

Desferrioxamine Mesilate 500 mg Powder for Injection
Desferrioxamine Mesilate 2 g Powder for Injection
The following information is intended for medical or healthcare
professionals only
Further to the information included in section 3, practical information on the
preparation/handling of the medicinal product is provided here.

Incompatibilities
Heparin is pharmaceutically incompatible with desferrioxamine mesilate
solutions.

Reconstitution and further dilution
Only clear pale yellow desferrioxamine mesilate solutions should be used.
Opaque, cloudy or discoloured solutions should be discarded. Unused portions
of opened vials must not be stored and should be discarded immediately.

If any of the following happen, tell your doctor immediately:


severe allergic reaction - you may experience a sudden itchy rash
(hives), swelling of the hands, feet, ankles, face, lips, mouth or throat
(which may cause difficulty in swallowing or breathing), and you may feel
you are going to faint
• fever with a sore throat and abdominal pain or severe diarrhoea
• severe skin infections
• severe breathing difficulties
• blackouts or fits
These are serious side effects. You may need urgent medical attention.
Most of these serious side effects are rare.

If any of the following side effects happen, tell your doctor as
soon as possible:
Very common (occurs in more than 1 in 10 people)
• a red/brown colouration of the urine often occurs during treatment. This
is caused by the presence of removed iron in the urine and is nothing to
worry about.
• aching muscles and joints
• leaking of injection fluid into surrounding tissue (infiltration) and dry
scabs (eschar) / crust at the site of injection
Common (occurs in between 1 in 100 and 1 in 10 people):
• rash, itching, pain, swelling, burning and hardening of the tissues at the
site of the injection, occasionally with fever, chill and feeling generally
unwell after the injection
• headache
Uncommon (occurs in between 1 in 1000 and 1 in 100 people):
• hearing loss
• tinnitus (ringing in the ears or head)
• asthma
• blisters and swelling at the site of injection
Rare (occurs in between 1 in 10,000 and 1 in 1000 people):
• blurred vision, impaired or loss of vision, inability to distinguish certain
colours (colour blindness), inability to see at night (night blindness), blind
spots, changes in the retina, cataracts (cloudy lenses), cloudiness on the
front of the eye (or cornea), visual disturbance in which objects appear to
be abnormally coloured (chromatopsia)
• dizziness, fits or seizures (mainly in patients on dialysis)
• all-over rash, which may be itchy
• growth problems in children
• nausea, vomiting, abdominal cramps, diarrhoea
• bone pain
• leg cramps
• decreased red blood cells (anaemia) which can make you look pale or
cause tiredness, headaches, dizziness or being short of breath when
exercising
• decreased platelets (thrombocytopenia) which can make you prone to
bleeding or unexpected bruises or nosebleeds
• low blood pressure (light-headedness, dizziness, faintness) can occur
if this medicine is not given correctly (see section 3. How you are given
desferrioxamine mesilate)
• abnormal liver function test results
• certain fungal infection of the sinuses, brain and lungs (which can
sometimes cause death)
Very rare (occurs in less than 1 in 10,000 people)
• a type of dementia
• numbness or pins and needles
• stomach and gut infections
• a serious condition which causes severe breathing problems called Adult
Respiratory Distress Syndrome
• lung infiltration (abnormal presence of fluid in the lung)
• abnormal kidney function test results
Frequency not known (cannot be estimated from the available data):
• decreased white blood cells (leucopenia) which can make you more
prone to infections (fever, chills, sore throat or mouth ulcers)
• kidney disease where you pass little or no urine, and may experience
drowsiness, nausea, vomiting and breathlessness
• increase of creatinine in the blood
Your doctor may take blood samples to monitor for changes in your blood
cells and liver or kidney function.
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.

5. HOW TO STORE DESFERRIOXAMINE MESILATE POWDER FOR
INJECTION
Keep out of the reach and sight of children.

Expiry
This medicine must not be used after the expiry date which is stated on the
vial label and carton after ‘EXP’. Where only a month and year is stated, the
expiry date refers to the last day of that month.

Storage
The vials should not be stored above 25°C.
Unused portions of opened vials must not be stored for later use. Prepared
injections or infusions should be used immediately, however, if this is not
possible they can be stored for up to 48 hours provided they have been
prepared in a way to exclude microbial contamination. The prepared
injections or infusions should not be refrigerated or frozen.

Visible signs of deterioration
Only clear, pale yellow solutions should be used. Opaque, cloudy or
discoloured solutions should be discarded.

Disposal
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6. FURTHER INFORMATION
What desferrioxamine mesilate contains
The active substance is desferrioxamine mesilate. After reconstitution, each
millilitre (ml) of solution contains 100 milligrams (mg) of desferrioxamine
mesilate.
There are no other ingredients.

What desferrioxamine mesilate looks like and contents of the
pack
Desferrioxamine mesilate is a white to cream coloured solid which comes in
glass containers called vials.
It may be supplied in packs containing 10 x 500 mg vials or 1 x 2 g vials.

Marketing authorisation holder and manufacturer responsible
for batch release in Europe
Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire,
CV31 3RW

Manufacturer
Hospira Australia Pty Ltd, Lexia Place, Mulgrave, Victoria 3170, Australia
This leaflet was last approved in 06/2013
The medicinal product should preferably be employed in the form of a 10%
solution, e.g. by dissolving the contents of one 500 mg vial in 5 ml of Water
for Injections. The 10% desferrioxamine mesilate solution can be diluted
with routinely employed infusion solutions (sodium chloride 9 mg/ml (0.9%),
glucose 50 mg/ml (5%), or sodium chloride 1.8 mg/ml (0.18%) and
glucose 40 mg/ml (4%)), although these should not be used as solvent for
the dry substance. Dissolved desferrioxamine mesilate can also be added to
dialysis fluid and given intraperitoneally to patients on continuous ambulatory
peritoneal dialysis (CAPD) or continuous cyclic peritoneal dialysis (CCPD).
Following dilution in Water for Injections, chemical and physical in-use stability
has been demonstrated for up to 48 hours at 20°C. From a microbiological
point of view, however, 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 and dilution should take place in controlled and
validated aseptic conditions.
After dilution, do not refrigerate or freeze.

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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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