DESFERRIOXAMINE MESILATE 2G POWDER FOR INJECTION

Active substance: DESFERRIOXAMINE MESILATE

View full screen / Print PDF » Download PDF ⇩

Transcript
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.
• 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.
2.
3.
4.
5.
6.

What Desferrioxamine Mesilate is and what it is used for
Before you are given Desferrioxamine Mesilate
How you are given Desferrioxamine Mesilate
Possible side effects
How to store Desferrioxamine Mesilate
Further information

1. WHAT DESFERRIOXAMINE MESILATE 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 ARE GIVEN DESFERRIOXAMINE MESILATE
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
• have problems with fits due to high levels of aluminium in the
brain
• have had problems with your sight or hearing during previous
treatments with desferrioxamine mesilate
• are due to have a radiography scan (some radiography scans
may be spoilt if desferrioxamine mesilate is used before the scan)
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 YOU ARE GIVEN DESFERRIOXAMINE MESILATE
This medicine is given by injection or infusion. It may be injected
into muscle, or infused under the skin, or into a vein or into the
abdomen, for patients on peritoneal dialysis.

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
Mesliate
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.

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.
Q62918
4XXXXX

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

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. All of these serious side effects are rare.

If any of the following side effects happen, tell your doctor as
soon as possible:
Very common side effect
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.
Common (occurs in less than 1 person in 10)
• rash, itching, pain, swelling, burning and hardening of the tissues
at the site of the injection
• fever after the injection
• feeling generally unwell after the injection
Uncommon (occurs in less than 1 person in 100)
• hearing loss
• tinnitus (ringing in the ears or head)
Rare (occurs in less than 1 person in 1,000)









impaired vision
dizziness
all-over rash, which may be itchy
growth problems in children
nausea, vomiting, abdominal cramps, diarrhoea
tiredness
unexpected bruises
low blood pressure

Very rare (occurs in less than 1 person in 10,000)





a type of dementia
numbness or pins and needles
bone pain
leg cramps

Other side effects which your doctor will check for
Desferrioxamine mesilate may lead to changes in your blood cells
and liver and kidney function. Your doctor may take blood samples
to monitor for these.
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
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
11/2009



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.
Q62918
4XXXXX

Expand view ⇕

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.

Hide
(web3)