DESFERRIOXAMINE MESILATE 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance: DEFEROXAMINE MESILATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Desferrioxamine Mesilate 500 mg & 2g Powder for Solution for Injection or
Infusion
Deferoxamine mesilate also known as Desferrioxamine mesilate
Read all of this leaflet carefully before you start taking 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 get serious, or you notice any side effects not listed in this leaflet please tell your
doctor or pharmacist.
The name of your medicine is the following:
Desferrioxamine Mesilate 500 mg Powder for Solution for Injection or Infusion
Desferrioxamine Mesilate 2 g Powder for Solution for Injection or Infusion
In the rest of this leaflet your medicine is called Desferrioxamine Mesilate Injection.
_________________________________________________________________
In this leaflet:
1. What Desferrioxamine Mesilate Injection is and what it is used for
2. Before you take Desferrioxamine Mesilate Injection
3. How to take Desferrioxamine Mesilate Injection
4. Possible side effects
5. How to store Desferrioxamine Mesilate Injection
6. Further Information
1. WHAT DESFERRIOXAMINE MESILATE INJECTION IS AND WHAT IT IS USED FOR
Desferrioxamine Mesilate Injection is used to remove excess iron or aluminium from your blood.
The active ingredient of Desferrioxamine Mesilate Injection is deferoxamine mesilate and it belongs to a group
of substances called ‘chelating agents’. This means that it binds to the iron and aluminium in the blood, to form
a complex which is then excreted from the body.
You may have too much iron or aluminium in your blood as a result of iron poisoning, due to certain illnesses
such as thalassaemia (a hereditary type of anaemia) and haemocromatosis (a disorder of iron metabolism), or
as a side effect of blood transfusion or kidney dialysis.
Desferrioxamine Mesilate Injection can also be used to test whether you have certain anaemias or diseases
affecting the amount of iron in your blood.
2. BEFORE YOU TAKE DESFERRIOXAMINE MESILATE INJECTION
The doctor or nurse giving you this medicine will ask some questions about you. They need the following
information before you have this medicine for the first time.
Do not take Desferrioxamine Mesilate Injection

If you have shown signs of hypersensitivity (severe allergy) to deferoxamine.
Do not take Desferrioxamine Mesilate Injection if the above statement is true.
Take special care with Desferrioxamine Mesilate Injection
Before treatment with Desferrioxamine Mesilate Injection starts, tell your doctor or nurse if:

You are pregnant, suspect you may be pregnant or planning to become pregnant.

You are breast-feeding.

You have any kidney problems.

You have a heart disorder.

You have thalassaemia (a type of anaemia).

You have hyperparathyroidism (a metabolic disease resulting in excess calcium in the blood and problems
with the bones).

Aluminium has affected your nerves. If so, you may be given a dose of clonazepam before you are given
Desferrioxamine Mesilate Injection.
During treatment with Desferrioxamine Mesilate Injection:

If you are treated with Desferrioxamine Mesilate Injection for a long time or you have kidney problems and
are on dialysis, deferoxamine may affect your vision or hearing. If this occurs you must tell your doctor
immediately. Your doctor may give you regular eye and hearing tests, usually every 3 months.

You must tell your doctor before having some radiotherapy diagnostic tests (X-rays or scans), as the
results of the tests may be false.

Deferoxamine may affect your child’s growth, if it is under 3 years of age. Your child’s doctor will regularly
check the body weight and height of your child, usually every 3 months.
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently taken any other medicines. Remember also
any medicines you may be taking that do not need a prescription.
If you are taking any of the following medicines it is very important to tell your doctor:

Prochlorperazine, a medicine used to control vertigo (sense of instability and rotation) or nausea and
vomiting (feeling or being sick) and some types of mental illness.

Erythropoietin, a medicine used to increase the number of red blood cells.

Vitamin C supplements.
Pregnancy and breast-feeding

If you are pregnant, or think you may be pregnant you must tell your doctor immediately, as deferoxamine
may cause problems to your baby, especially during the first three months of pregnancy.

If you are breastfeeding, you must tell your doctor as deferoxamine may be in the breast milk and may
affect your baby.
Your doctor will advise you if you should have this medicine during pregnancy and breast-feeding.
Driving and using machines
Desferrioxamine Mesilate Injection can make you feel dizzy or drowsy. It can also affect your vision or hearing.
Do not drive, operate machines or do anything else which requires concentration until you know how your
medicine affects you.
3. HOW TO TAKE DESFERRIOXAMINE MESILATE INJECTION
A doctor or a nurse will usually give you this medicine.
It will be diluted with water for injections and may be further diluted with glucose solution, sodium chloride
solution, a mixture of glucose and sodium chloride solution or added to a dialysis fluid before it is given to you.
It will be given as an injection into a muscle (intramuscularly), into a vein over a period of time via a drip (called
slow intravenous infusion), under the skin (subcutaneously), or into the abdominal cavity (intraperitoneally).
Your doctor will decide the amount (dose) of your medicine to give you. This will depend on your medical
condition, your body weight, your age and how well your kidneys are working.
The usual doses and ways of taking Desferrioxamine Mesilate Injection are as follows:
Acute iron poisoning:
Desferrioxamine Mesilate Injection is usually given intravenously (injected into a vein). The recommended dose
is 15 mg/kg body weight every hour. The dose may be reduced after 4 to 6 hours. The maximum recommended
dose is 80 mg/kg body weight every 24 hours.
Desferrioxamine Mesilate Injection may also be given to you intramuscularly (injected into a muscle). In this
case, the recommended dose is 2 g for adults and 1 g for children, given in a single injection.
Iron overload:
Desferrioxamine Mesilate Injection is usually given subcutaneously (a slow injection under the skin) or
intramuscularly (injection into a muscle). The way of taking Deferoxamine and the correct dose for you will be
determined by your doctor and it will depend on how much extra iron there is in your blood. The usually
recommended dose is 20 - 60 mg/kg body weight, given 5 - 7 times a week. For children under 3 years of age,
the average daily dose is not more than 40 mg/kg.
Aluminium overload:
Desferrioxamine Mesilate Injection is usually given by slow intravenous injection.
The correct dose for you will be determined by your doctor and it will depend on how much extra aluminium you
have in your blood.
If you are on dialysis, the usual dose is 5 mg/kg body weight, once a week. It will either be given during the last
60 minutes of your dialysis or 5 hours before your dialysis starts.
If you are on peritoneal dialysis (CAPD or CCPD), the usual dose is 5 mg/kg body weight, once a week.
Desferrioxamine Mesilate Injection is either mixed with the fluid in your dialysis bag or given by any of the other
ways listed above.
Diagnosis of conditions associated with iron overload:
Desferrioxamine Mesilate Injection is usually given intramuscularly (injected into a muscle). The usual dose is
500 mg. After you have received Desferrioxamine Mesilate Injection, your doctor or nurse will probably collect
urine samples for about 6 hours. They will then do tests on your urine to see how much iron is in it.
Diagnosis of conditions associated with aluminium overload:
The usual dose of Desferrioxamine Mesilate Injection is 5 mg/kg body weight. It is usually given by slow
intravenous infusion (slow injection into a vein) during the last hour of dialysis.
Your doctor or nurse will probably take a blood sample before you are given Desferrioxamine Mesilate Injection
and before your dialysis starts. You will probably have another blood test before your next session of
haemodialysis. Blood tests will show how much aluminium is in your blood.
Use in older patients:
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing
range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant
disease or treatment with other medicines.
If you take more Desferrioxamine Mesilate Injection than you should
As this medicine will usually be given to you by a doctor or nurse, is unlikely that you will have too much or too
little. However, if you have any concerns, tell your doctor or nurse.
If you forget to take Desferrioxamine Mesilate Injection
A doctor or a nurse will usually give you this medicine. If you miss one of your appointments, please let your
doctor know immediately.

If you stop taking Desferrioxamine Mesilate Injection
It is very important to finish the course of treatment your doctor has prescribed, even if you start to feel better. If
you do not finish the course of treatment, your condition may get worse again.
If you have any further questions on the use of your medicine, ask your doctor, nurse or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Desferrioxamine Mesilate Injection can cause side effects, although not everyone gets them.
The expected benefit of your medicine will usually be greater than the risk of you suffering any harmful side
effects.
Your urine may turn a reddish-brown colour. This is because the extra iron that sticks to
deferoxamine and passes into your urine is reddish-brown in colour. This is usually nothing to worry about, but if
you have any concerns you should talk to your doctor or nurse.
Important: The following are very serious side effects. If you get any of the below symptoms you must
seek medical advice immediately.

Serious allergic reaction. The first signs of a serious allergic reaction may be sudden itchy rash (hives),
swelling of the hands, feet, ankles, face, lips, mouth or throat, sudden difficulty in swallowing or breathing
and feeling that you are going to faint (low blood pressure).

Symptoms of a severe infection, such as fever, sore throat, abdominal pain (pain in the stomach or
intestines) and severe diarrhoea.

Impaired vision/eye disorders

Loss of hearing and tinnitus (a ringing or booming sensation in ears)

Serious skin infections
The chance of you having a side effect is described using words and numbers below.
The following are very common side effects. They probably affect more than 1 in 10 people:

Pain in muscles and/or joints

Pain, swelling, redness of skin, itch or formation of crust at the site of injection
The following are common side effects. They probably affect more than 1 in 100 people and up to 1 in 10
people:

Headache
• Nausea (feeling sick)

Fever

Itchy rash

Bone disorders, slowing down of growth (especially in children under 3)
The following are uncommon side effects. They probably affect more than 1 in 1,000 people and up to 1
in 100 people:

Vesicles (skin blisters containing fluid)
• Local swelling and burning sensation

Vomiting (being sick)
• Stomach pain

Asthma (difficulty in breathing and wheezing)
• Problems with the ears, such as tinnitus or loss of hearing.
The following are rare side effects. They probably affect more than 1 in 10,000 people and up to 1 in
1,000 people:

Eye problems, such as blurred vision, impaired vision or loss of vision, not being able to see colours
(colour blindness), not being able to see at night (night blindness), blind spots, changes in the retina (a
membrane at the back of the eye sensitive to light), and cloudiness on the front of the eye.

Low blood pressure (light headedness, dizziness, faintness).

Tachycardia

Shock

Infections caused by fungus.
The following are very rare side effects. They probably affect up to 1 in 10,000 people:

Allergic reactions.

Skin rash covering most of the body.

A serious condition which causes severe breathing problems called Acute Respiratory Distress Syndrome.

Diarrhoea.

Problems with the kidneys.

Blood disorders which can make you look pale or cause tiredness, headaches, nosebleeds, dizziness or
being short of breath when exercising. You might also get more frequent viral infections (fever, chills, sore
throat or mouth ulcers), or find that you bleed or bruise more easily than normal.

Stomach and gut infections.

Other effects such as dizziness, loss of feeling in their hands, feet, arms or legs, numbness or tingling (pins
and needles).

In patients on dialysis: personality changes, headache, confusion, paralysis of part or all of the body, stiff
neck, abnormal speech and eye movements.
In patients having too much aluminium in their blood, treatment with deferoxamine may result in decreased
serum calcium and aggravation of hyperparathyroidism.
If you experience any of these side effects, tell your doctor as soon as possible.
If you notice any side effects which are not listed in this leaflet, please tell your doctor, nurse or
pharmacist.
5. HOW TO STORE DESFERRIOXAMINE MESILATE INJECTION
Keep your medicine out of the reach and sight of children.
Do not use your medicine after the expiry date which is stated on the carton and on the label of the glass
container (vial) after abbreviation (EXP). The expiry date refers to the last day of that month.
Vial: Store below 25° C.
After dilution: Do not refrigerate or freeze.
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 and would normally not be longer
than 24 hours at 25°C.
Do not use the solution if it is not clear, not free of particles or there has been a colour change.
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 Injection contains
The active substance is deferoxamine mesilate. There are no other ingredients in your medicine.
What Desferrioxamine Mesilate Injection looks like
Desferrioxamine Mesilate Injection is a white or off-white powder for solution for injection or infusion. This
means that a liquid must be added to make a solution, before it can be given to you as an injection. In some
cases, more liquid may be added to make a weaker solution which can be given to you as an infusion (drip).
Normally, your doctor or nurse will prepare your medicine before it is given to you.
Contents of the pack
Each pack contains 10 vials (glass containers) of Desferrioxamine Mesilate Injection 500 mg or 1 vial of
Desferrioxamine Mesilate Injection 2 g. Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building 3, Office 115,
1065 Nicosia, Cyprus.
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Manufacturer: DEMO S.A., 21 km National Road Athens-Lamia, 14568 Krioneri, Athens, Greece.
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Desferrioxamine Mesilate 500 mg & 2g Powder for Solution for Injection or Infusion
DE: Deferoxamin 500 mg & 2 g Pulver zur Herstellung einer Injektions- oder Infusionslösung
IT: Deferoxamina 500 mg & 2g Polvere per soluzione iniettabile o infusione
CY: Deferoxamine Noridem 500mg & 2g Κόνις για ενέσιμο διάλυμα ή διάλυμα για έγχυση
EL: Deferoxamine Noridem 500mg & 2g Κόνις για ενέσιμο διάλυμα ή διάλυμα για έγχυση
This leaflet was revised in 08/2012
The following information is intended for medical or healthcare professionals only
Instructions for use and handling:
Single use only, whereby any unused solution should be discarded.
The use of freshly prepared solutions is recommended. Τhese maintain potency for at least 24 hours at 25°C.
The reconstituted solution should be clear. Do not use if particles are present.
Desferrioxamine Mesilate Injection should preferably be employed in the form of a 10% aqueous solution, by
dissolving the contents of one 500 mg vial in 5ml of Water for injections or 2g vial in 20 ml of Water for
injections.
Intramuscular administration: The volume of solvent should be not less than 3 mL for each gram of
deferoxamine mesilate (i.e. reconstitute each 500 mg vial of Desferrioxamine Mesilate Injection with not less
than 1.5 mL of Water for injections).
Intravenous administration: Administration by the intravenous route should be in the form of slow infusion.
The 10% deferoxamine mesilate solution can be diluted with routinely employed infusion solutions (Sodium
Chloride 0.9% Infusion, Dextrose 5% Infusion, combination of Sodium Chloride 0.9% and Dextrose 5% infusion
solutions, Ringer’s Lactate), although these should not be used as solvent for the dry substance. The rate of
infusion should not exceed 15 mg/kg/hr for the first 1 g of deferoxamine mesilate. Subsequent IV dosing must
be at a slower rate, not exceeding 125 mg/hr.
Subcutaneous Administration: Desferrioxamine Mesilate Injection should be administered over 8-24 hours,
utilizing a small portable pump capable of providing continuous mini-infusion.
Intraperitoneal administration: The 10% deferoxamine mesilate solution can also be added to dialysis fluid
and given intraperitoneally to patients on continuous ambulatory peritoneal dialysis (CAPD) or continuous cyclic
peritoneal dialysis (CCPD).

If this leaflet is difficult to see or read please contact the following
address for help: Fannin Limited, Fannin House, South County
Business Park, Leopardstown, Dublin 18, Ireland Tel +353-1-2907000

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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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