Desferal 500mg Vials Powder for Solution for Injection or Powder for Concentrate for Solution for Infusion

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Deferoxamine mesilate

Tilgjengelig fra:

Novartis Ireland Limited

ATC-kode:

V03AC; V03AC01

INN (International Name):

Deferoxamine mesilate

Dosering :

500 milligram(s)

Legemiddelform:

Powder for solution for injection/infusion

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Iron chelating agents; deferoxamine

Autorisasjon status:

Marketed

Autorisasjon dato:

1980-02-07

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DESFERAL
® 500MG VIALS POWDER FOR SOLUTION FOR INJECTION OR POWDER FOR
CONCENTRATE FOR SOLUTION
FOR INFUSION.
Desferoxamine mesilate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
- BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, nurse or
pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Desferal is and what it is used for
2.
What you need to know before you are given Desferal
3.
How you are given Desferal
4.
Possible side effects
5.
How to store Desferal
6.
Contents of the pack and further information
1.
WHAT DESFERAL IS AND WHAT IT IS USED FOR
The full name of your medicine is desferoxamine mesilate. In this
leaflet the shorter name Desferal
will be used.
Desferal is an injection used when you have too much iron or aluminium
in your blood (iron or
aluminium overload). It is a “chelating” agent. This means that it
sticks to the unwanted iron or
aluminium in the blood to form a compound which the body can get rid
of safely.
You may have too much iron or aluminium in your blood after iron
poisoning or as a side effect of
blood transfusions or kidney dialysis. Certain illnesses can also have
the same effect. The aim here is
to balance out your levels and avoid an overload occurring. In older
people, iron may be removed
from the blood in order to encourage a slow release of iron from body
stores that have already reached
a toxic level.
Desferal can also be used to test whether you have too much or too
little iron or aluminium in your
body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DESFERAL
DO NOT HAVE DESFERAL IF:
-
You are allergic to

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Desferal 500mg Vials Powder for Solution for Injection or Powder for
Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500mg deferoxamine mesilate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or powder for concentrate for
solution for infusion.
White to practically white lyophilised powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IRON OVERLOAD
_MONOTHERAPY IRON CHELATION TREATMENT OF CHRONIC IRON OVERLOAD_
primary and secondary haemochromatosis including thalassaemia
transfusional haemosiderosis; in patients in whom concomitant
disorders (eg severe anaemia, hypoproteinaemia,
renal failure) preclude phlebotomy.
Treatment of acute iron poisoning
For the diagnosis of iron storage disease and certain anaemias.
ALUMINIUM OVERLOAD - in patients under maintenance dialysis for end
stage renal failure with aluminium-related bone
disease and/or anaemia, dialysis encephalopathy; and for diagnosis of
aluminium overload.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
TREATMENT FOR CHRONIC IRON OVERLOAD
The main aim of chelation therapy in iron overload in young patients
is to achieve an iron balance and to prevent
haemosiderosis, while in the older patient a negative iron balance is
desirable in order to reduce slowly the increased
iron stores and to prevent the toxic effects of iron.
_ADULTS AND CHILDREN:_ Desferal therapy should be commenced after the
first 10-20 blood transfusions, or when serum
ferritin levels reach 1,000 ng/mL. Growth retardation may result from
iron overload or excessive Desferal doses. If
chelation is begun before 3 years of age, growth must be monitored
carefully and the mean daily dose should not
exceed 40mg/kg.
The dosage and mode of administration may be individually adapted
according to the degree of iron overload. The
lowest effective dosage should be used. To assess the response to
chelation therapy, 24 hour urina