DESFERAL 500 Milligram Pdr/Conc/Soln/Inj/Inf

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

DEFEROXAMINE MESILATE

可用日期:

Novartis Pharmaceuticals UK Ltd

ATC代码:

V03AC01

INN（国际名称）:

DEFEROXAMINE MESILATE

剂量:

500 Milligram

药物剂型:

Pdr/Conc/Soln/Inj/Inf

处方类型:

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

治疗领域:

Iron chelating agents

授权状态:

Authorised

授权日期:

1995-02-07

资料单张

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 al

产品特点

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