Desferal 2g powder for solution for injection vials

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Desferrioxamine mesilate

Tilgjengelig fra:

Novartis Pharmaceuticals UK Ltd

ATC-kode:

V03AC01

INN (International Name):

Desferrioxamine mesilate

Dosering :

2gram

Legemiddelform:

Powder for solution for injection

Administreringsrute:

Intraperitoneal; Intravenous; Intramuscular; Subcutaneous

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 09010300; GTIN: 5010678904017

Informasjon til brukeren

DESFERAL
® VIALS 500 MG AND 2 G
(DESFERRIOXAMINE MESILATE)
PATIENT INFORMATION LEAFLET
WHAT YOU NEED TO KNOW ABOUT DESFERAL
Your doctor has decided that you need this medicine to help treat your
condition.
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR
MEDICINE. IT CONTAINS IMPORTANT
INFORMATION. Keep the leaflet in a safe place because you may want to
read it again.
If you have any other questions, or if there is something you don’t
understand, please ask your
doctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone
else. It may not be the
right medicine for them even if their symptoms seem to be 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.
THIS MEDICINE WILL BE CALLED DESFERAL THROUGHOUT THIS LEAFLET
IN THIS LEAFLET:
1.
What Desferal is and what it’s used for
2.
What you need to know before you take Desferal
3.
How to take Desferal
4.
Possible side effects
5.
How to store Desferal
6.
Contents of the pack and other information
1.
WHAT DESFERAL IS AND WHAT IT’S USED FOR
Desferal is an injection used to remove excess iron or aluminium from
your blood.
Desferrioxamine mesilate, the active ingredient in Desferal, is a
substance called a ‘chelating’
agent. This means that it binds to the iron and aluminium ions 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 or as a
side effect of blood transfusion or kidney dialysis. Certain illnesses
can also have the same effect.
Desferal can also be used to test whether you have certain anaemias or
diseases affecting the
amount of iron in your blood.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESFERAL
SOME PEOPLE MUST NOT TAKE DESFERAL. TALK TO YOUR DOCTOR IF:

you think you may be allergic to Desferal or desferrioxamine.
YOU SHOULD ALSO ASK YOURSELF THESE QUESTIONS BEFORE TAKING DESFERAL:

Are you

Preparatomtale

OBJECT 1
DESFERAL VIALS, 500MG OR 2G
Summary of Product Characteristics Updated 11-Jul-2017 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Desferal
®
Vials, 500mg or 2g.
2. Qualitative and quantitative composition
Each vial contains desferrioxamine mesilate 500mg or 2g.
3. Pharmaceutical form
A sterile, lyophilised powder available in vials containing 500mg or
2g of desferrioxamine mesilate.
4. Clinical particulars
4.1 Therapeutic indications
Treatment for chronic iron overload, e.g.
• transfusional haemosiderosis in patients receiving regular
transfusions e.g. thalassaemia major
• primary and secondary haemochromatosis in patients in whom
concomitant disorders (e.g. severe
anaemia, hypoproteinaemia, renal or cardiac failure) preclude
phlebotomy.
Treatment for acute iron poisoning.
For the diagnosis of iron storage disease and certain anaemias.
Aluminium overload - In patients on maintenance dialysis for end stage
renal failure where preventative
measures (e.g. reverse osmosis) have failed and with proven
aluminium-related bone disease and/or
anaemia, dialysis encephalopathy; and for diagnosis of aluminium
overload.
4.2 Posology and method of administration
Desferal may be administered parenterally.
_For parenteral administration_:
The drug should preferably be employed in the form of a 10% solution,
e.g. 500 mg: by dissolving the
contents of one 500mg vial in 5ml of water for injection or 2 g: by
dissolving the contents of one 2 g vial
in 20 ml of water for injection. When administered subcutaneously the
needle should not be inserted too
close to the dermis. The 10% Desferal solution can be diluted with
routinely employed infusion solutions
(saline, glucose, dextrose or dextrose-saline), although these should
not be used as solvent for the dry
substance. Dissolved Desferal can also be added to dialysis fluid and
given intraperitoneally to patients on
continuous ambulatory peritoneal dialysis (CAPD) or continuous cyclic
peritoneal dialysis (CCPD).
Only clear pale yellow Desferal solutions