Desferrioxamine 500mg powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Desferrioxamine mesilate

Available from:

Pfizer Ltd

ATC code:

V03AC01

INN (International Name):

Desferrioxamine mesilate

Dosage:

500mg

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intramuscular; Intravenous; Intraperitoneal; Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09010300; GTIN: 5015997223108

Patient Information leaflet

Page 1 of 6
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 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 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 gets serious, or if you notice any side
effects not listed in this
leaflet, see section 4.
WHAT IS IN THIS LEAFLET:
1.
What Desferrioxamine Mesilate Powder for Injection is and what it is
used for
2.
What you need to know before you use Desferrioxamine Mesilate Powder
for Injection
3.
How to use Desferrioxamine Mesilate Powder for Injection
4.
Possible side effects
5.
How to store Desferrioxamine Mesilate Powder for Injection
6.
Contents of the pack and other information
1. WHAT DESFERRIOXAMINE MESILATE POWDER FOR INJECTION 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. WHAT YOU NEED TO KNOW BEFORE YOU USE DESFERRIOXAMINE
MESILATE POWDER FOR INJECTION
DO NOT TAKE 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. WARNINGS AND PRECAUTIONS
Tell your doctor or pharmac

Summary of Product characteristics

OBJECT 1
DESFERRIOXAMINE MESILATE 500 MG AND 2 G POWDER
FOR INJECTION
Summary of Product Characteristics Updated 14-Aug-2017 | Hospira UK
Ltd
1. Name of the medicinal product
Desferrioxamine Mesilate 500 mg and 2 g Powder for Injection.
2. Qualitative and quantitative composition
Desferrioxamine mesilate 500 mg or 2 g per vial.
Following reconstitution, each ml of solution contains 100 mg
desferrioxamine mesilate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection or infusion.
White to cream powder or lyophilised plug.
4. Clinical particulars
4.1 Therapeutic indications
Iron overload - acute iron poisoning; primary and secondary
haemochromatosis including thalassaemia
and transfusional haemosiderosis; in patients in whom concomitant
disorders (e.g. severe anaemia,
hypoproteinaemia, renal or cardiac failure) preclude phlebotomy; and
for the diagnosis of iron storage
disease and sideroblastic anaemia, auto-immune haemolytic anaemia and
other chronic 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
Desferrioxamine mesilate may be administered intramuscularly,
intravenously, or subcutaneously. When
administered subcutaneously the needle should not be inserted too
close to the dermis.
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% Desferrioxamine mesilate solution can be
diluted with routinely employed
infusion solutions (saline, glucose, dextrose or dextrose-saline)