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 should be used. Opaque, cloudy or discoloured solutions should be discarded. Heparin is pharmaceutically incompatible with Desferal solutions.
Treatment of acute iron poisoning
Adults and children:
Desferal may be administered parenterally. Desferal is an adjunct to standard measures generally used in treating acute iron poisoning. It is important to initiate treatment as soon as possible.
Parenteral Desferal treatment should be considered in any of the following situations:
• all symptomatic patients exhibiting more than transient minor symptoms (e.g. more than one episode of emesis or passage of one soft stool),
• patients with evidence of lethargy, significant abdominal pain, hypovolaemia, or acidosis,
• patients with positive abdominal radiograph results demonstrating multiple radio-opacities (the great majority of these patients will go on to develop symptomatic iron poisoning),
• any symptomatic patient with a serum iron level greater than 300 to 350 micro g/dL regardless of the total iron binding capacity (TIBC). It has also been suggested that a conservative approach without Desferal therapy or challenge should be considered when serum iron levels are in the 300 to 500 micro g/dL range in asymptomatic patients, as well as in those with self-limited, non-bloody emesis or diarrhoea without other symptoms.
The dosage and route of administration should be adapted to the severity of the poisoning.
Dosage:
The continuous intr