Desferal 500mg Powder for Solution for Injection

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

DEFEROXAMINE MESYLATE

Available from:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

DEFEROXAMINE MESYLATE

Units in package:

500mg mg

Manufactured by:

Wasserburger Arzneimittelwerk GmbH

Summary of Product characteristics

Novartis
Page 2
Approved Package Leaflet
04-Apr-2018
Desferal
®
DESFERAL

Chelating agent
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM (S)
It is a lyophilisate to be reconstituted with vehicle (water for
injection) before subsequent
administration as recommended.
Vials containing 500 mg white to practically white lyophilisate powder
for solution for
injection.
Colorless 7.5 mL clear, colorless glass vials, with rubber stopper,
aluminium cap with red
flip-off component.
ACTIVE SUBSTANCE (S)
One vial contains 500 mg of deferoxamine mesylate ( also known as
desferrioxamine
methane sulphonate).
Certain dosage strengths may not be available in all countries.
EXCIPIENTS
Not applicable.
INDICATIONS
THERAPEUTIC
Monotherapy iron chelation treatment for chronic iron overload, e.g.
•
transfusional hemosiderosis, as seen in thalassemia major,
sideroblastic anemia, auto-
immune hemolytic anemia, and other chronic anemias.
•
idiopathic (primary) hemochromatosis in patients in whom concomitant
disorders (e.g.
severe anemia, cardiac disease, hypoproteinemia) preclude phlebotomy.
•
iron overload associated with porphyria cutanea tarda in patients
unable to tolerate
phlebotomy.
Treatment for acute iron poisoning.
Treatment for chronic aluminum overload in patients with end-stage
renal failure (under
maintenance dialysis) with
•
aluminum-related bone disease,
•
dialysis encephalopathy or
•
aluminum-related anemia.
Novartis
Page 3
Approved Package Leaflet
04-Apr-2018
Desferal
®
DIAGNOSTIC
Diagnosis of iron or aluminum overload.
DOSAGE REGIMEN AND ADMINISTRATION
TREATMENT FOR CHRONIC IRON OVERLOAD
The main aim of chelation therapy in iron overload in well-controlled
patients is to maintain
an iron balance and to prevent hemosiderosis, while in overloaded
patients a negative iron
balance is desirable in order to reduce increased iron stores and
prevent the toxic effects of
iron.
CHILDREN AND ADULTS
Desferal therapy should be started after the first 10 to 20 blood
transfusions or when there is
evidence from clinical