ALEMBIC DEFERASIROX deferasirox 180 mg film-coated tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

deferasirox, Quantity: 180 mg

Διαθέσιμο από:

Alembic Pharmaceuticals Australia Pty Ltd

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

Excipient Ingredients: crospovidone; poloxamer; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; povidone; sodium starch glycollate type A; titanium dioxide; hypromellose; purified talc; macrogol 4000; indigo carmine aluminium lake

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

30

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

The treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older. ALEMBIC DEFERASIROX is also indicated for the treatment of chronic iron overload in paediatric patients aged 2 to 5 years who are unable to take desferrioxamine therapy or in whom desferrioxamine has proven ineffective. ,ALEMBIC DEFERASIROX is also indicated for the treatment of chronic iron overload in patients with non-transfusion- dependent thalassemia syndromes aged 10 years and older.

Περίληψη προϊόντος:

Visual Identification: Medium blue, oval, biconvex, film-coated tablet with beveled edges, debossed with "L" on one side and "664" on the other side. Approximately 13 mm in length and approximately 5 mm in width.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2020-11-16