QUETIAPINE XR GXP quetiapine (as fumarate) 150mg modified release tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

quetiapine fumarate, Quantity: 172.695 mg (Equivalent: quetiapine, Qty 150 mg)

Διαθέσιμο από:

Arrotex Pharmaceuticals Pty Ltd

INN (Διεθνής Όνομα):

Quetiapine fumarate

Φαρμακοτεχνική μορφή:

Tablet, modified release

Σύνθεση:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; povidone; macrogol 400; titanium dioxide; light magnesium oxide; magnesium stearate; carrageenan

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

60

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

Bipolar disorder - Maintenance treatment of bipolar 1 disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes. Treatment of depressive episodes associated with bipolar disorder (see dosage and administration). Treatment of acute mania associated with bipolar I disorder as monotherapy or incombination with lithium or sodium valproate. Efficacy of quetiapine in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation from the established effectiveness of quetiapine immediate release tablets. Schizophrenia - Treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy. Major depressive disorder (MDD)- Treatment of recurrent major depressive disorde in patients who are intolerant of, or who have an inadequate response to alternative therapies. Generalised anxiety disorder (GAD). Treatment of generalised anxiety disorder.

Περίληψη προϊόντος:

Visual Identification: White to off-white, round, biconvex, coated tablet, plain on both sides; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2014-01-17