QUETIAPINE ACTAVIS XR quetiapine (as fumarate) 400mg modified release tablets blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

quetiapine fumarate, Quantity: 460.6 mg (Equivalent: quetiapine, Qty 400 mg)

Διαθέσιμο από:

Medis Pharma Pty Ltd

INN (Διεθνής Όνομα):

Quetiapine fumarate

Φαρμακοτεχνική μορφή:

Tablet, modified release

Σύνθεση:

Excipient Ingredients: hypromellose; lactose monohydrate; magnesium stearate; purified talc; povidone; sodium chloride; titanium dioxide; macrogol 400

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

10, 30, 60, 100

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

Bipolar disorder,? Maintenance treatment of bipolar I 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 in combination with lithium or sodium valproate,Efficacy of quetiapine modified release tablets 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 Treatment of recurrent major depressive disorder (MDD) in patients who are intolerant of, or who have an inadequate response to alternative therapies.,Generalised anxiety disorder Treatment of generalised anxiety disorder (GAD).

Περίληψη προϊόντος:

Visual Identification: White coloured, round shaped, biconvex, film coated tablets, debossed with 'I4' on one side and plain on other.; 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:

Licence status A

Ημερομηνία της άδειας:

2016-03-21