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

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

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

Dostupno od:

Medis Pharma Pty Ltd

INN (International ime):

Quetiapine fumarate

Farmaceutski oblik:

Tablet, modified release

Sastav:

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

Administracija rute:

Oral

Jedinice u paketu:

10, 30, 60, 100

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

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).

Proizvod sažetak:

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

Status autorizacije:

Licence status A

Datum autorizacije:

2016-03-21