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

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

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

Tillgänglig från:

Medis Pharma Pty Ltd

INN (International namn):

Quetiapine fumarate

Läkemedelsform:

Tablet, modified release

Sammansättning:

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

Administreringssätt:

Oral

Enheter i paketet:

10, 30, 60, 100

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

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).

Produktsammanfattning:

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

Bemyndigande status:

Licence status A

Tillstånd datum:

2016-03-21