QUETIAPINE XR GXP quetiapine (as fumarate) 400mg modified release tablet blister pack

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

quetiapine fumarate, Quantity: 460.52 mg (Equivalent: quetiapine, Qty 400 mg)

Tillgänglig från:

Arrotex Pharmaceuticals Pty Ltd

INN (International namn):

Quetiapine fumarate

Läkemedelsform:

Tablet, modified release

Sammansättning:

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

Administreringssätt:

Oral

Enheter i paketet:

60

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

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.

Produktsammanfattning:

Visual Identification: White to off-white, capsule shaped, 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

Bemyndigande status:

Registered

Tillstånd datum:

2014-01-17