QUETIAPINE MEDIS XR quetiapine (as fumarate) 50mg modified release tablets blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

quetiapine fumarate, Quantity: 57.575 mg (Equivalent: quetiapine, Qty 50 mg)

Dostopno od:

Medis Pharma Pty Ltd

INN (mednarodno ime):

Quetiapine fumarate

Farmacevtska oblika:

Tablet, modified release

Sestava:

Excipient Ingredients: microcrystalline cellulose; hypromellose; povidone; purified talc; lactose monohydrate; magnesium stearate; sodium chloride; titanium dioxide; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350

Pot uporabe:

Oral

Enote v paketu:

10, 30, 60, 100

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Quetiapine modified release tablets are indicated for:,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).

Povzetek izdelek:

Visual Identification: Peach coloured, round shaped, biconvex film coated tablets, debossed with 'Q50' on one side and plain on other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status dovoljenje:

Licence status A

Datum dovoljenje:

2016-04-08