QUETIAPINE-ZP XR quetiapine (as fumarate) 200mg modified release tablets blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

quetiapine fumarate, Quantity: 230.3 mg (Equivalent: quetiapine, Qty 200 mg)

Disponível em:

Medis Pharma Pty Ltd

DCI (Denominação Comum Internacional):

Quetiapine fumarate

Forma farmacêutica:

Tablet, modified release

Composição:

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

Via de administração:

Oral

Unidades em pacote:

10, 30, 60, 100

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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).

Resumo do produto:

Visual Identification: Yellow coloured, round shaped, biconvex film coated tablets, debossed with 'I2' 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 de autorização:

Licence status A

Data de autorização:

2016-03-21