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

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

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

Disponible depuis:

Medis Pharma Pty Ltd

DCI (Dénomination commune internationale):

Quetiapine fumarate

forme pharmaceutique:

Tablet, modified release

Composition:

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

Mode d'administration:

Oral

Unités en paquet:

10, 30, 60, 100

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

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).

Descriptif du produit:

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

Statut de autorisation:

Licence status A

Date de l'autorisation:

2016-03-21