QUETIAPINE XR GXP quetiapine (as fumarate) 200mg modified release tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

quetiapine fumarate, Quantity: 230.26 mg (Equivalent: quetiapine, Qty 200 mg)

제공처:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Quetiapine fumarate

약제 형태:

Tablet, modified release

구성:

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

관리 경로:

Oral

패키지 단위:

60

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

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.

제품 요약:

Visual Identification: Yellow, 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

승인 상태:

Licence status A

승인 날짜:

2014-01-17