SEROQUEL XR

Land: Indonesië

Taal: Indonesisch

Bron: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Werkstoffen:

QUETIAPINE FUMARATE

Beschikbaar vanaf:

ASTRAZENECA INDONESIA - Indonesia

INN (Algemene Internationale Benaming):

QUETIAPINE FUMARATE

Dosering:

400 MG

farmaceutische vorm:

TABLET PELEPASAN LAMBAT

Eenheden in pakket:

DUS, 1 BLISTER @ 10 TABLET PELEPASAN LAMBAT

Geproduceerd door:

ASTRAZENECA PHARMACEUTICAL COMPANY LTD.

Autorisatie datum:

2018-08-01

Productkenmerken

1
SEROQUEL XR
™
50 MG, 150 MG, 200 MG, 300 MG AND 400 MG
_quetiapine fumarate _
EXTENDED-RELEASE TABLETS
QUALITATIVE AND QUANTITATIVE COMPOSITION
SEROQUEL XR 50
mg contains 50
mg quetiapine (as quetiapine fumarate).
SEROQUEL XR 150
mg contains 150
mg quetiapine (as quetiapine fumarate).
SEROQUEL XR 200
mg contains 200
mg quetiapine (as quetiapine fumarate).
SEROQUEL XR 300
mg contains 300
mg quetiapine (as quetiapine fumarate).
SEROQUEL XR 400
mg contains 400
mg quetiapine (as quetiapine fumarate).
For excipients, see _List of excipients._
PHARMACEUTICAL FORM
Extended-release tablet.
SEROQUEL XR 50
mg tablets are peach-coloured and engraved with
“
XR 50
”
on one side.
SEROQUEL XR 150 mg tablets are white and engraved with “XR 150” on
one side.
SEROQUEL XR 200
mg tablets are yellow and engraved with
“
XR 200
”
on one side.
SEROQUEL XR 300
mg tablets are pale yellow and engraved with
“
XR 300
”
on one side.
SEROQUEL XR 400
mg tablets are white and engraved with
“
XR 400
”
on one side.
THERAPEUTIC INDICATION
SEROQUEL XR is indicated for:
•
The acute and maintenance treatment of schizophrenia
•
Bipolar Disorder including:
o
manic episodes associated with bipolar I disorder
o
depressive episodes associated with bipolar disorder
•
Add-on treatment of major depressive episodes in patients with Major
Depressive
Disorder (MDD) who have had inadequate response after 6 weeks
treatment of
antidepressant monotherapy.
POSOLOGY AND METHOD OF ADMINISTRATION
Different dosing schedules exist for each indication. It must
therefore be ensured that
patients receive clear information on the appropriate dosage for their
condition. SEROQUEL
XR should be administered once daily, with or without food. The
tablets should be
swallowed whole and not split, chewed or crushed.
ADULTS:
FOR THE TREATMENT OF SCHIZOPHRENIA
The daily dose at the start of therapy is 300 mg on Day 1, 600 mg on
Day 2 and up to
800
mg after Day 2. The dose should be adjusted within the effective dose
range of 400 mg
to 800
mg per day, depend