Seroquel XR Tablet 400mg

Negara: Singapura

Bahasa: Inggris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

Quetiapine fumarate 460.50mg eqv quetiapine

Tersedia dari:

LUYE PHARMA (SINGAPORE) PTE. LTD.

Kode ATC:

N05AH04

Dosis:

400 mg

Bentuk farmasi:

TABLET, EXTENDED RELEASE

Komposisi:

Quetiapine fumarate 460.50mg eqv quetiapine 400 mg

Rute administrasi :

ORAL

Jenis Resep:

Prescription Only

Diproduksi oleh:

AstraZeneca UK Limited (Manufacture, QC testing, packing, final release)

Status otorisasi:

ACTIVE

Tanggal Otorisasi:

2008-07-29

Selebaran informasi

1 
05/ AC/SG/CNS.000-201-556.7.0

SEROQUEL XR 
_QUETIAPINE FUMARATE _
EXTENDED RELEASE TABLETS 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
SEROQUEL XR 50mg: Each tablet contains quetiapine fumarate
delivering a dose of 50 mg 
of quetiapine free base. 
SEROQUEL
 XR 150
mg: Each tablet contains quetiapine fumarate delivering a dose of 150
mg 
of quetiapine free base.

SEROQUEL XR 200 mg: Each tablet contains quetiapine fumarate
delivering a dose of 200 
mg of quetiapine free base. 
SEROQUEL XR 300mg: Each tablet contains quetiapine fumarate
delivering a dose of 300 
mg of quetiapine free base. 
SEROQUEL XR 400 mg: Each tablet contains quetiapine fumarate
delivering a dose of 400 
mg of quetiapine free base. 
For Excipients see ‘_Pharmaceutical particulars’_. 

PHARMACEUTICAL FORM 
Film coated, extended release tablet. 
SEROQUEL XR 50 mg tablets are capsule-shaped, peach coloured
and engraved with “XR 
50” on one side. 
SEROQUEL XR 150 mg tablets are capsule-shaped, white coloured
and engraved with “XR 
150” on one side. 

SEROQUEL XR 200 mg tablets are capsule-shaped, yellow coloured
and engraved with “XR 
200” on one side. 
2 
SEROQUEL XR 300 mg tablets are capsule-shaped, pale yellow coloured
and engraved with 
“XR 300” on one side. 
SEROQUEL XR 400 mg tablets are capsule-shaped, white coloured
and engraved with “XR 
400” on one side. 
CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
SEROQUEL XR is indicated for the treatment of schizophrenia. 
SEROQUEL XR is effective in preventing relapse in stable
schizophrenic patients who have 
been maintained on SEROQUEL XR. 
SEROQUEL XR is indicated for bipolar disorder: 
-  manic episodes associated with bipolar I disorder 
-  depressive episodes associated with bipolar disorder 
-  preventing recurrence in maintenance treatment of bipolar
disorder (manic, mixed or 
depressive episode) as mon

Karakteristik produk

1
SEROQUEL XR
®
_QUETIAPINE FUMARATE _
EXTENDED RELEASE TABLETS
QUALITATIVE AND QUANTITATIVE COMPOSITION
SEROQUEL XR 50mg: Each tablet contains quetiapine fumarate delivering
a dose of 50 mg
of quetiapine free base.
SEROQUEL
XR 150 mg: Each tablet contains quetiapine fumarate delivering a dose
of 150 mg
of quetiapine free base.
SEROQUEL XR 200 mg: Each tablet contains quetiapine fumarate
delivering a dose of 200
mg of quetiapine free base.
SEROQUEL XR 300mg: Each tablet contains quetiapine fumarate delivering
a dose of 300
mg of quetiapine free base.
SEROQUEL XR 400 mg: Each tablet contains quetiapine fumarate
delivering a dose of 400
mg of quetiapine free base.
For Excipients see ‘_Pharmaceutical particulars’_.
PHARMACEUTICAL FORM
Film coated, extended release tablet.
SEROQUEL XR 50 mg tablets are capsule-shaped, peach coloured and
engraved with “XR
50” on one side.
SEROQUEL XR 150 mg tablets are capsule-shaped, white coloured and
engraved with “XR
150” on one side.
SEROQUEL XR 200 mg tablets are capsule-shaped, yellow coloured and
engraved with “XR
200” on one side.
SEROQUEL XR 300 mg tablets are capsule-shaped, pale yellow coloured
and engraved with
“XR 300” on one side.
SEROQUEL XR 400 mg tablets are capsule-shaped, white coloured and
engraved with “XR
400” on one side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
SEROQUEL XR is indicated for the treatment of schizophrenia.
SEROQUEL XR is effective in preventing relapse in stable schizophrenic
patients who have
been maintained on SEROQUEL XR.
SEROQUEL XR is indicated for bipolar disorder:
-
manic episodes associated with bipolar I disorder
-
depressive episodes associated with bipolar disorder
2
-
preventing recurrence in maintenance treatment of bipolar disorder
(manic, mixed or
depressive episode) as monotherapy or in combination with lithium or
valproate.
SEROQUEL XR is indicated for use as add-on treatment of major
depressive episodes in
patients with Major Depressive Disorder (MDD) who have had sub-optimal
response to
antidepress