Riik: Singapur
keel: inglise
Allikas: HSA (Health Sciences Authority)
Quetiapine fumarate 57.56mg eqv quetiapine
LUYE PHARMA (SINGAPORE) PTE. LTD.
N05AH04
50 mg
TABLET, EXTENDED RELEASE
Quetiapine fumarate 57.56mg eqv quetiapine 50 mg
ORAL
Prescription Only
AstraZeneca UK Limited (Manufacture, QC testing, packing, final release)
ACTIVE
2008-07-29
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 Lugege kogu dokumenti
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 Lugege kogu dokumenti