Šalis: Singapūras
kalba: anglų
Šaltinis: HSA (Health Sciences Authority)
QUETIAPINE FUMARATE EQV QUETIAPINE
LUYE PHARMA (SINGAPORE) PTE. LTD.
N05AH04
100 mg
TABLET, FILM COATED
QUETIAPINE FUMARATE EQV QUETIAPINE 100 mg
ORAL
Prescription Only
ASTRAZENECA UK LTD
ACTIVE
1998-05-16
Page 1 of 22 05/AC/SG/CNS.000-072-297.12.0 SEROQUEL TM _QUETIAPINE FUMARATE _ TRADEMARK PRESENTATION _25 mg tablet:_ round, 6 mm, peach coloured, biconvex, film-coated tablet containing quetiapine fumarate delivering a dose of 25 mg of quetiapine free base. _100 mg tablet:_ round,_ _8.5 mm, yellow coloured, biconvex, film-coated tablet containing quetiapine fumarate delivering a dose of 100 mg of quetiapine free base. _200 mg tablet:_ round, 11 mm, white, biconvex, film-coated tablet containing quetiapine fumarate delivering a dose of 200 mg of quetiapine free base. _300 mg tablet: _capsule shaped, 19 mm x 7.62 mm, white, film-coated tablet containing quetiapine fumarate delivering a dose of 300 mg of quetiapine free base. For excipients see ‘Pharmaceutical Particulars’. INDICATIONS_ _ SEROQUEL is indicated for the treatment of: schizophrenia. acute manic episodes associated with bipolar I disorder. depressive episodes associated with bipolar disorder. preventing recurrence in maintenance treatment of bipolar I disorder (manic, mixed or depressive episode) as monotherapy or in combination with lithium or valproate. POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS _ _FOR THE TREATMENT OF SCHIZOPHRENIA: _ SEROQUEL should be administered twice daily, with or without food. For the treatment of schizophrenia: the total daily dose for the first 4 days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300 to 450 mg/day. Depending on the clinical response and tolerability of the individual patient, the dose may be adjusted within the range 150 to 750 mg/day. Page 2 of 22 _ _ _FOR THE TREATMENT OF MANIC EPISODES ASSOCIATED WITH BIPOLAR DISORDER: _ _ Perskaitykite visą dokumentą
Page 1 of 22 SEROQUEL ® _QUETIAPINE FUMARATE _ PRESENTATION _25 mg tablet:_ round, 6 mm, peach coloured, biconvex, film-coated tablet containing quetiapine fumarate delivering a dose of 25 mg of quetiapine free base. _100 mg tablet:_ round,_ _8.5 mm, yellow coloured, biconvex, film-coated tablet containing quetiapine fumarate delivering a dose of 100 mg of quetiapine free base. _200 mg tablet:_ round, 11 mm, white, biconvex, film-coated tablet containing quetiapine fumarate delivering a dose of 200 mg of quetiapine free base. _300 mg tablet: _capsule shaped, 19 mm x 7.62 mm, white, film-coated tablet containing quetiapine fumarate delivering a dose of 300 mg of quetiapine free base. For excipients see ‘Pharmaceutical Particulars’. INDICATIONS_ _ SEROQUEL is indicated for the treatment of: schizophrenia. acute manic episodes associated with bipolar I disorder. depressive episodes associated with bipolar disorder. preventing recurrence in maintenance treatment of bipolar I disorder (manic, mixed or depressive episode) as monotherapy or in combination with lithium or valproate. POSOLOGY AND METHOD OF ADMINISTRATION ADULTS FOR THE TREATMENT OF SCHIZOPHRENIA: SEROQUEL should be administered twice daily, with or without food. For the treatment of schizophrenia: the total daily dose for the first 4 days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300 to 450 mg/day. Depending on the clinical response and tolerability of the individual patient, the dose may be adjusted within the range 150 to 750 mg/day. _ _ FOR THE TREATMENT OF MANIC EPISODES ASSOCIATED WITH BIPOLAR DISORDER: SEROQUEL should be administered twice daily, with or without food._ _ As monotherapy or as adjunct therapy to mood stabilizers, the total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800 mg per day by Day 6 Perskaitykite visą dokumentą