Valsts: Singapūra
Valoda: angļu
Klimata pārmaiņas: HSA (Health Sciences Authority)
Quetiapine 25 mg (as 28.78 mg quetiapine fumarate)
SANDOZ SINGAPORE PTE. LTD.
N05AH04
25 mg
TABLET, FILM COATED
Quetiapine 25 mg (as 28.78 mg quetiapine fumarate) 25 mg
ORAL
Prescription Only
Genveon Ilac Sanayi ve Ticaret A.S.
ACTIVE
2010-07-26
QUETIAPINE SANDOZ 25 MG AND 100 MG TABLETS Page 1 of 16 1. NAME OF THE MEDICINAL PRODUCT Quetiapine Sandoz 25 mg Tablets. Quetiapine Sandoz 100 mg Tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Quetiapine Sandoz 25 mg Tablets Each film-coated tablet contains 25 mg quetiapine (as 28.78 mg quetiapine fumarate). Quetiapine Sandoz 100 mg Tablets Each film-coated tablet contains 100 mg quetiapine (as 115.13 mg quetiapine fumarate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Quetiapine Sandoz 25 mg Tablets Salmon-pink coloured, round film-coated tablet. Quetiapine Sandoz 100 mg Tablets Yellow, round (8.8 mm diameter) film-coated tablet, with a breaking notch on one side. The tablet can be divided into equal quarters. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of schizophrenia. • Treatment of acute manic episodes associated with bipolar I disorder. • Treatment of 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Quetiapine should be administered with or without food. ADULTS _FOR THE TREATMENT OF SCHIZOPHRENIA: _ Quetiapine should be administered twice daily, with or without food. The total daily dose for the first 4 days of therapy is 50 mg Quetiapine (Day 1), 100 mg Quetiapine (Day 2), 200 mg Quetiapine (Day 3) and 300 mg Quetiapine (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300 to 450 mg Quetiapine per day. Depending on the clinical response and tolerability of the individual patient, the dose may be adjusted within the range of 150 to 750 mg Quetiapine per day. _FOR THE TREATMENT OF MANIC EPISODES ASSOCIATED WITH BIPOLAR DISORDER: _ Quetiapine should be administered twice daily, with or without food. As monotherapy or as adjunct therapy to mood stabilizers, the total daily Izlasiet visu dokumentu