País: Armènia
Idioma: anglès
Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
olanzapine
Arpimed LLC
olanzapine
10mg
tablets film-coated
Prescription
SUMMARY PRODUCT CHARACTERISTIC (SPC) OLANZAPINE 5 MG AND 10 MG COATED TABLETS 1.1 BRAND NAME – OLANZAPINE 1.2 INTERNATIONAL NON-PROPERTY NAME - OLANZAPINE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Olanzapine 5 mg coated tablet contains: _ACTIVE INGREDIENT:_ olanzapine_ _ - 5 mg _For a full list of excipients, see section 6.1. _ Each Olanzapine 10 mg coated tablet contains: _ACTIVE INGREDIENT:_ olanzapine_ _ - 10 mg _For a full list of excipients, see section 6.1. _ 3. PHARMACEUTICAL FORM _Olanzapine, 5 mg coated tablets _ White or white off biconvex film-coated tablets. _Olanzapine, 10 mg coated tablets _ White or white off biconvex film-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults_ Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day. Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1). Preventing recurrence in bipolar disorder: The recommended starting dose is 10 mg/day. For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose. If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated. During treatment for schizophrenia, manic episode, and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis Llegiu el document complet