Country: Арменија
Језик: Енглески
Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
olanzapine
KRKA Polska Sp. z o.o.
N05AH03
olanzapine
5mg
tablets
(28/4x7/) in blister, (56/8x7/) in blister
Prescription
Registered
2020-02-06
1 1. NAME OF THE MEDICINAL PRODUCT Zalasta 5 mg tablets Zalasta 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Zalasta 5 mg tablets Each tablet contains 5 mg olanzapine. Zalasta 10 mg tablets Each tablet contains 10 mg olanzapine. Excipient with known effect Zalasta 5 mg tablets Each tablet contains 80.9 mg lactose. Zalasta 10 mg tablets Each tablet contains 161.8 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Zalasta 5 mg tablets Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “5”. Zalasta 10 mg tablets Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “10”. 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 CONFIDENTIAL Zalasta tablet 5 mg, 10 mg MODULE 1 VOL: 1; P: 7 / 39 2 _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 cli Прочитајте комплетан документ