Pays: Indonésie
Langue: indonésien
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
OLANZAPINE
PYRIDAM FARMA TBK - Indonesia
OLANZAPINE
5,00 MG
TABLET SALUT SELAPUT
DUS, 4 BLISTER @ 7 TABLET SALUT SELAPUT
LILLY, S.A. - Spain
2019-09-23
Zyprexa TAB_SAIL 4840 and 4965__leaflet for doctor_Proposed TC_V1 ZYPREXA ® OLANZAPINE 1. NAME OF THE MEDICINAL PRODUCT ZYPREXA 5 mg and 10 mg film coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 5 mg and 10 mg olanzapine. Excipient with known effect: Each coated tablet contains 156 mg and 312 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM ZYPREXA 5 mg Film Coated Tablets are round, white, film coated tablets imprinted with “LILLY” and numeric identicode “4115” ZYPREXA 10 mg Film Coated Tablets are round, white, film coated tablets imprinted with “LILLY” and numeric identicode “4117” 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Olanzapine is indicated for the acute and maintenance treatment of schizophrenia and other psychoses where positive symptoms (e.g., delusions, hallucinations, disordered thinking, hostility, and suspiciousness) and/or negative symptoms (e.g., flattened affect, emotional and social withdrawal, poverty of speech) are prominent. Olanzapine also alleviates the secondary affective symptoms commonly associated with schizophrenia and related disorders. Olanzapine is effective in maintaining the clinical improvement during continuing therapy in patients who have shown 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 and related disorder: 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 ma Lire le document complet