Ország: Indonézia
Nyelv: indonéz
Forrás: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
OLANZAPINE
PYRIDAM FARMA TBK - Indonesia
OLANZAPINE
10,00 MG
ORODISPERSIBLE TABLET
DUS, 4 BLISTER @ 7 ORODISPERSIBLE TABLET
CATALENT UK SWINDON ZYDIS LIMITED - United Kingdom
2021-04-21
Zyprexa Zydis_SAIL 4840 and 4965_leaflet for doctor-Proposed TC-V1 ZYPREXA ® ZYDIS ® OLANZAPINE 1. NAME OF THE MEDICINAL PRODUCT ZYPREXA ZYDIS 5 mg and 10 mg orodispersible tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 5 mg and 10 mg olanzapine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible Tablet ZYPREXA ZYDIS 5 mg and 10 mg orodispersible tablet is a yellow, round, freeze dried, rapid- dispersing preparation to be placed in the mouth or alternatively to be dispersed in water or other suitable beverage for administration. 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). 4.1.1 FURTHER INFORMATION ON CLINICAL TRIALS In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p=0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1). 4.2 POSOLOGY AND METH Olvassa el a teljes dokumentumot