ZYPREXA ZYDIS

Country: Ինդոնեզիա

language: ինդոնեզերեն

source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

active_ingredient:

OLANZAPINE

MAH:

PYRIDAM FARMA TBK - Indonesia

INN:

OLANZAPINE

dosage:

5,00 MG

pharmaceutical_form:

ORODISPERSIBLE TABLET

units_in_package:

DUS, 4 BLISTER @ 7 ORODISPERSIBLE TABLET

manufactured_by:

CATALENT UK SWINDON ZYDIS LIMITED - United Kingdom

authorization_date:

2021-04-20

SPC

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