ZYPREXA

Land: Indonesien

Sprog: indonesisk

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

Aktiv bestanddel:

OLANZAPINE

Tilgængelig fra:

PYRIDAM FARMA TBK - Indonesia

INN (International Name):

OLANZAPINE

Dosering:

5,00 MG

Lægemiddelform:

TABLET SALUT SELAPUT

Enheder i pakken:

DUS, 4 BLISTER @ 7 TABLET SALUT SELAPUT

Fremstillet af:

LILLY, S.A. - Spain

Autorisation dato:

2019-09-23

Produktets egenskaber

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