Olanzapine tablets film-coated

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

olanzapine

متاح من:

Arpimed LLC

ATC رمز:

N05AH03

INN (الاسم الدولي):

olanzapine

جرعة:

10mg

الشكل الصيدلاني:

tablets film-coated

الوحدات في الحزمة:

(30/3x10/) in blister

نوع الوصفة الطبية :

Prescription

الوضع إذن:

Registered

تاريخ الترخيص:

2023-03-21

خصائص المنتج

SUMMARY PRODUCT CHARACTERISTIC (SPC)
OLANZAPINE
5 MG AND 10 MG COATED TABLETS
1.1 BRAND NAME – OLANZAPINE
1.2 INTERNATIONAL NON-PROPERTY NAME - OLANZAPINE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Olanzapine 5 mg coated tablet contains:
_ACTIVE INGREDIENT:_ olanzapine_ _ - 5 mg
_For a full list of excipients, see section 6.1. _
Each Olanzapine 10 mg coated tablet contains:
_ACTIVE INGREDIENT:_ olanzapine_ _ - 10 mg
_For a full list of excipients, see section 6.1. _
3. PHARMACEUTICAL FORM
_Olanzapine, 5 mg coated tablets _
White or white off biconvex film-coated tablets.
_Olanzapine, 10 mg coated tablets _
White or white off biconvex film-coated tablets.
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
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 clinically indicated.
During treatment for schizophrenia, manic episode, and recurrence
prevention in bipolar disorder,
daily dosage may subsequently be adjusted on the basis