Zalasta tablets

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

olanzapine

Διαθέσιμο από:

KRKA Polska Sp. z o.o.

Φαρμακολογική κατηγορία (ATC):

N05AH03

INN (Διεθνής Όνομα):

olanzapine

Δοσολογία:

10mg

Φαρμακοτεχνική μορφή:

tablets

Μονάδες σε πακέτο:

(28/4x7/) in blister, (56/8x7/) in blister

Τρόπος διάθεσης:

Prescription

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2020-02-06

Αρχείο Π.Χ.Π.

1
1.
NAME OF THE MEDICINAL PRODUCT
Zalasta 5 mg tablets
Zalasta 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zalasta 5 mg tablets
Each tablet contains 5 mg olanzapine.
Zalasta 10 mg tablets
Each tablet contains 10 mg olanzapine.
Excipient with known effect
Zalasta 5 mg tablets
Each tablet contains 80.9 mg lactose.
Zalasta 10 mg tablets
Each tablet contains 161.8 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Zalasta 5 mg tablets
Tablets are round, slightly biconvex, slightly yellow tablets with
possible individual yellow spots
and an inscription “5”.
Zalasta 10 mg tablets
Tablets are round, slightly biconvex, slightly yellow tablets with
possible individual yellow spots
and an inscription “10”.
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
CONFIDENTIAL
Zalasta tablet 5 mg, 10 mg
MODULE 1
VOL: 1; P: 7 / 39
2
_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 cli