Azaleptine tablets

מדינה: ארמניה

שפה: אנגלית

מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

מרכיב פעיל:

clozapine

זמין מ:

Arpimed LLC

קוד ATC:

N05AH02

INN (שם בינלאומי):

clozapine

כמות:

100mg

טופס פרצבטיות:

tablets

יחידות באריזה:

(40/4x10/) in blister, (50/5x10/) in blister

סוג מרשם:

Prescription

מצב אישור:

Registered

תאריך אישור:

2019-09-19

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS AZALEPTINE 100 MG TABLETS
1.1 TRADE NAME OF THE MEDICINAL PRODUCT – Azaleptine
1.2 INTERNATIONAL NON-PROPERTY NAME - Clozapine
2. QUANTITATIVE AND QUALITATIVE COMPOSITION
Each Azaleptine, 100 mg tablet contains:
_ACTIVE INGREDIENT:_ clozapine – 100 mg;
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Yellow biconvex scored tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment-resistant schizophrenia
Clozapine is indicated in treatment-resistant schizophrenic patients
and in schizophrenia patients
who have severe, untreatable neurological adverse reactions to other
antipsychotic agents,
including atypical antipsychotics.
Treatment resistance is defined as a lack of satisfactory clinical
improvement despite the use of
adequate doses of at least two different antipsychotic agents,
including an atypical antipsychotic
agent, prescribed for adequate duration.
Psychosis during the course of Parkinson's disease
Clozapine is also indicated in psychotic disorders occurring during
the course of Parkinson's
disease, in cases where standard treatment has failed.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage must be adjusted individually. For each patient the lowest
effective dose should be
used. For doses not realisable/practicable with one strength, other
strengths of this medicinal
product are available. Cautious titration and a divided dosage
schedule are necessary to minimise
the risks of hypotension, seizure and sedation.
Initiation of clozapine treatment must be restricted to those patients
with a WBC count ≥
3500/mm
3
(3.5x10
9
/L) and an ANC ≥ 2000/mm
3
(2.0x10
9
/L) within standardised normal limits.
Dose adjustment is indicated in patients who are also receiving
medicinal products that have
pharmacodynamic and pharmacokinetic interactions with clozapine, such
as benzodiazepines or
selective serotonin re-uptake inhibitors (see section 4.5).
_Switching from a previous antipsychotic therapy to clozapine _
It is generally re