البلد: أرمينيا
اللغة: الإنجليزية
المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
clozapine
Arpimed LLC
N05AH02
clozapine
100mg
tablets
(40/4x10/) in blister, (50/5x10/) in blister
Prescription
Registered
2019-09-19
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 اقرأ الوثيقة كاملة