Țară: Armenia
Limbă: engleză
Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
risperidone
Arpimed LLC
N05AX08
risperidone
2mg
tablets coated
(30/3x10/) in blister
Prescription
Registered
2022-05-12
SUMMARY OF PRODUCT CHARACTERISTICS RISPERIDONE 2 MG COATED TABLETS 1.1 NAME OF THE MEDICAL PRODUCT - RISPERIDONE 1.2 INTERNATIONAL NON-PROPERTY NAME - RISPERIDONE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains 2 mg of risperidone For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablets. Oval biconvex, coated one-sided scored light green tablets; odorless. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Risperidone is indicated for the treatment of schizophrenia. Risperodone is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders. Risperidone is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer's dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others. Risperidone is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment. Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and educational intervention. It is recommended that risperidone be prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the treatment of conduct disorder of children and adolescents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Schizophrenia _Adults_ Risperidone may be given once daily or twice daily. Patients should start with 2 mg/day risperidone. The dosage may be increased on the second day to 4 mg. Subsequently, the dosage can be maintained unchanged, or further individualised, if needed. Most patients will benefit from daily doses between 4 and 6 mg. In some patients, a s Citiți documentul complet