Држава: Израел
Језик: Енглески
Извор: Ministry of Health
ARIPIPRAZOLE
UNIPHARM LTD, ISRAEL
N05AX12
TABLETS
ARIPIPRAZOLE 5 MG
PER OS
Required
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL
ARIPIPRAZOLE
ARIPIPRAZOLE
Ariply is indicated for the treatment of schizophrenia, for the treatment of moderate to severe manic episodes in Bipolar I disorder and for the prevention of a new manic episode in patient who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Ariply is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Efficacy was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode.Ariply is indicated for the treatment of irritability associated with autistic disorder. Efficacy was established in two 8-week trials in pediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods).
2017-12-31
1215E SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT _ARIPLY 5 _ tablets _ARIPLY 10 _ tablets _ARIPLY 15 _ tablets _ARIPLY 30_ tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Aripiprazole _ARIPLY 5: Each tablet contains 5 mg of aripiprazole and excipient: 26 mg lactose _ _ARIPLY 10: Each tablet contains 10 mg of aripiprazole and excipient: 52 mg lactose _ _ARIPLY 15: Each tablet contains 15 mg of aripiprazole and excipient: 78 mg lactose _ _ARIPLY 30: Each tablet contains 30 mg of aripiprazole and excipient: 156 mg lactose _ _ _ _For a full list of excipients, see section 6.1. _ 3. DOSAGE FORM Film-coated tablets _ARIPLY_ are yellow, circular, biconvex, film-coated tablets. _ _ 4. CLINICAL DATA 4.1 THERAPEUTIC INDICATIONS _ARIPLY_ is indicated for the treatment of schizophrenia. _ _ _ARIPLY_ is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1). _ _ _ARIPLY_ 5, 10, 15 is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Efficacy was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode (see section 5.1). _ARIPLY_ 5, 10, 15 is indicated for the treatment of irritability associated with autistic disorder. Efficacy was established in two 8-week trials in pediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods) (see section 5.1). SPECIAL CONSIDERATIONS IN TREATING PEDIATRIC SCHIZOPHRENIA AND IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER Psychiatric disorders in children and adolescents are often serious mental disorders with variable symptom profiles that a Прочитајте комплетан документ