Երկիր: Ինդոնեզիա
Լեզու: ինդոնեզերեն
Աղբյուրը: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 1 PREFILLED DUAL CHAMBER SYRINGE
2022-11-13
ABI-PI-0819-001.01 1 ABILIFY MAINTENA ® (ARIPIPRAZOLE) FULL PRESCRIBING INFORMATION _WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH _ _DEMENTIA-RELATED PSYCHOSIS_ ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. ABILIFY MAINTENA IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS _[SEE _ _WARNINGS _ _AND _ _PRECAUTIONS (5.1)]._ 1 INDICATIONS AND USAGE ABILIFY MAINTENA (aripiprazole) is indicated for : • Treatment of schizophrenia in adults _[see Clinical Studies (14.1)]_ • Maintenance monotherapy treatment of bipolar I disorder in adults _[see Clinical _ _Studies (14.2)]._ 2 DOSAGE AND ADMINISTRATION 2.1 DOSAGE OVERVIEW FOR THE TREATMENT OF SCHIZOPHRENIA AND MAINTENANCE MONOTHERAPY OF BIPOLAR I DISORDER ABILIFY MAINTENA is only to be administered by intramuscular injection by a healthcare professional. The recommended starting and maintenance dose of ABILIFY MAINTENA is 400 mg monthly (no sooner than 26 days after the previous injection). For patients who have never taken aripiprazole, establish tolerability with oral aripiprazo- le prior to initiating treatment with ABILIFY MAINTENA. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability. After the first ABILIFY MAINTENA injection, administer oral aripiprazole (10 mg to 20 mg) for 14 consecutive days to achieve therapeutic aripiprazole concentrations during initiation of therapy. For patients already stable on another oral antipsychotic (and known to tolerate aripiprazole), after the first ABILIFY MAINTENA injection, continue treatment with the antipsychotic for 14 consecutive days to maintain therapeutic antipsychotic concentrations during initiation of therapy. If there are adverse reactions with the 400 mg dosage, consider reducing the dosage to 300 mg once monthly. DISETUJUI OLEH BPOM: 07/09/2021 EREG10021412100093 EREG10021412100094 ABI-PI-0819-001.01 2 2.2 DOSAGE ADJUSTMENTS FOR MISSED DOSES If the second or t Կարդացեք ամբողջական փաստաթուղթը