País: Indonèsia
Idioma: indonesi
Font: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ESKETAMINE HYDROCHLORIDE
INTEGRATED HEALTHCARE INDONESIA - Indonesia
ESKETAMINE HYDROCHLORIDE
37.1 Mg
NASAL SPRAY
BOX, 1 BLISTER @ 1 PRE-FILLED NASAL SPRAY DEVICE
RENAISSANCE LAKEWOOD LLC - United States of America
2021-04-23
1. NAME OF THE MEDICINAL PRODUCT Spravato 28 mg nasal spray, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each nasal spray device contains esketamine hydrochloride corresponding to 28 mg esketamine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal spray, solution. Clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Spravato, in combination with a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin- Norepinephrine Reuptake Inhibitor (SNRI), is indicated for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode. Spravato is indicated, in conjunction with oral antidepressant therapy, for the rapid reduction of depressive symptoms in adult patients with Major Depressive Disorder who have acute suicidal ideation or behavior. The effectiveness of Spravato in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of Spravato does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of Spravato. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The decision to prescribe Spravato should be determined by a psychiatrist. Spravato is intended to be self-administered by the patient under the direct supervision of a healthcare professional. A treatment session consists of nasal administration of Spravato and a post-administration observation period. Both administration and post-administration observation of Spravato should be carried out in an appropriate clinical setting. Assessment before treatment Prior to dosing with Spravato blood pressure should be assessed. DISETUJUI OLEH BPOM : 28 APRIL 2022 EREG10037412100049 If baseline blood pressure is elevated the risks of short-term increases in blood pressure and benefit of Spravato treatment should be considered (see section 4.4). Spravato should not be a Llegiu el document complet