Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
SERTINDOLE
LUNDBECK ISRAEL LTD.
N05AE03
FILM COATED TABLETS
SERTINDOLE 4 MG
PER OS
Required
H. LUNDBECK A/S, DENMARK
SERTINDOLE
SERTINDOLE
For the treatment of schizophrenia. Due to cardiovascular safety concerns serntidole should only be used for patients intolerant to at least one other anti-psychotic agent. Sertindole should not be used in emergency situations for urgent relief of symptoms in acutely disturbed patients.
2022-09-30
[לוגו מדינת ישראל] [http://www.gov.il/] [http://www.gov.il/] [לוגו משרד הבריאות] [לוגו משרד הבריאות] [*5400] [http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx] [http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx] הציבור הרחב עסקים ומוסדות עובדים בבריאות חפש מידע תפריט * [סגירה] סגור * דף הבית [http://www.health.gov.il/] * אודות * אודות המשרד [http://www.health.gov.il/About/Pages/about_us.aspx] * תוכנית עבודה [http://www.health.gov.il/About/Pages/Agenda.aspx] * תקציב המשרד [http://www.health.gov.il/About/Pages/budget.aspx] * תרשים מבנה ארגוני [http://www.health.gov.il/About/Pages/OrganizationalStructureDiagram.aspx] * בעלי תפקידים [http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx] * יחידות המשרד [http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] * לשכות הבריאות [http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx?tab=3] * אמנת שירות [http://www.health.gov.il/About/sla/Pages/default.aspx] * אותות ופרסים [http://www.health.gov.il/About/Awards/Pages/mifal.aspx] * פרוייקטים תשתיתיים [http://www.health.gov.il/About/projects/shared_medical_info/Pages/default.aspx] * דרושים [http://www.health.gov.il/About/Careers/Pages/default.aspx] * מנכ"לי משרד הבריאות לדורותיהם [http://www.health.gov.il/About/Pages/GeneralManegerHistory.aspx] * יחידות המשרד * יחידות המשרד [http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] * לשכות הבריאות [http://www.health.gov.il/UnitsOffice/LB/Pages/default.aspx] * וועדות ומועצות [http://www.health.gov.il/Services/Committee/Pages/CommitteeList.aspx] * נושאים * בריאות הנפש [http://www.health.gov.il/Subjects/mental_health/Pages/default.aspx] * בריאות הסביבה [http://www.health.gov.il/Subjects/Environmental_Health/ Baca dokumen lengkapnya
קנ הז ןולע טמרופ ב רשואו קדבנ ונכותו תואירבה דרשמ י"ע ע ינויב 2015 PRISCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT SERDOLECT 4MG SERDOLECT 16MG 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 4 mg tablet contains: sertindole 4 mg Each 16 mg tablet contains: sertindole 16 mg Excipients: Each 4 mg film-coated tablet contains 60.78 mg lactose monohydrate. Each 16 mg film-coated tablet contains 95.08 mg lactose monohydrate. See section 4.4. For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Description of the tablets: 4 mg: Oval, yellow, biconvex film-coated tablets marked with “S4” on one side. 16 mg: Oval, rose, biconvex film-coated tablets marked with “S16” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sertindole is indicated for the treatment of schizophrenia. Due to cardiovascular safety concerns, sertindole should only be used for patients intolerant to at least one other antipsychotic agent. Sertindole should not be used in emergency situations for urgent relief of symptoms in acutely disturbed patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Sertindole is administered orally once daily with or without meals. In patients where sedation is required, a benzodiazepine may be co-administered. Page 1 of 12 Titration All patients should be started on sertindole 4 mg/day. The dose should be increased by increments of 4 mg after 4-5 days on each dose until the optimal daily maintenance dose, within the range of 12-20 mg, is reached. Due to the α 1 -blocking activity of sertindole, symptoms of postural hypotension may occur during the initial dose-titration period. A starting dose of 8 mg or a rapid increase in dose carries a significantly increased risk of postural hypotension. Maintenance Dependent on individual patient response, the dose may be increased to 20mg/day. Only in exceptional cases should the maximum dose of 24 mg be considered, as clinical trials have not demonstrated consisten Baca dokumen lengkapnya