Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
sertraline (sertraline hydrochloride)
Pfizer Manufacturing Deutschland GmbH
N06AB06
sertraline (sertraline hydrochloride)
50mg
tablets film-coated
(28/2x14/) in blister
Prescription
Registered
2022-03-01
spcde-1v37zo-ft-0 1 19.03.2021 PFIZER ((Logo)) Zoloft® 50, film-coated tablets SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Zoloft ® 50 mg, film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Zoloft 50 mg, film-coated tablets _ 1 film-coated tablet contains sertraline hydrochloride equivalent to 50 mg sertraline. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 50mg Film coated tablets: white, oval, biconvex, film-coated scored tablets, debossed with "Pfizer" on one side and "ZLT-50" on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sertraline is indicated for the treatment of: - Major depressive episodes. Prevention of recurrence of major depressive episodes. - Panic disorder, with or without agoraphobia. - Obsessive-compulsive disorder (OCD) in adults and paediatric patients aged 6- 17 years. - Social anxiety disorder. - Post-traumatic stress disorder (PTSD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Initial treatment _ _ _ _Depression and obsessive-compulsive disorder _ Sertraline treatment should be started at a dose of 50 mg/day. _ _ _Panic disorder, PTSD, and social anxiety disorder _ Therapy should be initiated at 25 mg/day. After one week, the dose should be increased to 50 mg once daily. This dosage regimen has been shown to reduce the frequency of early treatment emergent side effects characteristic of panic disorder. _Titration _ _ _ _Depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder and _ _PTSD _ spcde-1v37zo-ft-0 2 19.03.2021 Patients not responding to a 50 mg dose may benefit from dose increases. Dose changes should be made in steps of 50 mg at intervals of at least one week, up to a maximum of 200 mg/day. Changes in dose should not be made more frequently than once per week given the 24-hour elimination half-life of sertraline. The onset of therapeutic effect may be seen within 7 days. However, longer periods are usually necessary to demonstrate therapeutic response, especia Прочитать полный документ