Zoloft tablets film-coated

Страна: Вірменія

мова: англійська

Джерело: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активний інгредієнт:

sertraline (sertraline hydrochloride)

Доступна з:

Pfizer Manufacturing Deutschland GmbH

Код атс:

N06AB06

ІПН (Міжнародна Ім'я):

sertraline (sertraline hydrochloride)

Дозування:

50mg

Фармацевтична форма:

tablets film-coated

Одиниць в упаковці:

(28/2x14/) in blister

Тип рецепту:

Prescription

Статус Авторизація:

Registered

Дата Авторизація:

2022-03-01

Характеристики продукта

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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
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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