Zoloft tablets film-coated

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

sertraline (sertraline hydrochloride)

Доступна с:

Pfizer Manufacturing Deutschland GmbH

код АТС:

N06AB06

ИНН (Международная Имя):

sertraline (sertraline hydrochloride)

дозировка:

50mg

Фармацевтическая форма:

tablets film-coated

Штук в упаковке:

(28/2x14/) in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2023-11-25

Характеристики продукта

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((Viatris Logo))
Zoloft
®
50/100 mg, film-coated tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zoloft
®
50 mg, film-coated tablets
Zoloft
®
100 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.
_Zoloft 100 mg, film-coated tablets _
1 film-coated tablet contains sertraline hydrochloride equivalent to
100 mg sertraline.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
_Zoloft 50 mg, film-coated tablets _
Zoloft 50 mg film-coated tablets are white, oblong film-coated tablets
(10.3 x 4.2 mm) with a
score line and “Pfizer” embossed on one side and “ZLT 50” on
the other. The tablets can be
divided into equal doses.
_Zoloft 100 mg, film-coated tablets _
Zoloft 100 mg film-coated tablets are white, oblong film-coated
tablets (13.1 x 5 2 mm) with
“Pfizer” embossed on one side and “ZLT 100” on the other.
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 _
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29.03.2023
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 disord