Sulfasalazine-EN tablets gastro-resistant

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

sulfasalazine

Доступна с:

KRKA d.d.

код АТС:

A07EC01

ИНН (Международная Имя):

sulfasalazine

дозировка:

500mg

Фармацевтическая форма:

tablets gastro-resistant

Штук в упаковке:

(50/5x10/) in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2021-06-23

Характеристики продукта

PI_Text007209_1
– Updated:
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1.
NAME OF THE MEDICINAL PRODUCT
Sulfasalazin-EN 500 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 500 mg sulfasalazine.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
The tablets are:round, yellow to brownish-yellow, biconvex,
bevel-edged film coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sulfasalazin-EN is indicated for:
-
treatment of acute onsets and exacerbations of Crohn’s disease,
ulcerative colitis and proctitis,
-
maintenance of remission of ulcerative colitis and proctitis,
-
treatment of rheumatoid arthritis and juvenile idiopathic chronic
polyarthritis which have failed
to sufficiently respond to nonsteroidal anti-inflammatory drugs.
Sulfasalazin-EN can be combined with corticosteroids and metronidazole
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage should be adjusted according to the severity of the disease and
possible undesirable effects.
_Acute onset of ulcerative colitis and proctitis, and Crohn's disease_
Adults and children over 16 years of age should take 2 to 4 tablets (1
g to 2 g) 4 times a day.
Children over 2 years of age can be given 40 mg to 60 mg of the drug
per kg body weight a day.
With the induction of remission, the dose should be gradually reduced.
_Maintenance of remission of ulcerative colitis and proctitis_
The recommended maintenance dose for adults and children over 16 years
of age is 1 tablet (500 mg)
4 times a day.
Children over 2 years of age can be given 20 mg to 30 mg sulfasalazine
per kg body weight a day.
The duration of maintenance treatment is not limited.
_Rheumatoid arthritis and juvenile idiopathic chronic polyarthritis_
The recommended dose for adults and children over 16 years of age is 2
to 3 g a day. Treatment
should be started with 1 tablet (500 mg) of sulfasalazine a day. The
dose should be increased
gradually, at weekly intervals, so that after 4 weeks 2 tablets (1 g)
are