Arcoxia tablets film-coated

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

etoricoxib

Доступна с:

Merck Sharp & Dohme B.V. Waarderweg 39

код АТС:

M01AH05

ИНН (Международная Имя):

etoricoxib

дозировка:

60mg

Фармацевтическая форма:

tablets film-coated

Штук в упаковке:

(7/1x7/) in blister, (28/4x7/) in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2020-12-23

Характеристики продукта

2
SUMMARY OF PRODUCT CHARACTERISTICS
3
1.
NAME OF THE MEDICINAL PRODUCT
30 mg film-coated tablets
60 mg film-coated tablets
90 mg film-coated tablets
120 mg film-coated tablets
[To be completed nationally]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
Excipients with known effect:
30 mg tablet: 1.3 mg lactose (as monohydrate)
60 mg tablet: 2.7 mg lactose (as monohydrate)
90 mg tablet: 4.0 mg lactose (as monohydrate)
120 mg tablet: 5.3 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets (tablets).
30 mg tablets: Blue-green, apple-shaped biconvex tablets .
60 mg tablets: Dark green, apple-shaped, biconvex tablets .
90 mg tablets: White, apple-shaped, biconvex tablets .
120 mg tablets: Pale-green, apple-shaped, biconvex tablets .
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
is indicated in adults and adolescents 16 years of age and
older for the symptomatic relief
of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing
spondylitis, and the pain and signs of
inflammation associated with acute gouty arthritis.
is indicated in adults and adolescents 16 years of age and
older for the short-term treatment
of moderate pain associated with dental surgery.
The decision to prescribe a selective COX-2 inhibitor should be based
on an assessment of the individual
patient's overall risks (see sections 4.3, 4.4).
4
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
As the cardiovascular risks of etoricoxib may increase with dose and
duration of exposure, the shortest
duration possible and the lowest effective daily dose should be used.
The pat